The editors and crew at SBM have an announcement that needs to be made. This morning, Dr. Amy Tuteur tendered her resignation and will therefore no longer be a blogger at SBM. Some of you might already be aware of this development because Dr. Tuteur has already announced her decision on her own blog. That is why we considered it important to post an announcement here on SBM as soon as possible.

While we are sorry to see Dr. Tuteur go and wish her well in whatever future endeavors she decides to pursue, over the last several weeks it had become clear to both the editors of SBM and Dr. Tuteur herself that, although Dr. Tuteur had routinely been able to stimulate an unprecedented level of discussion regarding the issues we at SBM consider important, SBM has not been a good fit for her and she has not been a good fit for SBM. Over the last few days mutual efforts between the editors and Dr. Tuteur to resolve our differences came to an impasse. Unfortunately for all parties, that impasse appeared to be unresolvable and resulted in Dr. Tuteur’s decision to leave SBM.

As a result of Dr. Tuteur’s departure, we will be adjusting the posting schedule in order to cover her normal Thursday slot. Final decisions have not been made yet, but we expect that every weekday will continue to be covered, with at least one post per weekday. 

When I first heard that a retrovirus had been identified as a possible cause of chronic fatigue syndrome, I withheld judgment and awaited further developments. When I heard that two subsequent studies had failed to replicate the findings of the first, I assumed that the first had been a false alarm and would be disregarded. Not so.

 It’s a classic case of wishful thinking outweighing good judgment. One unconfirmed report of an association between the XMRV virus and chronic fatigue syndrome (CFS) resulted in a rush to test for the virus, speculation about possible implications, and even suggestions for treatment. And the subsequent negative studies did little or nothing to reverse the trend. 

XMRV is Xenotropic murine leukemia virus-related virus. In the past, there were reports that this retrovirus was associated with prostate cancer, but then other reports found no link. In 2009 a study was published in Science, “Detection of an Infectious Retrovirus, XMRV, in Blood Cells of Patients with Chronic Fatigue Syndrome” by Lombardi et al., reporting an association with CFS:

we identified DNA from a human gammaretrovirus, xenotropic murine leukemia virus–related virus (XMRV), in 68 of 101 patients (67%) as compared to 8 of 218 (3.7%) healthy controls.

Later, the researchers reported that up to 95% of CFS patients test positive with antibody testing. The study did not prove a causal relationship. The authors suggest that the retrovirus may reactivate other viruses, such as herpes viruses (the opposite is also possible). There could be many different viruses behind CFS/ME. And it could be that XMRV is an incidental finding secondary to the immune dysfunction  in CFS/ME. Two subsequent studies in the UK, here and here, also looked for the virus in CFS patients but both failed to find it.  

CFS is still a controversial diagnosis. Some observers have implicated psychological factors and somatization. Sufferers are on the defensive, wanting to validate CFS as a real physical entity. The finding of a virus was just what they were hoping for. They want to believe in it, and their emotions have clouded their judgment.

A battle has erupted between retrovirus believers and non-believers, each side attacking the other’s research and accusing them of bias. Some of the criticisms are based on virological laboratory procedural details that I am not competent to judge. Some of the other criticisms are about things I can understand.

The Science study came out of the The Whittemore-Peterson Institute. This institute was founded by a couple (the Whittemores) whose daughter had CFS and who was treated by Dr. Peterson with an experimental antiviral drug.   They are clearly biased towards finding a viral etiology. The researchers in the UK were similarly accused of bias towards finding a psychological etiology. Accusations of bias may be credible but don’t necessarily mean that the bias contaminated the results. Another criticism is less credible: the UK studies used a different set of criteria for diagnosing CFS.  Even if you think that some of the UK subjects didn’t qualify as having CFS, if even a few of them had CFS and the virus was really associated with it, the virus should have shown up in at least a few subjects. Critics have tried to rationalize away the negative findings in the UK by suggesting that the virus occurs regionally and is absent in the UK; but then if the virus were the cause of CFS, there wouldn’t be any CFS in the UK. 

So far we have one study for and two against the association of XMRV with CFS. More studies are underway that should settle the debate. If the virus is there, it will be found by other labs and a consensus will eventually develop as to whether there is an association. If an association is confirmed, there will still need to be further research to determine what the association means and whether there is a causal relationship. The logical response is to stay tuned, not to leap prematurely into testing and treatment.

Tests are already commercially available. One is offered by VIP Diagnostics, a company owned by the Whittemore family. It costs $450 and uses the same methods as were reported in the Science article. The website discloses that the tests have not been approved by FDA for diagnostic purposes and that medical expertise is required for test interpretation. The lab pays a royalty to the Whittemore-Peterson Institute for each test it performs.

In his Nov. 3, 2009 Lyndonville Times newsletter, Dr. David Bell offered this cogent advice:

I am reluctant to suggest to anyone that they spend big bucks for a commercial test now. We do not know if a particular test is accurate, and even if it is accurate we do not know what it means, and even if we did know what it meant we would not know what to do with it.

 That pretty much says it all. Nevertheless, patients are flocking to be tested. If they test positive, they can feel vindicated. If they test negative, they can rationalize that they may actually be positive but have a viral load too small to be picked up on the test at the moment; they might even rationalize that they are better off than if the test had shown a larger viral load. Win/win. 

 Antiretroviral treatments are already being proposed by some doctors. Most proposals are based on the drugs used for HIV/AIDS, on the assumption that antiretroviral AIDS drugs would be equally effective for the XMRV retrovirus. But that might well be a false assumption, and these are powerful drugs with worrisome side effects, not the sort of thing that you would want to try “just in case.”

Other concerns have been raised by the CFS community. Is XMRV sexually transmitted like HIV/AIDS? If you have chronic fatigue syndrome or another XMRV-related condition, should you take special precautions with your sexual partners, even if you’re in a committed relationship? Should you opt for not breastfeeding your children? Should you not even have children? 

I can understand the desperation of these patients. I can understand their need to believe anything that would validate their suffering. I can understand their motivation to try anything that might bring them relief. But I don’t want to see people wasting money on useless tests, I don’t want to see mothers unnecessarily worrying about whether it is safe to breastfeed their children, and I don’t want to see people suffering side effects from drugs they don’t need. A cautious wait-and-see approach is dictated by common sense and by an understanding of how often initial scientific research findings turn out not to be true. Like remarriage after divorce, the overblown enthusiasm for the XMRV/CFS connection is a triumph of hope over experience.

The news is finally filtering out to the rest of the world.

As Steve Novella and my good buddy pointed out a few days ago (and as Steve pointed out in an interview on NPR), Dr. Steven Laureys admitted that Rom Houben, the unfortunate victim of a car crash that left him in what had been diagnosed as a persistent vegetative state, was in fact not able to communicate through the woo known as facilitated communication. This came as no surprise to anyone who has followed FC over the years. In fact, what had come as a surprise is that Dr. Laureys could have been so easily taken in by pseudoscience that had been so thoroughly debunked in the 1990s. To his credit, though, after a period of initially stubbornly defending FC, he relented and allowed objective testing, and the result was predictable. It took a few days, but the English language world is learning of the failure of FC in Houben’s case:

The sceptics said it was impossible – and it was. The story of Rom Houben of Belgium, which made headlines worldwide last November when he was shown to be “talking”, was today revealed to have been nothing of the sort.

Dr Steven Laureys, one of the doctors treating him, acknowledged that his patient could not make himself understood after all. Facilitated communication, the technique said to have made Houben’s apparent contact with the outside world possible, did not work, Laureys declared.

“We did not have all the facts before,” he said. “To me, it’s enough to say that this method doesn’t work.” Just three months ago the doctor was proclaiming that Houben had been trapped in his own body, the victim of a horrendous misdiagnosis, and only rescued from his terrible plight thanks to medical advances.

What was not reported is that skeptics were involved in the testing of Rom Houben. I recently received a statement from the Belgian Skeptics (SKEPP):

At the request of the medical institution where Mr Houben is cared for, on February 4 2010 SKEPP was present as advisor for a planned test of this controversial method of communication, and we also conducted our own tests. From the staff of the institute we learned that during two years all attempts to establish any form of communication with the patient by detecting and coding minute movements of the eyes or any other body part had failed. With FC he now seemed to produce correct words and elaborate sentences. Indeed, his answers to our simple test questions were intelligible and sometimes elaborate, but when the facilitator did not know the questions, his answers were all completely wrong. Most of the time he typed with his eyes closed, but as soon as the keyboard was shielded from the facilitator’s view the typing produced gibberish and halted. There clearly was no communication with the patient, only with the facilitator. We wonder what world-shaking news there would have been to communicate if it hadn’t been for the spectacular answers the facilitator produced.

Our intent was to not to test Mr Houben, but to test FC, and once more we demonstrated that the method is a sham. This is not to deny that Mr Houben may have some limited consciousness. If so, how frustrating must it be for him to hear all the bogus messages being produced in his name, without any possibility to protest ? After our test we had a long conversation with Dr. Laureys. He insisted that we test more facilitators before drawing conclusions. We declined and advised him to clearly distance himself from the FC scam, which he has done today. Out of respect and to allow them time to discuss the results with the family and the dedicated staff, we agreed on a 2 weeks embargo before making the results of our test public. Of course, not everyone is convinced yet. In a phone conversation today Mr Houben’s mother told us that she still believes in FC, because “sometimes it had produced answers that only her son could have known”. She is convinced that Dr. Laureys will ultimately find a method to communicate with her son. His team is experimenting with other methods. Let’s hope her wish comes true.

Indeed.

I want to emphasize once again that those of us who blasted FC in the wake of this case said nothing about whether Mr. Houben is conscious or not. We merely pointed out that FC is a long-discredited sham and, from evidence of videos available on the Internet, clearly could not be a mechanism by which Houben communicated if he in fact has consciousness. I and others have also pointed out that it’s horrible enough to be conscious and trapped in a motionless, useless shell, but imagine how much more horrible it would be to be conscious, trapped in a motionless shell, and having the only hope for communication with the outside world coopted by a facilitator.

In any case, props to SKEPP. They done good. Real good. Now let’s hope that, if Houben is conscious, Dr. Laureys, chastened by this experience, will find a way to communicate with Houben that isn’t based on the ideomotor effect and wishful thinking.

This week on Science-Based Medicine I wrote an article about a new study looking at the onset of autism symptoms, showing that most children who will later be diagnosed with autism will show clear signs of autism at 12 months of age, but not 6 months. This is an interesting study that sheds light on the natural course of autism. I also discussed the implications of this study for the claim that autism is caused by vaccines.

Unfortunately, I made a statement that is simply wrong. I wrote:

Many children are diagnosed between the age of 2 and 3, during the height of the childhood vaccine schedule.

First, this was a vague statement – not quantitative, and was sloppily written, giving a different impression from the one I intended. I make these kinds of errors from time to time – that is one of the perils of daily blogging about technical topics, and posting blogs without editorial or peer-review. Most blog readers understand this, and typically I will simply clarify my prose or correct mistakes when they are pointed out.

However, since I often write about topics that interest dedicated ideologues who seek to sow anti-science and confusion, sometimes these errors open the door for the flame warriors. That is what happened in this case.

J.B. Handley, writing at Age of Autism, saw my error as a way to demonize me before his enthralled mobs – and he dives into his task with gusto – although without much care or attention to detail himself, as we will see. Handley also is clearly not interested in what the science actually says, only in grabbing a propaganda opportunity.

First, to clarify the facts, here is the childhood vaccine schedule from the CDC. As we can see, the majority of vaccines are given prior to the age of 2, many in fact at or before 12 months. While “height” is a vague term, it is certainly inaccurate in this case. Before I explore this issue further, however, let me address the other factual claim made in that statement.

I wrote that “many children are diagnosed between the ages of 2 and 3. About this statement Handley writes:

Firstly, the last time I checked, the average age of diagnosis for a child with autism was somewhere between 3-4 years of age, not 2-3.

In fact, the average age of diagnosis is 3.1 years (although to be fair other studies give the average at 3.6  – there is some regional variation).  This is “somewhere between 3-4 years of age” but Handley’s point is still incorrect. I did not write that the average age was between 2 and 3 but that many children are diagnosed between 2 and 3, which is certainly true if the average age at diagnosis is 3.1. In his exuberance, Handley simply got this wrong.

I don’t expect him to make a correction, however. The last time he attacked me, he make a rather amateurish mistake, confusing incidence and prevalence, and used his error as the basis of his criticism. He never admitted or commented in any way on his gross error.

But onto the substance of his latest attack. The point that I was trying to make, which I did in fact clarify later in my post, is that when parents attempt to date the onset of their child’s autism they typically will date the onset later than the true onset. As we now know, from multiple studies, true clinical onset (biological onset is likely earlier) is between 6 and 12 months. Parents may not notice this onset until much later, and formal diagnosis is later still. This diagnosis happens within the childhood vaccination schedule, so it is likely that parents will have some recent vaccine to point to when looking for factors that seem to correlate with the onset of autism.

That was my point – a point that I and many others have made previously. By pushing earlier the true clinical onset of autism this study adds to evidence against the involvement of later vaccines. It is true that many vaccine are given in the first year of life, and of course this study by itself does not let all vaccines off the hook – nor did I say that it does.

But I did discuss one vaccine in particular – the MMR vaccine. MMR has received more attention than any other vaccine as a potential cause of autism, thanks to the now-discredited work of Andrew Wakefield. The first dose of MMR is given at a minimum of 12 months of age, with the second dose being given between 4 and 6 years. Certainly this study is relevant to the claim that MMR is a significant cause of autism

There is much evidence to support the conclusion that there is no correlation between MMR and autism. It should be obvious that this study is further evidence against a correlation. If most children with autism show signs by 12 months, then a vaccine which is not given prior to 12 months cannot be to blame. This was not obvious to Handley, however. He wrote:

In fact, between the ages of 2 and 3, children receive all of 2 vaccines, accounting for 5.5% of the vaccines they receive, while a full 70%, including MMR, come in their first 12 months of life, perfectly matching the time when this new study reported the beginning of a regression into autism!

Wrong, Handley. The MMR does not come “in their first 12 months of life.” At the very earliest it comes AT 12 months, which obviously cannot be responsible for symptoms that are present by 12 months. Maybe Handley was just sloppy in his choice of words (but it is odd that he went out of his way to mention MMR by name). Or maybe he is guilty of all the things of which he falsely accused me. This is certainly the same kind of error I made, although more specific. My error was inadvertent and I have readily admitted my mistake and am taking great pains to correct it. Let’s see how Handley responds when this error is pointed out to him.

The bottom line is that this study does in fact add to the body of evidence against an association between MMR and autism, because of the timing of the onset of autism.

Handley also takes exception to my point that parents may not accurately observe and remember when the onset of their child’s symptoms were. He makes one obvious point – that onset is not a moment in time but a process. I agree – but never implied otherwise. But even for diseases and disorders of insidious onset, there usually is a relatively brief period of time when the patient or family member really notices it – and that is when they date the onset.

I have the experience of actually seeing and diagnosing patients, reviewing their histories and comparing them to documented evidence in some cases. So I, like other experienced clinicians, understand this phenomenon well. For example, I see many patients with dementia, like Alzheimer’s disease, and they or their family will often date the onset of symptoms at a point in time some months prior to presentation, often anchored to a specific event (a phenomenon actually known as “anchoring”). But when I probe for specific details, it is apparent that there were signs of dementia for 1-2 years prior to the family’s dating of the onset. Or, I may have the benefit of a documented exam or history, clearly showing onset prior to the memory of those giving the history.

Handley seems naive to all of this, and rather he is content to grossly mischaracterize my point as calling parents “dumb,” which, of course, I never did. This is because Handley’s purpose, in my opinion, is not to meaningfully explore the evidence, but to demonize scientists and physicians with whom he disagrees. Read the comments to his blog and you will see that his attempts at demonizing me and others are quite successful in the echochamber of his followers. He wrote:

Further, this notion by Novella that we parents are “telescoping” is simply the ridiculous introduction of a new and confusing term to try and explain away the chorus of tens of thousands of parents all screaming the same thing about what happened to their kids.

The authors of this study itself applied the concept of “telescoping” or dating autism onset as more recent that it really was. I simply used their term, which they in turn took from the literature. It is a well-described concept, not invented by me or this study’s authors – people remember events in the past as being more recent than they actually were. For Handley’s purposes, however, he wants to characterize a well-known and scientifically established psychological phenomenon as being equivalent to calling people stupid, or spinning reality.

I also showed that this phenomenon is absolutely relevant to the question of vaccines and autism, using the Cedillo case as an example. The Cedillos believed that their child acquired autism after receiving the MMR vaccine. However, home movies reviewed in the court case brought before the Autism Omnibus shows signs of autism in the first year – prior to the first MMR vaccine.

Further, Handley is now trying to argue that this new study supports a correlation between vaccines and autism. In fact, it does nothing of the sort. It does all but eliminate MMR, varicella, and Hep A as having any potential role in autism, as these vaccines all come after the onset of autism in most cases. Handley, if he were being intellectually honest, should admit this, but he doesn’t, and very dishonestly implies that MMR specifically is still a potential cause.

Average age of diagnosis of autism is about 3.1 years of age, and when that was the best information we had to go on the anti-vax movement argued that this showed a correlation with vaccines. Then clinical studies showed that the diagnosis could be reliably made between age 2-3 years of age, but that’s OK, that still correlates with vaccines. Now we know the age of clinical onset is between 6 and 12 months, and Handley is saying this still correlates with the vaccine schedule.

Since the HepB is given at birth, and other vaccines at 1-3 months, moving the diagnosis of autism up even further would still correlate with some vaccines. Since Handley is willing to blame any vaccines, regardless of type (live virus or otherwise) and ingredients (thimerosal or not) no age of onset would disprove his cherished vaccine hypothesis.

There is also nothing about the vaccine hypothesis that led anyone in the anti-vaccine camp to predict that the true age of onset of autism is earlier than it is being diagnosed, and certainly not to within 6-12 months of age. So Handley is just retrofitting – declaring whatever evidence there is as supporting his position.

Finally, Handley pulls the “pharma shill” gambit on me as part of his smear campaign. He trots out an accusation he has made before, portraying my association with the ACSH as being sinister. As I have already explained, my association with the ACSH is limited to me agreeing to advise them on areas of my expertise. That’s it. I have, in fact, performed zero work for them. I have had no contact with them, other than them sending me their public material, and I have never received any kind of remuneration from ACSH. I have corrected Handley on this before, so I know that he knows what he is writing is wrong, and he has failed to correct his errors.

Further my associations with the pharmaceutical industry are minimal – a couple lectures and consultations for nominal fees years ago (and nothing ever to do with vaccines). I have never received a dime from any company to express an opinion on a scientific topic, or write a particular blog or article. I suppose that Handley believes my many hours of work producing podcasts and blogs and promoting science and skepticism is all an elaborate smokescreen for shilling for industry, all without receiving a dime for my efforts, which makes me the worst shill ever.

Actually, I don’t suppose that at all. Rather I think that Handley knows that what he is writing is pure BS, especially since I have called him on it before, and openly challenged him to produce a shred of evidence to support his false accusations. But Handley knows the narrative of the anti-vaccination movement – everyone who denies that vaccines are evil are themselves evil shills for even more evil industry.

Conclusion

In the end, all that matters is the science, which clearly shows that there is no association between vaccines and autism. This one study has minimal implications for an alleged connection, except that it clears the most often implicated vaccine – MMR. It also supports other evidence that the onset of autism is earlier than many parents observe and much earlier than formal diagnosis, which calls into question any casual observations about the timing of onset to any potential triggers.

In my first article on this topic I was sloppy in that one sentence about the vaccine schedule – an error I have now corrected. But that error did not affect the relevant points I made in the rest of the article, which I have also amplified here.

J.B. Handley thinks he has scored some points for his side by jumping on my error, but he has only shown himself, once again, to be a propagandist with no regard for science, accuracy, or even common decency.

There once was a time when all food was organic and no pesticides were used. Health problems were treated with folk wisdom and natural remedies. There was no obesity, and people got lots of exercise. And in that time gone by, the average lifespan was … 35!

That’s right. For most of human existence, according to fossil and anthropological data, the average human lifespan was 35 years. As recently as 1900, American average lifespan was only 48. Today, advocates of alternative health bemoan the current state of American health, the increasing numbers of obese people, the lack of exercise, the use of medications, the medicalization of childbirth. Yet lifespan has never been longer, currently 77.7 years in the US.

Advocates of alternative health have a romanticized and completely unrealistic notion of purported benefits of a “natural” lifestyle. Far from being a paradise, it was hell. The difference between an average lifespan of 48 and one of 77.7 can be accounted for by modern medicine and increased agricultural production brought about by industrial farming methods (including pesticides). Nothing fundamental has changed about human beings. They are still prey to the same illnesses and accidents, but now they can be effectively treated. Indeed, some diseases can be completely prevented by vaccination.

So why are advocates of alternative health complaining? They are complaining because they long for an imagined past that literally never existed. In that sense, alternative health represents a form of fundamentalism. Obviously, fundamentalism is about religion and the analogy can only go so far, but there are several important characteristics of religious fundamentalism that are shared by alternative health advocacy. These include:

• The desire to return to a “better” lifestyle of the past.
• The longing for a mythical past that never actual existed.
• An opposition to modernism (in daily life and in medicine).
• And the belief that anything produced by evolution (or God, if you prefer) is surely going to be good.

Advocates of alternative health bemoan the incidence of diseases like cancer and heart disease without considering that they are primarily diseases of old age. That both cancer and heart disease are among the primary causes of death today represents a victory, not a defeat. Diseases of old age can become primary causes of death only when diseases of infancy and childhood are vanquished, and that is precisely what has happened.

Alternative health as a form of fundamentalism also makes sense in that it has an almost religious fervor. It is not about scientific evidence. Indeed, it usually ignores scientific evidence entirely. All the existing scientific evidence shows that all of the myriad claims of alternative health are flat out false. None of it works, absolutely none of it. That’s not surprising when you consider that it never worked in times past; advocates of alternative health merely pretend that it did, without any regard for historical reality.

Alternative health is a belief system, a form of fundamentalism, and like most fundamentalisms, it longs for a past never existed. It is not science; it has nothing to do with science; and it merely reflects wishful thinking about the past while ignoring reality.

Understanding the natural history of a disease is an important framework to have. It not only is critical for prognosis, but also informs us about diagnostic and screening strategies, is important to assessing interventions, and provides clues to causation.

There has been much debate about the early course of autism, specifically the earliest age at which autism may be detected. At present scientific evidence suggests that autism is dominantly genetic, and so researchers expect that there may be early signs of autism even in infancy. Traditionally, however, autism is not diagnosed until age 2-3, when parents bring their children to medical attention, or when signs are detected on routine well-child visits or in day-care.

Retrospective studies, largely involving review of home movies, have suggested that autism can be diagnosed as early as 6-12 months, suggesting that parental report is not an adequate screen because subtle signs are hard to detect without rigorous observation.

Now a group has published the first prospective study to address this question. They followed 25 children who were later diagnosed with autism spectrum disorder (ASD) (22 of which were high risk) and 25 low risk children who were later determined to have typical development (TD). They found:

These results suggest that behavioral signs of autism are not present at birth, as once suggested by Kanner, but emerge over time through a process of diminishment of key social communication behaviors. More children may present with a regressive course than previously thought, but parent report methods do not capture this phenomenon well. Implications for onset classification systems and clinical screening are also discussed.

More precisely, they carefully assessed the children, counting instances of eye contact and smiling, for example, and found that there were no statistically significant differences between the groups at 6 months, but that almost all measures were reduced in the ASD group by 12 months.

The study is rigorously designed, and its primary weakness is that it is a bit small. The authors also acknowledge that future studies should utilize longer periods of recorded observation. I would add that more frequent assessments between 6 and 12 months would help specify when the earliest divergence takes place. Replication of the study is therefore desirable.

But what these results indicate is that clear signs of autism emerge between 6 and 12 months of age. Further, social skills tend to be regressive in ASD between 6 and 18 months of age. It was previously thought that social regression was less common in ASD, but this study suggests it is the rule, not the exception. Meanwhile, language skills did not regress in this study, they continued to improve in the ASD group, just on a slower curve than the TD group.

Further the study documented that the parents generally did not recognize the social regression between 6 and 18 months. The authors refer to the well-known phenomenon of telescoping in which patients or family members will recall the onset of symptoms as being much more recent than they actually were.

Prior studies using home movies have shown that signs of autism can be detected between 8-12 months. A study looking at head circumference found statistical differences prior to 12 months. And one study looking at movements found differences between 4-6 months. So it seems the consensus of current evidence is that objective and detectable signs of autism emerge between 6-12 months. This study does not support detection prior to 6 months, but other studies do suggest this might be possible.

This study has implications for diagnostic categories of autism (specifically distinguishing regressive forms of autism from non-regressive forms, since most of the ASD children in this study showed social regression). It also is very informative regarding screening strategies. It suggests no utility to screening children prior to 6 months of age. Further, since ASD children continued to separate from TD children through 3 years of age, screening for ASD should not stop at 2 but continue to at least 3.

The authors, however, do not discuss one very significant implication of this study (although an implication already raised by prior studies demonstrating early signs of ASD) – the observation made by many parents that ASD symptom onset correlates with certain vaccinations. Many children are diagnosed between the age of 2 and 3, during the height of the childhood vaccine schedule. This lends itself to the assumption of correlation and causation on the part of some parents. The phenomenon of telescoping, whereby memories of time contract, will tend to reinforce this false correlation.

What this and other studies show is that not only is the assumption of causation fallacious, the observation of correlation is likely flawed as well. The true onset of autism in most ASD children likely began a year or two prior to the vaccines that are blamed as the cause.

This point was made most dramatically by the Cedillo case – one of the test cases brought before the Autism Omnibus court alleging vaccine injury causing autism. Cedillo’s parents alleged that their child developed autism as a result of a combination of the MMR vaccine and thimerosal from other vaccines. In courtroom testimony, however, experts were able to show with home movies that Cedillo showed clear signs of autism as an infant, prior to ever receiving the MMR vaccine.

The current study adds nicely to the growing consensus that the true clinical onset of ASD is between 6 and 12 months of age. Whether or not there are biological markers of ASD prior to that remains to be seen, but is not unlikely. Early and fairly uniform onset is consistent with genetic causes of ASD, rather than environmental causes.

Everybody knows that colonoscopy is the best test to screen for colorectal cancer and that colonoscopies save lives. Everybody may be wrong. Colonoscopy is increasingly viewed as the gold standard for colorectal cancer screening, but its reputation is not based on solid evidence. In reality,  it is not yet known for certain whether colonoscopy can help reduce the number of deaths from colorectal cancer. Screening with fecal occult blood testing (FOBT) and flexible sigmoidoscopy are supported by better evidence, but questions remain.  It seems our zeal for screening tests has outstripped the evidence. 

Statistics show that the life-time risk for an adult American to develop colorectal cancer (CRC) is approximately 6%. Colorectal cancer is the second leading cause of cancer deaths in the United States. In the US there are currently 146,970 new cases   and 50,630 deaths each year. Between 1973 and 1995, mortality from CRC declined by 20.5%, and incidence declined by 7.4% in the United States.  

The US Preventive Services Task Force (USPSTF) recommends screening for colorectal cancer (CRC) using fecal occult blood testing, sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and continuing until age 75 years.  

The American Cancer Society divides the available tests into these two categories and makes these recommendations for frequency of testing:

Tests that find polyps and cancer

• flexible sigmoidoscopy every 5 years* 
• colonoscopy every 10 years 
• double contrast barium enema every 5 years* 
• CT colonography (virtual colonoscopy) every 5 years*

Tests that mainly find cancer

• fecal occult blood test (FOBT) every year*,**
• fecal immunochemical test (FIT) every year*,**
• stool DNA test (sDNA), interval uncertain*

 Screening by colonoscopy seems to make more sense than other screening methods, because you can actually see the entire inside of the colon. Colon cancer is preceded by polyps and adenomas that progress to cancer. When a polyp is seen, it can be removed during the procedure. In this study, colonoscopic polypectomy resulted in a lower than expected incidence of colorectal cancer. But other studies suggest that the progression to cancer is not a steady process, and that  adenomas may regress.

There is good evidence here and here that any benefit of colonoscopy is restricted to left-sided colon cancers, with no impact on right-sided colon cancer; we don’t understand why. Some possible explanations are discussed here.  

There are pros and cons to each of the different screening tests.  Barium enemas and CT virtual colonoscopy involve significant doses of radiation. Colonoscopy only needs to be done every 10 years, but it involves an uncomfortable bowel prep, requires sedation, can cause serious complications like bowel perforation, and is unacceptable to some patients. FOBT screening is painless and harmless but has a lot of false positives and requires annual testing. Getting patients to come back every year for FOBT is problematic. Compliance and cost must be considered. Colonoscopy is expensive and there are not enough colonoscopists to screen everyone.

 Apart from all those peripheral considerations, what do we know about the bottom line: the ability of each screening method to prevent deaths from colon cancer?  According to the National Cancer Institute,  

• Studies have shown that FOBT, when performed every 1 to 2 years in people ages 50 to 80, can help reduce the number of deaths due to colorectal cancer by 15 to 33 percent.
• Studies suggest that regular screening with sigmoidoscopy after age 50 can help reduce the number of deaths from colorectal cancer, perhaps by as much as 50%, but the quality of evidence is not as good as for FOBT.
• it is not yet known for certain whether colonoscopy can help reduce the number of deaths from colorectal cancer.

No randomized controlled trials have tested whether colonoscopy reduces the incidence of CRC. Support for the role of colonoscopy in CRC prevention derives from indirect evidence and observational studies.

There is an excellent review of all the pertinent studies here.  Even though studies show that screening can reduce disease-specific mortality from colorectal cancer, there is little evidence that it reduces all-cause mortality.  So as far as we know, screening probably won’t prolong your life. It seems like it should: I don’t understand why it doesn’t, and it bothers me. This certainly isn’t the message we’re getting from the media and from the medical profession.

I’m guessing that if the appropriate studies were done and the technique of colonoscopy were optimized, a reduction in colon cancer deaths would be demonstrated. I’m guessing that colonoscopy would detect more cancers and precancerous lesions than FOBT or sigmoidoscopy, but I’m wondering whether the benefits of colonoscopy would outweigh the additional cost and risks compared to other screening methods. And I’m disturbed that a reduction in all-cause mortality has not yet been clearly shown for any screening method. We need more research to help us understand these issues.

Pending better evidence, I support the current USPSTF recommendations. I think patients should be told the pros and cons and choose which screening test they prefer. I have chosen annual FOBT for myself.

A MISCARRIAGE OF JUSTICE THAT HAD A (SORT OF) HAPPY ENDING

Back in September and then again last week, I wrote briefly (for me) about an incident that I considered to be a true miscarriage of justice, namely the prosecution of two nurses for having reported the dubious and substandard medical practices of a physician on the staff of Winkler County Hospital in Kermit, Texas. The physician’s name is Dr. Rolando Arafiles, and he happened to be a friend of the Winkler County Sheriff, Robert Roberts, who also happened to have been a patient of Dr. Arafiles and very grateful to him for having saved his life. The nurses, Anne Mitchell and Vickilyn Galle, were longtime employees of Winkler County Hospital, a fifteen bed hospital in rural West Texas. Although some of you may have seen extensive blogging about this before, I thought it very important to discuss some of the issues involved on this blog. Moreover, there is an aspect to this case that the mainstream media reporting on it has missed almost completely, as you will see. Finally, this case showed me something very ugly about my profession, not just because a doctor tried to destroy the lives of two good nurses through his connections to the good ol’ boy network in Winkler County

Let’s recap what happened, a story that reached its climax last Thursday. In 2008, Dr. Arafiles joined the staff of Winkler County Hospital (WCH). It did not take too long for it to become apparent that there were serious problems with this particular doctor. Mitchell and Galle, who worked in quality assurance were dismayed to learn that Dr. Arafiles would abuse his position to try to sell various herbal remedies to patients in the WCH emergency room and the county health clinic and to take supplies from the hospital to perform procedures at a patient’s home rather than in the hospital. No, it wasn’t the fact that Dr. Arafiles recommended supplements and various other “alt-med” remedies, it’s that he recommended supplements and various other “alt-med” remedies that he sold from his own business–a definite no-no both ethically and, in many states, legally. Mitchell reported her concerns to the administration of WCH, which did pretty much absolutely nothing. Consequently, on April 7, 2009, Mitchell and Galle anonymously reported their concerns to the Texas Medical Board (TMB). In June, WCH fired the two nurses without explanation.

That’s bad enough, but happened next is about as appalling as it gets. When Dr. Arafiles received a letter from the TMB informing him that he was being investigated, he went to his good buddy and patient Sheriff Roberts, who suddenly transformed from a small town sheriff to Jack Bauer on crack. Showing an initiative that one would think would normally be reserved for thieves, rapists, and murderers, Sheriff Roberts set himself to discovering the identities of the anonymous complainants against Dr. Arafiles with a vengeance. He interviewed each and every patient listed in the anonymous complaint, asked WCH administration to tell him which of its personnel would have had access to these patient records, and obtained a copy of the anonymous complaint. The description of the nurses as “females over 50″ allowed him to narrow down the possibilities to Mitchell and Galle. Sheriff Roberts then obtained a search warrant for Mitchell’s computer at WCH and found a copy of the letter of complaint on it. As a result, Sheriff Roberts charged Mitchell and Galle with the “misuse of official information,” a third degree felony that carries a potential penalty of 2-10 years in prison.

Yes, prison.

It also turns out that the sheriff had at some time in the past been in business with Dr. Arafiles selling a nutritional supplement called Zrii, even going so far as to hold meetings at the local Pizza Hut to recruit new sellers in what sounds very much like a multilevel marketing scam. Apparently unperturbed by his massive conflict of interest, the Sheriff apparently convinced Winkler County Attorney Scott Tidwell to forget Article 2.01 of the Texas Code of Criminal Procedure that is quoted so prominently under his name that “It shall be the primary duty of all prosecuting attorneys…not to convict, but to see that justice is done.” Although Galle was dropped from the case for unclear reasons, Tidwell pursued the case against Mitchell all the way to trial last week. It was a trial that had to be moved to neighboring county because the case had so polarized Winkler County. Fortunately, on Thursday, after less than an hour of deliberation the jury found Mitchell not guilty. It was a Pyrrhic victory. Yes, Anne Mitchell was not convicted and wouldn’t be going to prison for as long as 10 years. Yes, the jury had resoundingly slapped down Tidwell and Roberts, heaping humiliation on them. Yes, even the Winkler County judge (not the trial judge–remember, the trial had been moved to a different county) Bonnie Leck had testified in favor of Mitchell and that she had discussed her concerns about Dr. Arafiles with her. All of that is true, but Mitchell and Galle have been out of work since June and racked up huge legal bills, and their futures are anything but clear. Even though legally Mitchell and Galle are out of the woods, their futures are anything but clear. In the meantime, they have filed a civil suit that, if there is any justice left in this country, will result in Dr. Arafiles, Sheriff Roberts, County Attorney Tidwell, and the administration of WCH paying dearly for their misdeeds.

THE UNTOLD STORY

The story as relayed above and in the news was horrifying enough, but it’s worse than what was reported. The reason is that Dr. Arafiles is a lot worse than he came off in most news reports. In the news reports, Dr. Arafiles is mostly described as selling supplements, which doesn’t sound particularly bad. Even though evidence for the claims made for most supplements is lacking, so ingrained are supplements in our culture, in no small part thanks to the DSHEA of 1994, that many doctors do recommend them. Although I might frown on such recommendations as not being science-based, I couldn’t consider them so far outside the norm that on that basis alone I’d condemn Dr. Arafiles for anything other than being highly unethical in selling them to patients after seeing them in the emergency room or county health clinic. However, there was much more to the story than this. It turns out that Dr. Arafiles was much further down the rabbithole of woo than anyone reports. I learned of this when I was directed to a series of videos that Dr. Arafiles did with a man named Marc Neumann, in which both were guests on a television show that aired on God’s Learning Channel in October on Morgellons disease. I am listing them below, but don’t bother to try to watch them. Mr. Neumann made the videos private when they came to light, thanks to some bloggers. The reason I list them is in case Mr. Neumann decides to reactivate them. If he ever does, you’ll be able to see Dr. Arafiles himself in parts one, two, three, four, five.

I’m really sorry that you can’t view the content of the videos. It’s painful to watch, and Dr. Arafiles buys into a whole lot of woo about Morgellons disease. I also didn’t know who Marc Neumann was but a little Googling quickly located his Morgellons Research Organization. Unfortunately, you can’t access the English language portion of the website because Mr. Neumann has removed it, again apparently in the wake of the attention he got from certain bloggers, but the German language section is still there. So is one page that I can find. If you peruse it, you’ll notice that Neumann blames Morgellons on genetically modified organisms and a whole lot of woo.

Although I haven’t, Steve Novella, Wally Sampson, and Peter Lipson have all discussed Morgellons disease before on this blog. Suffice it to say that it is a condition that probably doesn’t exist as a distinct, biologic entity. By saying that I don’t mean that patients who are convinced they have Morgellons aren’t suffering and don’t have something wrong with them, but rather that whatever it is is not explained by the wastebasket of woo that “defines” Morgellons:

Morgellons is a multi-symptom disease that is just now starting to be researched and understood. It has a number primary symptoms:

Physical

• Sponanteously Erupting Skin lesions
• Sensation of crawling, biting on and under the skin
• Appearance of blue, black or red fibers and granules beneath and/or extruding from the skin
• Fatigue

Mental

• Short-term memory loss
• Attention Deficit, Bipolar or Obsessive-Compulsive disorders
• Impaired thought processing (brain fog)
• Depression and feelings of isolation

It is frequently misdiagnosed as Delusional Parasitosis or an Obsessive Picking Disorder.

There’s a good reason for that, namely because Morgellons actually very much resembles delusional parasitosis. Indeed, that is very likely what many, if not most, cases of Morgellons are in reality–a form of delusional parasitosis. For example, one aspect that is always claimed are “fibers” or “granules.” However, no advocate of Morgellons has ever been able to produce these fibers and show that they are anything other than contaminants from clothing or fibers from the environment or that these “spontaneously erupting skin lesions” are anything more than the consequence of scratching or picking at the skin due to sensations of crawling, itching, or biting on or under the skin.

Peter pointed this out, but if you really want to see the weakness of the evidence for the existence of these fibers as anything other than clothing fibres, check out the “research” section of pretty much any major Morgellons website. How hard would it be to recruit a bunch of people who think they have Morgellons, take fiber samples and possibly skin biopsies, and then subject the fiber samples to real chemical analysis and have real pathologists look at the skin biopsies systematically. That’s probably because pretty much every Morgellons “fiber” that I’ve ever seen presented as evidence of the disease looks more like oils and dirt from impacted pores, fibers from clothing, or clumps of dead skin cells that we all flake off. It doesn’t help that all the “evidence” on various websites has not been subjected to anything resembling peer review or independent replication. Indeed, every Morgellons website I’ve seen save one (Morgellons Watch, which concludes that the fibers are environmental and unrelated to any illness; that Morgellons is not a distinct disease; and that eople who think they have “Morgellons” probably have a mixed variety of physical and/or mental illnesses) demonstrate serious crank qualities. Indeed, Neumann’s site, the one being hawked by Dr. Arafiles, goes beyond even this and postulates that that the organisms causing Morgellons are some sort of genetically modified organism, a “bacterial-fungal GMO used as a bioinsectizide,” as he puts it. Some Morgellons even blame that woo of woo, chemtrails.

Does this mean Morgellons doesn’t exist? Possibly. Or it might exist, although, to be honest I very much doubt it. Still, there are lots of patients with symptoms to which they have placed the label “Morgellons” who are genuinely suffering. Unfortunately, attaching a label to these patients that is not rooted in science and evidence does them a disservice, and the very best that can be said is that evidence is sore lacking that there is even such a disease as Morgellons. That’s why it’s really hard to say whether the disease exists, because the “evidence” for Morgellons disease can only be found on websites devoted to promoting the idea that Morgellons exists as a distinct clinical syndrome. If you do a PubMed search, pretty much all you’ll find are articles on delusional parasitosis and commentaries asking whether Morgellons actually exists as a distinct disease entity. About the best evidence suggesting that Morgellons may be a distinct disease is a single case series consisting of 25 patients carrying a diagnosis of Morgellons from whatever source. Let’s just say I’m not convinced. It’s a small case series; there are no statistics to speak of; the autoimmune measures reported are wildly inconsistent; and there are no consistent abnormalities that stand out as pathognemonic of a distinct disease.

Whether Morgellons exists as a disease or is in fact a form of delusional parasitosis, however, it is a magnet for quackery and pseudoscience (which is why attaching a fake label to a probably nonexistent disease does patients who can be labeled with that pseudodisease does them no service at all), and Dr. Arafiles’ video is chock full of both. The reason I mention the videos is that they were his undoing in terms of showing just how deep into pseudoscience Arafiles had fallen. In part 5 Dr. Arafiles mentions a website, Health2Fit. Although nowhere on the website is Dr. Arafiles’ name mentioned, it’s clear that it’s Dr. Arafiles’ website because its contact information lists Kermit, TX as where it is located and, more importantly, Dr. Arafiles’ LinkedIn profile lists him as the owner of Health2Fit. (I’ve saved a screenshot in case Dr. Arafiles decides to try to make the evidence disappear down the memory hole the same way Marc Neuman has tried to make the English language portion of his website disappear.)

Dr. Arafiles, if he is smart, has plenty of reason to try to get rid of the evidence, because on the website he reveals himself not only to be anti-vaccine but heavily into pseudoscience. One example is that Dr. Arafiles sells colloidal silver (yes, that colloidal silver!) to treat H1N1 and seasonal flu. Worse, the website claims that colloidal silver is FDA-approved for treating the flu. As Peter points out, that is a lie, pure and simple. Moreover, on the same page, there are links to antivaccine websites like the National Vaccine Information Center, a lawyer specializing in vaccine exemptions, and to über-quack Gary Null testifying in New York. That’s right. Gary Null. That Gary Null, who is an HIV/AIDS denialist, an anti-vaccine loon (I’m being generous here), and a supporter of cancer quackery. To top it all off, Dr. Arafiles has a presentation on the swine flu with his name on the first slide that includes slides like this:

It looks as though Dr. Arafiles buys into the dreaded “toxin gambit” and the “aborted fetal tissue in the vaccines!” gambit. He even has a PDF of an article by the “Health Ranger” himself, Mike Adams entitled Ten Swine Flu Lies, as well as a link to an fear mongering article about mercury in the H1N1 vaccine. But it’s even worse than that. Dr. Arafiles appears to be selling colloidal silver for Morgellons disease as well. (Remember how I said that Morgellons disease is a magnet for quackery?) He’s also selling a very expensive water alkalinizer for $1495 on his website. Meanwhile, Dr. Arafiles actually testified in this case that diabetics heal as well as anyone else, which actually caused those attending the trial to laugh.

If anyone has any further doubt as to just how far outside the realm of science-based medicine Dr. Arafiles has wandered. I’ll mention two more tidbits. As Mike Dunford shows, in 2002 Dr. Arafiles appeared on a list of U.S. & International Physicians Who Offer IV Hydrogen Peroxide & Bioluminescence Therapy. But it’s even worse than that. In December 2009, there appeared a message from him on the Yahoo! newsgroup No Forced Vaccination to Sherri Nakken, an unabashedly anti-vaccine activist who bills herself as a “Hahnemannian Homeopath” and offers an online homeopathy course asking “When do I get my materials for the homeopathy class?” It would appear that not only is Dr. Arafiles anti-vaccine, but he is currently studying homeopathy as well.

The bottom line is that Dr. Arafiles is more than just a dubious doctor who has a penchant for supplements and a soft spot for a little bit of woo. He’s a doctor who has drunk the Kool Aid, someone who has been reported to the TMB on more than one occasion. Worse, Dr. Arafiles is in a position of power in an underserved rural area in far West Texas, and used that power, which derives from his privileged status as a doctor in the small town of Kermit and his connections with a sheriff who thinks nothing of ignoring his conflicts of interest, ignoring warnings from the TMB that what the nurses he pursued did was not wrong and was in fact state business, and abusing his power to punish two nurses for daring to try to do something to protect the citizens of Winkler County from him. Whether the TMB will do anything about it remains to be seen, but I’m not very optimistic.

BAD DOCTORS, QUACKS, AND THE PROBLEM OF REGULATION

It is hard to become a physician. It takes brains, patience, dedication, and, even in the age of 80 hour work weeks, an almost superhuman ability to take abuse. The flip side of this is that being a physician is a highly privileged position. After all, we hold human lives in our hands. People trust us enough to tell us things about themselves that they wouldn’t tell anyone else, possibly not even their spouses, in the hope that we can use that information to diagnose and treat them. Society has given me, as a surgeon, the supreme privilege of being able to take a knife to human flesh in order to try to cure women of breast cancer, and, back when I did more than just breast cancer surgery I used to joke that surgeons were allowed to forcibly rearrange people’s anatomy for therapeutic intent. We see parts of people that no one else sees, and we do things to people that no one else is allowed to do legally. It is a great power and a great trust.

Doctors like Dr. Arafiles abuse that power and trust.

Unfortunately, the sense of privilege has consequences. Once a person becomes a doctor, it shouldn’t be viewed by society as a right, but in effect it is. It is, in fact, very difficult in most states to strip a bad doctor of his medical license, and, even when sanctions are issued, it seems that every effort is made to get that physician back to practicing as fast as possible. You may recall a couple of years ago how I lamented the seeming powerlessness of the North Carolina Board of Medical Examiners in the face of Dr. Rashid Buttar’s autism and cancer quackery. Kim Atwood has also described how state medical boards often fail when confronted with physicians practicing medicine far outside the bound of what is science-based, tending to be lenient at first; sometimes even documented evidence of patient harm does not sway them. One reason is that state medical boards are often overwhelmed. It’s hard enough for them to keep up with disciplining physicians with substance abuse problems or taking sexual liberties with patients, much less adjudicating whether as treatment is science based and what is the standard of care.

However, I fear that it may be more than that. There is a strain of belief and attitude among many physicians that we really are a privileged class and that complaints against us are unwarranted. One need look no further than this post by the American Association of Physicians and Surgeons for this attitude. In a stunning post entitled Is there accountability for malice?, the AAPS takes Dr. Arafiles side against the nurses:

It has been open season for false allegations against physicians for too long. Each year too many physicians are distracted or even destroyed by malicious claims about them, whether in malpractice cases, sham peer review by hospitals or health plans, or witch-hunts by medical boards.

Is nurse Anne Mitchell guilty of acting in bad faith? The jury will decide.

Note the juxtaposition of complaints against false allegations against physicians with the disingenuous statement that “the jury will decide.” While that was literally true (the jury would and did decide–and it decided in under an hour that the allegations against Anne Mitchell were completely unjustified), it’s very clear where the AAPS stands on this issue, and it’s not with the whistleblowers or in favor of physician accountability:

The blogosphere is filled with rants against the doctor, Rolando G. Arafiles, Jr., M.D.; the prosecutor; and West Texas itself. The doctor has dark skin, a foreign accent, and some unconventional ideas. But his ideas and his practice are not on trial. The question before the court is whether the nurse, not the doctor, acted wrongfully.

This is an example of some spectacularly Orwellian misdirection. First off, the attacks in the blogosphere were against more than just Dr. Arafiles. They were against the Winkler County Sheriff who went to great lengths to hunt down the two whistle blowing nurses. They were against a clueless and vindictive prosecutor who decided to prosecute them. They were about payback against the nurse. In fact, the uproar was about about exactly the opposite of what AAPS thinks it’s about. It’s also spectacularly hypocritical of the AAPS to cry racism over this issue because Dr. Arafiles is Filipino when it has a history of some truly despicable and racist anti-immigrant rhetoric. Indeed, as I documented a year and a half ago, the AAPS is an organization that in essence believes that there should be no constraints on physicians “exercising their judgment.” They are an extreme example, but I’ve encountered such thoughts before. For example, on my Facebook page, a physician named Richard Willner weighed in:

This will have no effect on whistleblowing of RNs against MDs. I see them almost every day.

Followed by:

I also see outrageous RN complaints against MDs. If I was the RN Licensing Board, I’d discipline them for incompetence.

When I provided links to show what a miscarriage of justice this case is and to point out the information about Dr. Arafiles that I described in the first section of this post, Dr. Willner replied:

This Tx case is incredible. I have known all about it for a while. This is an aberation that can only occur in a local southern town.

My other opinion that many RNs write formal complaints on MDs for simply doing their jobs, writing correct orders that the RN are “not comfortable with”, that is a fact. If you want an unique view point just call me at 504-621-XXXX after rounds. This is a real problem for many MDs and it is not taught in Residencies.

To which I replied:

Nurses are supposed to question orders they aren’t comfortable with. They aren’t mindless automatons who are supposed to follow orders without question. They are professionals.

Now, I’m not going to deny that sham peer review based on anonymous complaints isn’t a problem in some hospitals. Physicians, however, appear to have an exaggerated view of just how common it is. As often as sham peer review is alleged by doctors, the AMA (not exactly a source that would be opposed to physicians rights) investigated and concluded:

Abuse of peer review is easy to allege but, for the reasons discussed above, can be difficult to prove. Considering the nature of the proceedings, it is to be expected that such charges will be raised by physicians who disagree with the results. In fairness, though, those who raise such claims should have the burden of proving them. Since the passage of HCQIA in 1986, the AMA is aware of only exceptional, isolated instances of peer review determinations that have resulted from improper motivations, rather than a good faith desire to improve patient care.

This may partly be explained by the difficulties in proving such a case and the legal disincentives against bringing this type of lawsuit. More likely, though, is that peer review abuse is a rarity. The legal obstacles make a claim of inappropriate peer review difficult to prove; they do not make it impossible. If abusive peer review were indeed “epidemic,” there would probably be a more substantial track record of definitive and proven malfeasance. The absence of such a record suggests that the claims of widespread or frequent “sham peer review” are speculative.

No doubt I’ll get an angry complaint or two, either in the comments or by e-mail, for taking this position, but you can be pretty sure that the AMA would be unlikely to cover up evidence of sham peer review, given its mission to promote the interests of physicians as a profession. Yet such is the widespread perception that peer review by hospitals resulting in false accusations and unjustified sanctions against doctors that doctors have a tendency to side with other doctors, particularly when it is nurses making the accusation. So powerful is that perception that it’s not just cranks like the AAPS who immediately doubted the Winkler County nurses and lept to defend Dr. Arafiles. And it doesn’t just stop there. Hospitals, state medical boards, virtually the entire establishment is tilted in favor of physicians when it comes to matters of physician misconduct. Our physician culture is to tend to close ranks when one of the tribe is attacked, and state medical boards are loathe to do anything about any but the most egregious offenses. That tendency has led some physicians to wrongly conflate the Winkler Nurses case with sham peer review and conclude that the nurses deserved to be punished for making what they assumed in a knee-jerk fashion to be a bogus complaint against the poor sainted Dr. Arafiles.

And that attitude is a threat to science-based medicine, arguably as serious a threat as the infiltration of quackery into bastions of science-based medicine and the corruption of medicine by “integration” with that quackery.

Dr. Arafiles’ case is about more than just Dr. Arafiles. It revealed serious problems with how physician misconduct is reported and how it is dealt with by hospitals and the governmental entities charged with protecting the public from bad doctors and even outright quacks. Perhaps most disturbing is the utter silence from major medical organizations other than the Texas Nurses Association, which rallied to set up a legal defense fund for Galle and Mitchell, and the American Nurses Association. To our disgrace as a profession, not a single major national physicians organization that I’m aware of stood by the nurses and their duty to report physician malfeasance or, at the very least, against the prosecution of fellow professionals who were being punished through the loss of their jobs and the potential loss of their freedom. The only physicians organization that spoke up was a crank organization that took exactly the wrong position on this matter. Instead of siding with patients and the need for physicians to be accountable, the AAPS supported punishing the nurses, likening them to nurses making false charges against physicians. All of this occurred in the face of the TMB having sent a very harsh letter telling County Attorney Tidwell that his prosecution was wrong, not based in law, and that it had “potentially created a significant chilling effect on the cooperation of any other hospital personnel who might have been able to provide additional information needed by the Board” to carry out its investigation of Dr. Arafiles.

Of course, that was almost certainly exactly the intent of the sheriff’s vendetta against these nurses, to keep his good budy Dr. Arafiles’ medical license safe and secure against the actions of the TMB and to intimidate other potential witnesses into silence. As Dr. Kate Scannell put it, the medical establishment send a clear, unmistakable message to nurses and non-physician health care professionals and workers: Don’t rock the boat. Doctors are supreme. Don’t question them. If you do, you risk everything, your job, your money, even your freedom.

This is hardly a situation that promotes the practice of science-based medicine or even something more basic, patient safety.

Why is my mind so clean and pure?  Because I am always changing it.

In medical school the old saying is that half of everything you learn will not be true in 10 years, the problem being they do not tell which half.

In medicine, the approach is, one hopes, that data leads to an opinion.  You have to be careful not to let opinion guide how you evaluate the data.  It is difficult to do, and I tell myself that my ego is not invested my interpretation of the data. I am not wrong, I am giving the best interpretation I can at the time. For years  I yammered on about how it made no sense to give a beta-lactam and a quinolone for sepsis until a retrospective study suggested benefit of the combination.  Bummer. Now when I talk to the housestaff about sepsis, I have to add a caveat about combination therapy.  It is why my motto is, only half jokingly,  ”Frequently in error, never in doubt”.

At what point do you start to change you mind?  Alter your message as a teacher?  Have new behavior?  Medicine is not all or nothing, black and white.  Changes are incremental, and opinions change slowly, especially if results of a new study contradict commonly held conclusions from prior investigations.

Nevertheless, I am in the process of changing my mind, and it hurts.  I feel like Mr. Gumby.

It is rare that there is one study that changes everything; medicine is not an Apple product.  Occasionally that there is a landmark  study that alters practice in such a dramatic way that there is a before and after.  As I write this I cannot think of a recent example in infectious diseases, but I am sure there is one.  The problem is that once practice changes, it seems as we have always done it that way.

For me, three is the magic number.  One study that goes against received wisdom warrants an ‘interesting, but give me more.’

Two studies, especially if using different methodologies with the same results gives and well, two is interesting, but I can argue against it.’ However, with two studies the seed of doubt is planted, waiting to be watered with the water of further confirmation.  Yeah. Bad metaphor.

Three studies with different methodologies independently confirming new concepts?  Then I say, ‘I change my mind. My brain hurts.’

There are now three studies concerning the issue of efficacy of the flu vaccine in the elderly.  You might remember my discussion of the Atlantic article several months ago. In that entry I discussed two articles  that suggested the flu vaccine may be less effective in the elderly than the studies demonstrated.

The argument was that the elderly who received the influenza vaccine were healthier at baseline than those that didn’t receive the vaccine and the deaths during flu season was not due to the protection from the vaccine, but due to the fact that healthier people are less likely to die when they get ill. In part this was demonstrated by showing decreased deaths in vaccinated populations when influenza was not circulating.  If insomnia is a problem, you can go back and read my post.   To quote my favorite author, me, I said

“One, it is an outlier, and outliers need confirmation. The preponderance of all the literature suggests that influenza vaccine prevents disease and death. If you do not get flu, you cannot die from flu or flu related illnesses. When outliers are published, people read them, think, “huh, that’s interesting”, but there is going to have to be more than one contradictory study to change my practice. But if “study after study” shows mortality benefit, and one study does not, it is food for thought, but not necessarily the basis of changing practice. The results, above all, needs to be repeated by others… In medicine we tend to be conservative about changing practice unless there is a preponderance of data to suggest a change is reasonable. Except, of course, if our big pharma overlords take us to a good streak house.”

Now we have a third article, “Evidence of Bias in Studies of Influenza Vaccine Effectiveness in Elderly Patients” from the Journal of Infectious Diseases.

In the study they examined the records of the elderly in the Kaiser Health System, their vaccination records, and their risk of death.  And the results were interesting.

“The percentage of the population that was vaccinated varied with age. After age 65, influenza vaccination increased until age 78 in women and age 81 in men, then decreased with increasing age. Vaccination coverage also varied in a curvilinear fashion with risk score, increasing with risk score to a risk score percentile of ?80%, then decreasing. In addition, as the predicted probability of death increased, vaccination coverage increased. Vaccination coverage was highest among members with a probability of death of 3%–7.5%. Those with a predicted probability of death in the coming year of 17.5% had a decreasing likelihood of influenza vaccination”

They then looked at mortality when flu was not circulating.

“A change in the pattern of vaccination had a striking effect on mortality. For members > 75 years old who had been receiving influenza vaccinations in previous years, not receiving a seasonal influenza vaccination was strongly associated with mortality in the months ahead (Table 1). A person who had received an influenza vaccination every year in the previous 5 years had a more than double probability of death outside the influenza season if he or she missed a vaccination in the current year, compared with a person who was vaccinated as usual (odds ratio, 2.17; P < .001). On the other hand, if a person did not receive any seasonal influenza vaccination in the previous 5 years, then receipt of a vaccination in the current year was associated with a greater probability of death. “

If they had a history of flu vaccine for five years and missed it, the probability of death went up.

If they did not have a flu vaccine for five years and got one, the probability of death went up.

They suggest in the first case, the patients may have had an increase in their co-morbidities and as a result did not get the vaccine and died of underlying diseases. Their increased risk of death was from accumulating prior illnesses.

In the second case, people who were healthy and did not seek care subsequently developed diseases that lead them to a doctor who advised the vaccine.  Their increase risk of death was due to new illnesses.

Either way, the uptake of the flu vaccine is more complicated than I had suspected and makes interpretation of efficacy of the vaccine in prior studies harder to evaluate.  The table shows an unexpected relationship between age, risk of death and use of the flu vaccine.

They say in the discussion

“We showed that, despite strong efforts to increase vaccination among the elderly population, vaccination is relatively low in the oldest and sickest portions of the population. Persons 65 years old with a 17.5% chance of death in the upcoming year are less likely to receive the influenza vaccine. Because persons who are most likely to die are less likely to receive the vaccine, vaccination appears to be associated with a much lower chance of dying; thus, the “effectiveness” of the vaccine is in great part due to the selection of healthier individuals for vaccination, rather than due to true effectiveness of the vaccine. Previous studies have argued that worsening health is associated with increasing vaccination. We found this to be a curvilinear relationship, in which increasing illness means increasing vaccination, up to a point, and then, as people come closer to the end of life, there is a decrease in vaccination coverage.”

They do not say the vaccine is not effective, but they suggest that there is a bias that may make the vaccine appear more effective in the elderly than it really is.  Reality is often more complex than one would think at the beginning.

After three studies I am reasonably convinced that efficacy of the flu vaccine in the elderly is potentially not as well understood as I had thought.

So do I think the flu vaccine is no longer useful in the elderly?  No.  I still think it is a reasonable intervention but it may not have the efficacy I would like.  But I have always known that, for a variety of reasons, the flu vaccine is not a great vaccine. But it is better than no vaccine. There are, as discussed in the earlier post on the vaccine, many lines of evidence to show that the flu vaccine has benefit; at issue is the degree of the benefit.  Perhaps what is needed is a better vaccine with adjuvants or multiple injections to get a better result in the elderly, who respond poorly to the vaccine.  Or perhaps it will be better to focus on increasing vaccination in those who care for or have contact with the elderly.  But when I talk to my patients and residents, when I get to part about flu vaccine efficacy, I will be a little more nuanced, use more qualifiers. I will tell them that the vaccine is like seat belts.  It does not prevent all death and injury, but if you had a choice, would you not choose to use seat belts?

In the end the data has to change the way I think about medicine, not matter how much it hurts.

Compare and contrast that with the anti-vaxers who have the belief that vaccines cause autism.  They look for data to support the pre-existing belief and ignore contrary data.  Opinion does not follow from data.

The most representative statement of their approach is on the 14 studies website where they say  ”“We gave this study our highest score because it appears to actually show that MMR contributes to higher autism rates.”

The key phrase in the whole site. Data that supports their position is good, data that does not is bad. What makes a study good is not its methodology or its rigor, or its reproducibility, or its biologic plausibility,  but if it supports vaccines casing autism.

Dr. Wakefield, as has been noted over the last week, had his MMR/autism paper withdrawn from Lancet not for bad science, but for dishonest science.  In medicine you can be wrong, but you cannot lie.  If the results of medical papers were shown to be fabrications, such as the papers of Scott S. Reuben, no one the medical field would defend the results.  Dr. Reuben, as you may remember, was found to have fabricated multiple studies on the treatment of pain.  Nowhere can I find web sites defending his faked research.  No suggestions it was due to a conspiracy of big pharma to hide the truth. No assertions that he is still a physician of great renown.   He lied and is consigned to ignominy.   Physicians who used his papers as a basis of practice no longer do so, or so I would hope.

The response to Dr. Reuban is in striking contrast to the defense of Dr Wakefield, where bad research combined with unethical behavior, results in

“It is our most sincere belief that Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers reporting on the retraction of a paper published in The Lancet in 1998 by Dr. Wakefield and his colleagues.

The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers served as judge and jury. Dr. Wakefield strenuously denies all the findings of the GMC and plans a vigorous appeal.”

Opinions did not change when the Wakefield paper was demonstrated to be not just wrong but false, the researcher’s behavior unethical, and the study could not be reproduced using similar methodologies.  Instead, the defense of Dr. Wakefield became, well, like a Jim Carrey shtick. The Mask defends retracted autism research. Fire Marshall Bill on the medical literature.  Jenny and Jim’s defense does make more sense read as comic performance art.  Andy Kaufmann would have been proud.

I wonder if the more grounded in fiction an opinion is, the harder it is to change, the more difficult it is to admit error.  I have to admit I cannot wrap my head around the ability of people to deny reality.  It is the old Groucho line come to life, “Who are you going to believe, science or your lying eyes?”

So I will, I hope, keep changing my mind as new information come in.  It is what separates real health care providers from acupuncturists and homeopaths and naturopaths and anti-vaxers.  It is what some truly great minds admit to doing.  As one deeper thinker and better writer than I said, kind of,

“The other terror that scares us from self-trust is our consistency; a reverence for our past act or word, because the eyes of others have no other data for computing our orbit than our past acts, and we are loath to disappoint them.

But why should you keep your head over your shoulder? Why drag about this corpse of your memory, lest you contradict somewhat you have stated in this or that public place? Suppose you should contradict yourself; what then? It seems to be a rule of wisdom never to rely on your memory alone, scarcely even in acts of pure memory, but to bring the past for judgment into the thousand-eyed present, and live ever in a new day. In your metaphysics you have denied personality to the Deity: yet when the devout motions of the soul come, yield to them heart and life, though they should clothe God with shape and color. Leave your theory, as Joseph his coat in the hand of the harlot, and flee.

A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines and anti-vaxers. With consistency a great soul has simply nothing to do. He may as well concern himself with his shadow on the wall. Speak what you think now in hard words, and to-morrow speak what to-morrow thinks in hard words again, though it contradict every thing you said to-day. — ‘Ah, so you shall be sure to be misunderstood.’ — Is it so bad, then, to be misunderstood?”

I get a lot of email asking me about various alternative therapies and supplements. A recurring theme on this blog has been the hyperbolic claims of alternative practitioners and supplement makers, and while I can’t answer every email, I can at least address some of them in the blog. Supplements are often marketed using unsupported health claims to which is appended the Quack Miranda Warning, essentially allowing the makers to say that the pill will have such and such a benefit, while simultaneously denying any responsibility for the claim.  Since the FDA isn’t examining these claims, it’s worth while to ask our own questions.

The latest email concerned a product called CardioFuel. Let’s take a closer look at this stuff.

According to the distributor:

CardioFuel is the most profound energy producing supplement on the market today! It does something like no other can: Increase energy at the most basic metabolic level, by increasing ATP (the biochemical energy unit of transfer) production. More ATP means more energy reserves to overcome chronic disease, beat the competition, and handle the everyday stressors of today’s fast paced world!

So to be taken seriously, there should be evidence that this product: 1) increases ATP, 2) increases “energy reserves”, and 3) helps overcome chronic disease and “the competition”. First, it is not possible to directly measure ATP in a human being under normal clinical conditions, so any claims about this must be an inference from markers of ATP metabolism, or a guess. We’ll see what the literature says about this below. Second, we need an operational definition of “energy reserves”. Does this mean fat stores? Glycogen stores? These things are measurable to an extent.  Finally, we can do a literature search to see if CardioFuel or an acceptable analog has been tested for its effect on relevant outcomes.

First, what is ATP?

ATP is adenosine triphosphate, a biological molecule with many functions, among them the transfer of energy. ATP is produced in several ways, most famously in the Krebs cycle, a complicated biochemical process which premeds are mercilessly forced to memorize. ATP contains three phosphate bonds, and the third bond contains a great deal of energy, energy that the body uses to fuel many biochemical processes. Each molecule of ATP contains a d-ribose moiety, a simple sugar upon which the molecule is built. One of the claims being made by the CardioFuel folks is that if we ingest more d-ribose, we can make more ATP and be more “energetic”.

First, ATP synthesis, like most biochemical processes, is subject to feedback regulation; ATP production and its byproducts feed back to reduce further ATP production. Second, it is not clear to me that simply providing more of this particular substrate would significantly boost ATP production. But with my limited knowledge of biochemistry, it seems like an interesting question to investigate.

CardioFuel claims that its “ATP boosting” properties are  not just from ribose, but also from other molecules such as carnitine and coenzyme Q10.  There is nothing in the published literature that I can find to support these claims.

From my perspective as a physician, I want to see results.  Regardless of what is posited to happen at the cellular level, I want to see outcomes studies supporting the claims that d-ribose, or preferably CardioFuel itself actually does what is claimed, which the marketer further specifies:

I created CardioFuel to help my patients who suffer serious energy-depleting chronic diseases, such as: heart disease (PVD), diabetes, neuromuscular disease, fibromyalgia, lung disease, Chronic Fatigue Syndrome, kidney disease, HIV/AIDS, etc. These diseases deplete ATP, which CardioFuel rapidly replaces, dramatically improving health, vitality, and Quality of Life (QOL).

A PubMed search for “CardioFuel” turned up nothing.  Of the ingredients claimed to boost energy, d-ribose is the one with the most literature—literature which is not favorable.  There are a number of pilot studies looking at d-ribose in exercise.  For example, one study of twelve cyclists found that, “D-ribose supplementation has no impact on anaerobic exercise capacity and metabolic markers after high-intensity cycling exercise.”  A slightly larger study of rowers compared dextrose (d-glucose) with ribose and found that, “…the dextrose group showed significantly more improvement at 8 weeks than the ribose group.”  Another small study found that,” ribose had no effect on performance when taken orally, at the dose suggested by the distributor.”Since I couldn’t find literature specific to CardioFuel, and my literature search failed to find significant support for claims of the ingredients of CardioFuel, I went to the CardioFuel website for further guidance.  Tellingly, there are no references to studies of CardioFuel itself but only for its purported ingredients. There are some chaotic lists of incomplete references.  For example, for coenzyme Q10, some of the references are listed, some just quoted without citation, and there is little data related to the claims of CardioFuel.  The section on “elite athletes” addresses ribose directly, but not with outcomes studies.

I can find no support for the claims made by the sellers of CardioFuel. But under the Dietary Supplement Health and Education Act of 1994 they are allowed to make these claims as long as they use the Quack Miranda Warning. I couldn’t find such a warning on any page of the website so I guess I must assume that all of the claims made by the company are verifiable. I can’t seem to verify them myself, but the data must be somewhere. Right?

Last week I wrote about a study that purported to show that antidepressants have no effect in mild to moderate depression. A careful reading of the paper shows that the authors dramatically overstated their findings, particularly in their public statements to the media. The study has another implication beyond the misleading claims about antidepressants. It is an object lesson in an ongoing and disturbing phenomenon in mainstream journalism, the wholesale reprinting of press releases of scientific papers instead of reading and analyzing the papers themselves.

Pick up any newspaper or magazine and you can read about the latest scientific breakthroughs in cancer, Alzheimer’s or heart disease. Just keep in mind that what you are reading is probably a commercial message direct from the authors, not an accurate representation of the paper itself. Medical journalists are supposed to interpret the findings of recent medical publications and present them to the general public in ways that they can understand. They are supposed to provide context for the discovery, explaining what it might mean for disease treatment or cure. Yet, they rarely do. Instead, they simply copy the press release.

Most people are unaware that scientists issue press releases about their work and they are certainly unaware that medical journalists often copy them word for word. Instead of presenting an accurate representation of medical research, medical journalists have become complicit in transmitting inaccurate or deceptive “puff pieces” designed to hype the supposed discovery and hide any deficiencies in the research.

Imagine if a journalist reviewing the newest Ford cross-over vehicle didn’t bother to drive the car, but simply copied the Ford brochure word for word. Could you rely on the journalist’s evaluation? Of course not. Yet that is precisely what medical journalists are doing each and every day.

Not surprisingly, there is a scientific paper describing recent trends in medical press releases. The paper in the of Annals of Internal Medicine, Press Releases by Academic Medical Centers: Not So Academic?, by Woloshin, and colleagues finds:

Of all 113 releases about human studies … [f]orty percent reported on inherently limited studies (for example, sample size <30, uncontrolled interventions, … or unpublished meeting reports). Fewer than half (42%) provided any relevant caveats…

Among the 87 releases about animal or laboratory studies, most (64 of 87) explicitly claimed relevance to human health, yet 90% lacked caveats about extrapolating results to people…

Twenty-nine percent of releases (58 of 200) were rated as exaggerating the finding’s importance…

Almost all releases (195 of 200) included investigator quotes, 26% of which were judged to overstate research importance…

Although 24% (47 of 200) of releases used the word “significant,” only 1 clearly distinguished statistical from clinical significance. All other cases were ambiguous …

Why is this a problem? The harm extends beyond the obvious point that it is deceptive, and a failure of medical journalists to do their job, which is to interpret the accuracy and relevance of scientific publications when writing about them. Because medical journalists credulously publish press release as if they were true, they are constantly publishing conflicting reports, contributing to the public’s distrust of medical research. Each day seems to bring a new report of a food, or a drug that will prevent or cure cancer. Within a week or a month or a year, the journalists are reporting that that food or drug does not prevent or cure cancer.

To the public, it looks like medical researchers are constantly making mistakes. Today they claim that a food will prevent cancer. Next month, the same food will be found to cause cancer. In reality, medical research never demonstrated either claim, but medical journalists reported preliminary findings or flawed research as if they were definitive even though that was untrue.

The willingness of journalists to pass on the information in press releases without checking is not just a function of laziness. Journalists often lack the knowledge of science and statistics that is needed to analyze the paper. Moreover, journalists appear to suffer from a misunderstanding of the scientific literature. Publication of a scientific paper is not the end of a process confirming the truth of a paper; it is only the beginning. Publication does not mean that the findings should be accepted uncritically; it merely means that the findings are worthy of being included in the ongoing public discussion that characterizes science.  The findings of the paper may ultimately be deemed worthless or wrong.

The Annals of Internal Medicine has done an important service in bringing this disturbing practice to light. You can’t believe what you read about medical research in newspapers and magazines because medical journalists are simply copying press releases, not analyzing the research for accuracy or relevance. Therefore, in the interest of accuracy and relevance, I must disclose a caveat to this important scientific paper. In what surely is an unintentional irony, The Annals of Internal Medicine publicly unveiled the paper and its findings by issuing a press release.

Surgeon and journalist, Atul Gawande, is getting quite a bit of deserved press and blog attention for his new book, The Checklist Manifesto: How to Get Things Right. The premise of his book is simple – checklists are an effective way to reduce error. But behind that simple message are some powerful ideas with significant implications for the culture of medicine.

One of the biggest ideas is that medicine has culture – a way of doing things and thinking about problems that subconsciously pervades the practice of medicine. This idea is not new to Gawande, but he puts it to powerful practice.

The Humble Checklist

Gawande tells not only the story of the checklist but of his personal experience designing and implementing a surgery checklist as part of a WHO project to reduce morbidity and mortality from surgery. He borrowed the idea from other industries, like aviation, that use checklists to operate complex machinery without forgetting to perform each little, but vitally important, step.

The surgery checklist includes things like making sure the patient received pre-op antibiotics, making sure that blood is on hand for emergency transfusions, and also making sure that every member of the surgical team knows everyone else’s name.

In those hospitals in which the checklist was enforced surgical complications decreased on average by more than a third. That is a significant reduction, and saved hundreds of lives. This kind of impact is akin to the introduction of sterile technique.

Checklists are effective, Gawande argues, because some systems in our civilization have become too complex for the human mind to master. We have essentially crafted a civilization that is beyond our ability to manage using just raw brain power. Further, the consequences of minor mental error can be catastrophic – forget to flip one switch on a jet bomber and the plane may crash, killing everyone aboard. Make a decimal point error in dosing a medication and the patient may die.

Checklists minimize the probability of these small but consequential errors occurring.

This much of the story has been told numerous times on countless blogs and interviews as Gawande is conducting his book tour.

But the really interesting stuff are the other concepts behind the checklist, especially those that have to do with the culture of medicine.

The Culture of Medicine

Culture can be a strange and powerful thing – bestowing upon individuals a suite of assumptions, morals, attitudes, and mental habits of which they may not even be aware. In my opinion the most powerful part of Gawande’s book is when he steps back to consider what the culture of medicine is and how it affects practice (of course, with particular focus on the checklist).

He observes that in medicine the problem of increasing complexity has been handled by increasing expertise and specialization. Mistakes are minimized by training and repetition – so that procedures and patient management become routine. There is something to be said for training and repetition, but Gawande argues that medicine is now too complex for this strategy to be adequately effective. It is a setup for failure.

Rather we need to take the approach that other industries have taken – assume individuals will fail, but create a system that will catch them – the checklist.

This approach works, but may rub some physicians the wrong way – those trained in the culture of individualism and personal prowess and responsibility (sometimes referred to within medical circles as the “cowboy” approach – a term meant to be a little derogatory, although simultaneously containing a measure of respect).

Here I think that Gawande may be a little biased by his surgical background, and I think he may underappreciate that each specialty within medicine has its own subculture. Coming from a specialty at the more nerdy and less cowboy end of the medical cultural spectrum, I find nothing threatening about the concept of checklists or similar safeguards.

I also think this culture is generational – my experience with younger doctors in training is that they readily, even eagerly, adopt systems that help them avoid mistakes. They never knew a day when medicine was not so horrifically complex and ever changing that physicians could not use some external help to aid their inadequate brains.

Discipline and the Rise of the Machines

Another aspect of medical culture that Gawande touches on is the broader culture of professionalism itself. He argues that most professions are built upon the ethics of selflessness, expertise, and trustworthiness. However, some professions include the additional ethic of discipline – an ethic that is perhaps lacking in medicine.

Discipline in this context means doing the right things in detail every time. People and cultures have varying ability to be rigidly disciplined, but in general humans lack the kind of discipline that would preclude even the occasional lapse. A checklist is an outside imposition of discipline – to shore up a specific human weakness.

Taking this concept one step further, I would add that discipline is something machines do very well. If you give a computer a set of instructions, you can count on it to perform those instructions millions of times without variation.

I recently discussed elsewhere that there will likely be an increasing role of expert systems in the practice of medicine. This  includes things like systems for analyzing radiographic studies and highlighting potential pathology, checking for drug-drug interactions when new prescriptions are written, suggesting possible diagnoses to be considered, and, yes, running through checklists or algorithms of proper evidence-based management. This may be as simple as reminding a physician to consider prescribing cardiovascular prophylaxis to their 60 year old patient with hypertension (something which does not happen as often as it should).

The checklist is therefore just one of many similar interventions that can aid all health care providers in the practice of their profession. And the advent of computers will likely aid in the implementation of checklists, algorithms, reminder systems, and automatic cross-checks – all with the goal of minimizing error and optimizing the practice of medicine.

Conclusion

Science-based medicine has been incredibly successful in extending and improving human life. It is also, in some ways, a victim of its own success. We now have more knowledge than any single expert can hope to know. We have developed advanced medical technology that works wonders, but amplifies the consequences of even minor errors. And we have raised the bar of expectation and professionalism to dizzying heights.

Gawande’s book not only provides us with an additional tool to deal with this growing complexity, but he encourages the entire profession (and other professions) to step back and look at the culture(s) and systems of medicine – to examine and challenge our assumptions, assess our approach to problem solving, and reconfigure ourselves to move forward.

I would like to step back even further and observe that Gawande’s book represents the deepest strength of the medical culture – it is earnestly self reflective. Harriet Hall’s post from yesterday represents another example of this, reflecting on the need to optimize the human element of every patient interaction, in the face of advancing technical demands.

Meanwhile the overarching purpose of science-based medicine is to reflect upon the optimal relationship between science and the practice of medicine.

BACKGROUND: A BAD, BAD LAW

One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

In other words, when a supplement is marketed it’s more or less the honor system. No registration with the FDA is required. After all, supplements are food, not medicine! In effect, the government can’t really do anything unless problems are reported after the supplement is marketed. Even worse, the definition of “supplement” has become very broad, as Quackwatch points out:

DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

In other words, under the DSHEA, substances that are clearly not foods can be marketed as supplements, including herbs and other botanicals (the vast majority of which are marketed as having a beneficial medicinal effect and some of which contain chemicals that do act as drugs). As long as the manufacturer is careful not to make specific health claims, it’s all good. In other words, a “nutritional support” statement claimed for a supplement must not be a “drug” claim; i.e., it must not claim that the supplement can be used for the treatment or prevention of a disease. Supplement manufacturers easily evade this requirement by making vaguer claims related to organs or systems, such as claiming that a product “boosts the immune system,” “supports heart health,” or something similar, often accompanied by what Dr. Lipson has sarcastically referred to as the “quack Miranda warning“:

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

It doesn’t take too much searching to find supplement advertising that does claim to treat, cure, or prevent disease.

The DSHEA was the greatest boon to supplement manufacturers ever. In its wake, the supplement industry exploded, racking up huge increases in sales. Indeed, a recent GAO report estimated that the supplement industry has grown to a $23.7 billion industry in 2007. Moreover, so lax is the regulation of supplements that it took a very extreme and egregious act, namely the marketing of an industrial chelator as an “antioxidant” supplement for the treatment of autism, before the FDA finally acted. Over the years, supporters of science-based medicine and sound public policy have made efforts to alter or repeal the DSHEA. All have failed. Tom Harkin and Orrin Hatch are powerful patrons, and Utah is home to many supplement manufacturers, whose interests Hatch zealously defends. Indeed, when adulterated supplements manufactured in Utah caused Olympic athletes to test positive for banned drugs and the International Olympic Committee warned athletes to avoid banned supplements, particularly those manufactured in Utah, Hatch leapt to the defense of the supplement manufacturers:

…he [Hatch] has been unapologetic in his support for the supplement industry, having battled the FDA and other federal agencies over the regulation of vitamins, herbals, and other natural medicines for more than a decade…Hatch considers his 1994 law, DSHEA, a triumph on behalf of consumer health freedom. But a close look suggests that if anything, DSHEA (or the Hatch Act, as body builders call it) has left Americans “free” to serve as guinea pigs for a multibillion-dollar industry, much of which is built on a foundation of fraudulent claims, pyramid schemes, and lousy manufacturing practices.

We here at Science-Based Medicine have said much the same thing multiple times. Last week, I learned that yet another effort is being made to strengthen the DSHEA and close some of its loopholes. This effort comes in the form of a law under consideration, the Dietary Supplement Safety Act of 2010. It is a law proposed by, of all legislators, John McCain.

Can the Dietary Supplement Safety Act of 2010 fix the DSHEA?

On February 3, 2010 Senator John McCain (R-AZ) gave a speech announcing new legislation that he was introducing, the Dietary Supplement Safety Act of 2010:

Like many of you, I am looking forward to watching the Super Bowl this Sunday and the Winter Olympics later this month. However, a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy. Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.

It is for precisely this reason that today Senators Dorgan and I are proud to introduce the Dietary Supplement Safety Act of 2010. All Americans should know the exact ingredients of any dietary supplement they use and the FDA must have the tools necessary to ensure the safety of dietary supplements.

This legislation would require dietary supplement manufactures to register with the FDA and fully disclose the ingredients contained in the supplement. Surveys have found that a majority of dietary supplement users believe the FDA approves the safety of dietary supplements prior to market introduction. However, that is not the case. In fact, dietary supplement manufacturers’ advertised claims of safety and effectiveness are not reviewed or approved by the FDA.

The complete text of the bill can be found here. Perhaps the most promising aspect of the McCain-Dorgan Bill is that it provides the FDA with mandatory recall authority if a supplement is found to be unsafe or harmful. Part of the reason that the government could do little about, for example, ephedra, which it took the FDA over a decade to be able to ban, despite multiple deaths linked to supplements containing it. Perhaps the most notorious death attributed to ephedra-containing supplements was that of Steve Bechler, a pitcher for the Baltimore Orioles, who died of heat strokefollowing a spring training workout in 2003. The medical examiner found that ephedra toxicity played a “significant role” in Bechler’s sudden death. Sad to say that cleaning up sports seems to be the primary motivation behind Senator McCain’s decision to take on the DSHEA, rather than protecting the public at large, but, whatever his motivation, it is good to see a legislator trying to make some corrections to the abomination of a travesty that is the DSEA of 1994. Indeed, as long as 6 years ago, McCain appeared to get it:

McCain voted for DSHEA, the 1994 law that gutted the federal government’s authority to oversee supplements — and that triggered the explosive growth in the sale of everything from horny goat weed to bee feces. But he says: “I’m not satisfied at all. The bill I voted for, frankly, I was not as aware of it as I should have been.”

Now McCain would like to force makers of supplements or any substance that affects the human body to test their products before bringing them to market. Given that the supplement manufacturers have huge political influence in Congress — they can mobilize millions of loyal customers, and they have a powerful patron in Sen. Orrin Hatch, R-Utah — that’s not likely to happen.

The bill has a number of good features. One part that I like is that the DSSA mandates that all adverse events be reported to the FDA, including non-serious ones. As mentioned by Senator McCain, it also includes expanded power for the FDA to issue cease distribution and notification order requiring that the manufacturer cease sales and marketing of the supplement in question. It also provides a mechanism for a hearing within ten days for the manufacturer to defend itself against the charges. After the hearing, the FDA may then issue a formal recall if it finds adequate evidence that the supplement is unsafe. While it is true that the DSHEA does currently allow the FDA to ban supplements, it does not, as I understand it, give the FDA the power to issue a rapid order to cease distribution or to mandate a recall this quickly, nor does it require supplement manufacturers to register with the FDA. All in all, it is a welcome modification of a very bad law. Although it does not go far enough, it is a bill that supporters of science-based medicine should support.

Not surprisingly, the supplement industry is very much opposed to this bill. For example, the Council for Responsible Nutrition (CRN) was fast to respond to Senator McCain’s press conference. In a bit of denialist double-speak that would make tobacco manufacturers blush, the CRN had the audacity to claim that requiring the reporting of all adverse events, not just serious ones, would not do anything to protect consumers. Even more Orwellian, the CRN actually claimed with (apparently) a straight face that the supplement industry had lobbied to “increase the regulation under which the supplement industry operates” and to “increase funding for the FDA’s enforcement efforts.” It supports a different bill, the Senate Food and Drug Administration Food Safety and Modernization Act (S.510), sponsored by Senator Richard Durbin (D-IL).

My reading of Durbin’s bill is that, although it too has a number of good features, it does not really address the supplement industry, at least not directly. Rather, it concentrates primarily on sanitation, and adulteration, the inspection of food manufacturing facilities, and regulation of imported food. Indeed, it appears to be primarily an agricultural bill to regulate food safety, and it says nothing about supplements explicitly. Of course, given that the law considers supplements food, supplements would fall under the law, but the law doesn’t really look as though it would actually do much about supplements. Certainly, it would not require supplement manufacturers to report all adverse events. No wonder the supplement industry likes it better than the McCain bill. S.510 would do little or nothing to reform the DSHEA, and that’s how the supplement industry likes it. Indeed, founder executive director of the American Botanical Council, Mark Blumenthal, essentially said as much when he argued that a new law isn’t necessary, claiming that all that is necessary is “robust enforcement” of the DSHEA. That is, of course, laughable, because even if the DSHEA were enforced to the letter, the problem would remain, namely that the FDA can do nothing about harmful supplements until after the fact and or about deceptive health claims made by supplement manufacturers–again, which is just the way the supplement industry likes it. Indeed, the record of the supplement industry has been to push for the passage of the DSHEA, which weakened the FDA’s authority to protect the public against dangerous supplements, and to fight every substantive effort to fix that travesty of a law.

In fact, if you want the attitude of supplement manufacturers encapsulated, just look at the reaction of attorney Jonathan W. Emord, a flack for the supplement industry:

Emord said a requirement to report non-serious adverse events was “laughable”.

“If it is not serious why bother?” he wondered, noting ‘seriousness’ had not been defined. “Is it when the vitamin bottle drops to the floor and the cat eats every one?”

Of course, I could point out that the FDA does define serious adverse events. Basically an SAE is a complication that is either life-threatening or require hospitalization and requires mandatory reporting. Even then, there was no guarantee that an adverse event due to a supplement would be reported because often such events are not linked to various supplements that people take. However, there are quite a few adverse events that might not fall under the FDA’s definition of “serious” that are significant, and there is currently no requirement that these be reported.

I’m not a politician, nor am I a political blogger. I don’t know what the chances are that the DSSA will pass congress. I’m not very optimistic, though. For one thing, it’s being introduced by a Senator from the minority party, although Senator Byron Dorgan (D-ND) is a Democrat. More importantly, it’s likely to run into a buzzsaw of opposition, thanks to Senators Hatch and Harkin. On the other hand, the publicity of the Winter Olympics may help get this bill some traction, and the emphasis of athletes who have either been harmed or tested positive for banned substances, thanks to adulterated supplements. Still, my guess is that the bipartisan tag-team of woo, Senators Harkin and Hatch, will guarantee that the DSSA dies a quiet death. Hatch will do it for his campaign contributors in the supplement industry; Harkin will do it because he’s a true believer.

I’d love to be proven wrong, but doubt that I will be. After all, Senator McCain has been trying to tighten regulation of the supplement industry since 2004. For all the features it shares with the DSSA, I don’t think Durbin’s bill goes far enough because it doesn’t directly address supplements in a manner in which they need to be addressed to fix the DSHEA, and that is why I prefer the McCain bill at present. In fact, even the McCain bill doesn’t appear to go far enough in that it seems to leave the DSHEA largely intact in terms of what supplement manufacturers are allowed to say in their advertisements. Even so, the McCain-Dorgan bill strikes me as unlikely to pass unless there is a groundswell of public support for it, which is why I hope you will contact your Senators and tell them you support the bill and hope that they will support it too.

Whatever bill passes, the McCain or Durbin bill, as has been true for 16 years now, something needs to be done to fix the the DSHEA, or, as I like to call it, the Supplement Manufacturer’s Protection Act. As long as the DSHEA remains intact, it’s more or less the honors system for supplement manufacturers, and I don’t trust supplement manufacturers any more than many trust big pharma. In fact, in many cases, they are becoming one and the same. Big pharma recognizes profit potential when it sees it, and supplements can be marketed without all that pesky and expensive testing that are required for new drugs.

In 1925, Francis Peabody famously said “The secret of the care of the patient is in caring for the patient.” A new book by Norman Makous, MD, a cardiologist who has practiced for 60 years, is a cogent reminder of that principle.

In Time to Care: Personal Medicine in the Age of Technology, Dr. Makous tackles a big subject. He attempts to show how modern medicine got to where it is today, what’s wrong with it, and how to fix it. For me, the best part of the book is the abundance of anecdotes showing how medicine has changed since Dr. Makous graduated from medical school in 1947. He gives many examples of what it was like to treat patients before technology and effective medications were introduced. He describes a patient who died of ventricular fibrillation before defibrillators were invented, the first patient ever to survive endocarditis at his hospital (a survival made possible by penicillin), a polio epidemic before polio had been identified as an infectious disease, the rows of beds in the tuberculosis sanitariums that no longer exist because we have effective treatments for TB. He tells funny stories: the patient who was examined with a fluoroscope and told the doctor he felt much better after that “treatment.” He describes setting up the first cardiac catheterization lab in his area. No one who reads this book can question the value of scientific medicine’s achievements between 1947 and 2010. Today we can do ever so much more to improve our patients’ survival and health. But in the abundance of technological possibilities, the crucial human factor has been neglected.

Individualized care, which involves the use of science-inspired technology, is not personal care. Alone, it is incomplete. It does not provide the necessary reassurance that can only be provided through a trusted physician who focuses upon the totality of the person and not just upon a narrow technological application to a disease. Time and personal commitment are needed to build the mutual understanding and trust that are fundamental to personal care….the continued acceleration of science, technology, and cost has intruded on personal care in our country. This has also occurred during a time in which American individualism and its accompanying sense of entitlement have become more of a cult than ever before. In the absence of personal attention, patients demand more testing, but testing does not satisfy the need for personal interaction.

Makous invokes the Golden Rule: “Over the course of my career, I learned to treat patients as I would like to be treated under similar circumstances.”

Some of his recommendations:

• Unhurried visit
• Undivided attention to patient (not to chart or recording device)
• Sitting down to talk to the patient
• Laying on of hands
• Humor
• And finally, “Most patients will choose a doctor who enjoys their company.”

Makous points out that the “holistic” approach to medicine is nothing new: Hippocrates introduced the concept in the 5th century BC and good clinicians have always used it.

Medicine is an applied science, not an exact science, and often the best the physician can do is make an educated guess. The better the doctor knows the patient and the better he incorporates the personal element of care, the more educated the guess. For instance, knowing whether a patient is typically stoic or a complainer helps us decide how seriously to take his complaints. The “worried well” typically complain about every little thing; the stoic may not realize they are ill until they can’t get out of bed.

He thinks that evidence-based medicine only helps with about 5% of a physician’s work. Surely evidence-based medicine constitutes a larger percentage than that, but perhaps what he means is that when he is trying to make a difficult clinical decision there is only a pertinent, useful clinical study to guide him in about 5% of cases. Study populations may not be representative of the individual in the doctor’s office. Studies isolate one condition: your patient may have many others. “No study has been done that can’t be faulted in its extrapolation to the individual.” Most studies generate as many questions as they answer.

I agree with much of what he says, but then he goes too far:

The assumption is that physicians relying on personal experience have been on the wrong track and their practices need to be changed. In reality, the opposite is true.

No, relying on personal experience is a recipe for self-deception, and those practices need to be tested. There’s a danger in too much “personalization” of medicine: the doctor can be seduced into believing he is wiser than he really is and into rejecting science. If you think every patient is so different that scientific studies don’t apply, then anything goes. You can find an excuse to try any treatment you can think of. This is similar to the pitfalls of CAM’s claims of individualized treatment, as recently described by David Gorski.

Doctors today must please two masters: the patient and the healthcare organization. Care is fragmented, and specialists feel obligated to do more tests. Consultants often assume they are expected to do certain tests rather than to decide for themselves if the tests are really warranted. They are concerned about liability if they fail to do a test. They are reimbursed for doing the test, but are not reimbursed for the time needed to evaluate the patient holistically and determine if the test is really in his best interest. They are content to assume that the referring physician has already done that. But the referring physician may not know enough about the test to decide, and he may be assuming the consultant will decide appropriately. Costs and malpractice litigation rise as a result. Poor Medicare reimbursement means many doctors are refusing to accept new Medicare patients. We need a system to get more compassionate care to geriatric patients, more time with their doctors, not more technology.

Physicians are reimbursed lavishly for doing procedures but not for spending extra time talking to patients. They are not reimbursed adequately for counseling about preventive measures. Makous suggests that detailed advice on obesity and smoking might be better addressed as a public health concern and provided by non-physicians.

This is a thoughtful book by a wise old soul who has “been there, done that.” It is well worth reading for the insight it provides into recent medical history and for its reminder that doctors should treat patients as they themselves would want to be treated.

On Science-Based Medicine, several of us have at various times criticized state medical boards for their tolerance of unscientific medical practices and even outright quackery. After all, Dr. Rashid Buttar still practices in North Carolina and the medical board there seems powerless to do anything about it. However, state medical boards have other functions, one of which is to respond to complaints of unethical and dubious behavior about doctors. Key to this function is protection; i.e., if someone reports a doctor, that person needs to be sure that the state will protect her from retaliation from that doctor of the hospital. About five months ago, I reported a true miscarriage of justice, the sort of thing that should never, ever happen. In brief, it was the story of two nurses who, disturbed at how a local doctor was peddling his dubious “herbal” concoctions in the emergency room of the local hospital when he came in to see patients, reported him to the authorities. Moreover, they had gone up the chain of command, first complaining to hospital authorities. After nothing happened for months, they decided to report the physician, Dr. Rolando Arafiles, to the Texas Medical Board because they honestly believed that this physician was abusing his trust with patients and behaving unethically by improperly hawking herbal supplements that he was selling in the rural health clinic and the emergency room of Winkler County Memorial Hospital.

Even though under whistleblower laws the identities of these nurses should have been kept secret, after he learned that a complaint had been filed against him Dr. Arafiles went to his buddy the Winkler County Sheriff Robert L. Roberts, who left no stone unturned in trying to find out who had ratted out Dr. Arafiles:

To find out who made the anonymous complaint, the sheriff left no stone unturned. He interviewed all of the patients whose medical record case numbers were listed in the report and asked the hospital to identify who would have had access to the patient records in question.

At some point, the sheriff obtained a copy of the anonymous complaint and used the description of a “female over 50? to narrow the potential complainants to the two nurses. He then got a search warrant to seize their work computers and found a copy of the letter to the medical board on one of them.

The result was this:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

On Saturday, the New York Times reported on the story, as there have been significant developments since August. Specifically, although the charges against one of the nurses has been dismissed, Anne Mitchell, RN, is going to stand trial beginning today:

But in what may be an unprecedented prosecution, Mrs. Mitchell is scheduled to stand trial in state court on Monday for “misuse of official information,” a third-degree felony in Texas.

The prosecutor said he would show that Mrs. Mitchell had a history of making “inflammatory” statements about Dr. Rolando G. Arafiles Jr. and intended to damage his reputation when she reported him last April to the Texas Medical Board, which licenses and disciplines doctors.

Mrs. Mitchell counters that as an administrative nurse, she had a professional obligation to protect patients from what she saw as a pattern of improper prescribing and surgical procedures — including a failed skin graft that Dr. Arafiles performed in the emergency room, without surgical privileges. He also sutured a rubber tip to a patient’s crushed finger for protection, an unconventional remedy that was later flagged as inappropriate by the Texas Department of State Health Services.

Charges against a second nurse, Vickilyn Galle, who helped Mrs. Mitchell write the letter, were dismissed at the prosecutor’s discretion last week.

So let me get this straight (yet again). A dedicated nurse does what her professional code of ethics demands that she do, even knowing at the time that she did it that it might cost her her job, and the end result is that the good ol’ boy network in Texas tries to throw her in jail for three years on trumped up charges that even the Texas Medical Board states are bogus. Even Ms. Galle won’t be unscathed. As the Texas Nurses Association points out, she will have a felony indictment on her record, which will haunt her the rest of her professional career. In fact, in all my years in medicine, I cannot recall a more blatant example of punishing a whistleblower or of the good ol’ boys network getting together to punish an uppity nurse who dared to call a doctor out on his unethical behavior, which was described in a bit more detail in the NYT story:

It was not long after the public hospital hired Dr. Arafiles in 2008 that the nurses said they began to worry. They sounded internal alarms but felt they were not being heeded by administrators.

Frustrated and fearing for patients, they directed the medical board to six cases “of concern” that were identified by file numbers but not by patient names. The letter also mentioned that Dr. Arafiles was sending e-mail messages to patients about an herbal supplement he sold on the side.

Mrs. Mitchell typed the letter and mailed it with a separate complaint signed by a third nurse, who wrote that she had resigned because of similar concerns about Dr. Arafiles. That nurse was not charged.

To convict Mrs. Mitchell, the prosecution must prove that she used her position to disseminate confidential information for a “nongovernmental purpose” with intent to harm Dr. Arafiles.

One thing that I hadn’t known before is that Sheriff Robert L. Roberts had been a patient of Dr. Arafiles and credited him with saving his life, and he went on a vendetta, abusing his power in an outrageous manner to track them down. One wonders if he spends as much effort trying to hunt down real criminals, such as thieves and murderer, as he did in trying to hunt down two nurses doing their duty. Moreover, from the NYT story, the justifications of Stan Wiley, hospital administrator for Winkler County Hospital, made it clear (to me, at least) that the reason the hospital is standing by Dr. Arafiles is not because he’s a good doctor, but rather because they have a hard time recruiting doctors to west Texas, having recruited Dr. Arafiles even though he had a restriction on his license and had been in trouble with the state medical board before. Particularly galling and disingenuous was his claim:

Mr. Wiley said he believed that the nurses had acted in bad faith because they went to the state despite his internal efforts to discipline Dr. Arafiles. But, he said, “I don’t believe they did it on a personal vendetta.”

Unfortunately for Mr. Wiley, that does not appear to be the definition of “bad faith” under Texas law. It does not require that the whistleblower wait for the hospital to act on reports against a doctor, contrary to what Wiley said. He may think that’s bad faith, but it’s not. Mitchell and Galle could have gone straight to the Texas Medical Board without even trying to go through the hospital administration if they had wanted and it would not have been bad faith. As the story explains, under Texas law, good faith requires only a reasonable belief that the conduct being reported is illegal, and the Texas State Medical Board has stated that it believes the nurses reported Dr. Arafiles’ activities in good faith. Wiley is just plain wrong about this; it isn’t even close. The most likely explanation for his supporting this outrageous abuse of prosecutorial power is that hospital administration was roundly embarrassed (as it should be) when this story came out. It didn’t act; so Mitchell and Galle did. That these two nurses felt obligated to risk their careers (and, even though they couldn’t have known it at the time, their freedom) by reporting Dr. Arafiles derived not from bad faith, but from the ineffectiveness of the hospital’s response.

Indeed, the very fact that Sheriff Roberts and County Attorney Scott D. Tidwell continue to pursue this case to trial strongly suggests that it is not Ms. Mitchell who’s engaging in a vendetta. Rather, it’s Dr. Arafiles through his buddy Sheriff Roberts and the clueless County Attorney Scott Tidwell who are all teaming up to engage in a bit of payback against two brave but hapless nurses. It’s so blatantly obvious from even a cursory examination of the case, and a deeper examination only reinforces this point. It is utterly outrageous and unforgivable, and there’s definitely something rotten in west Texas, specifically Winkler County. Regardless of whether Dr. Arafiles is guilty of abusing his medical license and practicing medicine that endangers patients, what’s rotten in west Texas goes under the names of Dr. Rolando Arafiles, Jr., Sheriff Robert L. Roberts, Jr., and County Attorney Scott M. Tidwell.

Not to mention Winkler County Hospital.

ADDENDUM: You and I can help fight this abuse of power by contributing to Mitchell and Galle’s legal defense fund through the a link on the Texas Nurses Association website’s front page. Mitchell and Galle’s careers have been ruined through this malicious prosecution; they can’t find work and may never be able to find work as nurses again, at least not in west Texas, and they’ve racked up huge legal bills trying to defend themselves.

“Ridiculing RCTs and EBM”

Last week Val Jones posted a short piece on her BetterHealth blog in which she expressed her appreciation for a well-known spoof that had appeared in the British Medical Journal (BMJ) in 2003:

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

Dr. Val included the spoof’s abstract in her post linked above. The parachute article was intended to be humorous, and it was. It was a satire, of course. Its point was to call attention to excesses associated with the Evidence-Based Medicine (EBM) movement, especially the claim that in the absence of randomized, controlled trials (RCTs), it is not possible to comment upon the safety or effectiveness of a treatment—other than to declare the treatment unproven.

A thoughtful blogger who goes by the pseudonym Laika Spoetnik took issue both with Val’s short post and with the parachute article itself, in a post titled “NotSoFunny – Ridiculing RCTs and EBM.”

Laika, whose real name is Jacqueline, identifies herself as a PhD biologist whose “work is split 75%-25% between two jobs: one as a clinical librarian in the Medical Library and one as a Trial Search Coordinator (TSC) for the Dutch Cochrane Centre.” In her post she recalled an experience that would make anyone’s blood boil:

I remember it well. As a young researcher I presented my findings in one of my first talks, at the end of which the chair killed my work with a remark that made the whole room of scientists laugh, but was really beside the point…

This was not my only encounter with scientists who try to win the debate by making fun of a theory, a finding or …people. But it is not only the witty scientist who is to *blame*, it is also the uncritical audience that just swallows it.

I have similar feelings with some journal articles or blog posts that try to ridicule EBM – or any other theory or approach. Funny, perhaps, but often misunderstood and misused by “the audience”.

 Jacqueline had this to say about the parachute article:

I found the article only mildly amusing. It is so unrealistic, that it becomes absurd. Not that I don’t enjoy absurdities at times, but absurdities should not assume a life of their own.  In this way it doesn’t evoke a true discussion, but only worsens the prejudice some people already have.

Jacqueline argued that two inaccurate prejudices about EBM are that it is “cookbook medicine” and that “RCTs are required for evidence.” Regarding the latter, she made reasonable arguments against the usefulness or ethics of RCTs for “prognostic questions,” “etiologic or harm questions,” or “diagnostic accuracy studies.” She continued:

But even in the case of interventions, we can settle for less than a RCT. Evidence is not present or not, but exists on a hierarchy. RCT’s (if well performed) are the most robust, but if not available we have to rely on “lower” evidence.

BMJ Clinical Evidence even made a list of clinical questions unlikely to be answered by RCT’s. In this case Clinical Evidence searches and includes the best appropriate form of evidence.

1. where there are good reasons to think the intervention is not likely to be beneficial or is likely to be harmful;
2. where the outcome is very rare (e.g. a 1/10000 fatal adverse reaction);
3. where the condition is very rare; [etc., for a total of 6 more categories]

In asserting her view of another inaccurate prejudice about EBM, Jacqueline took Dr. Val and Science-Based Medicine to task:

Informed health decisions should be based on good science rather than EBM (alone).

Dr. Val: “EBM has been an over-reliance on “methodolatry” - resulting in conclusions made without consideration of prior probability, laws of physics, or plain common sense. (….) Which is why Steve Novella and the Science Based Medicine team have proposed that our quest for reliable information (upon which to make informed health decisions) should be based on good science rather than EBM alone.”

Methodolatry is the profane worship of the randomized clinical trial as the only valid method of investigation. This is disproved in the previous sections.

The name “Science Based Medicine” suggests that it is opposed to “Evidence Based Medicine”. At their blog David Gorski explains: “We at SBM believe that medicine based on science is the best medicine and tirelessly promote science-based medicine through discussion of the role of science and medicine.”

While this may apply to a certain extent to quack[ery] or homeopathy (the focus of SBM) there are many examples of the opposite: that science or common sense led to interventions that were ineffective or even damaging, including:

• protective effects of beta-carotene on lung cancer (opposite)
• protective effects of vitamin E on cardiovascular disease (opposite) or certain cancers (neutral)
• protective effects of the prone sleeping on Sudden Infant Death Syndrome (opposite)
• Protective effects of corticosteroids in severe head trauma (opposite)
  etcetera.

As a matter of fact many side-effects are not foreseen and few in vitro or animal experiments have led to successful new treatments.

At the end it is most relevant to the patient that “it works” (and the benefits outweigh the harms).

Furthermore EBM is not -or should not be- without consideration of prior probability, laws of physics, or plain common sense. To me SBM and EBM are not mutually exclusive.

Jacqueline finished by quoting a few comments that had appeared on the BMJ website after the parachute article. Some of them (not all, I’m happy to report) revealed that their authors lacked a sense of humor. Another argued that “EBM is not RCTs.” Still others argued that RCTs are valuable for precisely the reason illustrated by Jacqueline’s examples listed above: that even some, seemingly safe and effective treatments—based on science or common sense or clinical experience—have eventually been shown, when subjected to RCTs, to behave otherwise. No one at SBM would argue the point.

Science-Based Medicine is Not Opposed to Evidence-Based Medicine

I am confident in asserting that we at SBM are in nearly complete agreement with Jacqueline regarding how EBM ought to be practiced. We are, I’m sure, also in agreement that many objections to EBM are specious. Among these, soundly criticized on this site, are special pleadings and bizarre post-modern arguments. The name “Science-Based Medicine” does not suggest that we are opposed to EBM. What it does suggest is that several of us consider EBM to be incomplete in its gathering of evidence, incomplete in ways that Jacqueline herself touched upon. I explained this in a series of posts at the inception of SBM in 2008 (wait for the link), and I discussed it further at TAM7 last summer. As such, Managing Editor David Gorski invited me to respond to Jacqueline’s article. I am happy to do so because, in addition to clarifying the issues for her, it is important to review the topic periodically: The problems with EBM haven’t gone away, but readers’ memories are finite.

Let me begin by asserting that everyone here agrees that large RCTs are the best tools for minimizing bias in trials of promising treatments, and that RCTs have repeatedly demonstrated their power to refute treatment claims based solely on physiology, animal studies, small human trials, clinical judgment, or whatever. I made the very point in my talk at TAM7, offering the Cardiac Arrhythmia Suppression Trial and the Women’s Health Initiative as examples. We also agree that there are some situations in which RCTs, whether for logistical, ethical, or other reasons, ought not to be used or would not yield useful information even if attempted. Parachutes are an example, but there are subtler ones, e.g., the efficacy of pandemic flu vaccines or whether the MMR vaccine causes autism. As we shall see, however, the list of exceptions offered by Jacqueline and BMJ Clinical Evidence is neither a formal part of EBM nor universally accepted by EBM practitioners.

To reiterate: The most important contribution of EBM has been to formally emphasize that even a high prior probability is not always sufficient to establish the usefulness of a treatment—parachutes being exceptions.

EBM’s Scientific Blind Spot

Now, however, we come to an important problem with EBM, a problem not merely of misinterpretations of its tenets (although such are common), but of the tenets themselves. Although a reasonably high prior probability may not be a sufficient basis for incorporating a treatment into general use, it is a necessary one. It is, moreover, a necessary basis for seriously considering such a treatment at all; that is, for both scientific and ethical reasons it is a prerequisite for performing a randomized, controlled human trial. Rather than explain these points here and now, I ask you, Dear Reader, to indulge me by following this link to a post in which I have already done so in some detail. I’ll wait here patiently.

……………….

Are you back? OK. Now you know that we at SBM are in total agreement with Jacqueline that EBM “should not be without consideration of prior probability, laws of physics, or plain common sense,” and that SBM and EBM should not only be mutually inclusive, they should be synonymous. You also know, however, that Jacqueline was mistaken to claim that EBM already conforms to those ideals. It does not, and its failure to do so is written right into its Levels of Evidence scheme—the exceptions that she offered, including those quoted from BMJ Clinical Evidence, notwithstanding. You know all of this because you’ve now seen several examples (there are many more) from that wellspring of EBM reviews, Jacqueline’s own Cochrane Collaboration. (There is another, more subtle reason for prior probability being overlooked in EBM literature, but it is an optional exercise for the purposes of today’s discussion).

EBM and Unintended Mischief

The problems caused by EBM’s scientific blind spot are not limited to the embarrassment of Cochrane reviews suggesting potential clinical value for inert treatments that have been definitively refuted by basic science, although that would be sufficient to argue for EBM reform. The Levels of Evidence scheme has resulted in dangerous or unpleasant treatments being wished upon human subjects in the form of RCTs, case-control studies, or case series even when existing clinical or scientific evidence should have been more than satisfactory to put such claims to rest. The Trial to Assess Chelation Therapy (TACT)—the largest, most expensive, and most unethical trial yet funded by the NCCAM—was originally justified by these words in an editorial in the American Heart Journal in 2000, co-authored by Gervasio Lamas, who would later become the TACT Principal Investigator:

The modern standard for accepting any therapy as effective requires that there be scientific evidence of safety and efficacy in a fair comparison of the new therapy to conventional care. Such evidence, when widely disseminated, leads to changes in clinical practice, ultimately benefitting patients. However, the absence of a clinical trial does not disprove potential efficacy, and a well-performed but too small “negative” trial may not have the power to exclude a small or moderate benefit of therapy. In other words, the absence of evidence of efficacy does not constitute evidence of absence of efficacy. These concepts constitute the crux of the lingering controversy over chelation therapy…

Such an argument, with its obvious appeal to the formal tenets of EBM, was made and accepted by the NIH in spite of overwhelming evidence against the safety and effectiveness of Na₂EDTA chelation treatments for atherosclerotic vascular disease, including the several “small” disconfirming RCTs, comprising approximately 270 subjects, to which Dr. Lamas alluded. It was also accepted in spite of its violating both the Helsinki Declaration and the NIH’s own policy stipulating that preliminary RCTs should demonstrate efficacy prior to a Phase III trial being performed.

A 2006 Cochrane Review of Laetrile for cancer would, if its recommendations were realized, stand the rationale for RCTs on its head:

The most informative way to understand whether Laetrile is of any use in the treatment of cancer, is to review clinical trials and scientific publications. Unfortunately no studies were found that met the inclusion criteria for this review.

Authors’ conclusions

The claim that Laetrile has beneficial effects for cancer patients is not supported by data from controlled clinical trials. This systematic review has clearly identified the need for randomised or controlled clinical trials assessing the effectiveness of Laetrile or amygdalin for cancer treatment.

Why does this stand the rationale for RCTs on its head? A definitive case series led by the Mayo Clinic in the early 1980s had overwhelmingly demonstrated, to the satisfaction of all reasonable physicians and biomedical scientists, that not only were the therapeutic claims for Laetrile baseless, but that the substance is dangerous. The subjects did so poorly that there would have been no room for a meaningful advantage in outcome with active treatment compared to placebo—as we have recently seen in another trial of a quack cancer treatment. The Mayo case series “closed the book on Laetrile,” the most expensive health fraud in American history at the time, only to have it reopened more than 20 years later by well-meaning Cochrane reviewers who seemed oblivious of the point of an RCT.

A couple of years ago I was surprised to find that one of the authors of that review was Edzard Ernst, a high-powered academic who over the years has undergone a welcomed transition from cautious supporter to vocal critic of much “CAM” research and many “CAM” methods. He is now a valuable member of our new organization, the Institute for Science in Medicine, and we are very happy to have him. I believe that his belated conversion to healthy skepticism was due, in large part, to his allegiance to the formal tenets of EBM. I recommend a short debate published in 2003 in Dr. Ernst’s Focus on Alternative and Complementary Therapies (FACT), pitting Jacqueline’s countryman Cees Renckens against Dr. Ernst himself. Dr. Ernst responded to Dr. Renckens’s plea to apply science to “CAM” claims with this statement:

In the context of EBM, a priori plausibility has become less and less important. The aim of EBM is to establish whether a treatment works, not how it works or how plausible it is that it may work. The main tool for finding out is the RCT. It is obvious that the principles of EBM and those of a priori plausibility can, at times, clash, and they often clash spectacularly in the realm of CAM.

I’ve discussed that debate before on SBM, and I consider it exemplary of what is wrong with how EBM weighs the import of prior probability. Dr. Ernst, if you are reading this, I’d be interested to know whether your views have changed. I hope that you no longer believe that human subjects ought to be submitted to a randomized, controlled trial of Laetrile!

Finally, for the purposes of today’s discussion, let me reiterate another point that must be considered in the context of establishing, via the RCT, whether a treatment works: When RCTs are performed on ineffective treatments with low prior probabilities, they tend not to yield merely ‘negative’ findings, as most physicians steeped in EBM would presume; they tend, in the aggregate, to yield equivocal findings, which are then touted by advocates as evidence favoring such treatments, or at the very least favoring more trials—a position that even skeptical EBM practitioners have little choice but to accept, with no end in sight. Numerous such examples have been discussed on this website.

The first sentence that I ever posted on SBM, a quotation from homeopath David Reilly, was a perfect illustration of this misunderstanding:

Either homeopathy works or controlled trials don’t!

Dr. Reilly was correct, of course, but not in the way that he supposed. If there is anything that the history of parapsychology can teach the biomedical world, it is the point just made: that human RCTs, as good as they are at minimizing bias or chance deviations from population parameters, cannot ever be expected to provide, by themselves, objective measures of truth. There is still ample room for erroneous conclusions. Without using broader knowledge (science) to guide our thinking, we will plunge headlong into a thicket of errors—exactly as happened in parapsychology for decades and is now being repeated by its offspring, “CAM” research.

Conclusion

These are the reasons that we call our blog “Science-Based Medicine.” It is not that we are opposed to EBM, nor is it that we believe EBM and SBM to be mutually exclusive. On the contrary: EBM is currently a subset of SBM, because EBM by itself is incomplete. We eagerly await the time that EBM considers all the evidence and will have finally earned its name. When that happens, the two terms will be interchangeable.

I had an interesting conversation with a reporter today. She called me to get a “medical/skeptical” counterpoint for an article she is preparing on energy healing. Although I don’t know if she’ll faithfully represent what I had to say, we had an entertaining exchange and so I decided to capture the essence of it here. I’m curious to see which parts of our conversation remain in her final article, due out on February 19th. (Stay tuned for that).

Apparently a local hospital in Maryland is now offering nurse-guided therapeutic touch and Reiki healing for inpatients. She decided to interview the practitioners involved, and turned to me for comment. I did not have the benefit of preparing in advance or having references handy – so I gave it my best shot. I’d be interested to know how you might have responded differently.

1. Is there any scientific evidence that energy healing works?

No. There is currently no conclusive evidence that energy healing is more effective than placebo.  Furthermore, there’s no known mechanism whereby an unmeasurable energy could be manipulated to improve one’s health. Such ideas hearken back to a point in history when we didn’t understand the pathophysiology of disease. Hundreds of years ago we had no idea about bacteria, viruses, and the genetics of cancer for example. We did the best guess work we could – and chalked up diseases to mysterious energy imbalances. But thanks to scientific inquiry, we now know a lot more about the true causes of disease.

2. Why do patients turn to “alternative medicine” modalities like energy healing?

In my view, there are two things that drive people to try alternative medicine: 1) They are not satisfied with their current medical treatment – either because there is no cure or sufficient palliation for their disease/condition, or they may have been misdiagnosed, or their emotional needs have not been adequately addressed and 2) People want to feel in control of their health. Unfortunately, the human death rate is still 100%, no matter how hard we try to cheat it. There comes a time when each of us will be very unhappy with our “health outcome.”

I also think that our fragmented healthcare system (with all its perverse incentives) results in a high degree of frustration, access problems, and insufficient time actually getting to the bottom of diagnostic conundrums. Best Doctors estimates that up to 20% of patients have been given the wrong medical diagnosis – probably because the patients were rushed through a busy office without their medical history (and all the tests and medical records) being adequately reviewed. Our broken system sets people up to look further for solutions – and sometimes the path of least resistance is to pay an alternative medicine practitioner to hear your case.

3. Do you think CAM is popular?

It depends on how you define CAM. If you take the broadest definition of it (and include vitamins and prayer as types of CAM) then, yes, most people have tried it. But if you’re asking how many Americans regularly use Reiki, Reflexology, or healing touch, the number is probably less than 1%. While it’s true that more and more academic institutions are setting up “integrative medicine centers” to incorporate CAM into scientific medical practices, I’m also seeing a growing number of skeptics online and in mainstream media. Newsweek took Oprah to task for her steady parade of TV pseudoscience, Amy Wallace exposed the anti-vaccine movement at Wired Magazine, Dave Whelan is doing some quackery exposes at Forbes, and AP’s Marilynn Marchione has taken on false cancer cures. Even Washington is showing a hint of skepticism – with John McCain’s new bill essentially seeking to bring supplements back under some degree of control by the FDA.

4. Do you think that CAM practitioners are intentionally dishonest and selling their therapies for profit?

Some may be that way, but the majority probably really believe in what they’re doing. There is a tendency for CAM practitioners to support their beliefs with anecdotes, though. They believe that their treatments “work” because they’ve witnessed patients getting better. Of course, a certain percentage of patients will always get better on their own. I also think that there’s great value in “talk therapy” – discussing an illness with a empathic listener can reduce anxiety and make a person feel better. CAM practitioners spend a lot of time listening and expressing empathy – which is probably their secret to success (not the “magical” properties of energy healing).

Remember that placebos have effects, and are especially good at modulating the perception of pain or emotional disturbances. I have no doubt that many CAM therapies have placebo effects.

5. What do you think of reflexology?

The idea that body parts and organ systems can be influenced by applying pressure to the feet is part of an old fashioned system of thinking. There is no “humunculus” on the feet (or ears for that matter) and we have proven that with modern brain imaging. Reflexology was created before we understood how the nervous system works or the complex pathophysiology of disease.

But foot massage does feel good, so I can see why some people might be drawn to reflexology as a proxy for a good foot massage.

6. What do you think of healing touch in hospitals?

I’m not a fan. I think it’s misleading to patients – to use the credibility and trust of the hospital’s “brand” to make patients think that they’re receiving a scientifically-proven therapy.  There’s no conclusive evidence that touching patients makes a difference in most disease outcomes – and I would wager that blocking off time for nurses to engage in compassionate dialog with patients would have a similar positive emotional effect. Why the pretense that something scientific is happening? Let’s just make time for normal caring gestures and some good talk therapy.

7. What about yoga and Pilates?

There’s no doubt that exercise – in pretty much any form – is good for the body. Stretching exercises are a valuable part of physical fitness, and core strengthening can reduce the chance of low back injuries for example. I think that yoga and Pilates – and Tai Chi or bowling for that matter – all have a roll in healthy activity levels. These kind of low impact exercises are particularly good for the elderly, and can help to keep the mind active as well.

As Harriet Hall has written (http://www.sciencebasedmedicine.org/?p=353), psychiatry bashing is a popular media sport. There seems to be a bias against treatment of psychiatric disabilities, and a common claim is that antidepressants are no better than placebo. The New York Times illustrated both the perpetuation of the myth that antidepressants are ineffective, and the increasing and disturbing tendency of major media organizations to confuse the wholesale acceptance of medical press releases with medical journalism.

In Popular Drugs May Help Only Severe Depression The New York Times credulously publicized the findings of a recent study that claimed to show that antidepressants are ineffective in treating mild and moderate depression. Yes, that’s what the study showed, but the study itself is so limited, so fraught with problems, and the conclusions are so misleading that the article is a terrible disservice.

Before we consider what the study showed, let’s think about what kind of evidence we’d need to conclude that antidepressants don’t work.

First, although there are different types of antidepressants, the term used colloquially refers to antidepressants of a specific type, SSRI’s or selective serotonin receptor inhibitors. There are other, older types of antidepressants that are rarely used today because of their unpleasant side effects. Hence any study that claims to show that “antidepressants” are ineffective, must look at SSRIs.

Second, there are literally thousands of studies of SSRIs, and it would be helpful to aggregate the results. Aggregating results can be done in a type of paper known as metaanalysis. Metaanlysis adds the results of multiple similar studies to find trends that might not be apparent in individual small studies. But a metaanlysis is subject to several important limitations that must always be considered. The most important limitation is that the authors of the metaanalysis choose the papers to be included. Bias can be introduced by examining only papers that have a desired outcome; that can be accomplished by restricting the inclusion criteria in arbitrary ways.

Let’s look at the study, Antidepressant Drug Effects and Depression Severity. According to the abstract:

Randomized placebo-controlled trials of antidepressants approved by the Food and Drug Administration in the treatment of major or minor depressive disorder were selected. Studies were included if their authors provided the requisite original data, they comprised adult outpatients, they included a medication vs placebo comparison for at least 6 weeks, they did not exclude patients on the basis of a placebo washout period, and they used the Hamilton Depression Rating Scale (HDRS). Data from 6 studies (718 patients) were included…

… The magnitude of benefit of antidepressant medication compared with placebo increases with severity of depression symptoms and may be minimal or nonexistent, on average, in patients with mild or moderate symptoms. For patients with very severe depression, the benefit of medications over placebo is substantial.

According to one of the authors was interviewed for the NYTimes article:

“The message for patients with mild to moderate depression,” Dr. DeRubeis said, “is, ‘Look, medications are always an option, but there’s little evidence that they add to other efforts to shake the depression — whether it’s exercise, seeing the doctor, reading about the disorder or going for psychotherapy.’ ”

Let’s go back and compare the paper to the criteria we identified above. The first criterion was to look at the antidepressants currently used in clinical practice. But out of the 6 studies in the metaanalysis, 3 looked at imipramine, a tricyclic antidrepressant that has not been the standard of care for over a decade because of its unpleasant side effects. The other three studies looked at Paxil (paroxitene). Paxil is an SSRI, but it is only one member of the class of SSRIs. Although all SSRIs share the same mechanism of action, they have different profiles of effectiveness and side effects. Therefore, generalizing from Paxil to all SSRIs cannot be justified.

So in terms of clinically relevant information, the paper included only 3 studies of an SSRI. How did the authors whittle down thousands of papers on SSRI effectiveness to only 3? According to the authors:

The criteria for inclusion required studies to be randomized placebo controlled trials of an FDA-approved antidepressant in the treatment of the full range of patients with major or minor depressive disorder … In addition, the studies had to include an ADM/placebo comparison of at least 6 weeks’ duration and HDRS scores at intake and at the end of treatment. Studies were excluded if they excluded patients on the basis of a placebo washout period. The final inclusion criterion was that individual patient-level data had to be available for analysis.

Are these criteria relevant? Certainly, the inclusion of only RCTs is a reasonable criterion. However, it is not clear why the availability of patient level data is a relevant criterion. Most RCTs, from an enormous range of clinical investigations, do not include patient level data, and using that as a criterion is bound to exclude most studies.

Finally, the decision to remove studies that included a placebo washout period also excludes a vast swath of psychiatric studies. That decision is more defensible, however, since there is disagreement among psychiatric researchers about whether a placebo washout period introduces bias into the study. A placebo washout period involves treating everyone in both arms of the study with placebo for an initial period of time, often 3 weeks. People who respond to placebo are then excluded from the study. The theory is that excluding known placebo responders makes it easier to identify real effects.

Others have argued that excluding known placebo responders up front necessarily makes the drug effects look better than they would have. For example, in a traditional placebo controlled RCT, there might be 30% who respond to placebo and 50% who respond to the medication under study, for a difference of 20%. If some placebo responders are identified during a washout period, let’s say 20% of patients, they will be excluded. The final results may be that 10% responded to placebo and 50% responded to the medication under study, for a difference of 40%, making the medication under study look better.

There is one indisputably arbitrary criterion that is acknowledged by the authors. The initial analysis identified 23 studies, but they could only gain access to the data in 6 studies, so they simply ignored the other 17.

In summary, then, by using questionable exclusion criteria, the authors accessed only 3 clinically relevant studies (the Paxil studies), involving only one SSRI. It is not clear that these studies are representative of existing studies on SSRIs, or even if they can be generalized to other SSRIs. Dr. Rubeis’ assertion that for patients with mild to moderate depression there is little evidence that “medications” add to efforts to treat the depression cannot be justified by the findings in his study. I find his claims to be irresponsible. The paper adds to the literature on antidepressants but is so limited that it cannot tell us whether antidepressants are effective for mild to moderate depression.

In 1998 Andrew Wakefield and 11 other co-authors published a study with the unremarkable title: Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Such a title would hardly grab a science journalist’s attention, but the small study sparked widespread hysteria about a possible connection between the mumps-measles-rubella (MMR) vaccine and autism spectrum disorder (ASD).

The study itself has not stood the test of time. The results could not be replicated by other labs. A decade of subsequent research has sufficiently cleared the MMR vaccine of any connection to ASD. The lab used to search for measles virus in the guts of the study subjects has been shown to have used flawed techniques, resulting in false positives (from the Autism Omnibus testimony, and here is a quick summary). There does not appear to be any association between autism and a GI disorder.

But it’s OK to be wrong in science. There is no expectation that every potential finding will turn out to be true – in fact it is expected that most new finding will eventually be found to be false. That’s the nature of investigating the unknown. No harm no foul.

Andrew Wakefield, however, was apparently guilty of more than just getting it wrong, or even of being a sloppy scientist. He has been the subject of an ethics investigation by the General Medical Council who recently concluded that:

The General Medical Council ruled he had acted “dishonestly and irresponsibly” in doing his research.

David Gorski has the full report on the GMC ruling, which I will not repeat.

What is also at issue, however, is the integrity of the published peer-reviewed medical research. Again – there is not the expectation that peer-reviewed research will always get the answer right. In fact, the published research stands as an important record of error – the blind alleys, red herrings, false correlations, and erroneous conclusions that are part of the history of science.

However, error should not include scientific fraud, or science that is thoroughly misrepresented. One aspect of the transparency demanded by science, and increasingly an issue, is disclosure of potential conflicts of interest. This is the issue that first got Wakefield in hot water with the Lancet – the journal that published his original research. Wakefield was being paid as an expert by lawyers who were suing over alleged vaccine injury. In fact some of the children in the study were the children of parents who were suing. This is a massive conflict of interest.

When this came to light the Lancet responded by contacting the co-authors of the article and essentially asking them if they still stand by the results of the study. Ten of the original 12 authors of the study retracted their support for the study and its interpretation. In 2004 the Lancet published a retraction. However, it was only a partial retraction, and the study remained as part of the published literature.

In the wake of the GMC ruling, however, the Lancet has once again reviewed the study and concluded that there is now sufficient evidence of wrongdoing on Wakefield’s part to print a full retraction. Here is the entire text of the article:

Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were “consecutively referred” and that investigations were “approved” by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.

This should be the final nail in the coffin of this controversial and harmful study. Coming 12 years after the original paper, after just about every element of the research and its findings have been refuted, the Lancet retraction almost seems unecessary. But it is necessary and important. As the retraction indicates – it removes this dubious research from the published record.

While we can all celebrate this move, I also believe it highlights the need for scientific journals to have a lower threshold in retracting published studies that are found to be fraudulent, or are so flawed either ethically or scientifically that they should never have been published in the first place.

The process of editorial and peer-review is not perfect, and given the number of papers that are published there is no way to keep dubious, even fraudulent, research from slipping past the goalies. But peer-review does not stop when a paper is published – in fact that is when it begins in earnest. So it is common for serious problems with a paper to be discovered only after they are published. When this happens, the journal editors should be willing to admit error and correct their mistakes.

An example of the importance of correcting the published record is the Cha/Wirth/Lobo study conducted at Columbia University and published in the Journal of Reproductive Medicine in 2001. The study alleged to find that intercessory Christian prayer doubled the success of in-vitro fertilization. However, Rogerio Lobo, presented as the lead author, later acknowledged that he had nothing to do with the conduction of the study. His name was removed from the authors list in 2004.

But much worse than that, Daniel Wirth, who is not an MD and is not affiliated with Columbia University and who seems to be most responsible for the study results, was indicted by a federal grand jury and pleaded guilty to conspiracy to commit fraud. (See this excellent article by Bruce Flamm for all the details.) Essentially this study was conducted by a paranormal researcher with the resume of a con-artist.

And yet, the Journal of Reproductive Medicine has refused to admit error and retract the paper. It remains listed on PubMed, without any hint that the study has been seriously called into question.

They have published a clarification by the third author, Kwang Cha, who is digging in and defending the paper, writing:

This deliberate design constraint made it impossible for Mr. Wirth to have played any role in manipulating or altering the data.

I find it very difficult to believe that manipulation was “impossible.” I think Dr. Cha overestimates the ability to protect against deliberate fraud, and underestimates the cleverness of those who choose to commit fraud. Cha would have us believe that it is more likely he proved the efficacy of a miraculous intervention than that someone guilty of fraud may have committed fraud.

While this study has been scientifically discredited, it remains part of the published record and continues to be cited by supporters of the efficacy of prayer.

Conclusion

I applaud the Lancet for finally retracting the Wakefield study and removing it from the published record. It should not, however, have taken this long.

BACKGROUND

In my not-so-humble opinion, the very kindest thing that can be said about Andrew Wakefield is that he is utterly incompetent as a scientist. After all, it’s been proven time and time again that his unethical and scientifically incompetent “study” that was published in The Lancet in 1999 claiming to find a correlation between vaccination with MMR and autistic regression in autistic children with bowel symptoms was at best dubious science and at worst fraudulent. For one thing, as investigative journalist Brian Deer found, Wakefield was in the pocket of trial lawyers, who were interested in suing vaccine manufacturers, to the tune of £435,643 in fees, plus £3,910 expenses beginning even before his infamous “study” started accruing patients. Even though the study itself used the typical careful and relatively neutral language that we all expect from scientists, Wakefield himself was not nearly so circumspect. In a press conference announcing the Lancet study, he said:

He told journalists it was a “moral issue” and he could no longer support the continued use of the three-in-one jab for measles, mumps and rubella.

“Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people,” Dr Wakefield said at the time.

And so began one of the most contentious health stories of this generation.

Wakefield’s Lancet paper, even interpreted as sympathetically as possible, concluded nothing that justified such language. Yet his rhetoric, along with sensationalistic and credulous British journalists, ignited a firestorm of fear over the MMR that has not yet subsided now, over a decade later. Vaccination rates plummeted in the UK, and measles, a disease once thought to be under control, has surged back and become endemic again. It is a feat that Jenny McCarthy and Jim Carrey appear to be trying to replicate right here in the U.S. with their wonderfully Orwellian-named Green Our Vaccines activism and ceaseless promotion of anti-vaccine messages.

More recently, at the Autism Omnibus hearings, we learned from a world expert in the polymerase chain reaction, Dr Stephen Bustin, that the techniques used in the laboratory running PCR on the clinical specimens from Wakefield’s clinical trial were so shoddy, so devoid of routine controls necessary in any PCR experiment, that the measles sequences reported as amplified in Wakefield’s followup to his Lancet study were false positives derived from plasmids with measles sequences in them contaminating the laboratory. Then, in late 2008, Mady Hornig and colleagues at Columbia University published an attempted replication of Wakefield’s study. They failed. There was no association between vaccination with MMR and autistic regression, nor could Hornig find any evidence that measles in the gut was any more common in the autistic children studied than in the neurotypical controls. This study was particularly devastating to Wakefield because it was carried out by a researcher who had previously been sympathetic to the myth that vaccines cause autism, as evidenced by her infamous “rain mouse” study and, even more close to home, using the same laboratory that had performed Wakefield’s PCR, which had apparently cleaned up its act in the years following its work on Wakefield’s specimens.

When it comes to the science, there is no doubt. No reputable scientist has been able to replicate Wakefield’s findings, and there is a remarkable convergence and agreement of findings of major studies looking for a correlation between MMR vaccination and autism: There ain’t one. Indeed, closing out 2009 was the publication of yet another study that failed to find any correlation between MMR and autism, or, as I put it at the time, yet another nail in the coffin of the myth that the MMR vaccine causes autism. Andrew Wakefield’s repeated claims that the MMR can cause or “trigger” autism in some children is deader than dead as a scientific hypothesis and without a basis in scientific or clinical evidence. True, Wakefield tried to counter with a horribly unethical and badly designed primate study that seemed custom-designed to be used in court rather than in the court of scientific inquiry. It didn’t help and only made Wakefield’s Thoughtful House, Wakefield’s Fortress of Solitude in Texas to which he retreated in the wake of the revelations about his conduct, look even worse. Even a credulously “balanced” TV story by NBC news and Matt Lauer couldn’t hide the dubiousness nature of what goes on there.

Of course, while the science refuting Wakefield’s pseudoscience and evidence showing Wakefield to be incompetent and unethical continued to roll in, a little less than a year ago, it got even worse for him. Brian Deer reported that Wakefield very well may have engaged in scientific fraud in the “research” (and I do use the term loosely) that led to the publication of his Lancet paper in 1999. Through it all, the General Medical Council began an inquiry into whether Andrew Wakefield behaved unethically in the “research” that resulted in his 1999 Lancet report. It should be pointed out that the investigation of the GMC began before Deer’s latest revelation of potential fraud; rather it was far more concerned with how Wakefield ran his study and recruited patients. Nonetheless, the revelations nearly a year ago about Wakefield’s playing fast and loose with research methodology could not help but contribute to the sense that the Good Ship Wakefield had been torpedoed below the water line and was taking on water fast.

As the investigation and hearings wound on seemingly endlessly for two and a half years, Wakefield’s supporters intermittently waged an increasingly histrionic and ridiculous propaganda offensive to try to preemptively discredit the GMC’s findings. As it became clear that finally after all this time the GMC was on the verge of announcing its ruling, I noticed that the anti-vaccine crank blog Age of Autism was ramping up an increasingly bizarre and unhinged last minute propaganda campaign, complete with reposting a hilariously inapt post by Mark Blaxill comparing Wakefield to Galileo and the GMC to the Inquisition, complete with references to Stalin and Mao (I suppose I should be relieved that Blaxill refrained from playing the Hitler card); a defense of “that paper” by Wakefield himself; claims that parent witnesses had been “silenced” at the GMC hearings; and a whole series of posts by John Stone trying to discredit the GMC.

And then on Thursday, the GMC ruled.

ANDREW WAKEFIELD: “IRRESPONSIBLE” AND “DISHONEST”

The general findings in the GMC’s ruling should have come as no surprise at all to anyone who had been following Wakefield’s activities, as I have been for the last five years, although I must admit I was pleasantly surprised by the lack of weasel words in it. On Thursday, the BBC reported:

Dr Andrew Wakefield’s 1998 Lancet study caused vaccination rates to plummet, resulting in a rise in measles — but the findings were later discredited.

The General Medical Council ruled he had acted “dishonestly and irresponsibly” in doing his research.

No kidding. Here is a sentence from the actual GMC report:

In reaching its decision, the Panel notes that the project reported in the Lancet paper was established with the purpose to investigate a postulated new syndrome and yet the Lancet paper did not describe this fact at all. Because you drafted and wrote the final version of the paper, and omitted correct information about the purpose of the study or the patient population, the Panel is satisfied that your conduct was irresponsible and dishonest.

The Panel is satisfied that your conduct at paragraph 32.a would be considered by ordinary standards of reasonable and honest people to be dishonest.

That’s about as plain a statement of Wakefield’s mendacity as I can imagine. In fact, I’m very surprised that the GMC report was so blunt. But wait, there’s more, as described in this BBC news report:

The verdict, read out by panel chairman Dr Surendra Kumar, criticised Dr Wakefield for the invasive tests, such as spinal taps, that were carried out on children and which were found to be against their best clinical interests.

The panel said Dr Wakefield, who was working at London’s Royal Free Hospital as a gastroenterologist at the time, did not have the ethical approval or relevant qualifications for such tests.

The GMC also took exception with the way he gathered blood samples. Dr Wakefield paid children £5 for the samples at his son’s birthday party. Dr Kumar said he had acted with “callous disregard for the distress and pain the children might suffer.”

He also said Dr Wakefield should have disclosed the fact that he had been paid to advise solicitors acting for parents who believed their children had been harmed by the MMR.

Two of Dr Wakefield’s former colleagues at the Royal Free were also ruled to have broken guidelines.

Professor John Walker-Smith and Professor Simon Murch both helped Dr Wakefield carry out the research.

The complete 143 page report can be read here. It is truly a damning document. While it cleared Wakefield of some charges, it found that Wakefield was in breach of managing public finances, that the funds he controlled were not used for their intended uses, and that, most shocking of all, he performed procedures on a child for research purposes without the approval of his Ethics Committee. Having found that some of the most damning allegations made against Wakefield are true, the GMC will now deliberate over what sanctions will be indicated. These can range from a rebuke to the stripping of Wakefield’s medical license from him (or, as the British put it, his being “struck off”). Of course, given that Wakefield has moved to Austin, Texas, there to form Thoughtful House, an institution dedicated to the practice of what many, including myself, consider to be autism quackery based on anti-vaccine beliefs, even if the GMC does ultimately strip Wakefield of his medical license very likely it would have little or no significant effect on his practice. After all, Wakefield does not treat children himself. He can’t. He does not have a Texas medical license. Wakefield’s partner Dr Arthur Krigsman is the one doing colonoscopies on autistic children for what appear to be questionable indications, as was portrayed in the aforementioned NBC special with Matt Lauer, and his other partner Dr Bryan Jepson treats them with DAN! protocols.

Indeed, well do I remember one part of the Lauer special in particular. Specifically, it was the part where Lauer asked for Wakefield’s anecdotal experience about whether these children “get better.” Wakefield, of course, responded in the affirmative. (Never mind that what Lauer should have asked Wakefield is whether he has data from randomized controlled clinical trials to support his belief that autistic children “get better” at Thoughtful House. He doesn’t.) Moreover, pretty much every child undergoing endoscopy at Thoughtful House (85%, according to Dr Krigsman) ends up with a diagnosis of “autistic enterocolitis,” which is, as far as science can tell, almost certainly a nonexistent syndrome given that autistic children do not appear to exhibit bowel complaints at a higher frequency than neurotypical children. In the case of Tom Kasemodal, the autistic child whose endoscopy was featured in the NBC report, Dr Krigsman was hard-pressed to find grossly visible abnormalities during the procedure. (”Mild or softer findings,” he said about Tom.) Of course, on pathology, Thoughtful House pathologists apparently found “mild inflammation.” And what did Krigsman prescribe? Lots of supplements, daily laxatives, and periodic colon cleansing. Can you imagine subjecting an autistic child to laxatives and colon cleanses? How do you get a severely autistic child to cooperate for a “colon cleanse”? I have no idea, and I don’t want to think about it.

If the NBC report with Matt Lauer is any indication, apparently such is the “medicine” practiced at Thoughful House, and I must emphasize that the GMC ruling will almost certainly do absolutely nothing to stop it. As when he was at the Royal Free Hospital in North London, Wakefield bills himself as a “researcher” and does not practice clinical medicine, at least not on the surface of it, although the NBC special sure made it look to me as though he participates as a consultant in the care of the autistic children brought to Thoughtful House. If the GMC were to “strike off” Wakefield from the rolls of licensed physicians, it would at least be a further moral victory in addition to the ruling itself, but Thoughtful House would still exist and, under Wakefield’s leadership, still be subjecting autistic children to the sorts of therapies shown on the NBC report and who knows what else.

ANDREW WAKEFIELD, “BRAVE MAVERICK DOCTORS,” AND A CULT OF PERSONALITY

In the decade since his Lancet paper began the movement that led to the resurgence of measles in the U.K., Andrew Wakefield has become a hero to the movement dedicated to the discredited idea that vaccines cause autism. He is the prototypical “brave maverick doctor” and don’t need no steeenkin’ science to know that he’s “recovering” autistic children. Evidence of this is everywhere; so I’ll pick and choose. Perhaps the most obvious manifestation of the Wakefield cult of personality is the nausea-inducing website We Support Dr Andrew Wakefield. I first became aware of this website last year after Brian Deer’s revelations regarding the likely scientific fraud committed by Andrew Wakefield came to light. Consistent with its defense of Wakefield then, on the day that the GMC’s findings were announced, the website declared it a “sad day for the future of our children” and further declared:

The General Medical Council’s (GMC) verdict today concerning Dr Andrew Wakefield brings together autism organizations across the United States who stand united in support of him, unequivocally renounce the GMC’s findings, and demand an investigation into possible conflicts of interests at the GMC. We further challenge the U.K. and U.S. governments to offer grants for gold standard research into why so many children with autism have gastrointestinal pathology, as well as any links between this pathology and the symptoms of autism, before all of the children of the world are affected.

Today’s verdict by the General Medical Council epitomized their negligence in respecting all of the sound scientific studies worldwide replicating the findings of Dr Andrew Wakefield. In the United States we will continue to fund studies replicating Wakefield’s work. We will focus more heavily on helping to educate the British public about the dangers of the MMR. We will look with renewed vigor into possible misconduct by the GMC. And, most importantly, we will continue to recover children from autism thanks, in large measure, to Dr Wakefield’s pioneering work. We have witnessed and applaud the sustained courage and dignity of Dr Andrew Wakefield. He has stood by the children, and we will stand by him.

This statement is signed by AutismOne (which I’ve discussed before), the Autism Research Institute, Generation Rescue (big surprise there, given that GR has already declared its support for Andrew Wakefield in no uncertain terms and, in the lead up to the GMC’s findings, tried its best to demonize GMC and cast doubt on the legitimacy of the entire proceeding), SafeMinds, Schafer Autism Report, Talk About Curing Autism (TACA), Unlocking Autism. In other words, organizations supporting the scientifically discredited vaccine-autism link are all lining up to support this statement. Notice how the statement alleges conflicts of interest and misconduct on the part of the GMC without any actual evidence of such COIs. Also notice how it declares that other researchers have “replicated” the findings of Andrew Wakefield. Of course, that is true if you count the dubious and researchers associated with Wakefield himself, but no reputable researchers have been able to replicate his findings. Most recently, as I pointed out above, a sympathetic researcher named Mady Hornig, who had previously published research seemingly supporting a link between thimerosal and autism, failed to replicate Wakefield’s results. Finally, notice how, despite numerous studies supporting the safety of the MMR and its lack of association with autism or bowel complaints in autism, these organizations continue to cling to the belief that the MMR is “dangerous” and vow to “educate” the public about the “dangers” of the MMR vaccine.

Consistent with previous reactions to criticisms of the anti-vaccine movement or one if its leaders, some of these organizations are also going on the attack, painting themselves as the underdog being persecuted for speaking truth to power. For instance, here’s what the TACA wrote:

The most frightening aspect of these GMC findings is the silencing effect it could cause to scientist and researchers. These verdicts now prove that researchers who stumble upon science that is controversial have to worry about losing their licenses and careers.

Consistent with the persecution complex that the anti-vaccine movement has, yesterday AoA contributor Martin Walker tried with some truly Bulwer-Lytton-worthy writing and incredibly heated rhetoric to show just how much reason has checked out among Wakefield’s defenders:

As the recitation of the crimes of Dr Wakefield came to an end, it appeared as if Dr Wakefield, had in the mid nineties, been some kind of inhuman Nazi experimenter practicing on children in the heart of England; an overlooked human vivisector who stalked a large North London hospital committing serious crimes with the two other criminals in his firm, invisible to his colleagues and unseen by the hospital administration.

It’s actually funny that Walker would mention Nazis. It was Nazi experimentation, among other things, that led to the Helsinki Declaration, the Belmont Report and the Common Rule in the US, and all the other protections for human subjects involved in clinical research. These rules are quite strict, although some would argue whether they’re even strict enough. They prevent atrocities like the Tuskegee syphilis experiment. They are the same rules that Wakefield flouted.

Undeterred by reality, Walker then likens the ruling to a knight’s jousting (and you don’t have to guess who’s the Black Knight):

Today I know will be one of those times that signify a dark night of the soul, for defendants, parents and campaigners alike. This afternoon the defendants will be knocked from their horses by rib smashing lance blows, on the ground they will lie dazed and have to figure whether it is right or even possible to remount and continue the battle. Parents will contemplate the bleak landscape of their children’s illness without any treatment and with open skepticism from medical practitioners from whom they seek help. Activists and campaigners like myself will have to face the melancholic prospect of either continuing the campaign or slipping away to support apparently more equitable battles.

This particular battle is a post-modern struggle, one in which the most powerful forces, multinational companies, reshape the world hand in hand with governments. This is a struggle from which parents and citizens have been expunged. A blind struggle, in an age where all the ties between governments and citizens have been severed, where it is no longer possible for citizens to have any real effect on either the processes of industrial science or of national politics.

It’s a post-modern struggle alright, just not in the way that Walker means.

Perhaps the most over-the-top conspiracy-packed “defense” of Andrew Wakefield comes from Mark Blaxill, published on the anti-vaccine crank blog Age of Autism and entitled Naked Intimidation: The Wakefield Inquisition is Only the Tip of the Autism Censorship Iceberg. All the hallmarks of a persecution complex and crankery are there.

Claims that the GMC finding was designed to “intimidate” those “brave maverick scientists”? Check:

The GMC proceeding is a frightening and thoroughly modern form of tyranny. It makes you shudder to think what Stalin or McCarthy might have accomplished if their public relations had been more skillful and better organized.

The extremity of the GMC’s verdict — all three men guilty on all counts — lays bare any pretense that the British medical establishment cares one whit about the welfare of its patients. Let’s put in perspective the actions at issue here. No children were harmed and no parent or guardian has complained about the care these three men provided. In fact, the procedures involved were routine, the resulting treatments standard and the careful attention to gastrointestinal illness in autistic children has recently been endorsed by a consensus statement published in the journal Pediatrics (no friend of the autism community). Considered in this light, the GMC hearing process stands exposed for what it is. It was not about medical standards. It was not about evidence. It was not even civilized. It was, rather, a naked exercise in intimidation, a fateful moment of moral decision in which the medical industrial complex exposed its ruthless, repressive essence. They are a frightening bunch and their conduct here raises issues well beyond autism.

The only thing frightening about this case is how much Andrew Wakefield got away with and how long it took for him to be exposed as the unethical fraud he’s been shown to be by Brian Deer, the GMC, and numerous other sources. It should also be noted that Wakefield was not found “guilty on all counts,” although he was found guilty on several of the most egregious counts. Blaxill really should read the whole report.

Attacks on peer review? Of course, they’re there too:

Since the National Institutes of Health (NIH) hold a virtual monopsony (“a sole or predominant buyer” in a particular market) on scientific research in the United State, NIH grant reviews are one prominent place where researchers can be effectively intimidated. One scientist, who authored a sensitive, previous publication, when asked to join in the effort to draft a review paper, demurred with the following explanation.

I have had two rejections of NIH grants in the last two weeks. This is most remarkable, in that the grants were not deemed good enough to even be scored. In my X years on the faculty, I have never had an unscored grant. Moreover, in one grant it is clear that there is a personal vendetta ongoing. This is not totally surprising but nonetheless disturbing. I am not ready to throw my career away, and I don’t look at how Andy Wakefield has handled such problems as a good model for me. It is vital that the science of this problem get out, and this is where I want to focus my attention. Therefore, I have decided that I do not want my name on [this new review publication], for I don’t need more persecution right now, and as good as the paper is (and I think it is extraordinary), it is not going to be a definitive scientific publication. I am enclosing a section I wrote-some of this is already included-feel free to use any of it.

If an intrepid researcher goes so far as to submit a paper for publication, that’s where the more overt forms of censorship can enter in, all in the guise of “peer review.” Admittedly, rejection at the point of peer review is a common part of science, but the autism problem is especially radioactive and is a place where I have seen the unmistakable cold hand of censorship take many forms: some unwelcome research can be headed off at the pass, with journal editors making clear that papers on certain autism topics are unwelcome and won’t even be sent out for review; or unwelcome papers can be sent to anonymous reviewers the editor knows to be hostile to the topic of environmental influences;

Let’s see: I just found out on Friday that not only was a revision of a paper I wrote still not deemed acceptable for publication in the journal to which I submitted it, but I also found out that I didn’t get a grant I really wanted that I had thought I had a good chance of getting. That’s academia and biomedical science. It happens all the time (although I can’t recall having had such a one-two body blow to my ego in one day). The latter case is somewhat apt in that the reviewers praised my proposed experimental design as being excellent but were skeptical of the primary hypothesis itself. Obviously, I must be too close to The Truth about breast cancer and how to treat it, and the breast cancer industry is trying to “silence” me! (Yeah, yeah, that’s what I’ll tell myself.) In any case, the complaint that “I’ve never had a grant not scored” is not indicative of “censorship.” The amount of money available for the NIH to fund grants compared to the number of grants submitted fell precipitously between 2003 and 2009. Lots of senior researchers who had never had a grant found to be “not worthy” of being given a numeric score (which indicates that the study section deemed it to be in the bottom half–or even bottom 60% — of the grants being ranked and therefore possessing no chance of being funded that round) have suddenly had grants coming back unscored. (Join the club and stop whining, those of us in the trenches ruefully respond!) In these tight fiscal times, that’s just reality. In this sort of environment, though, it’s easy for scientists to tell themselves that they’re the victim of groupthink whether there’s anything to it or not.

However, Blaxill had more in store for me. He completely shattered yet another of my irony meters when he wrote his conclusion:

The GMC verdict, that honest scientists like Andy Wakefield have “failed in their duty”, makes a mockery of the value of civil debate in an open society.

The medical industrial complex is closing ranks. It’s time for responsible citizens — health consumers and principled scientists alike — to raise their voices in opposition.

No, the anti-vaccine movement has made a mockery of civil debate in an open society. Its reflexive reaction to attack the messenger when criticized is legendary. Journalists have been the victims of it. Our fearless leader Steve Novella has been a victim of it. Paul Offit has been nearly continuously a victim of such bile and harassment, up to and including frivolous lawsuits. Sometimes, it gets incredibly vicious, as when AoA represented Paul Offit, Steve Novella, and journalists Trine Tsouderos and Amy Wallace as sitting down to have a Thanksgiving feast, the main course of which was a dead baby. I myself have been harassed similarly on many occasions.^{1,2,3,4,5,6,7}

I suppose that’s the definition of “civil” debate from the anti-vaccine movement.

THE CULT OF ANTIVACCINATIONISM

As I have pointed out on numerous occasions before, both here and elsewhere, the anti-vaccine movement has much in common with cults. It believes, despite all scientific evidence, that vaccines cause autism and many other chronic health conditions. Its adherents see themselves as the keeper of a hidden truth that “they” don’t want you to know about, a “truth” that it desperately wants everyone to know. No facts, no science can sway them, and when one of their prophets is found to have behaved unethically, to have had massive conflicts of interest, and possibly even to have falsified research, it’s all part of a plot by The Man to keep them down.

That is why, as necessary as it is for the GMC to have ruled against Andrew Wakefield, I know that it will not stop him from plying his trade on children in Texas, and I especially know that it will only feed his cult of personality by adding martyr to his list of attributes in their eyes. It will not stop him from raking in money hand over fist. Even videos like this showing Wakefield joking over children fainting and throwing up as he prepared to draw blood from them after bribing them to agree to it won’t change that:

Yes, that is laughter and joking, and that is one incident that led the GMC to declare Andrew Wakefield’s “callous disregard” for children. That is the real Andrew Wakefield.

When will the madness end? I fear that it will only end when vaccine-preventable diseases return to the point where every parent fears them again. No, it’s more than that. Vaccine-preventable diseases are already returning. That’s why I fear it will only end when they return to the point where the fear of disease is more intense than the fear of the vaccine-autism bogeyman. In the meantime, while Third World countries clamor for life-saving vaccines and Bill Gates pledges $10 billion to bring vaccines to the world, here in the developed world we have men like Andrew Wakefield feeding an irrational fear of vaccines that threatens to reverse all the progress of the last few decades.

Maybe 20 years from now, we’ll need the Bill and Melinda Gates Foundation to be pledging billions of dollars to bring vaccines to us.