Researchers at the US Naval Research Laboratory (NRL) announced that they have successfully tested a process to convert seawater into jet fuel. They can extract CO2 both dissolved and bound from the water as a source of carbon, and can extract H2 through electrolysis. They then convert the CO2 and hydrogen into long chain hydrocarbons:
NRL has made significant advances in the development of a gas-to-liquids (GTL) synthesis process to convert CO2 and H2 from seawater to a fuel-like fraction of C9-C16 molecules. In the first patented step, an iron-based catalyst has been developed that can achieve CO2 conversion levels up to 60 percent and decrease unwanted methane production in favor of longer-chain unsaturated hydrocarbons (olefins). These value-added hydrocarbons from this process serve as building blocks for the production of industrial chemicals and designer fuels.
They claim that with this process they can mass produce jet fuel for $3-6 per gallon. They tested the fuel on a model airplane, and it appeared to work fine.
The mainstream media is reporting the story this way (from the Huffington Post):
Currently, most of the Navy’s vessels rely entirely on oil-based fuel, with the exception of some aircraft carriers and submarines that use nuclear propulsion, reports the International Business Times. The ability to render fuel from seawater may change that.
No, it won’t. The reason the navy is talking about jet fuel and testing the fuel on model planes, rather than talking about fuel for their ships, is that converting seawater into hydrocarbon fuel requires more energy than you get back. This is not a method for creating fuel, but rather for storing energy as fuel.
If you have a nuclear-powered aircraft carrier, you still need jet fuel for all the jets. If, however, you can use that nuclear power to manufacture jet fuel, then you will be more self-sufficient.
If, however, your ship is fueled by oil, there is no utility to this process except to waste energy. Theoretically you could have solar or wind-power on board that you can then use to make fuel from seawater, but such a source of energy is unlikely to produce a significant amount of fuel at sea.
The Huff Po article acknowledges this limitation, at the end of their article, but somehow fails to recognize that this invalidates that rest of the discussion in the article.
Such a method, if it can be scaled to mass production with high efficiency, would be useful in a zero-carbon economy. A nuclear power plant, for example, could provide the energy for this process in order to mass produce fuel for cars, trucks, jets, and other machines that cannot efficiently run directly off of solar power or some other clean energy.
Such a process would also be carbon neutral – if you are extracting the CO2 from the environment (in this case from sea water), then when you burn the fuel you are simply returning the CO2 back to the environment. This contrasts with burning fossil fuels in which we are releasing CO2 that has been sequestered for millions of years.
Even if we will soon have fully electric cars that can be recharged with solar panels, we will still need jet fuel. I don’t envision solar-powered jets anytime soon.
Of course this technology is only useful if we expand our non-fossil fuel energy production. We have some unused capacity in our current system also. Nuclear power plants can use their off-peak capacity, for example, to make fuel from sea water. In order to displace all fossil fuels with synthetic fuels, however, I suspect we would need to add significant capacity, although I have not seen a detailed analysis taking into considering such fuel production methods.
Biofuels may also play a role, but I am not sure if they will ever be a significant contributor to our energy infrastructure. The main problem is land – growing raw material for conversion to biofuels can displace food production, the demand for which will only get greater. There are potential solutions involving growing raw material in bodies of water or using cellulose from waste plant material or from non-crop land. So I remain open minded about biofuels, but at present they are not a good solution and we just have to wait and see what develops.
The fuel from sea water technology may turn out to be a very useful process. It is disappointing, however, that so many people still don’t get the basic idea that such processes do not create energy, they consume energy. The media reporting on this news story was mostly misleading. Readers would have to read all the way down to the end, and then see for themselves that the last comment invalidates the rest of the article. That is a science-reporting fail.
I will be at NECSS this weekend – the Northeast Conference on Science and Skepticism, in New York City. This is an excellent conference full of science and critical thinking lectures and panels. My podcast, the SGU, will be recording a live show on stage Saturday.
I will also be running two 1-hour workshops on critical thinking on Friday. I will be moderating a panel debate on GMO which should be very exciting. Finally I will be on a neuroscience panel talking about the uses and abuses of neuroscience.
Our keynote this year is Lawrence Krauss. You can see the full line up of speakers at www.necss.org.
Online registration will remain open today (Thursday), and onsite registrations are welcome. You can register for one day or the entire weekend. There is also a comedy show Friday night, stimulus response, in which, apparently, I will be skewered by a professional improv comedy group. (They did my brother Jay last year and it was hilarious – so he made sure I got payback this year.)
Please come up and say hi if you will be at NECSS. Also, the SGU will have a swag table so you can stop by there as well.
I just saw the trailer of a new movie, The Principle. The movie is produced by Robert Sungenis, who writes the blog Galileo Was Wrong. Sungenis is what we technically call a kook. He believes the earth is at the center of the universe and that there was no Jewish holocaust, but rather the Jews were conspiring with Satan to take over the world.
Sungenis, however, is apparently a kook with money, so he is making a documentary film preaching his bizarre notions to the world. This much is nothing new. There are plenty of such films out there, like What the Bleep Do We Know and Expelled. They superficially follow the science documentary format, but they have an ideological agenda.
This film, unfortunately, will be narrated by Kate Mulgrew, who played Captain Janeway on Star Trek: Voyager. Old Star Trek stars lending their fame to pseudoscience is also, sadly, nothing new.
I was surprised to see Lawrence Krauss and Michio Kaku in the film. I know that Kaku has been flirting with the edges of responsible science promotion, but not Krauss. I suspect that they were duped into being interviewed for the film.* Perhaps they were not aware of the film’s editorial stance. (I will be seeing Krauss this weekend and will ask him.)
Krauss did tweet about the movie: “It is nonsense,” in case there was any doubt there.
It seems that Krauss and Kaku are there to simply say how strange and mysterious the cosmos are, and to discuss the edges of our current knowledge. This is a common ploy – focus on what we do not currently know in order to make it seem like we don’t know anything. The movie trailer opens with Mulgrew saying that everything we think we know about the universe is wrong.
Apparently Sungenis thinks he is smarter than the entire scientific community. Perhaps he thinks that modern science is all a conspiracy.
That the sun is at the center of our solar system, the earth revolves about the center of gravity between the earth and sun (which lies beneath the surface of the sun, which makes it reasonable to say the earth revolves about the sun), and that the universe itself has no center, are all well-established scientific ideas. Most people take these conclusions for granted and may not know the lines of evidence that support them.
One line of evidence is simply precise observations of the movements of the sun and the other planets, combined with the physics of gravity, including general relativity. If our model of how planetary mechanics works were so far off, I doubt our probes would have reached the outer planets – an accomplishment of scientific precision that is utterly astounding.
If scientists were so profoundly wrong as Sungenis claims we would not have been rewarded by such pretty pictures of Saturn and Jupiter.
Another line of evidence is stellar parallax. Parallax is the apparent change in position of relatively near objects compared to the background of relatively farther objects. Nearby stars shift in position relative to the distant background stars. They do so with amazing regularity on a yearly cycle, resulting from the earth revolving about the sun.
Stellar parallax alone (predicted by Galileo before our observations were precise enough to detect it) is strong evidence for heliocentrism. How does Sungenis answer this?
He argues that, while the sun revolves about the earth, the rest of the universe revolves about the sun, so that they are shifting their relative position to the earth causing the parallax.
Of course, this causes more problems than it solves. First, the universe is no longer geocentric. Everything but the earth revolves about the sun. Second, such a system does not actually fit our obsevations. And finally – how the hell do distant galaxies revolve about our sun?
Sungenis’s answer is that the earth (but I guess really the sun) is at the gravitational center of the universe, and objects really revolve about the center of mass, which is the earth.
This, of course, is utter nonsense. There is something called the inverse square law. Gravity becomes weaker as the square of the distance. This means that objects are much more affected by the gravity of nearby objects than the tug of distant objects – even if that distant object is the center of mass of the universe (which, by the way, does not exist).
The sun, therefore, has a greater pull on the earth than any more distant object. The earth and the sun have to be revolving around their mutual center of gravity, with only slight tweaks from other objects in the solar system. Meanwhile the entire solar system is revolving about the center of gravity of the galaxy.
This is the way it has to be.
Sungenis does not have a workable system. He has a ridiculous kluge that falls apart if you even glance at it sideways, let alone carefully inspect it.
Sungenis has made a documentary that does document something useful – the notion that there is no belief so absurd that there isn’t someone who will not only believe it but dedicate their time and effort to promoting it. The human brain can get trapped in even the most astoundingly ridiculous belief, and can contort itself into a Gordian knot of logic and rationalizations.
There is also another lesson, one for science communicators. Carefully vet anyone asking you to be interviewed for their film. We should have learned this lesson from Expelled.
*Update: This is from Krauss’s blog:
“I have no recollection of being interviewed for such a film, and of course had I known of its premise I would have refused. So, either the producers used clips of me that were in the public domain, or they bought them from other production companies that I may have given some rights to distribute my interviews to, or they may have interviewed me under false pretenses, in which case I probably signed some release. I simply don’t know.”
Indiegogo is rapidly earning a reputation for not caring whether or not they fund pure pseudoscience. This, in my opinion, is a bad business model, not to mention morally dubious.
I wrote previously about an Indiegogo campaign to fund a free energy device – a “home quantum energy generator.” Indiegogo claims to have a process to weed out fraud from their campaigns, but this one apparently slipped through their process. When I e-mailed Indiegogo to question them about this campaign, I received nothing but a generic response.
Now pandodaily has been covering a new Indiegogo campaign for a “miracle” device – the GoBe by Healbe. The company claims on their Indiegogo page:
GoBe is the only way to automatically measure calorie intake—through your skin. Simply wear it to see calories consumed and burned, activity, hydration, sleep, stress levels, and more, delivered effortlessly to your smartphone.
They have raised almost a million dollars. Pandodaily has done a great job of investigating the company. It looks as if they are a Russian company with a minimal footprint in the US. They have no patents, have not published any data, and have no history of producing real medical devices. No one outside the company has seen or tested a working prototype. Read the article for all the sordid details. I want to delve a bit further into the alleged science behind their claims.
One huge red flag for any scientific claims – especially one involving a working device – is when there is no trail of scientific progress leading up to the alleged device. Scientific advances tend to proceed through necessary steps. You have to establish the basics before you get to the more advanced applications.
For anyone following a particular scientific field you can see the paper-trail of a scientific advance as each incremental step is published and debated by the community. It’s a dynamic process. When a company or researcher claims to have made a breakthrough that is many steps ahead of the public transparent science, this is a red flag. Companies coming out of nowhere with advances that are 10-20 years or more ahead of their time is the stuff of movies, not reality.
In this case, what exactly is Healbe claiming? They claim to use a small wearable impedance device to measure water and glucose levels inside cells. With this information they employ an algorithm (in other words – a black box) to somehow calculate total calories consumed and burned by the wearer. These claims involve multiple highly unlikely advances.
The basic claim is that the company has developed a non-invasive method for measuring blood glucose. If this were true, why wouldn’t they market it first just as a glucose monitor for diabetics? They could then use the millions they would make to develop the specific application they are now claiming, to calculate caloric intake and burning.
There are multiple companies working on non-invasive glucose monitoring. The most promising approach seems to be near infrared technology. An Israeli company, for example, claims to have such a device but it is not yet on the market. We do seem to be on the brink of such devices coming out, but it will likely take several years for them to be properly tested and receive approval.
Healbe claims to use a different technology, impedance. There is also research into impedance spectroscopy to measure blood glucose, but this is the less promising technology. Such devices are more cumbersome, less accurate, and require calibration to the specific patient.
If measuring blood glucose non-invasively were the extent of the claims, I would be highly suspicious – such claims are not implausible, just a bit ahead of schedule. My suspicions would be based on the lack of a paper trail. For the other devices we have published studies with actual data.
This is a common scam – take an emerging technology for which there is already some buzz and simply claim to have developed it fully. There will be a lot of basic science papers you can point to in order to lend credibility to your claims. The technology is obviously plausible otherwise scientists would not be talking about it. The scam is simply pretending to have leapfrogged 10-20 years ahead of all the competition. We are seeing this now with all the fraudulent stem cell clinics popping up.
We are not done with the GoBe, however. The real implausibility here is that the company claims to have developed an algorithm to extrapolate from water and glucose level measurements to total caloric intake and output. For this claim the basic science simply isn’t there.
Caloric intake comes from carbohydrates, proteins, and fats. Glucose management in the body is a bit complex, and blood glucose levels are just one factor. There are lots of other factors, including fat storage, liver storage of carbohydrates, insulin levels and resistance, and metabolic rate.
Being able to estimate total caloric intake and output from water and blood glucose levels, if this is even possible, would likely require decades of research to sort out all the variables. This would like require a collaboration among many researchers and institutions, and we would be seeing hundreds of published papers establishing the basic knowledge necessary for such technology.
Put simply, this is not the sort of thing that is going to come from a previously unknown company in Russia with no track record of producing such technology, let alone conducting the necessary biomedical research.
The only conclusion I can come to is that this device is a total scam. The chance of it doing what it claims to do is practically zero. It’s possible the company believes they have a working device and are just scientifically illiterate and deceiving themselves. It’s also possible they have realized that crowdfunding campaigns are the perfect scam.
This leads us to an important question – what is the responsibility of sites like Indiegogo to protect their users from fraud? We can argue the ethics of this endlessly. Should the buyer beware, or does Indiegogo have a responsibility not become accessories to fraud? But here’s the thing – Indiegogo claims to protect their users from fraud. They write:
Indiegogo has a comprehensive fraud-prevention system to protect our users. Campaigns and contributions that have been flagged by our fraud detection system go through a thorough review. If we find fraudulent contributions on your campaign, we may remove them from your campaign.
Whether or not you feel they should protect against fraud, they claim that they do. Clearly, however, they are not doing a great job. In addition to funding a fake free energy device, they are now on the brink of funding a fake health monitor. Pandodaily also points to another dubious medical device funded through Indiegogo, a small device the manufacturer claims can detect the nutritional content of food. The device, however, cannot possibly work as described.
Crowdfunding is new regulatory territory. Medical devices need to be approved by the FDA, and marketing claims can be reviewed by the Federal Trade Commission. Do either of these agencies have any power to regular a crowdfunding campaign, even if it is for a medical device? Are crowdfunding campaigns commercial speech regulated by the FTC? I have inquiries out to both agencies to get their opinions.
Meanwhile Indiegogo is clearly failing to live up to their claims to protect their users from fraud, at least in the cases I discuss above. There is still time to do the right thing for the GoBe device as the funds have not been released. So far Indigogo says everything is on the up and up. I predict if they release the near million dollars to the company the funds will disappear into a Russian bank and we will never see them again.
We like to categorize and apply labels. This can be helpful in wrapping your mind around complex reality, as long as you avoid the pitfall of allowing labels to become mental straitjackets.
I often discuss various categories of people who are failing, in one or more important ways, to apply critical thinking. These categories are not meant to be dismissive, but rather to help understand various styles of thinking that lead people astray. For example there are deniers, true-believers, ideologues, and cranks.
Perhaps the most interesting category is the conspiracy theorist. I also find them to be the most consistent in their style of reasoning and argument. I do wonder, however, how much of this consistency is due to and underlying reasoning style and how much is culture. When I get the same fallacious argument over and over again, is that because they are all reading the same source material?
I recently came across a conspiracy website offering advice on how to answer “anti-conspiracy theorists” (their word for skeptics). Anyone who has had a conversation with a conspiracy theorist will recognize the style and tone, and now here it is codified in a primer for budding conspiracy theorists.
The article, however, also reveals the logical errors that underlie the conspiracy belief system. Let’s go through each point.
“You sound like a conspiracy theorist.”
RESPONSE: “Conspiracy Theorist? Now tell me the truth, where did you hear that term…on TV? (Laugh.) …So let me get this straight. Are you saying that men in high positions of power are not capable of criminal activity and telling lies to the general public? Are you really that naive?” (Laugh as you say this.)
As you can see this is a literal script. Right up front we see what I have found to be the typical attitude of the conspiracy theorists – anyone who does not buy their fantastical theories is “naive,” – said with dismissive laughter. This response is also a straw man.
Of course people in power are capable of lying and criminal activity. There are even genuine conspiracies. The recent lane-closing scandal in New Jersey was a conspiracy of at least several civil servants who lied and conspired to abuse their power to punish their political enemies (heedless of collateral damage).
When we talk about conspiracy theorists we are talking about grand conspiracies. These are conspiracies that involved large numbers of people, a vast expanse of power and control, unbelievable secrecy, and often sustained for years or decades. Of course there is no sharp demarcation between a small and plausible conspiracy and a grand conspiracy, but the larger the conspiracy would need to be, the more implausible it becomes. The largest grand conspiracies simply collapse under their own weight.
Ah, but the author has heard this response before and has an answer:
“You’re absolutely right. I agree with you 100%. It is impossible to totally cover up a conspiracy so massive. That’s why I know about it! What you must understand is that they don’t have to cover it up totally. Even a bucket that has a few leaks can still do the job of carrying water from here to there! They only need to fool 80% of the public, which isn’t hard to do when you control the major networks and newspapers.”
Of course the conspiracy theorists have to have learned about the conspiracy, but this entirely misses the point. Conspiracy theorists don’t have actual evidence. They don’t have leaked information, documents, photographs, or any hard or direct evidence of their specific conspiracy theory. As you will see from later responses – they simply believe they have perceived a pattern in events.
This cuts to the heart of the logical fallacies at the core of conspiracy thinking. The conspirators in grand conspiracies have as much power, control, and reach as they need to pull off the conspiracy. Any missing evidence was covered up by the conspiracy. Any evidence against the conspiracy or for a more prosaic explanation was planted. Any events that would seem to undermine the conspiracy theory were clearly false flag operations.
Conspiracy theories are therefore immune to evidence. They are closed, self-contained belief systems that resist their own critical analysis. That is why they are a mental trap.
Often conspiracy theorists are generally smart people (even if they lack certain critical thinking skills). Smart people, however, are good at rationalizing and erecting elaborate belief structures. This anti-conspiracy theorist essay is just another example of that – a string of rationalizations dismissing the very serious and legitimate criticisms of the grand conspiracy position.
Also note how casually the author assumes that the conspirators control the major networks and newspapers. This, of course, explains why journalists are not exposing the conspiracy – they are all part of it. The rabbit hole goes down all the way.
In response to ridicule, the author recommends:
“Can I ask you an honest question?” (Wait for “yes”) Do you consider yourself an open minded, critical thinking person – yes or no? (Wait for “yes”) Then how can you possibly ridicule an opinion when you haven’t even done 10 minutes of research into the matter? That’s kind of ignorant don’t you think?” (Wait for response.)
I would like to point out here that these responses generally are designed to be rhetorical tricks, rather than genuinely engaging with a critic. The failure to genuinely engage seems to be a universal feature of every category of non-skeptic. To be fair, you can see this in every sub-culture, but at least skeptics profess to understand the need to engage and strive to do so.
The response here assumes that the skeptic has not done any research. This is a common ploy. Of course, I do advise that skeptics refrain from commenting definitively on topics with which they are not adequately familiar. But the response here is often a straw man.
This strategy here is often combined with moving the goalpost – no matter how much research you have done, it’s not enough. Of course, no generalist skeptic can dedicate as much time and effort to one area as a believer. This often evolves into the “12 foot stack” gambit. Unless you have read my 12 foot stack of evidence, you can’t comment on my bizarre theory.
This approach can be effective in deflecting criticism but is not legitimate. First, it is possible to be familiar with a body of evidence, and to have examined the best cases and authoritative summaries from proponents – more than sufficient to have an informed opinion, without dedicating one’s life to studying every detail.
Second, the burden of proof is on the proponent, and challenging someone with any kind of theory to make their case and put their best evidence forward is perfectly legitimate.
Finally, any claim can be analysed for logical validity and plausibility. It is possible to find flaws in someone’s reasoning, separate from the specific details of evidence. If someone tells me the world is run by lizard people and gives me a string of logical fallacies to make their case, I can determine that it is simply not worth reading through their 12 foot stack of evidence they believe supports their position. Typically I will read a representative sample to gauge the quality of evidence, or challenge proponents to give me their best evidence.
With regard to plausibility, one common criticism of grand conspiracies is that government are simply not sufficiently competent to pull them off. To this point the author responds:
“Don’t confuse your incompetant [sic], dim witted Congressman or Senator with the shadow government. The dark covert elements who stage these events are very skilled at carrying out, and concealing, their plots. Take for example the Manhattan Project.”
The Manhattan Project was a military secret kept in a time of world war, and only for a finite amount of time. Again, skeptics acknowledge that secrets can be kept, as long as they are contained. This is not relevant, however, to the immense scope of claiming a world-ruling shadow government.
Also, this response misses the point about competence. I don’t think that human beings are competent enough to pull off conspiracies as large as the ones that theorists often claim, such as the New World Order the author favors. He seems to think that people in the superficial government are all buffoons, bu the shadow government is run by a separate breed of people who have incredible competence.
The (somewhat scary) truth is that the world is run by ordinary people, although many of them are smart and dedicated. They all, however, have full range of human frailty and failings to some extent.
Grand conspiracies would require incredible dedication, foresight, masterful planning, impeccable execution, all to an extent that I have never witnessed in any person or organization. The conspirators are a cartoon – they don’t exist in our reality.
(The Unresolved Detail Trick) “If this is a conspiracy then explain to me how they managed to do x, y, and z?”
RESPONSE: “I don’t have every missing piece of this puzzle. But I have enough pieces to KNOW that the government-media version is false!
There is a kernel of legitimacy here. Complex theories cannot always explain every detail. The real world is complex, and we can’t always trace every complex chain of cause and effect.
Of course, this complexity cuts both ways. It is this complexity that makes grand conspiracies implausible.
But further, this point can be overplayed and become a cop-out. If someone points out a fatal flaw in one’s theory, it is not legitimate to wiggle out of this criticism by simply saying that they cannot explain every detail.
This particular response also reveals a major flaw in conspiracy thinking. The conspiracy theorist believes that all they need do is poke holes in the standard version of events. Ironically they often do this by challenging people to explain every little detail of what happened, which often cannot be done. What they do not do, however, is provide a plausible alternative explanation for which there is direct evidence.
Their major false assumption is that, if they can find holes or anomalies in a standard explanation of events, there must be a conspiracy. They then make the argument from ignorance and fill in the holes with their preferred conspiracy, for which there is no evidence because the conspirators hid all the evidence.
However, you can find apparent anomalies in any complex historical event. There are simply too many moving parts to be able to reverse engineer everything that happened. There are also numerous opportunities for apparently weird coincidences, which are almost guaranteed by the law of large numbers.
On the point of coincidence, he writes:
“If it were just one or two coincidences, I would agree with you. But when you have a series of 10,15, 20 different anomolies [sic], the law of statistics PROVES that they can’t all be just “coincidence”.
Actually, statistics demonstrate that apparent coincidence should happen all the time. The conspiracy theorists are simply wrong here. They are following their naive gut reactions to apparent coincidence, when statisticians can rigorously demonstrate that such events are common place.
They also ignore the power of confirmation bias. When you are looking for anomalies, you will find them. People are good at pattern recognition. Further, “anomaly” is a very open criterion. Just about anything can be considered an anomaly.
Conspiracy theorists can therefore comb through a vast data set of event details looking for apparent anomalies which they can define any way they wish. With this method you can find large numbers of apparent anomalies in any event. This, however, is their evidence for a conspiracy.
(The Isolated Piece of Evidence Trick) “Other than citing some historical events, you still haven’t shown me one piece of evidence that this was a conspiracy. Tell me just one thing that most proves a conspiracy.”
RESPONSE: “That’s a trick question! If I tell you “just one thing”, you’ll just climb on your high horse and dismiss it as a “coincidence”. What I want to show you is TWENTY THINGS! But you’re too closed minded to consider the case in its totality! You won’t even watch a You Tube video let alone read the case! I sure hope you never get selected to serve on a jury! You want everything boiled down to a simplistic media sound byte. Unless you will commit to a few hours of study, I’m wasting my time with you. Why are you so afraid to study this? (Wait for a response.)
Again, there is a kernel of truth here, but the author misses several important points. It is often not legitimate to challenge someone to defend their theory with one piece of evidence. Evolution, for example, is a conclusion based upon multiple independent lines of evidence each with many pieces.
However, there are individual pieces of evidence that are compelling in and of themselves. A single fossil of a human ancestor may not prove evolution, but it is certainly a compelling piece of evidence.
What skeptics are often really asking is not to prove the conspiracy with one piece of evidence, but to show any piece of evidence that is compelling. Show us your best evidence. But also – go ahead, make your case with a suite of evidence (just don’t let that turn into the 12-foot-stack gambit).
With evolution, you will notice, each piece of evidence has to stand on its own as a legitimate piece of evidence. Conspiracy theorists don’t have any such evidence – just a string of apparent coincidences and anomalies. They are essentially building a case out of circumstantial evidence.
Of course, if you are working backwards to a desired conclusion, and have loose criteria for what counts as evidence, and allow tangential and circumstantial evidence – you can build a case for literally any theory, no matter how wacky or implausible.
What conspiracy theorists are not doing is hypothesis testing. Predict what evidence there should be, and show us that this evidence distinguishes between the presence or absence of a conspiracy. Or show us smoking gun evidence. That is usually what skeptics mean when they ask for one piece of evidence – not one piece to prove the entire conspiracy theory, but one piece of direct (not circumstantial) evidence; enough to take the theory seriously.
“If this were true, the media would be all over it! It would be on the front page of every newspaper in America.”
RESPONSE: “The media, the government, the International bankers, Hollywood, and academia are all part of the same incestuous complex. The media is part of the conspiracy, so why would you expect them to tell you the truth?” (Wait for response.)
Whenever you uncover a problem with the conspiracy, just deepen the conspiracy. That will solve all problems. It also renders the conspiracy theory unfalsifiable.
How do they know the media is part of the conspiracy? Because they aren’t revealing the conspiracy? This is circular reasoning.
When challenged about how many people a world-wide media conspiracy would involve, he responds:
“The corruption doesn’t come from the outside-in. It comes from the top-down. If the ownership of a major media organization decides that a certain story is to be spiked, or if another story is to be hyped, then the rest of the organization follows. If a low level reporter decides to defy his bosses, he will lose his job and be blacklisted.”
Two words – freelance journalist. In fact, this is increasingly the model in the internet age. Huge centralized organizations with top-down control are going away. Now, freelancers submit article to the AP or Reuters and papers will pick them up. Where’s the top down control?
Also, has the author actually spoken to anyone in the media? Do they have any idea how much freedom vs control they have? Are stories squashed without clear justification?
I always get the feeling that conspiracy theorists (and many others, to be fair) treat large organizations as black boxes. They are run by drones, not people, and operate by their own inscrutable rules and motivations. It is a cartoon version of reality, uninformed by the actual people involved.
What the author’s responses really reveal are the logical fallacies and errors in thinking that drive and sustain grand conspiracy theories. They are ultimately cut off from reality because they are insulated from the kinds of evidence and critical thinking that could actually determine if the conspiracy theory were real or even plausible.
As you can see, however, conspiracy theorists have erected an elaborate justification for their logical fallacies.
Change blindness is a fascinating phenomenon in which people do not notice even significant changes in an image they are viewing, as long as the change itself occurs out of view. Our visual processing is sensitive to changes that occur in view, but major changes to a scene can occur from one glance to the next without our noticing in many cases.
(See the color changing card trick for an example.)
One group of researchers believe they have a working hypothesis as to why our brains might have evolved in this way. Their idea is that the visual system will essentially merge images over a short period of time in order to preserve continuity – a process they call the continuity field. In essence our brains are sacrificing strict accuracy for perceived continuity.
This is in line with other evidence about how our brains work. Continuity seems to be a high priority, and our brains will happily fill in missing details, delete inconsistent details, and even completely fabricate information in order to preserve the illusion of a continuous and consistent narrative of reality.
Visual continuity is important because otherwise the world would appear jittery to us, constantly morphing as shadows play across an object, or our angle of view changes. This could be highly disruptive and distracting.
The researchers also point out that in the real world objects are fairly stable. They don’t pop in and out of existence, or morph into other objects. So not being perceptive to such changes would not be a big sacrifice and would not be likely to affect fitness. If something is actually moving or changing in our visual field we are very sensitive to that, and our attention will be drawn to it.
Neuroscientists, however, can contrive all sorts of impossible scenarios in order to probe our processing of sensory information. We did not evolve with video or photography, but researchers can use this technology to test how our brains process information.
They also give real world examples, such as the movies. There are often continuity errors in movies, missed by the vast majority of movie-goers.
To test their hypothesis of a continuity field, the researchers had subjects orient a white bar on a video screen to match the just-viewed black bars. They found that the subjects would orient the white bar in a position that was the average of the last several black bar images seen. It is as if their visual systems were averaging out about a 15 second window of similar images in a similar location. The effect was not present when the white bar was distant from the black bars on the screen, only when they overlapped.
Of course, it is difficult to extrapolate from such a specific study result to exact brain functions. This is very tangential evidence. But it was a test of a specific hypothesis, and the results do support the hypothesis, which I also think is plausible and in line with previous research.
While we can’t make too much of this one study, it is a consistent part of a larger picture that is emerging from neuroscience research. Our brains construct our perception of reality. They have algorithms that determine what sensory information to pay attention to, and essentially ignore the rest.
Further, the constructive process highly favors continuity over accuracy. In most everyday situations the sacrifice to accuracy will not be practically significant. However, at times the sacrifice will result in the misinterpretation of our sensory experience.
Researchers can force this using optical illusions and other contrived experimental setups. But significant misinterpretations can also occur “in the wild” outside of a laboratory setting. In such cases people may have strange experiences they find difficult to explain. They are likely to then reach for culturally available explanations, such as ghosts or UFOs.
People who have such strange experiences may later proclaim that they know what they saw. Chances are, however, they don’t. They have a reconstructed memory of a constructed sensory experience that we know is highly flawed.
There has been a recent increase in attention paid to the old question about food dyes and behavior in children. The idea that food coloring causes hyperactivity in children started with Ben Feingold in the 1970s. He popularized his “Feingold diet” for ADHD, which is still being promoted by some today.
Initial research showed a possible connection between certain food dyes, especially synthetic dyes, and hyperactive behavior in children. However, the next 20 years produced better controlled studies that did not show the alleged effect. It seemed like just another case of preliminary positive evidence that did not hold up to later more rigorous replication. Serious scientific interest in the question waned with this negative data.
However, recent popular interest in such issues has caused another wave of research. Dr. Oz’s website, for example, discusses the issue, giving it credence. Unfortunately, while it has renewed interest in the food dye question, the more recent research has not definitively answered the core question.
This is a complex research area because hyperactivity is often a subjective judgment, and behavior in children is subject to observer effects and placebo effects. Strict blinding and controls are therefore necessary.
Several recent reviews come to similar conclusions, which are more than a bit wishy washy. The Dr. Oz article cited one meta-analysis, but the conclusion of the analysis hedges:
Despite indications of publication bias and other limitations, this study is consistent with accumulating evidence that neurobehavioral toxicity may characterize a variety of widely distributed chemicals. Improvement in the identification of responders is required before strong clinical recommendations can be made.
Like other reviews and meta-analyses, they find a small effect, but also find serious problems in the data such as publication bias. They also find that the effect is most significant in a subset of children (called responders). While it is plausible that a subset of children, due to genetic differences, may have an adverse effect to some food dyes, while others do not, this makes interpreting the research more tricky.
A restriction diet benefits some children with ADHD. Effects of food colors were notable were but susceptible to publication bias or were derived from small, nongeneralizable samples. Renewed investigation of diet and ADHD is warranted.
Again we see there are problems with publication bias (a tendency to publish positive studies more than negative studies), but also point out problems with the sample sizes. They also found an effect in some children but not others.
At present there does not seem to be a definitive answer to the question of whether or not any specific food coloring or combination of food dyes worsens the symptoms of ADHD or contributes to hyperactivity in children with or without ADHD. To clarify, there is no research showing that food dyes cause ADHD, the question is restricted to short term effects on behavior.
There are some common themes in the reviews and meta-analyses. The existing research is currently inadequate to definitively answer the question, and further research is warranted. There appears to be publication bias affecting such reviews. Many studies are small, have problems with selecting subjects, and have small and inconsistent effects.
It is possible there is an adverse effect on behavior in a subset of children.
I agree with one reviewer who concluded:
While these strictures could have positive effects on behavior, the removal of food dyes is not a panacea for ADHD, which is a multifaceted disorder with both biological and environmental underpinnings.
An effect from food dyes is possible, but its overall effect on ADHD is likely minor and only one piece to a larger puzzle. Unfortunately this leaves us without a clear recommendation for consumers.
It may seem obvious to recommend to parents of children with ADHD to try a dye-restricted diet in their children to see if it works. However, such subjective evaluation by parents is likely to be overwhelmed with confirmation and observer bias. It still may not be unreasonable to try it. At least there is no health risk to such a trial. But I would advice caution in interpreting the results, and weigh any perceived benefit against any inconvenience or added cost. I would not recommend draconian measures in the hopes of a dramatic effect.
Mostly I hope to see some further rigorous trials to more definitively put this question to rest.
Science Based Medicine last covered the increasingly common practice of laboring while immersed in water, in many cases followed by delivering the baby while still submerged, a little over four years ago. In that post, Dr. Amy Tuteur focused primarily on the contamination of the water with a variety of potentially pathogenic bacteria and the associated risk of infection. She also touched on the some of the other risks of giving birth underwater and made some excellent arguments against many of the claims made by proponents. I recommend reading that post and the ensuing comments.
This week, a new joint clinical report from the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) on immersion in water during labor and delivery was published in both the April Pediatrics and on the ACOG website. The media has responded with the typical flurry of falsely dichotomous coverage, pitting maternal-fetal medicine experts against midwives and other waterbirth proponents and leaving it up to the reader to decide which side is right. This March 23rd, an NPR article by Nancy Shute is a particularly frustrating example of weak medical reporting. In the article she essentially portrays giving birth underwater as an established and safe practice and medical experts as overly focused on a few flimsy anecdotes and case reports:
“Case reports are the lowest form of evidence,” Shaw-Battista counters. She is completing a study of 1,200 women who labored or birthed in water, and says they did as well or better than women who did not. “Given the bulk of the data, I don’t think we should use case reports to reject options that women are currently enjoying.”
Like many proponents, Shaw-Battista, who is the director of the Nurse-Midwifery Education Program at UCSF, touts unpublished data and subjective claims. About the only thing she says in the article that I can’t argue with is that if a family is going to deliver underwater it should be “conducted with a trained professional, be planned, and follow established guidelines.” I may not support the practice, but there absolutely should be somebody present who knows to get the baby out of the water right away without causing an avulsion of the umbilical cord, to not put the baby back in what amounts to sewer water for any reason, and who can perform neonatal resuscitation if necessary. That’s more likely to happen when a waterbirth takes place at a hospital or birthing center, which many do, but is decidedly less likely to be the case during a home birth, many of which are attended by laypersons with little to no experience in dealing with complications of any kind.
In the article, Shute also significantly misrepresents a 2009 (updated a bit in 2011) Cochrane review of immersion in water in labor and birth, and not just by calling it a 2012 review, which is when it was made available online:
A 2012 Cochrane review found no harm to the baby in 12 randomized controlled trials of water labor or birth involving 3,243 women, and less use of epidural anesthesia.
Yes, the Cochrane review looked at 12 studies, but 9 of them only involved immersion during the first stage of labor, which ends upon complete cervical dilation. The AAP and ACOG aren’t too worried about the first stage of labor other than the possibility that sitting in a tub of water might possibly interfere with providing appropriate emergency medical care in the event of a complication. They also ask nicely that facilities providing water immersion during the first stage of labor to please keep the tubs clean, however.
They admit that there may be some benefit in that there appears to be a little, and I mean a little, less use of spinal/epidural analgesia and that progression to the second stage of labor (delivery of baby but not the placenta) might move a little faster. It is questionable how clinically significant these benefits are however. And there is absolutely no evidence whatsoever that water immersion improves outcomes related to the baby. Only three of the studies used in the Cochrane review looked at the actual delivery, and they were unable to draw any conclusions regarding safety and efficacy.
A fine example of complementary and alternative reality in regards to labor and delivery can be found at Waterbirth International, which is run by >Barbara Harper, a nurse who preaches the benefits of waterbirthing all over the world and who is a proud proponent of rebirthing-breathwork. Rebirthing-breathwork is the concept that suppressed negative emotions can be healed by reliving one’s birth…and breathing a lot. Also there is something in there about cells having feelings. Harper gets the last word in the NPR article:
“I think this is backlash from the gaining popularity of water birth,” says Barbara Harper, founder of Waterbirth International, an advocacy organization…One thing that happens in a water birth, you as the attending physician pretty much have to stand there with your hands in your pockets and let it happen without your participation. That is pretty scary to a physician-oriented institution.”
How’s that for a straw man? Medical experts are apparently only skeptical of waterbirth because we don’t get to participate, which I have little doubt is code for “we don’t like it cause we don’t get paid.” I wonder if she works for free.
I believe that most rational people, even those with no medical experience, intuitively understand that delivering a baby into a body of water, even a sterile one, would be inherently risky. Human newborns, as with all other primates (take that Discovery Institute) breathe almost immediately upon arrival into this world. This helps to initiate a chain of events that assists the neonate in transitioning from fetal to adult circulatory patterns, and there are millions of years of evolutionary momentum behind this process. But besides being a completely unnatural act, something that usually sends proponents of pseudoscience running, there are numerous potential risks involved with giving birth underwater.
Before I discuss the risks, however, allow me to pass along the proposed benefits so that you might make an informed risk-versus-benefit determination for yourself. The following information comes from a Waterbirth International FAQ on the subject and is fairly representative of what other organizations claim and of the degree of misinformation patients are subjected to. Here is another example of information supportive of waterbirthing available online that goes much further, even implying that premature infants and other babies at high risk of complications, such as large babies at risk of becoming stuck at the shoulders during delivery, are good candidates. There is also a reference to the “aquatic ape” hypothesis hidden in there.
The most common proposed benefit of water labor and birth is less pain, and therefore a better chance of achieving a “natural” childbirth without drugs for maternal comfort. This desire for a drug-free childbirth is based on the naturalistic fallacy, misleading claims of risk by proponents, a large helping of misogyny, and dubious ethics on the part of medical professionals who would otherwise never allow a patient to suffer. Other more objective claims are that it speeds up labor, decreases the need for C-sections, and reduces the number of trauma-requiring interventions. Proponents also claim that decreased maternal stress hormones are better for the baby, and that the newborn transition will be gentler which just has to be a good thing. The rest are entirely subjective, such as increased relaxation, improved sense of well-being and control, or involve how satisfied the mother was with the process.
So what kind of evidence base supports these claims of benefit? According to the recent statement from the AAP and ACOG, and I’m paraphrasing a bit, it ain’t good. The following quote works too:
Most published articles that recommend underwater births are retrospective reviews of a single center experience, observational studies using historical controls, or personal opinions and testimonials, often in publications that are not peer reviewed.
The authors also point out that there is a complete absence of any basic science, in either animals or humans, to support the proposed physiologic benefits of giving birth to a human underwater. Plenty for fish though.
Another huge problem with the evidence for water labor and birthing, whether published in peer reviewed journals or anecdotes on websites and documentaries, is the lack of consistent definitions. What defines water labor and waterbirth varies from situation to situation and between institutions. Timing, temperature, maternal health problems and location can vary significantly. And I’ve already given you an example of a so-called science reporter conflating safety data from just labor with safety of underwater birth, which is at the very least extremely misleading, and potentially dangerous. There is also a complete lack of blinding and virtually no controlling for the other aspects of the birthing environment when comparing standard to underwater deliveries.
What does the available evidence support after taking into account the poor quality of available data? Not a whole lot. As I stated earlier, there appears to be a modest, though perhaps not clinically significant, decrease in the use of pain-reducing procedures. There also appears to be a decrease of about half an hour in the time it takes for labor to progress to full dilation, but again this is hampered by a lack of controlling for potential confounders. There is no good data to support a difference in delivery-associated trauma, the need for vacuum or forceps assistance, or the need for a C-section. There is no evidence to support claims of benefit to the newborn. But it does seems that mothers are more satisfied with delivery underwater, which may only be a result of theatrical placebo employed by waterbirth attendants.
Now that I hope I’ve made it clear just how flimsy the case for giving birth underwater is, it is time to discuss the potential risks. Similar to the data held up by proponents as supportive of their claims of benefit, the risk of underwater birth is largely based on individual case reports and series, although the basic science foundation is solid. This means I can’t tell you how common it is for these complications to arise, but of course the burden of proof does fall on the proponents to show benefit. That being said, the risks that have been reported can be quite serious, even deadly. I’ll just list them:
These risks, although rare, are potentially catastrophic. There are numerous case reports/series of deaths and significant morbidity. One study that was not included in the Cochrane review because it involved a comparison of standard delivery and waterbirth of infants with dystocia (abnormal or difficult childbirth/labor) showed that 12% of the babies born underwater required NICU admission while none of the babies born dry, relatively speaking, did. The only variable in a delivery that can lead to fresh water drowning, for instance, is the choice to have a waterbirth. That alone, in my opinion, is enough to establish that at this time the risk outweighs the benefit. The incidence of these adverse outcomes is likely much higher when an infant with risk factors is born underwater. Essentially the same issues that come up with home births in general are exacerbated by adding water.
Why don’t babies breathe when they are born underwater? According to Barbara Harper, there are many reasons, including that God doesn’t want them to, but four that stand out:
1. Prostaglandin E2 levels from the placenta which cause a slowing down or stopping of the fetal breathing movements. When the baby is born and the Prostaglandin level is still high, the baby’s muscles for breathing simply don’t work, thus engaging the first inhibitory response.
Healthy babies born without difficulty typically breathe within ten seconds of birth, but many breathe right away. The likely reason that there isn’t a higher incidence of aspiration of water after delivery is that the standard approach is for the attendant to remove the baby from the water right away, though with care to not damage the umbilical cord. A sick baby may have already begun gasping breaths while still in the womb, and they often pass stool prior to delivery which can be aspirated and cause a great deal of morbidity and mortality. If a sick baby were to be born into water, they are almost certainly at increased risk of drowning.
2. All babies are born experiencing mild hypoxia or lack of oxygen. Hypoxia causes apnea and swallowing, not breathing or gasping.
This demonstrates a complete misunderstanding of newborn physiology around the time of birth. Yes, oxygen saturation levels in newborn babies are not 100%. They slowly rise over the first several minutes of life to normal levels. So this is true in that sense. In regards to apnea, I can only assume that she means primary apnea. This occurs when an infant is unable to achieve adequate oxygenation through breathing once the placental supply of oxygen is diminished. It is never normal for a newborn to be apneic, but it is somewhat common.
Primary apnea, when it occurs, often responds to simple stimulation to breathe as occurs during drying and providing a clear airway, while secondary apnea, which occurs after a prolonged lack of oxygen delivery to the brain, requires more aggressive resuscitation. Again, babies typically breathe within a few seconds of birth. So the attendant at a water delivery must quickly retrieve them from the water. I’m sure they make it seem like a gentle and loving thing, but as soon as the kid hits the water, the clock is ticking and such a nonchalant reference to apneic newborns is frightening.
3. Fetal lungs are already filled with fluid. That fluid is there to protect the lungs, and keep the spaces open that will eventually exchange carbon dioxide and oxygen. It is very difficult, if not improbable, for fluids from the birth tub to pass into those spaces that are already filled with fluid. One physiologist states that “the viscosity of the fluid naturally occurring in the lungs is so thick that it would be nearly impossible for any other fluids to enter.
This is true, prenatally. But the onset of labor signals a surge of chemicals called catecholamines that signal the lungs to quickly reabsorb fluid. This is why babies that are born without labor, such as via a scheduled C-section, often have a transient period of fast breathing related to some retained fluid in the lungs. The lungs are not “filled with fluid” at the time of delivery however, and will readily accept a bolus of fresh water as has been reported many times. In fact, premature infants, and sometimes even those delivered at term, often have medicines purposefully squirted into the lungs via an endotrachial tube right after birth. They get in there just fine.
4. The last important inhibitory factor is the Dive Reflex and revolves around the larynx. The larynx is covered all over with chemoreceptors or taste buds. The larynx has five times as many as [sic] taste buds as the whole surface of the tongue. So, when a solution hits the back of the throat, passing the larynx, the taste buds interprets [sic] what substance it is and the glottis automatically closes and the solution is then swallowed, not inhaled.
The dive reflex occurs in aquatic mammals primarily but there is a weaker version in humans. It involves a reduction in heart rate and a shunting of blood from the peripheral vasculature to the vital organs, primarily the heart and brain, allowing for an extended duration of breath holding. This reduction in heart rate can actually sometimes be put to medical use in young patients presenting with one type of arrhythmia called supraventricular tachycardia. We hold a bag of ice water over the entirety of their face. Strange but true.
The dive reflex only occurs when the face is submerged in very cold water. Breath holding associated with submersion in cold water is an involuntary process where breathing is centrally inhibited. What waterbirth proponents are confusing the dive reflex with here is drowning. During drowning, when water hits the airway there is spasm of the surrounding musculature and closure of the epiglottis. This prevents aspiration and forces swallowing of the water, which is why there is risk of hyponatremia in fresh water drowning. Eventually the spasm will relax and water will be taken into the lungs.
These are the people delivering our babies. When waterbirths take place in cold water, which they never do because that would interfere with the pleasurable experience of the mother, they can talk about the diving reflex. Or if they are delivering a seal. You know what really interferes with the pleasurable experience of the mother? A dead baby.
One final time, the reason why more babies don’t tend to aspirate water after a waterbirth is timing and luck. They are retrieved prior to the first breath, which may be a little delayed because of reduced stimulation to a baby born underwater. It is as simple as that. Some babies will always breathe too soon. Sick babies are more likely to breathe too soon. If a baby develops primary apnea, and stimulation to breathe is delayed because they are underwater, their heart rate will plummet and prolonged lack of oxygen to the brain will lead to them requiring substantial resuscitation.Final thoughts
The conclusion of the AAP/ACOG statement that has waterbirth proponents so bent out of shape is extremely well-reasoned. They admit that water immersion during the first stage of labor might have some very limited benefit as discussed above. But they stress that there isn’t evidence to support improved perinatal outcomes, and that if a mother chooses to relax in a pool filled with water it shouldn’t get in the way of other aspects of appropriate care. Of course lay midwives attending a home waterbirth might have a different opinion regarding what those are.
In regards to actually delivering in the water, the authors conclude that the safety and efficacy is not established. They state, based on the many case reports of severe complications and lack of quality evidence to support maternal or fetal benefit, that any underwater deliveries should be considered an experimental procedure and take place in the context of a clinical trial with informed consent. And there is the rub. I have grave concerns that appropriate informed consent is currently not being obtained, that the benefits are overhyped and the risks downplayed beyond what is supported by the evidence. A lack of proper informed consent violates one of the four foundational principles of medical ethics, which is a respect for the patient’s personal autonomy.
There are few things as intimate and emotionally powerful as the process of giving birth. The variables inherent in this process range from the fairly minor, such as what music a mother would like to listen to during labor, to the extremely important choices of where and how the baby is to be born and who is to be in attendance at the delivery. Many of these choices have relatively little if any impact on the health of the newborn baby or on the risk of maternal complications, but rather help to mold and shape the overall experience of childbirth to the mother’s liking. Regardless of the importance of each choice, it should come as no surprise that they are as subject to personal biases, logical fallacies, and social and cultural influences as any other decision.
Expectant mothers, and often their families, put a great deal of focus on the subjective experience of childbirth, and this is understandable as the memories being forged will last a lifetime. There is unfortunately, for many families, an idealized perfect labor and delivery experience that often appears to be based more on television and movie portrayals or the anecdotes of friends than on explanations by science-based healthcare professionals. But sometimes this ideal experience is molded and shaped by biased healthcare professionals employing motivated reasoning, or by nonprofessional lay practitioners who hold themselves up as birthing experts.
They all likely mean well and want what is best for the mother and baby, but that is not an excuse. Childbirth is a time of great vulnerability. All parents want their children to enter the world happy and healthy, and to stay that way as they grow. Unfortunately, when this all-too-human desire to have a positive birth experience and a healthy baby is hijacked by excessive worry based on false or misleading information, people can make uninformed and potentially deadly decisions. My provisional conclusion is that choosing to deliver a baby underwater is such a decision. If proponents are at some point able to present good evidence to show that the benefit of waterbirth outweighs the risk, I will gladly change my opinion.
-Dr. Jen Gunter, an evidence-based OB/GYN and pain medicine physician, also recently discussed the AAP/ACOG statement on her website. She agrees that introducing water to the birthing mix shouldn’t get a free ride.
-Finally, here is a satirical look at the extremes people go to in an effort to have a memorable birthing experience.
“Will Tylenol harm my baby?”
Pharmacists are among the most accessible of health professionals, and so we receive a lot of questions from the public. No appointment required, and the advice is free. Among the most frequent sources of questions are women seeking advice on drug use in pregnancy. This is an area where some health professionals are reluctant to tread. Some prefer to redirect all of these questions to physicians. But physicians are not always easily accessible, and few want to make an appointment just to ask what appears to be a simple question: Is it safe, or not? Admittedly, addressing questions about drug use in pregnancy can be challenging. There are no randomized controlled trials we can look to — there’s only messier, less definitive data. Our responses are filled with cautious hedging about risk and benefit, describing what we know (and don’t know) about fetal effects. In the pharmacy, one of the most common questions from pregnant women is about the use of acetaminophen (aka paracetamol aka APAP), more commonly known by the brand name Tylenol. Google “Tylenol and pregnancy” and you get 4.8 million results. Which source should you trust?
It should come as no surprise that acetaminophen has generated several posts over the years at SBM. It’s one of the most commonly-used medicines worldwide, starting in infancy for fever, right through towards end-of-life pain control in the elderly. As an ingredient, acetaminophen is packaged into hundreds of prescription and non-prescription drugs. Acetaminophen has a good safety profile when used appropriately. However it is among the most harmful of drugs in overdose, and the ease at which overdose can occur makes acetaminophen the cause of hundreds of cases of liver failure per year. Given this frequency of use, and a unique risk profile, there are continued questions about its safety and efficacy. Regulators (and manufacturers) continue to experiment with ways to make the drug available, while minimizing the risk of unintentional harm.
Pain in pregnancy, and the desire to treat it, is common. Beyond the non-pregnancy causes everyone can experience, like headaches and colds, the pregnant body is undergoing a rapid transformation that may not be painless. Weight gain of 25 or more pounds leads to posture changes and painful joints from head to toe. Low back pain is common, and it can be worse at night, leading to insomnia. Pelvis pain, knee pain, and hip pain are also common, and can be quite debilitating. While non-drug measures should always be attempted before considering drug treatment, severe or prolonged pregnancy pain may require the consideration of drug treatment.
Acetaminophen is the current go-to drug for pain control in pregnancy. There is good evidence to show that it does not increase the risk of major birth defects above the baseline risk (2-3%) that is inherent to any pregnancy. Acetaminophen can be used throughout pregnancy, and as long as the dosing is appropriate, side effects are remarkably rare. With a safe history of use and a low risk of side effects, acetaminophen is widely used when pain control with drugs is required.
The risks and benefits of drug use in pregnancy can’t be looked at in isolation. There is always an alternative, and the relative risks and benefits must be weighed. Doing nothing is always an alternative for pain, so the consequences of untreated pain need to be considered. But when pain is severe, other drugs might be considered. Stacked up against the alternatives, acetaminophen looks pretty good. Anti-inflammatory drugs like ibuprofen must be avoided in the later stages of pregnancy, due to the concerns about cardiovascular toxicity. Compared to the anti-inflammatory drugs, acetaminophen is unlikely to cause gastrointestinal ulcers, blood disorders, or kidney problems. Nor does acetaminophen appear to increase the risk of cardiovascular events such as heart attacks and strokes. Compared to the anti-inflammatory drugs, acetaminophen also has few interactions with other drugs, so it can safely be used for pain relief in pregnant women on other medications, or with other medical conditions where other pain relievers might have unwanted effects.
Beyond acetaminophen and the anti-inflammatories are the narcotics. The addictive properties of narcotics are well known, and they affect the fetus, too. Compared to a drug like codeine or morphine, acetaminophen provides a non-addictive alternative that may be more appropriate for short-term or long-term pain issues when drug treatment is being considered.
Now there’s a new study suggesting that the risk and benefit of acetaminophen in pregnancy may not be so clear. The paper is from JAMA Pediatrics, and it’s entitled “Acetaminophen Use During Pregnancy, Behavioral Problems, and Hyperkinetic Disorders”. Zeyan Liew and colleagues conducted a study of over 64,000 children and mothers who were enrolled in the Danish National Birth Cohort between 1996 and 2002. The Cohort was established to ask (and answer) questions about pregnancy and early childhood and the relationship to diseases that emerge later in life. Pregnant women were recruited with the intention to conduct long-term studies as these women (and their children) age.
The design of the study was straightforward. Acetaminophen use was assessed through telephone interviews before and after birth. Measurements of ADHD and hyperkinetic disorders after birth were measured by:
Not surprisingly for a drug that is recommended for use in pregnancy, more than half of all of the study’s participants used acetaminophen at some point during pregnancy. There was a relationship found: Children whose mother used acetaminophen during pregnancy had a higher risk of a hospital diagnosis of HKD (hazard ratio 1.37, confidence intervals 1.19-1.59), receipt of ADHD medication (hazard ratio 1.29, confidence intervals 1.15-1.44) or having ADHD-like behaviors as defined by the standardized questionnaire (hazard ratio 1.01-1.27). There was also a positive relationship with the number of trimesters of use. Numerous confounders were studied and there was no relationship found.
There are a lot of strengths to this study that merit a close consideration of the findings. It’s a big data set that was powerful enough to detect a very subtle difference. The analysis was generally very well done. It was prospective, so the risk of bias due to time and memory (“recall bias”) was minimal. There were three independent data points collected, and two (hospital diagnoses and prescriptions) were objective measurements. There was a consistent trend observed: The risks appeared higher with use in more than one trimester, and when the duration of use (in weeks) increased. This was observed across the different endpoints. We can never say correlation equals causation with a non-randomized study, but does this study suggest it’s time to change the guidance on acetaminophen?
There were a few important limitations. Investigators failed to fully evaluate the family history of behavior disorders in parents. In diseases where there is good evidence for genetics having a substantial role, this is a significant limitation. The use of ADHD-prescriptions may not be a great measure either, given the lack of certainty about the diagnosis of ADHD (although this should have affected both groups equally). It could also be that acetaminophen use is just a signal or proxy for something else — and the acetaminophen is just what we’re noticing, and not the actual cause. It could be another condition or cause that the pregnant women are taking acetaminophen for. Finally there’s considerable uncertainty about the dosing and timing. The measurements of exposure was not ideal — in some cases it had to be estimated for women who could not recall when they took the drug. In addition, the overall dosing (e.g., average number of tablets) wasn’t available).
Probably the biggest fault to the study isn’t actually a flaw — it’s one of how meaningful these results really are. The absolute risks of ADHD remain tiny. Most of the headlines mention the relative risk: (“30% MORE LIKELY TO EXHIBIT ADHD”) when it’s the absolute risk that needs to be considered. The biggest difference as measured at age seven was the variation in the standardized questionnaire: 34 per 1 000 in the group “ever took acetaminophen”, versus 25 per 1 000 in the “never took acetaminophen” group. Recall, that’s a survey result — not a diagnosis. On balance, if the effect is real, it very minor, and the vast majority of the cases of ADHD are being detected in women who took no acetaminophen at all.Conclusion
I have mixed feelings about these studies. On one hand, these databases give us the ability to evaluate very subtle effects that we could never otherwise identify. They also allow us to make inferences about relationships when randomization isn’t feasible or even ethically possible. And they may lead to further studies to help us better understand risk and benefit. When it comes to acetaminophen and ADHD, we can be reassured that if there is any causal effect from acetaminophen, then the effect is very slight. There’s no evidence to suggest that acetaminophen is driving the perception of growing incidence of ADHD. And studies like these are also a reminder to health professionals that we cannot take anything for granted — we need to look carefully yet critically at any new evidence. But there’s a downside to studies like these. Unwarranted panic is one, often driven by reporting that hypes the “statistically significant” without providing insight and context. Pushing women towards other, less safe alternatives could cause more harm.
Does the study change how we manage pain in pregnancy? It shouldn’t. No drug should be taken in pregnancy unless it’s necessary — acetaminophen is no exception. But there’s no reason for pregnant women to suffer from pain unnecessarily. Acetaminophen remains the drug of choice when pain control is necessary in pregnancy.References
Liew Z., Ritz B., Rebordosa C., Lee P.C. & Olsen J. Acetaminophen Use During Pregnancy, Behavioral Problems, and Hyperkinetic Disorders, JAMA Pediatrics, DOI: 10.1001/jamapediatrics.2013.4914
Antivaxxers spread misinformation. This does not have to be the case – I can envision those who wish to function as watchdogs on the vaccine industry or prioritize personal freedom over government programs (even good ones), but who strive to be logical and evidence-based. The culture within the anti-vaccine movement, however, is not logical and evidence-based. Rather, they spread whatever misinformation supports their rather extreme ideology – that vaccines do not work and are dangerous.
Countering anti-vaccine misinformation can be almost a full time job. It is the proverbial game of whack-a-mole, especially in the social media age where old debunked anti-vaccine memes can resurface over and over again on Facebook or Twitter. The game is also rigged in that it is easier to spread fear with misinformation than to reassure with accurate information. Even if we address every anti-vaccine trope, parts of the public can be left with the vague sense that there is something dangerous about vaccines, or that the government is not playing entirely straight with us.
In any case, here is this week’s edition of whack the anti-vaccine mole. The particular varmint that popped its head up recently is the claim that 2-5% of children who receive the MMR vaccine (mumps-measles-rubella trivalent vaccine) contract measles from the vaccine. This specific claim was made on the realfoodeater blog (another thing you should know about the anti-vaccine community is the broad overlap with the natural, alternative medicine, and conspiracy subcultures). The blogger gave as a reference a conversation she had with an unnamed doctor at DeVos Children’s Hospital.
This, of course, is a huge problem with medical information on social media – much of it is second-hand information passed through non-experts, often through thick ideological filters. Can there be any truth to this particular claim?
The measles component of the MMR vaccine is a live attenuated virus. Some vaccines use only parts of organisms, some used whole killed organisms, and some use live attenuated viruses. A live virus vaccine does cause an actual infection, just a weakened one that the immune system should have no problem fighting off, resulting in lasting immunity without having to suffer from the full-blown illness.
Viruses are attenuated for such vaccines by culturing them in a non-human medium, in this case, chicken embryos. The virus essentially adapts to the non-human host and over time loses its adaptations to humans and so becomes less virulent. In the case of the attenuated measles virus, it replicates much more slowly in human hosts, giving the immune system time to gear up and wipe it out before it can cause any serious problems.
Where the 2-5% figure likely comes from is that this percentage of children who receive the MMR vaccine will get a mild measles-like rash. This is not full-blow measles, however. It is easy to see how the blogger could have misunderstood this kind of information.
In order for the vaccine to cause an actual measles infection the attenuated virus would need to mutate back to its wild type, regaining some of its lost virulence. This can theoretically happen, but is extremely rare.
The meme that kids get measles from the vaccine goes beyond this one blogger. An anti-vaccine chiropractor, Tim O’Shea, makes this claim overtly. He has two references to support his claim – neither of which have anything to do with contracting measles from the vaccine. They report measles outbreaks among high school and secondary school children.
The reports, in fact, demonstrate that the MMR vaccine is mostly effective. These particular outbreaks spread through children who did not have antibodies to the measles virus. In the second report, for example, 99% of the students had been vaccinated, but 4.1% did not seroconvert (in line with other published data on antibody rates in those vaccinated). The outbreak spread only to those without antibodies.
Without the high vaccination rate of this population, the small outbreak could have become a major epidemic. It is entirely unclear how O’Shea concludes from these studies that either vaccines cause measles or that the vaccine does not work. He writes:
Before 1978, measles was a minor, self-limiting, immune-building disease of childhood. You wanted your child to get it because they would have lifetime immunity. Then in 1978, the MMR shot suddenly became part of the vaccine package for all kids. 3 doses. Even though the incidence was down by 90% by then.
After a decade or so, many incidents like the 2 cited above began occurring all over the country – groups of kids who obviously got measles from the shot itself. They got the exact disease the shot was pretending to prevent. Such examples continue to the present.
He does not explain how children contracted measles from a vaccine they received over a decade earlier. Here we also see other anti-vaccine memes – that the diseases vaccines prevent are not so bad, and that they were on their way out anyway, and the vaccines just made things worse. This is abject science denial.
This meme is epitomized in the book Melanie’s Marvelous Measles, claiming that it is good for children to contract these diseases as it builds “natural” immunity. I’m still waiting for the sequels – Peter’s Powerful Polio, and Tina’s Terrific Tetanus.
The World Health Organization, however, spells out the real toll of measles:
Measles is also a significant cause of blindness in developing countries. This is not a benign disease.
The notion that measles builds the immune system is also misleading. The immune system develops perfectly well without this particular infection. Infection results in immunity to measles alone. Of course, vaccination results in immunity to measles with far less risk.Conclusion
Anti-vaccine sources make demonstrably incorrect claims about diseases and vaccines. This is not a matter of opinion – they are doing it wrong.
The examples above are just the tip of the iceberg. They get the science wrong by making factual errors and misinterpreting the evidence. Further, when their mistakes are pointed out to them, they rarely make corrections. They continue to use the discredited arguments.
This is the pattern of behavior of an ideological group engaging in motivated reasoning. Some of them, however, have computers and spread their misinformation like a virus.
I guess that makes SBM a vaccine in that analogy. Now we just have to figure out how to increase compliance.
Addendum: I had asked the CDC if there were any reported cases of full measles (not just mild symptoms) from the MMR vaccine and this is their response:
We are aware of 3 reported potential cases of measles contracted from the MMR vaccine. These 3 cases are from published reports in persons with immune deficiencies which described measles inclusion body encephalitis after measles vaccination, documented by intranuclear inclusions corresponding to measles virus or the isolation of measles virus from the brain among vaccinated persons. The time from vaccination to development of measles inclusion body encephalitis for these cases was 4–9 months, consistent with development of measles inclusion body encephalitis after infection with wild measles virus. In one case, the measles vaccine strain was identified.
Three total cases, and only one in which the measles vaccine strain was identified. This is out of millions of doses given. This is rare indeed.
A bit of good news for a change: a “Perspective” article in the New England Journal of Medicine describes how point-of-care ultrasound devices are being integrated into medical education. The wonders of modern medical technology are akin to science fiction. We don’t yet have a tricorder like “Bones” McCoy uses on Star Trek, but we are heading in that direction, and the new handheld ultrasound devices are a promising development.
The stethoscope has become iconic, a symbol of medical expertise draped proudly around the neck by doctors and other medical personnel. Before it was invented, doctors could only try to listen to a patient’s heart by direct application of ear to chest. In 1816, Laennec interposed a tube of rolled paper between ear and chest, and the stethoscope was born. It quickly became an essential tool, allowing us to hear the distinctive murmurs produced by different heart valve abnormalities, to take blood pressures, to detect the wheezing of asthma or the collapse of a lung , to hear the bruits caused by atherosclerotic narrowing of blood vessels, to detect intestinal obstructions by listening for borborygmi (I love that onomatopoeic word!).
The stethoscope allows us to hear sounds produced by the body, but sound also allows us to see inside the body. Diagnostic ultrasound has a multitude of uses. With prenatal sonograms, we can determine the sex of a fetus, watch it suck its thumb, and even take its picture for the family album. With echocardiography we can evaluate heart valves, see fluid accumulation in the pericardium, observe the thickness and motion of the heart wall, and even quantify the efficiency of the pumping process. Ultrasound lets us see clots in blood vessels and stones in the gallbladder, evaluate abdominal organs, detect cysts, screen for carotid artery narrowing and abdominal aortic aneurysms, and guide needles into the body for therapeutic and diagnostic purposes.
Modern imaging methods allow us to see abnormalities in the living patient that were once only detectable on autopsy. Because of this, medical autopsies are no longer so useful and their rates have declined drastically although forensic autopsies are still required by law. It’s really amazing what we can see with CT scans, MRIs and ultrasound. I recently had an echocardiogram and my mind was boggled as I looked into my own heart and watched the valves open and close. I developed a new respect for my heart as I watched the organ pumping away, working assiduously to keep me alive, with never a moment’s rest. The visual experience was impressive, but perhaps even more impressive was the way the technician was able to precisely measure the thickness of the ventricular wall and quantify the ejection fraction, measuring the amount of blood that was being pushed out of the ventricle with every heartbeat.
Instead of writing an order for technicians to do these tests, doctors now have the option of using ultrasound technology themselves as part of the physical exam at the bedside or in the office. Several US medical schools are offering ultrasound training as early as the first year, even in orientation programs. Ultrasound is used in classes of anatomy, physiology, and physical diagnosis, and eventually on clinical rotations. Harvard has students performing ultrasounds on each other. Mt. Sinai is issuing hand-held ultrasound units to all internal medicine interns.
Studies have shown that first year medical students using these devices are better at detecting cardiac abnormalities than cardiologists (75% vs. 49%) and better at judging liver size than specialists palpating the liver. In the future, ultrasound may well become a standard part of the physical exam. The stethoscope was an extension of the doctor’s sense of hearing, and ultrasound extends the doctor’s senses in far more versatile ways.
Providing these devices to students may not be an unalloyed good. Proper use requires extensive training. False positives and negatives will occur. Students will rely on technology and neglect other diagnostic skills like palpation and auscultation. Full conventional ultrasound studies will still be needed for confirmation and further detail.
Consider this criticism:
Notwithstanding its value, I am extremely doubtful because its beneficial application requires much time, and gives a good deal of trouble both to the patient and the practitioner.
No, that wasn’t criticism of ultrasound, it was an 1829 comment about the stethoscope. Old dogs (and old docs) are slow to learn new tricks, and any new-fangled technology is bound to meet with some resistance. The real question is whether its use will improve medical practice and patient outcomes. It seems logical that it will, but that premise, like any other, will have to be evaluated by controlled scientific testing. I am optimistic.
Developments in scientific medicine are far more awe-inspiring than anything alternative medicine has to offer. Invisible acupuncture meridians and chiropractic subluxations can’t compete with watching your own heart valves open and close.
Reality is a lot more satisfying than fantasy.
Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be.
Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure.
This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions.
I had at least two other ideas for what I thought would be informative, entertaining, and timely posts, but then late last week I found out about a new development in Burzynski’s latest battle to try to use patients as weapons again to bring pressure to bear on the FDA (as he did in the 1990s) to allow patients with brain tumors to be treated with ANPs under single patient INDs, also known as compassionate use exemptions or expanded access programs. Such exemptions allow some patients who have no good conventional options access to unapproved investigational agents. Ironically, one of the most damning findings about the Burzynski Research Institute and Burzynski Clinic from the FDA investigation last year was how Burzynski would play fast and loose with the rules regarding approval by the institutional review board (IRB) of such exemptions. IRBs are committees mandated by the Office for Human Research Protections (OHRP) to protect human research subjects by approving and monitoring clinical trials to make sure that patients are not placed at undue risk, that proper informed consent is given, and that clinical trials conform to all ethical and legal requirements. Let’s just put it this way. The FDA caved. You’ll see what I mean shortly. Worse, it caved in a way that basically abdicated its responsibility.
Those of you who read my not-so-super-secret other blog will realize that I’ve already begun the discussion over there, making part of this post repetitive. However, there have been new developments over the weekend, and I very much want a record of this abdication of duty by the FDA on this blog as well—in more detail, of course.“Just when I thought I was out, they pull me back in.”
Sadly, the brief little quote from Michael Corleone (as played by Al Pacino) in The Godfather, Part III, basically sums up my feelings with respect to Stanislaw Burzynski. Every time I think that I can give the topic a rest for a while (and, believe me, I do want to give it a rest), something invariably seems to happen to pull me back in. So it was Thursday evening, when I was made aware of a new development so disappointing that I’m still wiping the dirt off my chin from my jaw dropping to the floor. Even more amazing is that my disappointment stems from my perception of cynicism that actually was not Burzynski’s, but rather by the FDA in response to Burzynski’s cynical use of cancer patients as shields and weapons against the FDA that has led some of us who support science-based medicine to be subjected to criticism from the families of patients with cancer, who have been erroneously convinced that Stanislaw Burzynski is their loved ones’ last chance to survive. Actually, I can’t tell if it’s a cynical move or a breathtakingly naïve move, but it’s a huge mistake regardless, as you’ll see. I’m guessing that some will think of it as a very clever move, and so it is, but it’s a cleverness we could use less of.
About a year ago, Burzynski was once again investigated by the FDA. Because of the death of a patient due to hypernatremia (elevated sodium level) due to ANPs in 2012, the FDA put a partial clinical hold on his pediatric clinical trials and extended it to all of his clinical trials. What this means is that, although Burzynski can continue to treat patients who are already in his clinical trials, he can’t enroll any new patients in them. Of course, one of the big issues with Burzynski that contributed to his problems is that he abused the FDA process known as the single patient IND, which is more commonly known as the compassionate use exemption. These are special case exemptions in which a single patient is allowed access to an investigational agent outside the auspices of a clinical trial. Indeed, when the FDA slapped him down most recently, in December, one of its findings was just that: Burzynski abused the single patient IND process and his institutional review board (IRB), the committee that’s supposed to oversee clinical trials and safeguard the interests and safety of clinical trial subjects, played fast and loose with the rules.
Since the appearance of a USA TODAY story by Liz Szabo spelling out all of these issues, Burzynski has been frantically trying to save his empire. Whether “encouraged” by Burzynski or just by one of the patient groups that have become true believers, patients with deadly cancer have been starting petitions, pressuring legislators to intercede on their behalf to the FDA, and paint Burzynski’s ANPs as their only hope of survival. I have no doubt that these patients believe it, but they have the potential to inadvertently do great mischief to the law, either through their use of their tragic stories to promote misguided “right to try” laws or through their use of patient stories to pressure the FDA to loosen protections on human subjects in clinical trials. Perhaps the most tragic story is that of Rafael Elisha Cohen, a six-year-old child with medullablastoma who is not doing well and whose parents have been at the forefront of pressuring the FDA. As horrible as the Cohens’ situation is—and we all understand that it’s a horrible, horrible thing to have a child dying of brain cancer—unfortunately, the FDA appears to have decided to cave. The other day, on a Facebook page dedicated to raising money and pressuring the FDA, Devorah Teicher Cohen announced:
Thanks to everyones hard work the FDA did end up approving the Antineoplastins for compassionate use – they do not let Dr B administer it.
The condition is, if an oncologist request this protocol FDA will issue compassionate use within 24 Hours.
FDA recognizes the data of those who survived aggressive brain tumors due to the ANP and is therefor after a long and cruel wasting TIME period allowing it. There are currently 8 pediatric patients that need this medicine NOW!!!!
Refael Elisha can not travel at this point…so we would need an oncologist in the NY area… we are in touch with other kids that are ready to get on a plain if they get the signal of a cooperating oncologist.
It is beyond words to express our sadness that FDA ended approving the drug but Elisha is in critical condition at the moment.
We are not holding our breath and are trying different alternatives , If HASHEM wills it we will get the medicine but if not, that is from Hashem for the good. in the meantime Please put your fillers out there and message me in privet if you have any leads , even if not in NY it might work out for the other desperate children.
im copying the announcement from ANP site
Wanted: One brave courageous oncologist or oncologists willing to examine and treat up to eight pediatric brain cancer patients who have run out of treatment options and now require a Compassionate Use IND Emergency Treatment protocol from the U.S. Food and Drug Administration. The ANP Coalition needs your help now. Please visit www.anpcoalition.org or call (925) 699-9116. Thank You
When I first saw this message on the Prayers for Elisha Facebook page, I was cautious. I could find confirmation of this news nowhere else, not even on the ANP Coalition webpage. Then, on Friday afternoon, Liz Szabo, the USA TODAY reporter who previously published her epic expose of the Burzynski cancer machine back in November, basically confirmed the report with a followup story in USA TODAY, FDA agrees to let patients get controversial drug:
The Food and Drug Administration has agreed to allow a handful of cancer patients to receive unapproved drugs from a controversial Texas doctor, but only if they can find another physician to administer them.
The drugs are made by Houston doctor Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. While his supporters consider him a medical maverick, mainstream doctors describe him as a snake-oil salesman. Burzynski has claimed for more than 36 years to be able to cure certain hard-to-treat brain tumors with drugs he calls antineoplastons. The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer.
Burzynski has been unable to give these drugs since 2013, when the FDA placed his experiments on hold after the death of a 6-year-old New Jersey boy taking antineoplastons. In December, the FDA sent Burzynski a warning letter, noting that he inflated his success rates and failed to report side effects and to prevent patients from repeatedly overdosing. The Texas Medical Board also charged Burzynski last year with false advertising.
None of this stopped the FDA from caving:
The FDA acknowledged Friday that it has agreed to allow them to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials.
Can anyone figure out why I can’t make up my mind whether this decision, if what the Cohens say is true, is stunningly cynical or stunningly naïve on the part of the FDA? Instead of standing firm for science and gently continuing to point out that it can’t allow any more single patient INDs for ANPs be approved based on science, Burzynski’s past violations of FDA regulations, and, above all, the need to follow the FDA’s mandate and mission to protect vulnerable cancer patients, instead the FDA has dangled more false hope of a single-patient IND in front of Elisha’s family (and the eight other children petitioning for such INDs). It’s hard to believe that the FDA is not aware that it is incredibly unlikely that any reputable pediatric oncologist would agree to administer ANPs under these conditions, given Burzynski’s reputation.
In a way, what the FDA is doing inadvertently compounds the families’ agony. Now they have hope again, except that this time it’s doubly false: False because, based on existing evidence and what we know now, ANPs almost certainly don’t work and false because of how incredibly unlikely it is that any pediatric oncologist will take on such a patient and administer ANPs, given Burzynski’s history, the utter lack of supporting science for the efficacy of ANPs, and the not-inconsiderable amount of work and expense that would be necessary in order to do so. The families will now be showing up in the offices of pediatric oncologists, begging them to agree to do a single patient IND and administer ANPs to these patients. Ditto some adult oncologists. Indeed, according to Szabo’s report, Liza Covad-Lauser, wife of rock star Sammy Hagar’s drummer David Lauser, claims that she has already found a doctor willing to administer the antineoplastons. One wonders if this doctor knows what he is getting himself into. As cynical as it might sound of me to say so, I can’t help but wonder whether being the wife of a member of a rock star’s band, who can garner signatures on petitions by other rock stars, has an effect.
Here’s why the FDA’s action is doubly cynical (or nave). As alluded to in Szabo’s article, according to FDA regulations, there are a number of requirements for a single patient IND and several things any physician seeking to administer an investigational agent as a single patient IND must do. Here’s the most important one that makes it even more unlikely that any single patient IND will be granted, except for perhaps briefly as an “emergency exemption” in which IRB approval can be briefly deferred:
5. Informed Consent Statement that states that informed consent and approval of the use by an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.
See what I mean? Even if a family were to find an oncologist willing to jump through all the hoops to get a patient on a single patient IND to be treated with ANPs, that single patient IND would still have to be approved by the IRB of the institution where that oncologist practices. Sure, the oncologist could declare the treatment an “emergency”—although in none of the cases that I’m aware of other than that of Elisha Cohen could be properly termed an emergency so urgent that the physician couldn’t wait a week or two to have the IRB formally discuss the IND, even if ANPs actually did have any efficacy—and start treatment pending IRB approval, but as soon as the IRB convened to discuss the IND, very likely the plug would be pulled. No more ANPs. Remember, these would be real IRBs, not Stanislaw Burzynski’s sham IRB chaired by an old crony of his.
There’s another question to consider. Stanislaw Burzynski routinely used to treat some of these patients for free, supplying ANPs for no cost and waiving case management fees. No doubt this offer was primarily for publicity, to blunt the accusation that, based on the exorbitant amounts of money charged to previous patients, Burzynski is in it for the money. So, not surprisingly, according to Szabo’s report, Burzynski is still offering to provide the drug for free. That’s all well and good, but it leaves all the other expenses of treatment, which will not be paid for by insurance because ANPs are not an FDA-approved drug. Who’s going to pay for all of that? While it is true that some of the families have raised quite a bit of money (Elisha’s family, for instance, has raised nearly $150,000), others aren’t so lucky.A massive Burzynski propaganda victory?
Supporters of Stanislaw Burzynski wasted no time in using the FDA decision to defend Burzynski and, ironically, to attack the FDA. Many of you might remember McKenzie Lowe, the 12-year-old girl diagnosed with diffuse intrinsic pontine glioma (DIPG) in 2012. Her family has been trying to have her treated by Stanislaw Burzynski, making videos and lobbying Congress. Indeed, they succeeded in persuading their senator, Senator Kelly Ayotte (R-NH), to write to the FDA urging it to consider allowing McKenzie to be treated by Burzynski. On a Facebook page Friends of McKenzie Lowe, a message was posted on Sunday simultaneously rejoicing at the news as evidence that McKenzie has a chance to live and lambasting Liz Szabo:
As you all probably have read in the USA Today the FDA has agreed to let Mckenzie and the other people who want to use ANP CAN USE IT!!!! FANTASTIC!!!!! But as you can see the writer of the article is very bias on the negative side. As usual she one again took something good for these patients and in stead of focusing on the positive response from the FDA she took another swing at bashing Dr. Burzynski and his clinic. There was no mention of or comments from Anthony Stout, Rick Schiff, Jessica Ressel, Randy Hinton, Philip Norton and many many more..
Let’s go back in history to all the nay Sayers that said Christopher Columbus was crazy. The world is flat, you will fall off the end. Hmmm. Einstein was a quack… Hmmm. Isaac Newton and Galileo were also shunned by their peers… Thank god they had the fortitude to push aside the nay sayers and continue to prove them ALL wrong. Imagine where we would ALL be today if they had listened to their critics and not persevered with what they believed.
Unfortunately, this is known as the Galileo Gambit, a nice, concise term used to argue that if you are vilified for your ideas it must mean that you are right. Unfortunately, what supporters of pseudoscientists and quacks frequently forget is that there are two requirements necessary to be able to credibly claim the mantle of Galileo. Not only must you be vilified, but you must be correct. Only one of these applies to Stanislaw Burzynski, and it isn’t the second one.
As has been the case whenever I’ve discussed patients like McKenzie Lowe, Liza Covad-Hauser, Rafael Elisha Cohen, and others, I understand, at least as much as it is possible to understand without actually being in their shoes. As I’ve pointed out before, it was only five years ago that my mother-in-law died of widely-metastatic breast cancer. Burzynski couldn’t have saved her. ANPs couldn’t have saved her. And I know I’m going to take some flak for saying this, but ANPs cannot save McKenzie Lowe. At least, there is no convincing evidence that they can, and, quite frankly, the only blame for why this is true should be placed at the feet of Stanislaw Burzynski himself. He’s the one who, thinking himself the “brave maverick doctor” to whom the rules of science don’t apply, has failed to produce such evidence. While I understand the desperation these families are feeling, I keep hoping that they will realize that it is not doing McKenzie, Elisha, or any of the others any favors to subject them to toxic chemotherapy—and, make no mistake, ANPs are toxic chemotherapy, efforts of advocates to paint them as “natural” and “nontoxic” notwithstanding. As I’ve pointed out time and time again: If there’s anything worse than dying of a terminal illness, it’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit in the process.
I can totally understand why families like the Lowes might become very excited about the possibility of being able to use ANPs. As misled as they have been and mistaken as their belief is, they do, after all, genuinely believe that ANPs represent the last chance their loved ones have to be able to survive their cancer. Unfortunately, our old “friend” and Burzynski’s very own propagandist, Eric Merola, who has produced two fawning “documentaries” about the Great Man chock full of misinformation and exaggerations, coupled with attacks on Burzynski critics and skeptics, has no such excuse and deserves none of the compassion that we should all have for patients dying of brain tumors and the families who love them. Not surprisingly, he, too, has leapt into the fray with a typically frothing-at-the-mouth conspiracy-laden pile of fetid dingos’ kidneys of a response to Liz Szabo’s story, in which he examines it line-by-line and basically responds with typical Burzynski propaganda, misinformation and lies.
There’s too much there for a full response in this post. Besides, most of the misinformation that’s there I’ve covered before, often multiple times. Perhaps I’ll respond a bit more on my not-so-super-secret other blog. Here, I simply want to point out a few of the most egregious examples. For example, here is probably the most egregious lie on Merola’s part:
A DIPG in a child has never been cured in medical history — why would the FDA make such a claim in this case? It’s quite simple, the science proved it works and cures in many cases, and therefore the science was allowed to progress. There are no “claims” other than what can be proven. Maybe it’s because the cancer industry doesn’t like anyone else “claiming” anything as they own the luxury of claiming what cancer medications work or not work — and we know how well that has worked out for us.
As I’ve pointed out before, this is, quite simply, untrue. It’s also been pointed out time and time again to Merola that this is untrue. Long-term survival for patients with DIPG is rare, definitely, but it’s always dangerous to make an absolute statement like the one that Merola has done. Contrary to Burzynski’s claim, there are occasional long-term survivors, some of whom received little or no therapy, such Connor Frankenberg, a child from Germany, and two patients who underwent spontaneous remission. There is even a site, the DIPG Registry, whose purpose is reporting on how patients with DIPG do and promoting Just One More Day, a registered non-profit 501(c)(3) organization dedicated to helping families affected by a diffuse intrinsic pontine glioma, established by the families of DIPG victims. The DIPG Registry concludes that, although the vast majority of children with DIPGs do poorly:
The bottom line is: 1) we really don’t understand DIPGs, and 2) there are children who have been diagnosed with DIPGs-based on the incomplete knowledge that we currently have- who truly have had spontaneous regression of their tumors and 3) most of the children with reports of spontaneous regression have been very young.
Young like Tori Moreno, I might add.
The big problem is that Burzynski appears not to keep good enough records to demonstrate one way or the other whether he can cure DIPG, and we already know from recent FDA findings and Liz Szabo’s USA TODAY report that he has misclassified partial and complete responses. Yes, DIPG is a horrible disease, with only 10% surviving beyond two years. Unfortunately, there is no convincing evidence that Burzynski can do any better than conventional oncology, much less cure DIPG, as much as his propagandist Eric Merola repeats the claim that he can. Worse, Burzynski hasn’t published a single one of his completed phase II clinical trials, even though he’s had well over 15 years to complete them. With tumors this lethal, most such trials should be completed within five years, which brings us to more of Merola’s misinformation:
The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer.
The above links are examples definitive published evidence. Notice how this writer links to a PDF highlighting her point, vs. the National Cancer Institute (NCI) website itself. Is it perhaps because on the NCI website it clearly says:
“A phase II study also conducted by the developer [Burzynski] and his associates at his clinic reported on 12 patients with recurrent and diffuse intrinsic brain stem glioma. Of the ten patients who were evaluable, two achieved complete tumor response, three had partial tumor response, three had stable disease, and two had progressive disease. Patients ranged in age from 4 to 29 years.”
The NCI felt its own source to be “definitive enough”, why not Liz?
Merola clearly does not understand the difference between “responses” and cures. Similarly, he does not understand what constitutes “definitive evidence.” (Hint: It isn’t case reports, tiny case series published in bottom-feeding journals, or incomplete phase II trials. Moreover, just because the NCI cited a crappy review article by Burzynski that reported partial results phase II trials, a ten year old partial report of a phase II trial, a dubious paper published in an integrative medicine journal, and another review article published by Burzynski in a journal that appears not to be even indexed by PubMed does not constitute “definitive evidence” that ANPs work. All it means is that the NCI was examining the existing published evidence on its way to writing this:
To date, no randomized controlled trials examining the use of antineoplastons in patients with cancer have been reported in the literature. Existing published data have taken the form of case reports or series, phase I clinical trials, and phase II clinical trials, conducted mainly by the developer of the therapy and his associates. While these publications have reported successful remissions with the use of antineoplastons, other investigators have been unable to duplicate these results  and suggest that interpreting effects of antineoplaston treatment in patients with recurrent gliomas may be confounded by pre-antineoplaston treatment and imaging artifacts.[11,14,16] Reports originating from Japan on the effect of antineoplaston treatment on brain and other types of tumors have been mixed, and in some Japanese studies the specific antineoplastons used are not named. In many of the reported studies, several or all patients received concurrent or recent radiation therapy, chemotherapy, or both, confounding interpretability.
Mr. Merola, that’s hardly “definitive”! Nor is the “definitive” study by Hidaeki Tsuda featured in the second Burzynski movie, given that nothing has been published to allow us to evaluate the methods. Nor is the fact that The Lancet Oncology apparently editorially rejected a manuscript submitted by Burzynski evidence of any sort of “conspiracy” against him. Indeed, I now probably know why Burzynski’s manuscript was rejected. Look at the title: “Glioblastoma multiforme: A report of long-term progression-free and overall survival of 8 to over 16 years after antineoplaston therapy and a review of the literature”. Yes, the title seems to indicate that this is just another small case series. No wonder The Lancet Oncology didn’t even bother to send it out for review!
Of course, Merola can’t resist a swipe at yours truly, who was quoted in the article:
A guy who is paid to write blogs attacking this innovation and other innovations that compete with the status quo, a guy who has never once met a Burzynski patient, never once visited the Burzynski clinic, a guy who supposedly finished his residency and now writes “thought police” blogs for a living — yeah, let’s hear more about what this guy has to say, that’s productive. He does fit the angle for Liz’s one-sided propaganda, so I understand why she included his irrelevant opinion.
I don’t know whether to laugh or be annoyed at Merola’s continued lies about me. Once again, I do not need to visit the Burzynski Clinic to know that ANPs almost certainly don’t work. I did finish my residency and am board certified in surgery. If Mr. Merola doesn’t believe that, he can go to the American Board of Surgery website and search for my name in the section that lets the public verify the board certification of surgeons, realizing that you can’t become board certified without finishing an accredited residency. Finally, I don’t actually blog for a living. It’s my hobby. I’m not paid at all for my work at SBM, and at my not-so-super-secret other blog I make a small amount of money that I could completely do without if that gig ever went south or I decided to bolt. As for having something worthwhile to say, well, let’s just say that I’d put my record for science-based analysis against Mr. Merola’s record for pseudoscience-based propaganda any day, particularly in light of his latest paean to another brave maverick, this time promoting the long-discredited cancer quackery known as laetrile.
At least Merola included a link to my page on SBM. He seems to think it’s something nefarious, while I’m more than happy to include a link to it here. Please, read.Why did the FDA cave?
What is puzzling to me is why the FDA caved. While it is true that the ANP Coalition managed to get a few misguided legislators, the most prominent of whom was Senator Kelly Ayotte (R-NH), to write letters to the FDA urging that it consider allowing ANPs to be made available through single patient IND/expanded access to their constituents, the letters were fairly wishy-washy. Moreover, the Change.gov petition to the White House response to a We The People online petition to have the FDA allow Elisha Cohen access to ANPs through compassionate use exemption resulted in a response that, boiled down to it essence, said that it’s the FDA’s job to make such decisions, and let the FDA do its job, along with links to various FDA web pages with information about investigational drugs and information about how the FDA could be contacted. It was a shockingly reasonable response.
One rationale reported in Szabo’s article seems to be that by allowing ANPs to be used but excluding Burzynski from having anything to do with administering them other than producing them, in essence, relegating him to the role of a drug manufacturer, useful data might be obtained and patients protected while obtaining that useful data. This is utter nonsense. As Howard Ozer is quoted in Szabo’s article:
“This is a cop-out,” says Ozer, director of the University of Illinois Cancer Center, who studied Burzynski’s research results in the 1990s.
“Because it can be toxic and cause life-threatening sodium problems, patients (who take antineoplastons) are at risk and could die,” Ozer says.
The scientific community will learn nothing by giving these patients antineoplastons, because there will be no comparison group, Ozer says. Any doctor who agrees to give antineoplastons could be biased in favor of them, which could skew the results.
Exactly. As Dr. Peter Adamson points out in the article, after 37 years, if antineoplastons were the wonder drugs that Burzynski claims them to be, scientists would know it by now. ANPs aren’t wonder drugs. There isn’t even any evidence that they’re better than standard-of-care, as dismal as that is for DIPG.
It is possible that one of the Senators or other legislators did indeed pressure the FDA, leading the relevant enforcement officials to come up with this decision in order to get them off their backs without actually doing anything. They could credibly say, “Hey, we offered compassionate use, but I’m sure you’ll agree that, given his history, we can’t let Burzynski be the one to administer the ANPs on compassionate use. Look at his history of playing fast and loose with IRBs and not obeying the rules with respect to INDs.” This might even sound convincing and seem clever, which is why I rather suspect that Dr. Henry Friedman is right when he says:
“It will deflect criticism from anybody who says the FDA is unilaterally denying dying patients something that could help them,” says Friedman, deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University in North Carolina, who also reviewed Burzynski’s studies in the 1990s. “It will get FDA off the hook.”
That, I believe, is exactly why the FDA did it, not to help dying children. Unfortunately, the consequences of the FDA’s decision are likely to be disastrous. Long-suffering families will have false hope extended to them once again, only to find out that it’s a useless offer. In addition to continuing to scramble to raise money, they’ll scramble to find oncologists willing to do the not-inconsiderable work to get a single-patient IND approved and administer ANPs, something few, if any of them, are likely to succeed at. The families don’t know it yet, but what the FDA has done will only add to their misery. Indeed, I’ve already seen reports that patients have contacted “dozens” of pediatric oncologists looking for one who will administer ANPs, and, given that the number of pediatric oncologists in the US is small, a significant proportion of them are likely to be contacted.
Meanwhile, Burzynski gets a propaganda victory, thanks to the FDA’s failure to enforce its own standards, and alt-med proponents get another conspiracy theory to add to the list of conspiracy theories surrounding Burzynski already.
Every single time – bar none – I have had a conversation with someone about CAM and its modalities, they are absolutely astonished when I explain to them what the modality really is. One story I love telling comes from my friend in the year behind me. His parents are professional chemists and he came home one day and saw his mother had a bottle of homeopathic medicine. He asked why and she gave the typical non-committal response of “well, I thought it may help and I saw it on the shelf at the pharmacy.” He explained what homeopathy actually is and they were absolutely dumbfounded. They are well aware of Avogadro’s number, after all. People generally don’t study what the CAM in question actually is – merely the fluff PR garbage that gets touted around and without direct and clear demonstration of harm, give it a pass as a result. After all, the business of real medicine is time consuming and difficult enough.
Participating in activities that have a permanent record gives one the fortunate, or unfortunate, opportunity to revisit the past and see just how you worked early in a career.
It was sobering, as third year resident, to see the notes I had written as an intern. Man. It was amazing how unsophisticated my medical thinking had been a little over two years’ prior. How little I understood about the ins and outs of diagnosis and treatment even after four years of medical school. It is part of the reason I think it is a joke, albeit a cruel joke, that naturopaths and other pseudo-medical providers think they can function as primary care providers after a few years of alternative edjamacation.
I have a similar experience every now and then when I see the notes from early in my Infectious Disease practice, now heading into 24 years. Not quite as painful, but still remarkable in how much I didn’t know then. My ID podcast is an ongoing reminder of how much I still do not know. The last 34 years have been my personal linear acquisition of knowledge from the exponential production in the medical, and non-medical, world. Ignorance isn’t bliss, but an ever-expanding hole that can never be filled.
There is nothing wrong with ignorance per se. It depends on what you do with it. Ignorance can be a condition you can spend a lifetime attempting to overcome.
My early career in the world of SBM was defined by a remarkable naiveté. I thought people who used the various pseudo-medicines were simply ignorant, they lacked basic information about the topic and all I had to do was supply that information. They would read/listen to my explanation and think, ‘Oh. That’s how it works’ and move on. That is partly how medical training works. Once you learn how some therapy or procedure does or does not work, you behave accordingly. Eventually. Change is painful, and I do notice as I age how much harder it is to make an intellectual change. Habit is so comfortable.
There was certainly a large helping of ignorance with a side of hubris on my part. But that is how you increase knowledge. Discover the gaps and fill them.
I have not thought much about ignorance. Most of my time is spent on the hows and whys of the acquisition of knowledge. Part of my job and my hobby is to be an educator. I think of residents, myself, and my readers as an empty glass to be filled with facts and their relationships. A simplistic idea, but how I spend a huge amount of my time. I take in information, organize it, synthesize it, and then pass it to others, hopefully in a clever manner.
Others have thought about ignorance in a more comprehensive way. Robert N. Proctor is such a person and he has coined a term for the cultural production (and study) of ignorance: Agnotology. The author delineates several kinds of ignorance in the paper, and they make for a good conceptual framework for understanding ignorance.
And though distinctions such as these are somewhat arbitrary, I shall make three to begin the discussion: ignorance as native state (or resource), ignorance as lost realm (or selective choice), and ignorance as a deliberately engineered and strategic ploy (or active construct).
And he points out that:
Ignorance has many interesting surrogates and overlaps in myriad ways with—as it is generated by—secrecy, stupidity, apathy, censorship, disinformation, faith, and forgetfulness,
I have tended to think of ignorance only in the first definition: simply lacking knowledge on a topic or having wrong or incomplete knowledge. No one can know everything or anything perfectly. It is the kind of ignorance I thought I was combatting when I started my blogging career and why I spend an inordinate amount of time on Pubmed.
It leads to the second kind of ignorance, that of selective choice. Due to time and interest (not all topics in the universe are equally interesting) there are areas about which I choose to have a minimal knowledge. Diet, I admit, bores me. I pay little attention to the ongoing debates as to the best diet and what is good and mad to eat. I eat for pleasure or fuel and not for health and it is not a part of my professional life.
Other examples of selective ignorance occur in professional education. Medical schools and residency give short shrift to pseudo-medicine and critical thinking, and probably justifiable so. There is just so much time and neuronal space for the jaw-droppingly huge amount of information that becoming a physician requires. I have mentioned before that I was in medical school and training from 1980 to 1990. That decade of my life was spent learning my profession. My kids used to like to watch I Love the 80′s on VH1 and I recognized nothing from the show: the movies, the music, the fashion, the memes were are new to me. Most people lose a decade of life to drugs or alcohol; mine was to medicine. I have a huge selective ignorance concerning the 80′s and if the show is any evidence, it was a good thing.
Even more impressive in their selective ignorance is the training in pseudo-medicines:
Ignorance is a product of inattention, and since we cannot study all things, some by necessity—almost all, in fact—must be left out. “A way of seeing is also a way of not seeing—a focus upon object A involves a neglect of object B.”
And best typified by the curricula at a naturopathic school, but the same is true for any pseudo-medical education. Vast quantities of time are spent on areas divorced from reality: homeopathy, acupuncture, hydrotherapy etc. The effort to absorb these fantasies is, by their nature, going to prevent acquisition of knowledge about reality.
There is a similar process occurring at chiropractic schools, where they like to brag about their education:
According to the American Chiropractic Association, the course of study to become a chiropractor includes 4,200 hours of classroom, laboratory and clinical experience in “orthopedics, neurology, physiology, human anatomy, clinical diagnosis including laboratory procedures, diagnostic imaging, exercise, nutrition rehabilitation and more.”
I am not impressed. That 4,200 hours is 525 eight-hour days, a little under a year and a half. It would be so much more impressive if they said their training was 15,120,000 seconds. The bigger the number the better the education. My internal medicine training was seven years, plus two more for infectious diseases. And what good is all that training if it is being applied to the fantastical ideas of fixing subluxations? It is like learning horse anatomy to take care of unicorns. But it also ensures ignorance in areas of reality-based medicine.
The most interesting form of ignorance is the third:
Ignorance as strategic ploy, or active construct
The focus here is on ignorance-or doubt or uncertainty-as something that is made, maintained, and manipulated by means of certain arts and sciences. The idea is one that easily lends itself to paranoia: namely, that certain people don’t want you to know certain things, or will actively work to organize doubt or uncertainty or misinformation to help maintain (your) ignorance. They know, and may or may not want you to know they know, but you are not to be privy to the secret. This is an idea insufficiently explored by philosophers, that ignorance should not be viewed as a simple omission or gap, but rather as an active production. Ignorance can be actively engineered part of a deliberate plan.
The author uses the tobacco industry as an archetype of an industry that manufactures ignorance and starts the paper with a quote:
Doubt is our product. Brown & Williamson Tobacco Company, internal memo, 1969
The manufacture of doubt is common in the pseudo-medical world. It could not exist without it. I do not know if ignorance is bliss for pseudo-medicine, but it is a requisite.
The false information that underlies all pseudo-medicine, from the popularity of pseudo-medicine in the US, to the efficacy of acupuncture to the safety of chiropractic to the mechanism of reiki relies on the production of massive amounts of ignorance. And so has some aspects of real medical treatments. Pharmaceutical companies have not been hesitant to borrow methods from their tobacco brethren. Although science can be an antidote to the production of ignorance in the real world, the pseudo-medical world is often invulnerable.
Examples of ignorance as strategic ploy in the pseudo-medical world abound and can, for a time be effective, as Megan Sandlin demonstrated, although:
In the end, I couldn’t continue to deny the science. It’s hard to believe now how easily I bought into everything I was hearing from the anti-vaccine crowd. It seems extremely obvious now: doctors aren’t evil, scientists aren’t trying to kill your kids with toxins, and vaccine researchers aren’t just trying to scam you out of your money.
Natural News and the Mercola site are probably the Ford and GM of medical ignorance production, but there are numerous boutique producers. I ran across Why You Never Need A Tetanus Vaccine, Regardless of Your Age or Location by Dave Mihalovic, ND, whose ignorance production I have discussed before
Mr. Mihalovic identifies himself as “a naturopathic medical doctor who specializes in vaccine research.” However, just where the research is published is uncertain as his name yields no publications on Pubmed. BTW. I specialize in beer research. Same credentials.
Tetanus is a rare disease in the US. I have seen one case, years ago as a fellow, in an elderly immigrant who had never received the vaccine. Having every muscle spasm at once is horrible for the victim.
From 1922-1926, there were an estimated 1,314 cases of tetanus per year in the U.S. In the late 1940′s, the tetanus vaccine was introduced, and tetanus became a disease that was officially counted and tracked by public health officials. In 2000, only 41 cases of tetanus were reported in the U.S. … Approximately 20 percent of reported cases end in death.
Tetanus in the U.S. is primarily a disease of adults, but unvaccinated children and infants of unvaccinated mothers are also at risk for tetanus and neonatal tetanus, respectively. From 1995-1997, 33 percent of reported cases of tetanus occurred among persons 60 years of age or older and 60 percent occurred in patients greater than 40 years of age. The National Health Interview Survey found that in 1995, only 36 percent of adults 65 or older had received a tetanus vaccination during the preceding 10 years.
Worldwide, tetanus in newborn infants continues to be a huge problem. Every year tetanus kills 300,000 newborns and 30,000 birth mothers who were not properly vaccinated.
A rare, awful, and mostly preventable disease, it is caused by Clostridium tetani. The bacteria, found in the soil, gets into damaged tissues, releases its toxin and the result is tetanus.
Tetanus toxin, tetanospasmin, is extremely potent and can cause severe disease yet not cause the production of antibody. A curiosity of many toxins made by Clostridia, be it botulism, tetanus or gas gangrene, is the purpose of the toxins in the wild (i.e. the dirt), which remain a mystery. As an anaerobe it can be difficult to grow.
Of course, as is his métier, and no doubt a result of his naturopathic training where his understanding of microbiology and infectious diseases is profoundly ignorant, he says:
The tetanus bacteria may be a factor in tetanus. The toxin may be involved in some way but that these are fundamental causes is nonsense, otherwise the disease would be more common, in view of the fact that the bacteria is so frequently found on and in our bodies.
The real cause of tetanus is not a germ, but dirt and filth. The bacteria are harmless when placed into a surgically clean wound. Tetanus develops when drainage of a wound is checked and dirt is retained in the tissues.
The patient suffering from tetanus should be put to bed, permitted to rest, kept warm and fasting should be immediately instituted. They should receive all the salubrious hygienic influences and the fasting should be continued until all symptoms have disappeared.
Advice and treatment that, if followed, could result a repeat of when parents’ fear of vaccinations nearly killed their son or worse:
Auckland parents Ian and Linda Williams thought they had made an informed choice not to vaccinate their children, but after their son ended up in intensive care with a tetanus infection they realized they had made a terrible mistake.
The problem with reality is it doesn’t care if you are ignorant. You can reject and substitute your own where dirt causes tetanus and vaccines are worthless. Get the perfect storm of bad luck and you will get tetanus if not vaccinated.
Pseudo-medicine is producing ignorance at a vastly higher rate than medicine can produce an approximation of the truth. But it will always be that way. It is why I lobbied for Sisyphus to be the emblem of the Society for Science-Based Medicine.
I glanced at my pharmacy license recently, and noticed I became a licensed pharmacist almost exactly twenty years ago. Two decades seems like a long time to do pretty much anything, yet I can still vividly recall some of the patients I encountered early in my career, working evenings in a retail pharmacy that drew heavily on the alternative medicine crowd. It was the first pharmacy I’d ever seen that sold products like homeopathy, detox kits, salt lamps, ear candles, and magnetic foot pads. And the customers were just as unorthodox. There were some that told me they manipulated their own pH, and others that insisted any prescription drug was designed to kill. And there was a huge clientele that relied on the pharmacy for their “bioidentical” hormones. It was an instructive learning experience, as it was as far from the science of pharmacy school as you could expect to find in a place that still called itself a pharmacy. One of the really interesting aspects of that pharmacy was the enormous supply of vitamins and supplements for sale. It stretched over multiple aisles and even back into where the drugs were kept, as there were some brands kept behind the counter. This wasn’t for any regulatory reason – it was because these were the “naturopathic” supply, the brands often recommended by naturopaths. In order for this pharmacy to sell them they had to keep the products behind the counter, presumably to grant these supplements a veneer of medical legitimacy. After all, they were “special”, and had the prices to prove it.
It was in this setting that I began to understand the practice of the naturopath. Toronto is home to one of the handful of naturopathy schools in North America, so there are a lot of naturopaths in Toronto. At the time I didn’t know much about naturopathy other than it was some sort of alternative-to-medicine, and their recommendations tended to involve a lot of supplements – and when I say a lot, I mean hundreds-of-dollars-per-month habits for some customers. All of this was good for sales, and for the pharmacy, but it left me perplexed about the medical merits of these products and of naturopaths, especially since I’d never heard of diagnoses like candida overgrowth, detox, adrenal “fatigue”, hormone “depletion”, and widespread nutritional depletion in my pharmacy education.
I started researching naturopathy, and what I learned concerned me. Regular readers to the blog will be familiar with naturopathy, but depending on where you live, the likelihood that you may encounter a naturopath (or someone that consults one) may vary. Naturopathy has been described at SBM as a chimera, something that’s imagined, but in reality is illusory or impossible to achieve. That’s an apt description for naturopathy, as the practice is a strange assortment of unorthodox, discarded, and disparate alternative health practices, linked by a philosophy based on pre-scientific ideas of medicine. The central belief, vitalism, posits that living beings have a “life force” not found in inanimate objects. Vitalism as a hypothesis in medicine was reasonable 200 years ago, but despite being disproved by Wöhler in 1828, it continues to thrive in naturopathy. Naturopathic treatment ideas are grounded in the idea of restoring this “energy”, rather than being based on objective science. It is perhaps unsurprising that disparate practices like homeopathy, acupuncture and herbalism are all part of naturopathy, yet don’t cause any cognitive dissonance for its practitioners. Given there’s no need to justify or rationalize practices in scientific terms, pretty much anything goes, as long as it aligns with this belief system. To be fair, not all naturopath advice is bunk. Some can be sound. Unfortunately this isn’t because there is good scientific evidence to support that practice, but rather that the beliefs and philosophy of naturopathy happen to align with science:
I love being able to look at new approaches that may come along and to ask myself, “Is this within the bounds of the philosophy I so embrace?” And if not, to let it go.
With philosophy rather than objective evidence guiding what a naturopath decides to promote, it should not be surprising that there are serious concerns about the standard of care offered. A letter published a few years ago in Allergy, Asthma, & Clinical Immunology documents the concerns about naturopathy in Canada and any naturopathic alignment to science-based methodologies. Timothy Caulfield and Christen Rachul found that the most widely advertised practices in Alberta and British Columbia lacked a sound evidence base. They concluded:
A review of the therapies advertised on the websites of clinics offering naturopathic treatments does not support the proposition that naturopathic medicine is a science and evidence-based practice.
Among the interventions promoted by naturopaths were (no surprise) homeopathy, chelation, acupuncture and hydrotherapy. And among the top conditions naturopaths claimed to treat were allergies. People suffering with allergies are a target market for naturopaths – which is concerning, because potentially life-threatening conditions are no place for pseudoscience. About five years ago, a coalition of seven Canadian allergy organizations wrote a letter (PDF) to the British Columbia Minister of Health, protesting the plan to allow naturopaths to perform allergy testing and treatment. They identified multiple concerns about the ability of naturopaths to treat allergies, given their diagnostic and treatment methods are not based on scientific standards. Since that letter was written, some of their cautions have already come to pass. I’ve already described how Canadian naturopaths (working with pharmacies, sadly) have turned unvalidated IgG blood testing into a lucrative market to diagnose fake food “intolerances” with the secondary market of selling supplements to correct for all the new dietary restrictions that are recommended.
I was reminded of allergies again this week when a colleague passed on a post from a naturopath about seasonal allergies. Before we go into that post, it’s worth reviewing the scientific evidence on seasonal allergies. The medical term is allergic rhinitis and you’re probably familiar with the symptoms: itchy watery eyes, sneezing, runny nose and nasal congestion, cough, and fatigue are all typical. It’s common, affecting 10-30% of the population, and while it’s not life threatening, can be quite debilitating. Seasonal allergies are usually caused by pollen, and you can often tell what you’re allergic to by checking the pollen counts. Trees, grasses and weeds can all cause seasonal allergies. Pollen exposure causes reactive individual to product antibodies, which bind to mast cells in the nasal mucosa and basophils in the blood. Subsequent exposure to the same allergen causes mast cell activation and the typical cascade of symptoms. The diagnosis is based on a clinical examination, but many people diagnose themselves – they take an antihistamine and see if they feel better. (Not a strategy I recommend.) The ideal treatment is avoidance, but that’s difficult, so many rely on drug therapy. The main categories of treatments are the inhaled steroids (e.g., Flonase) which reduce the allergy cascade by direct action in the nasal passages, and the oral antihistamines, which centrally reduce histamine activity. For most, these products are effective and well-tolerated. Medical consultation is always advisable to ensure the diagnosis is clear, and referrals to allergists are warranted for complex cases. There are several other forms of treatments, with allergy shots generally reserved for the most refractory situations.
Naturopaths consider themselves to be primary care providers comparable to medical doctors, so their advice can justifiably be compared against the same standard. Naturopath Shawna Darou’s bio notes she “graduated from the Canadian College of Naturopathic Medicine (www.ccnm.edu ) at the top of her class and was the recipient of the prestigious Governor’s Medal of Excellence” so presumably her advice is representative of what you should expect from a naturopath. Here’s what she advises to “prepare your immune system” in her column on seasonal allergies:
A liver-focused cleanse before the start of your allergy season. This often makes a great impact on your allergy susceptibility. If you have severe allergies all summer, then a second cleanse mid-summer is also recommended. Most people schedule a 10-20 day cleanse in late March or early April.
Not a good start. Cleansing is pure pseudoscientific quackery, and there is no evidence that “cleansing” even occurs, or that has any effect on seasonal allergies. Your liver doesn’t need any cleansing, allergies or not, and your susceptibility to an allergen has nothing to do with a fictitious treatment. Allergies can wax and wane season to season based on pollen levels and even individual responses, and that variation can occur regardless of any “cleanse”.
Testing for food sensitivities. Chronic, long-term food sensitivities cause significant stress on the immune system and prime your body to react to seasonal allergens. If you reduce overall immune system stress by removing food intolerances from your diet, seasonal allergy symptoms will be minimized. If you haven’t already had a food intolerance test, please ask about one.
Naturopaths regularly promote unvalidated and clinically useless IgG blood testing to diagnose imagined food intolerances, in part because it’s a primer to sell unnecessary supplements. What’s never disclosed is the fact that IgG blood testing hasn’t been clinically validated to diagnose intolerance to a single food product, yet naturopaths claim to test for hundreds of these food “sensitivities”. Allergy organizations explicitly warn against this testing:
The Canadian Society of Allergy and Clinical Immunology (CSACI) is very concerned about the increased marketing of food-specific immunoglobulin G (IgG) testing towards the general public over the past few years, supposedly as a simple means by which to identify “food sensitivity”, food intolerance or food allergies. In the past, this unvalidated form of testing was usually offered by alternative or complementary health providers, but has now become more widely available with direct-to-consumer marketing through a nationwide chain of pharmacies. There is no body of research that supports the use of this test to diagnose adverse reactions to food or to predict future adverse reactions.
Continuing on through the advice:
Purchase a neti pot or a saline nasal spray, which are methods for clearing out the sinuses. Using this daily (1-2x) during allergy season will flush the allergenic pollens out of your nasal passages which will also help to minimize your symptoms.
Irrigating the nasal passages with saline or a neti pot is reasonable advice, is incorporated into conventional treatment guidelines, and is widely recommended by family physicians. It’s an example of where the naturopathic philosophy happens to align with the actual evidence. Neti pots and nasal rinses are generally low risk, but users must ensure they use distilled or previously-boiled water, as plain tap water may have a brain-eating amoeba that can kill.
Watch your stress levels: high stress hormones (cortisol especially) can worsen allergies or make you more susceptible to them. Find methods to lower your stress such as: yoga, exercise, breathing exercises, guided imagery or meditation. If you need further support to lower stress hormones, certain supplements can help to lower cortisol while you work on the external factors.
Neuroimmunology is a real science examining the relationships between the nervous system and the immune system. This advice, however, is unproven speculation. There is no published evidence to suggest you can meaningfully manipulate your allergy symptoms by will alone. Having said that, none of this is likely to be harmful – with the possible exception of supplements, which are unnecessary. With the exception of real medical conditions like adrenal insufficiency, your cortisol levels are not something you need to concern yourself with.
Mold alert: In the past few summers, there were high counts of mold spores circulating. Symptoms most commonly observed are around the eyes – swelling, itching, watering, rashes. In general, people who are sensitive to external molds often have an internal yeast imbalance which makes the immune system more sensitive to external moulds [sic]. If this applies to you, please ask about a ‘yeast-cleanse’ to prevent mold allergies this summer.
Molds can cause allergic rhinitis, so this is an opportunity to promote a made-up disease – candida (yeast) overgrowth. Yeast cleanses are just another variation of the detoxification myth that naturopaths believe, despite the lack of any scientific justification or evidence of effectiveness. People with seasonal allergies don’t have a yeast imbalance, and they don’t need a yeast cleanse: they need to prevent and control histamine release. There’s no fake disease that needs to be invoked.
If you are still getting allergies, even after these recommendations, there are also some natural alternatives to antihistamines that can be used that have no side-effects. Examples include: vitamin C, quercitin, various herbal combinations, homeopathic nasal sprays and specific homeopathic remedies.
Instead of recommending demonstrably effective treatments, like antihistamines, there’s the recommendation for unproven and ineffective treatments. There’s no persuasive evidence that vitamin C, quercitin or any herbal medicines have any meaningful effects comparable to drug therapies, or are backed by adequate scientific evidence to support their use. And herbal remedies are not innocuous. Some, like echinacea, feverfew, and chamomile are members of the ragweed family and could aggravate, rather than relieve, allergies.
Homeopathic nasal sprays are simply saline nasal sprays – there are no active ingredients, yet you’re charged even more for the memory of some substance that was diluted out of existence. Homeopathy is a placebo system, and the “remedies” are usually pure sugar pills – completely inert and without medicinal effects. There’s no scientific justification for homeopathy in the management of seasonal allergies – or for any medical condition, for that matter.Conclusion
Naturopaths purport to be science-based primary care providers and claim to have the training equivalent to medical doctors. Surveys of naturopathic practices suggest naturopaths do not offer treatments that are science-based, a finding that is consistent with the recommendations examined from a Canadian naturopath. While they claim to treat the “root cause” of disease, their recommendations suggest they lack (or reject) objective evidence about the scientific nature of conditions like seasonal allergies. With a practice that prioritizes philosophy over science, naturopaths are tilting at medical windmills.
Anyone publicly writing about issues of science and medicine from a pro-science perspective likely gets many e-mails similar to the ones I see every week. Here’s just one recent example:
Im sorry the medical community has become decadent and lazy as most that follow your stance could care less to study the real truth. I have also seen it much more deviant as many professionals know the risks and harm vaccination cause but continue to push it through there practices because of pure greed. Many are also scared of loosing there practices for not following the corrupt industry. Im sorry but the medical industry has become drug pushing decadent slobs that only care about there bottom line.
The e-mailer clearly has a particular narrative that he is following (in addition to the amusingly common poor grammar and spelling). He even writes at one point in our exchange, “the details really don’t matter at this point what matters is what the bigger picture…” He is certain of his big picture conspiracy narrative. The details are unimportant.
Being on the receiving end of an almost constant barrage of such medical conspiracy theories it might seem that such beliefs are extremely common. Of course, such e-mails are self-selective and therefore not representative of the general population. I was therefore interested to see a published survey polling the general population about such beliefs. The survey is published in JAMA Internal Medicine, authored by Eric Oliver and Thomas Wood.
Here are the six survey questions and the percentage who agree or disagree (the rest indicating that they do not know).
The Food and Drug Administration is deliberately preventing the public from getting natural cures for cancer and other diseases because of pressure from drug companies. (37% agree, 32% disagree)
Health officials know that cell phones cause cancer but are doing nothing to stop it because large corporations won’t let them. (20% agree, 40% disagree)
The CIA deliberately infected large numbers of African Americans with HIV under the guise of a hepatitis inoculation program. (12% agree, 51% disagree)
The global dissemination of genetically modified foods by Monsanto Inc is part of a secret program, called Agenda 21, launched by the Rockefeller and Ford foundations to shrink the world’s population. (12% agree, 42% disagree)
Doctors and the government still want to vaccinate children even though they know these vaccines cause autism and other psychological disorders. (20% agree, 44% disagree)
Public water fluoridation is really just a secret way for chemical companies to dump the dangerous byproducts of phosphate mines into the environment. (12% agree, 46% disagree)
The numbers are not surprising, in fact I would have guessed they were a bit higher, but again that perception is likely distorted by my e-mail inbox. They found that 49% of Americans agreed with at least one conspiracy, and 18% agreed with three or more. This is in line with the level of belief in non-medical conspiracies. They did not publish, but I would be interested, in the percentage of people who said they disagreed with all of the conspiracies. Many of the respondents indicated that they did not know if a particular conspiracy were true, likely because they had not heard of it before, but were unwilling to disagree on plausibility grounds alone.
An earlier study by Oliver and Wood found similar percentages for political conspiracies. In that study they concluded that belief in conspiracy theories does not track with any particular ideological belief, but rather with a, “willingness to believe in other unseen, intentional forces and an attraction to Manichean narratives.”
This would seem to be true for the 18% who believe in three or more medical conspiracies – they have a tendency to believe in conspiracies. For those who believe in only one or two conspiracies, that might have less to do with personality and more to do with culture and ideological beliefs.
The second part of their study is perhaps more interesting. They found a strong predictive correlation between belief in the above conspiracies and a host of medical behaviors. Conspiracy believers were more likely to use herbal supplements, use alternative medicine, and eat organic food, and less likely to vaccinate, use sunscreen, and have regular physicals.
The largest effect sizes were for taking herbal supplements, which went from 13% for zero conspiracy beliefs to 35% for three or more. Buying from local farms was similar, going from 14% to 37% respectively, while using sunscreen only decreased from 38% to 30% respectively.
I would have been interested in seeing other responses, such as the percentage who visit a naturopath or chiropractor. I would predict that more hard-core use of clearly “alternative” practices (more than just taking supplements) would be a strong predictor of belief in medical conspiracies. This is based upon the observation (documented in many of the articles here on SBM) that much CAM promotion is intimately tied with medical conspiracy thinking. Anti-vaccine sites, for example, often promote homeopathy and other alternatives to vaccinations. Mike Adams of naturalnews is perhaps the most dramatic example of the convergence of CAM and all manner of conspiracy theories.Conclusion
This survey by Oliver and Wood indicates that belief in medical conspiracies is fairly common, and that such beliefs are not benign, but correlate negatively with important medical behaviors. It’s difficult to tease out cause and effect, and this survey makes no attempt to do so. It’s possible that the same personality profile is attracted to both conspiracy theories and alternative medical practices. It’s also possible that the CAM subculture encourages belief in conspiracy theories, and that the conspiracy subculture encourages rejection of mainstream medicine and acceptance of fringe ideas. I think all of these factors conspire together to create the effect we are seeing in this survey.
The medical community would be well-served if they understood the phenomenon of medical conspiracies. In fact, it can be viewed and addressed as a public health issue. Medical institutions can take such beliefs more seriously, rather than just dismissing them as fringe. Efforts to educate the public about critical thinking, scientific methodology, and how the institutions of medicine work and are regulated, might reduce the popularity of such conspiracy theories.
I also think we need to have as much transparency as possible in scientific and regulatory processes. Secrecy or even opaqueness tends to breed paranoia.
This data (if I may indulge in a little self-promotion) also highlights the importance of efforts such as science-based medicine, the goal of which is to popularize understanding of the science of medicine, and taking a critical view of popular misconceptions, including medical conspiracy theories. I would argue academic and medical institutions to take such efforts more seriously.
For those who dismiss advocates of the “natural” as ignorant of science and deluded by the logical fallacy that natural = best, Nathanael Johnson’s new book is an eye-opener: All Natural: A Skeptic’s Quest to Discover if the Natural Approach to Diet, Childbirth, Healing, and the Environment Really Keeps Us Healthier and Happier. If nothing else, it is a testament to the ability of the human mind to overcome childhood indoctrination in a belief system, to think independently, and to embrace science and reason.
Nathanael Johnson was brought up by hippie parents who subscribed to every “natural” belief and fad. His mother nearly died of a postpartum hemorrhage when he was born at home (he weighed 11 pounds!). His parents didn’t report his birth, and he didn’t have a birth certificate. He co-slept with his parents, never wore diapers (imagine the clean-up!), was allowed to play in the dirt and chew on the snails he found there, was fed a Paleolithic diet, was never allowed any form of sugar, didn’t know there was such a thing as an Oreo cookie, was home-schooled, and did not know that public nudity was taboo until he and his brother shocked the folks at a church picnic by stripping naked to go swimming in the lake. Nudity was customary in his home, and he was encouraged to “let his balls breathe.”
As he grew up, he started to question some of the dogmas he had learned from his parents. He had been taught that good health resulted from forming connections with nature, but he found that nature “generally wanted to eat me.” Now an adult and a journalist, he understands science and how to do research. He tried to read the scientific literature with an unbiased mindset, asking questions about the subjects in his book’s title rather than looking for evidence to support any prior beliefs, and he arrived at pretty much the same conclusions we science-based medicine folks did. But he still appreciates that a natural approach has value, and he seeks to reconcile nature with technology. He calls his book a comfortable refuge from people who are driven to extremes.
When his wife was pregnant, he interviewed home birth advocate Ina May Gaskin, visited birthing centers, looked up statistics about C-sections and fetal monitoring, and decided what he wanted was “No Nonsense Evidence-Based Midwifery.” He and his wife found exactly that in a hospital where nurse-midwives delivered the babies and high-tech care was immediately available for emergencies. All went well, but throughout his wife’s labor and delivery he worried about whether they had made the right choice. Afterwards, he realized that more worry was in store: no matter how he tried to protect his newborn daughter, she would, in the course of her life, be hurt, would suffer, and would eventually die. A nurse told him “Whenever there’s uncertainty or discomfort, people tend to want to fix it. We have absolutely no tools in this culture for simply accepting, but that’s what you have to do sometimes.” These are wise words that patients might do well to consider before seeking the false certainties offered by alternative medicine.
He investigates food and identifies three faulty assumptions:
He decides that eating scientifically is impossible because no diet advice is well-supported by science. Both science-based diets and natural diets go beyond the evidence and produce gurus who claim certainty where there is complexity. They are like two sides of the same coin. He argues for rediscovering the pleasure of food rather than just eating to satisfy hunger or to eat the “right” number of calories of the “right” foods. At the same time, he realizes that telling people to eat what they enjoy would be catastrophic for those with metabolic disorders and laughable for those who can’t afford it.
He describes his brief and disastrous experimentation with a raw food/live food diet. He discovers that when he thought he was avoiding toxins, he was just ingesting different toxins, plant toxins. He says yes, there is probably something out there trying to make us sick or eat our brains, but there is very little certainty about which toxins are harmful to the human body in what doses over a lifetime. It would be a worthy goal for science to identify all toxins and remove them from our diet, but “I can’t wait that long for dinner.”
He investigates vaccines. He offers the insight that when parents ask a pediatrician about vaccine risks, they are looking for advice from someone who has seriously considered the risks and the objections of anti-vaxxers rather than just dismissing them. Simple reassurance that science has decreed vaccines necessary is counterproductive. He counters the argument that we have insufficient proof that vaccines are safe by citing Wendell Berry’s advice that the trick is not to find certainty, but to act thoughtfully with partial knowledge. (That’s the trick of science-based medical practice, too.) He comes to a new understanding of vaccines as a “natural” means of protecting children from disease. He realizes that “unnatural” means things he doesn’t understand. The more he learned about things like vaccines, the more natural they seemed.
He puts a new spin on the old canard that doctors only treat symptoms, not underlying causes. After his appendectomy, he asks the surgeon why it happened to him and why it happened when it did. He gets only a vague answer. “Conventional medicine is concerned with helping pragmatically, using the information available to accomplish what it can…you don’t have to know why a fire started to put it out.”
He talks about placebos, describing Benedetti’s research. He suggests there is a role for metaphor in medicine. His mother tried “Earthing” and felt better, less driven, less scattered, better able to enjoy the moment. She realized it might be a placebo effect, but she felt a sense of connection with the earth. He suggests that she was being “healed by a metaphor.”
He argues for a kinder, gentler practice of medicine. He thinks the Flexner report had the effect of eclipsing the patient. And certainly, part of the appeal of “integrative medicine” is the way it returns the focus back to the “whole” individual patient. In a way, it is “a manifestation of love.” He tells about a doctor who prescribed suicide drugs for terminal patients and found that none of his patients actually used them. Their discomfort was not caused by their disease, but by their loss of control. He wished he had realized that was the underlying problem and had been able to remedy it more effectively. “When healing is reduced to a battle between technology and disease, patients lose both responsibility and control.”
He tells about a pediatrician who spent hours educating his patients about asthma, diabetes and allergies, and measured his success by the fact that for the last 5 years of his career not a single patient from his practice had to go to the ER for complications of those diseases. He voluntarily cut his own paycheck by $50,000 a year by teaching the parents of hemophiliac children to administer clotting factors at home instead of coming to his office each time.
Johnson investigates organic farming, industrial pig farms vs. small family operated pig-friendly farms, and forestry management for multi-use purposes rather than as a single crop. He even investigates raw milk, recognizing the dangers of infection, but also learning that milk from grass-fed, pampered cows has a different microbial flora that might conceivably have a beneficial effect on health by protecting humans from more harmful bacteria. He suggests there may be ways to achieve the economies and successes of mass food and lumber technology with more animal-friendly, tree-friendly, and human-friendly methods. He makes it sound as if it’s definitely worth a try.
We are all isolated beings struggling for survival, but we are also part of a larger whole. The technological perspective builds a protective barrier around us; the natural approach sees us as part of a nurturing whole, invites nature in, and fosters relationships. Nathanael Johnson argues for neither the technological nor the natural perspective, but for reunification. He says:
I can’t do without technology: I’m not willing to give up antibiotics, or movies, or ice cubes, or germ theory, or space exploration. But I’m also dismayed by the way faith in technological progress tends to trade away beauty, and wonder, and joy, and all of those slippery, unquantifiable things that – in the end – make life worth living.
There’s a lot of good science and common sense in this book. It gave me a better understanding of what those “natural” advocates are thinking, and of ways in which modern medical practice could be improved. The only quibble I had with it is that he talks about right brain/left brain differences that are not substantiated by recent evidence.
I love that term, because it succinctly describes the infiltration of pseudoscientific medicine into medical academia. As I’ve said many times, I wish I had been the one to coin the phrase, but I wasn’t. To the best of my ability to determine, I first picked it up from Dr. R. W. Donnell back in 2008 and haven’t been able to find an earlier use of the term. As much as I try to give credit where credit is due, I have, however, appropriated the term “quackademic medicine” (not to mention its variants, like “quackademia”), used it, and tried my best to popularize it among supporters of science-based medicine. Indeed, one of my earliest posts on this blog was about how quackery has infiltrated the hallowed halls of medical academia, complete with links to medical schools that have “integrative medicine” programs and even medical schools that promoted the purely magic-based medical modalities known as reiki and homeopathy. It’s been a recurrent topic on this blog ever since, leading to a number posts on the unethical clinical trials of treatments with zero or minimal pre-trial plausibility, the degradation of the scientific basis of medicine, and the acceptance of magical thinking as a means of treating patients in all too many medical centers.
One strong candidate for quackademic ground zero, if there can be such a thing for the phenomenon like quackademic medicine, which is creeping up like so much kudzu in the cracks of the edifice of science-based medicine (SBM), is the University of Arizona. U. of A. is, of course, the home of one of the originators of the concept of quackademic medicine and one of its most famous and tireless promoters, Dr. Andrew Weil. Dr. Weil, as you might recall, has even been the driving force for creating a highly dubious “board certification” in integrative medicine. Sadly, apparently this new board certification has been so popular among physicians wanting to “integrate” a little quackery into their practices, that its first examination has been delayed from May to November 2014, so that the American Board of Physician Specialties can figure out how to accommodate the unexpectedly large number of applicants.
So what happens when a patient arrives at U. of A. for treatment? I found out last week when I received an e-mail, which led to a fairly long e-mail exchange, with a man whose son was diagnosed with leukemia and is being treated at the University of Arizona Cancer Center (UACC). Although this man gave me permission to use his name, I am going to decline to do so because there is a child involved, although anyone involved in his case at U. of A. will likely quickly be able to identify who the man is. It turns out that he is a professor at U. of A. in a humanities department (which is why I’ll refer to him henceforth as the Professor), and, even though he is not a scientist, he clearly knows how to think (which would not be surprising if you knew what department he was in). In his e-mail, he told me how appalled he was at the sorts of treatments being offered to his son:
I was appalled to discover that the center offers treatments like Reiki, Reflexology, Acupuncture, Cranial massage, etc. These treatments are advertised as “healing”–including boosting one’s immune system, complementing conventional chemotherapy etc. I wrote the the [sic] director of the center who at first expressed concern and thanked me for calling these things to her attention. She said she would convene a board of physicians to look into it. After three months went by, I wrote to her asking for an update. She told me the board was still working on it and that she was “confident they would take care of it”. I have been asking her for a timeline and she is not returning my emails.
At first I thought this was probably the pernicious influence of Andrew Weil, but I have since discovered that cancer centers around the country are offering these “treatments” including places like Sloan-Kettering. Because of this, I’ve concluded there is no point in going to the media to try to expose what’s going on.
Of course, blogs are the media. The new media, but media nonetheless. At least I like to think so.
The Professor is probably correct about going to the traditional media, though. There probably is little point in going to the press, although we can always hope. Most of the time, when the press looks into the infiltration of quackademic medicine into medical academia, the result is a story like this appalling one from a year and a half ago in which NBC News chief medical correspondent Nancy Snyderman strongly embraced quackademic medicine to the point that she even said that if a doctor “doesn’t know” about integrative medicine, “I think it’s time to ask for a referral to someone who does.” It made me sad to see a woman who normally stands up for science, at least with respect to vaccines and combatting the antivaccine movement, to fall so hard for pseudoscience when it exists at Memorial Sloan-Kettering Cancer Center. Even I have had to hang my head in shame when I discovered that my alma mater both for medical and undergraduate school, the University of Michigan, actually has a program in anthroposophic medicine.
Unfortunately, although I hoped that the Professor would make as much of a stink as he could, I felt compelled to warn him that I doubted he would be successful because this sort of “integration” of quackery with academic medicine is very much entrenched at the University of Arizona. It started with the pernicious influence of Andrew Weil, but if Dr. Weil were to drop dead or retire today I doubt that it would change much, if at all, because quackademic medicine has had years to become embedded in the culture there. To put it bluntly, U. of A. is one of the centers of quackademic medicine in the US, if not the world, and I don’t see that changing any time soon. I also looked up UACC’s director, Dr. Ann E. Cress, and noted that she’s an interim director, which makes it highly unlikely that, even if she were so inclined, she could do much of anything. An interim cancer center director isn’t going to be able to take on Andrew Weil. It also doesn’t help that there are researchers at U. of A. like Dr. Myra Muramoto, who recently scored a $3.1 million from the National Cancer Institute (NCI)—not the National Center for Complementary and Alternative Medicine, mind you, the NCI—to do this:
Dr. Myra Muramoto, Arizona Cancer Center member and associate professor in the Department of Family and Community Medicine at the University of Arizona College of Medicine, has received $3.1 million from the National Cancer Institute to develop and evaluate a new program to train chiropractors, acupuncturists and massage therapists in effective ways to help their patients and clients quit tobacco.
The grant will fund “Project Reach,” which will partner over the next five years with Pima County chiropractors, acupuncturists, massage therapists and their office staff to evaluate ways they can best help their patients quit tobacco.
That’s a big chunk of change of the sort that cancer centers value above all, money from NCI grants. When cancer centers are being considered for NCI-designated comprehensive cancer center status (NCI-CCC)—or trying to renew their status—one huge consideration is the level of NCI funding its investigators have. Basically, for this purpose NIH grants are good, but NCI grants are the best. That’s why any investigator with a $3.1 million NCI grant will have outsized influence and an NCI-CCC or any cancer center seeking NCI designation. Of course, because chiropractors, acupuncturists, and massage therapists often claim, without valid scientific evidence, to be able to help people quit smoking with their woo, such a grant would almost certainly have the effect of encouraging referrals of smokers to these practitioners, to make sure enough patients accrue to the study funded by the grant.Quackademic medicine at UACC
It turns out that U. of A. does indeed offer its patients tons of “supportive” care therapies not rooted in science. A quick look at its Survivorship Care page reveals:
In collaboration with the medical and psychosocial services at The University of Arizona Cancer Center, we will work with patients to:
Notice the quackademic medicine “integrated” with potentially science-based modalities for supportive care: acupuncture, botanicals, “mind-body” medicine. Note how such useless modalities like acupuncture are listed as being, in essence, co-equal with various dietary, lifestyle, and coping modalities. This is basically how quackademic medicine “rebrands” what should be science-based modalities as somehow being “alternative” or outside the mainstream. It then lumps them together with modalities that are pure quackery (acupuncture, reiki, therapeutic touch, etc.), the implication being that it’s all part of a lovely “complementary and alternative medicine” (CAM) package that represents the “best of both worlds.” Of course, we at SBM reject the idea that there are “two worlds,” citing the oft-repeated adage that there is no such thing as “alternative medicine.” Rather, there is medicine that has been scientifically demonstrated to work. There is medicine that has not been scientifically shown to work. There is medicine that has been shown not to work. The reason “alternative medicine” is alternative is because it falls into one of the latter two categories. What do you call alternative medicine that’s been shown scientifically to work?
I know, I know. We say this a lot here, but it’s true. Also true is Mark Crislip’s almost famous adage, which I like to use in almost all of the talks I give about “integrative” medicine these days:
If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.
As I’ve said many times before, I wish I had thought of this quote.Trying to hide the stench of cow pie in the apple pie
Make no mistake about it, UACC is “integrating” fantasy with reality by offering reflexology (or, as I like to call it, a nice foot and hand massage with delusions of grandeur), reiki (or, as I like to call it, faith healing substituting Eastern mysticism for Judeo-Christian beliefs), craniosacral massage (or, as I like to call it, a nice scalp massage with delusions of grandeur), healing touch (also known as therapeutic touch, which I like to call reiki without the foreign name), and many others. At least, I wasn’t able to find anywhere that the UACC offers homeopathy to patients, although one of the most famous of the “magical grants” awarded by NCCAM was to a University of Arizona researcher in Dr. Weil’s department to study homeopathy.
It didn’t take too long for it to become clear to the Professor that UACC was not dealing with him in good faith. At least, that’s what he told me in a subsequent e-mail. What led him to believe this was a combination of not getting his e-mails answered and then what happened after he complained about perhaps the most egregious example that he found at UACC. He first brought this issue up back in December, and, after several requests to have a meeting, the Professor became frustrated and basically sent a threat to go to the media. Shortly after that, the web page on the UACC site that had so disturbed the Professor became this:
Yes, that’s a big “Access Denied” message. One wonders whether UACC deleted the page or just hid it so that you need a University of Arizona login to see it. Maybe one of our readers from U. of A. could check and report back here.
Thankfully, due to the magic of Google Cache, we can see what was there until as recently as a week ago:
One wonders if the administration of UACC, out of concern that the Professor might actually do what he said he would do (shop his story around to newspapers), got rid of the web page for Frank Schuster. Of course, it’s not so easy, as I showed above, and, in case anyone’s interested, I’ve saved a web archive of the page for permanent archival purposes (for me, that is).
I can see why the UACC administration would be embarrassed enough to act like this. On the now defunct page, potential patients for UACC were treated to incredible claims like:
Very simply, Reiki is energy that flows through the body of the practitioner, and conveyed through the hands into the body of the recipient. It is subtle energy, but it can be felt – usually as a warmth, tingles or slight pressure.
And, perhaps the most ridiculous claim of all:
Any particular effects cannot be predicted. The energy is intelligent and it will do whatever is best. What can be stated is that it will help any condition.
That’s right. Apparently this “healing energy” from the “universal source” is so intelligent that it will do whatever is needed or best. That totally must be why it can’t be studied! Its effects are so darned unpredictable! It’s also hard not to note that on the old web page about Mr. Schuster there was a link to his practice’s web page Energy-Therapy.net, where there’s also a link to his blog Energy Therapies, which appears not to have been updated since 2005 but is quite revealing nonetheless. Indeed, in one post on Mr. Schuster’s web page, we see a claim that speaks for itself:
ALL illness and disease are indications of an unbalanced or depleted energetic condition. The resulting manifestation as pain or anxiety is the body’s way of letting you know that something in your life is out of balance.
But don’t worry, Mr. Schuster can help. You don’t even have to come to his practice or UACC! That’s because, you see, Mr. Schuster offers distance healing:
Distant Healing is defined as a “mental intention on behalf of one person, to benefit another at a distance.”
In this context, prayer is a mental act of intercession in which the believer (pray-er) puts himself “between” God and the recipient.
God then uses the prayer (pray-er) as the conduit for the request – be it healing, therapy, or another type of petition. God’s healing power is directed through the healer to the person in need. If that person is present, the power can be conveyed through touch. In the event that person cannot be present, God’s healing power is effectively conveyed by mental intention through the thought process. In this realm distance is not a consideration.
One might not believe any of this, nor have faith that this kind of healing can occur. Actually, that is irrelevant. The only faith that really matters is that of the healer or pray-er. The single requirement of the recipient is to be in a receptive mode, open to healing possibilities. It is not necessary to believe that the acts of prayer, distant healing or touch healing are effective.
This is, of course, completely unscientific. It’s religion, pure and simple. In fact, I would argue that it’s just another form of faith healing, given how Mr. Schuster invokes God as the source of the “healing power.” And it’s only $25 for four 15 minute sessions! (More if you want to donate more.) What a bargain! At least there’s a quack Miranda warning at the bottom of the page, and one notes that Mr. Schuster also includes a plug for NCCAM.
I don’t know whether Mr. Schuster actually offers distance healing to UACC patients, although it’s clear from his web page that he offers it. Regardless of whether he offers it to UACC patients or not, I hope that I would not be alone in arguing that mystical nonsense like reiki (which Mr. Schuster appears to implicitly admit to be faith healing) has no place in an academic medical center, much less an NCI-CCC like UACC. There are only 41 NCI-CCCs in the entire country. I’m faculty at one and am proud of having been on the faculty of two different NCI-CCC’s. The NCI designation is supposed to mean that these cancer centers are the best of the best, adhering to only the highest standards of patient care, research, and community engagement. To see an NCI-CCC offering faith healing, distance healing, and treatments based far more on magical thinking, religious and mystical ideas, and prescientific concepts of disease, such as reiki, reflexology, and acupuncture, embarrasses me almost as it would to learn these modalities were being promoted for patients by my own cancer center as though they were legitimate treatment modalities. Fortunately, they are not, which is one reason I’m proud of my cancer center, but I nonetheless fear this occurrence. After all, if M.D. Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center can fall so deep into the rabbit hole of woo, I’m under no illusion that it can’t happen where I work too. All it would take is a new cancer center director, a new director of supportive services who is more “open” to these sorts of treatments, or maybe a new member of the board of directors who is woo-friendly. SBM is fragile these days.
Perhaps Dr. Cress feels the same way, along with many of the other excellent science-based clinicians and researchers based at UACC. I doubt it’s a coincidence that there isn’t a single mention of CAM or “integrative medicine” in a recent history of UACC published on the UACC blog last fall. In a way, I feel a bit sorry for Dr. Cress in that, as an interim director, she probably has neither the authority nor inclination to deal with this issue definitively. She probably wants to let whoever is appointed the next permanent director deal with it. Whatever the case, the Professor still doesn’t know whether Mr. Schuster is still affiliated with UACC or not, the removal of his web page from public view notwithstanding. I’m not sure that even the minimal action of removing from the UACC website a webpage that links to a website offering distance healing would have happened if the Professor hadn’t been faculty at the University of Arizona and threatened to go to the press.
Maybe they were concerned that people would also notice that Mr. Schuster’s other website, Paths-Mind-Is-It.com, offers a veritable cornucopia of dubious products, such as Increased Synchronicity, which claims to be able to:
Hey, if Mr. Schuster can send healing messages over distances, why not forward or backward in time, too? Yes, basically, his PATHS “utilize proprietary breakthrough technology” that claims this:
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RDT or Rapid Data Transfer facilitates high-speed communication between an on-line Theater Presentation and the human subconscious.
As best I can figure, PATHS are multimedia computer presentations that claim to be able to do all sorts of things for you, including improving your stem cell health, strengthening your connective tissue, and doing quantum meditation. Note that the word “quantum” features prominently in this “technology,” and regular readers know what the use of that word almost always indicates in this context.What remains of the cow pie
Even if Mr. Schuster is indeed gone from UACC, there’s a lot of woo that remains there, as the Professor mentioned in his e-mails. Specifically, he pointed out something called The Seven Levels of Healing, a program created and offered by Dr. Jeremy Geffen, MD, FACP, who is described as a “board certified medical oncologist and leading expert in integrative medicine and oncology and is the author of the book The Journey Through Cancer: Healing and Transforming the Whole Person.” I think I’ll quote the Professor about why he found this so objectionable, because, really, without letting myself go, I’d have a hard time putting it better myself. In his criticism, the Professor also cites examples from Dr. Geffen’s website:
Today I’m in the cancer center and I’ve noticed something else. You offer here something called “The Seven Levels of Healing”. I looked up this program. Level 7 is about the nature of spirit. Here’s one thing they say:
Spirit is our true nature: timeless, eternal, and dimensionless, the source from which all awareness, all creativity and, ultimately, all healing flows.
As you know, this claim is scientific nonsense. One may have religious faith in such a claim, but is it appropriate for this claim to be made by the cancer center? The description continues:
The goal of “The Nature of Spirit” is to assist each person to discover this spiritual aspect of themselves, and to bring this into full, ongoing awareness. When what we experience as physical reality is threatened, it is more important than ever before to remember that another part of us is timeless and eternal, and remains strong, healthy, and powerful, no matter what our physical circumstances may be. In recognizing the nature of our spiritual selves, and the incredible mystery of awareness itself, we uncover the source of ultimate love and freedom — an infinite ocean from which healing can be drawn.
Again, completely unscientific claims about healing. As far as I know, the “Seven Levels of Healing” program is free. This makes it less objectionable, although in my mind, it is still objectionable for the cancer center, a supposedly scientific, evidence-based institution, to be pushing what is essentially religion. Moreover, in the description of level 3: “The Body as Garden”, they say the following:
Here we explore the full spectrum of complementary approaches to healing: nutrition; exercise; massage; yoga; herbal therapies; Ayurvedic, Tibetan and Chinese medicine; acupuncture; homeopathy: chiropractic; and visualization. We do not offer or promote these approaches as cancer treatments per se, and we do not believe that they should be viewed in this manner. However, we do believe that they can supplement conventional care by cleansing, toning, relaxing, and strengthening the body, thus giving health and well-being the greatest chance to emerge.
Although these claims are vague, it would be quite natural for someone to interpret them as meaning that these treatments, some of which are offered at the center for a fee, can aid in one’s recovery from cancer. I know of no evidence to support this claim. And do you have any idea what they mean by ‘cleansing’ and ‘toning’ the body? Do these terms have any scientific meaning in this context?
Likely, the Professor learned of this program through a fliers or pamphlet like this one. He is quite correct, too. By offering this particular program, UACC has irresponsibly placed its imprimatur and thus the assumed imprimatur of science on pseudoscience and mystical, religious mumbo-jumbo. There is no excuse for this.
This “Seven Levels of Healing” represents a program by a physician who is not UACC faculty but is promoted by UACC to its patients. It offers homeopathy, which, no matter how much homeopaths try to deny it, is pure quackery, as we’ve described many, many times here. Ayurveda and traditional Chinese medicine are modalities based on prescientific ideas of how diseases work not unlike the four humors in prescientific European medical traditions. Worse, according to the biography on the website, Dr. Geffen is apparently “focused on implementing ‘The Seven Levels of Healing’ program in cancer centers throughout the United States, along with writing, speaking, and consulting with hospitals, cancer centers, and professional organizations in developing leading-edge integrative programs for medicine, wellness, and life.” Although several cancer centers appear to have adopted the “Seven Levels of Healing” woo, from what I can tell, UACC is the only NCI-CCC that is involved, making it by far the most prominent cancer center to be using Dr. Geffen’s program. I really hope that I don’t learn of any more.
Given the infiltration of quackademic medicine into even the most respectable medical centers, it’s hard to know whether UACC is merely the cancer center that’s gone the farthest down the rabbit hole of pseudoscience or whether I just don’t know of ones that are even worse. Given the large shadow that Andrew Weil casts over the medical school there, it might well be so that, when it comes to quackademic medicine in oncology, UACC reigns supreme. As prominent as M.D. Anderson and Memorial Sloan-Kettering Cancer Centers are, as far as I can tell, neither of them has yet offered distance healing to their patients, although many are the academic medical centers that offer a quackery only slightly removed from distance healing, namely reiki. After all, what’s the difference between saying you can channel “healing energy” from the “universal source” into a patient if you’re in the room with him or if you’re thousands of miles away? In my mind, not much. At least one academic medical center offers homeopathy. (Actually, I wish it were only one.)Can anything be done?
Often, I’m asked something like, “What’s the harm?” After all, UACC and the other cancer centers that offer up “integrative oncology” don’t deny patients science-based treatments for their cancer. True enough. However, as the Professor demonstrates, the existence of “integrative oncology” programs has a profoundly confusing effect on patients and their families, who, quite reasonably, assume that an NCI-CCC would not offer any treatments that were not science-based. Consequently, the line between science and pseudoscience is becoming increasingly blurred, to the point where even a lot of physicians have a hard time telling the difference when it comes to modalities like acupuncture, which has been the most successful at projecting a facade of science over prescientific mystical origins and a mid-20th century resurrection based on political need in China, thanks to low quality studies and random noise in clinical trials. Worse, this infiltration has led to grossly unethical clinical trials, such as the Gonzalez trial, in which patients undergoing a “natural” therapy for cancer did much worse than conventional therapy, even for a disease with as grim a prognosis as pancreatic cancer. Perhaps an even more pernicious effect (actually, there’s no “perhaps” about it) is that this blurring of the lines between science and pseudoscience so badly batters the filters against pseudoscience that a cancer center like UACC can allow practitioners like Frank Schuster and Dr. Jeremy Geffen to be associated with its programs, and even hire them to provide unscientific medicine.
My first wish is that more patients like the Professor would so vigorously protest the infiltration of quackery into academic medical centers like UACC. My second wish is that it would take more than the potential embarrassment of publicity about a practitioner that even the quackiest of quackademics can’t defend to push a cancer center to act to protect the scientific basis of cancer care. Maybe the Professor can serve as an example of the first wish, but I fear I will not live to see the second ever fulfilled.
Earlier this month, the typical media outlets were abuzz (“Childhood nightmares may point to looming health issues“) with the results of a newly published study linking early childhood nightmares and night terrors with future psychotic experiences. Expressing little in the way of skepticism, most reports simply regurgitated the University of Warwick press release. The research, published in the quite legitimate journal Sleep, is interesting but I’m not sure it tell us anything that we don’t already know. And it certainly doesn’t support any causal relationship between sleep disorders of any variety and “delusions, hallucinations, and thought interference”. But before we delve into the specifics of the paper, I believe a quick review of sleep, and sleep problems, in children is in order.What is sleep?
To the outside observer, sleep appears as an altered level of consciousness where response to our environment and voluntary movements are noticeably decreased. But, with a certain degree of variability, the line between sleep and wakefulness is pretty thin. This distinguishes it from the increasing stimulation required to reverse other states of altered consciousness such as lethargy, obtundation, stupor and ultimately coma, which is not acutely reversible. I don’t plan on getting too technical, but there is obviously much more to sleep than that. Physiologically our metabolic demands drop a bit, and we enter a generalized anabolic or “growth” state during which a number of beneficial processes take place, predominantly, we think, involving the brain.
Sleep is a vital aspect of human life that has appears to have both physiological and psychological purpose, and is essentially universal in the animal kingdom. All you need to do is observe a cat for more than five minutes to see that we aren’t the only animal species that both needs and seemingly enjoys sleep. In fact, if you could talk to a nematode, it would likely go on for hours about how much it enjoys sleeping in on Sundays. Humans spend roughly a third of their lives asleep, but the percentage of each day devoted to sleep is significantly higher during infancy and early childhood.
We don’t know why the need to sleep became part of the blueprint for life so early on in our evolutionary history, and researchers certainly haven’t worked out all of the nuances of why humans and other animal species continue to be so dependent on it throughout the lifespan. It is likely that its purpose has broadened over time as species branched out into new environments. There are a number of leading hypotheses, however. And barring some amazing technological or medical advance, we appear to be stuck with sleep.
Again, there are many proposed purposes for sleep. Much of the evidence relies on the observation of what happens to our bodies when we don’t get any. Poor sleep affects a number of physiologic processes, and there are probably consequences that we aren’t even aware of yet. Ultimately, a complete lack of sleep, although rare, is fatal.
Many of the hypotheses for the purpose of sleep involve its potential restorative powers, with proponents invoking evidence of increased clearance of waste products from the brain during sleep, as well as improved wound healing and immune system function. How do you truly boost your immune system? Sleep is probably a better means than any supplement or bogus healing modality and considerably cheaper. Sleep also may play a role in clearing out the cobwebs so to speak, by weeding out weak neuronal connections, allowing memory and learning to function optimally and supporting cognition. There are numerous studies detailing the effects of poor sleep on these processes.
Another school of thought involves the role of sleep in development. This stems from observations that babies sleep more than older kids and adults, and in particular active or REM sleep occurs for longer periods of the day in the very young in the vast majority of animal species. We also know that interference with REM sleep in the young can lead to a variety of negative development outcomes later in life. Perhaps this explains the origins of both muscle inhibition and dreams, as activating the brain without the risk of injury may be a pivotal aspect of proper development. Maybe REM sleep persists into adulthood as part of general brain maintenance. Who knows? But this doesn’t hold water in all species. Marine mammals don’t develop REM sleep until adulthood.
The weakest of the potential purposes for sleep appear to involve energy conservation and life preservation. Metabolic processes only slow down by about 5-10% during sleep, and animals that hibernate, a time of more significant drop in energy usage, still need to sleep afterwards. And decreasing consciousness with predators around seems like a risky means of taking a rest if that was all it was about. Avoiding predators by sleeping during their peak activity doesn’t explain why apex predators sleep or why sleep is still required the day after a sleepless night.
Clearly there is also a behavioral component to our desire to sleep. We get sleepy when we need sleep, although this doesn’t always translate to actually being able to fall asleep. At times our bodies face an almost overwhelming demand. It makes sense that this drive to sleep occurs because of some vital physiological importance, but sometimes we feel the urge to sleep for purely psychological reasons, even when we have consistently been obtaining a reasonable amount. There can be great pleasure in taking a nap on a day off. Sleepiness seems to occur with certain environmental cues as well, often accompanying boredom and sadness.
When asked about the reasons we sleep, William Dement, a sleep expert who was part of the early research on REM sleep, famously said “As far as I know the only reason we need to sleep that is really, really solid is because we get sleepy.”Sleep problems in kids
Sleep is incredibly important to growth and development in children. Unfortunately sleep problems are very common, occurring across the age spectrum. They range from mild and occasional inconveniences accepted by most parents as normal aspects of childhood development to full blown disorders with a significant negative impact on the quality of life for patients and their loved ones. In general, anywhere from a quarter to half of children have difficulty with sleep at some point.
The structure and patterns of sleep are in flux throughout childhood. How many hours each day that we sleep, the specific percentages of REM and non-REM sleep, the duration of sleep cycles and how sleep is distributed over a day all change over time. So do the behaviors associated with sleep. Sleep problems manifest in a variety of ways during childhood as well.
An infant deprived of the recommended average of 15 hours of daily sleep over the first year of life (newborns often need 16-20 hours) may be irritable, feed poorly, and have delays in the acquisition of developmental milestones. And adding parental lack of sleep to the mix can be disastrous as it decreases their ability to handle stress appropriately. Lack of sleep in older children can result in learning difficulties and continued developmental challenges. Behavior, memory and attention problems can affect school performance. Even issues with weight gain and obesity have been linked to lack of sleep. And unfortunately, difficulties with sleep in childhood have often been found to be predictive of a wide range of future problems such as depression and anxiety, drug use, obesity and sleep disorders.
As in the adult population, there are a variety of sleep disorders found in children. The typical screening tool used by pediatricians is the BEARS, which consists of trigger questions for different age groups that can help reveal problems in one or more of five sleep related categories: Bedtime problems, Excessive daytime sleepiness, Awakenings during the night, Regularity and duration of sleep and Snoring. Probably the most common sleep disorder in kids is behavioral insomnia. Though it is extremely common for young children to wake up during the night, it can be a big problem if they have not learned how to fall back asleep without parental assistance and it occurs repeatedly each night. Behavioral insomnia also occurs, typically in older kids, because of a lack or inconsistency of limit-setting. These children simply refuse to go to bed. Again, it is common for there to be some resistance to calling it a night during childhood but at a certain point it becomes excessive.
Children can also suffer from disorders of the circadian rhythm, typically presenting in adolescence or young adulthood. The most common circadian rhythm problem is delayed sleep phase syndrome, where there is an inability to fall asleep and wake up during conventionally desired time periods. Sleep-related breathing disorders, in particular obstructive sleep apnea, is an increasingly common problem in children. This occurs when there is intermittent blocking of the upper airway, either partial or complete, that impedes airflow during sleep. It can lead to drops in the amount of oxygen in the blood and is associated with heart disease and hypertension in addition to behavior and learning difficulties.
The final category of sleep disorders commonly seen in children, and the one which the study on nightmares and future psychosis looked at, are the parasomnias. These are, at least to me, the most fascinating of the sleep disorders and certainly the group that gets the most coverage in the media. Parasomnias are discrete behavioral episodes that happen at any point during the sleep process, causing an interruption but generally not impacting the overall quality of sleep like insomnia or circadian rhythm disorders do. They do often lead to a great deal of parental distress however.
The parasomnias, which include nightmares, night terrors, sleepwalking, sleep talking, confusional arousals, bedwetting, teeth grinding, excessive or unusual movements and sleep paralysis are very common. There isn’t a lot of long term data, but one large cross-sectional study revealed that nearly 90% of children had at least one between the ages of 2.5 to 6 years of age. My 5-year-old daughter for example both talks in her sleep and often has confusional arousals during the night. It’s adorable. There appears to be a huge decrease in incidence once children reach school age but some parasomnias do persist or occur later in childhood and even in adulthood. Some only occur in adults. Studies on kids have primarily consisted of parental recall however, and mild events may not be recognized by parents. So we have to take the numbers in older kids with a grain of salt.Night terrors
I could write an entire post just on these parasomnias, but for this post I’ll focus on nightmares and night terrors as they were focused on in the study. Night terrors occur during stage 3 and 4 non-REM sleep and are classified as a disorder of partial arousal along with confusional arousals and sleepwalking. They tend to happen as children are transitioning into lighter sleep or even into wakefulness.
There appears to be a genetic predisposition to having this type of parasomnia. One twin study that looked 323 pairs was very supportive, showing 6 times the incidence in identical versus fraternal twins, and another study revealed more than twice the likelihood of night terrors in the child of a sleepwalking parent. There are common triggers for these arousals as well, including obstructive sleep apnea, restless leg syndrome and reflux. Removing the trigger can stop the parasomnia. Anxiety, poor sleep and fever have also been shown to be triggers. The partial arousal parasomnias all typically occur during early childhood and gradually go away with time as the amount of slow wave sleep decreases, with very few teens and adults having them. EEG findings reveal unstable deep sleep.
Night terrors can be very impressive and scary for parents. The child appears to be sleeping soundly when suddenly they begin screaming. They are red faced and sweat profusely, reflecting the increase in autonomic nervous system activity. Their hearts are racing. They may even jump out of bed as if fleeing from some invisible monster and they are inconsolable or very confused and disoriented if awakened. Eventually, after 10-20 minutes of seeming terror, they fall back asleep and will have no recollection of the event in the morning. It’s no wonder that historically these events may have been attributed to demon possession or evidence of other paranormal activities.
We think that night terrors occur in anywhere from 1% to 6.5% of young children, and in about 2.5% after adolescence. Again, there appears to be a substantial genetic predisposition. They are usually infrequent and benign, perhaps occurring only once or twice a month, so parental reassurance is usually all that is needed. When causing a problem, the first step is making sure that the child is getting adequate sleep. Toddlers need naps during the day for instance but many aren’t given time to do so. Addressing other potential triggers is also an important step in managing significant night terrors. Finally, there are cases of severe refractory events, sometimes putting the child at risk of injury, that require a low dose sedative for a few months. Although there are only anecdotal reports, scheduled awakening prior to the typical time of the event, followed by reassurance and allowing the child to fall back asleep may help.Nightmares
Nightmares are disturbing dreams, differentiated from night terrors by occurring during REM sleep, that lead to sudden wakefulness and emotional distress. They can involve a variety of intense emotions, such as sadness, anger, or disgust, not just the stereotypical fear and anxiety. Nightmares tend to occur during the early morning, as opposed to late evening with night terrors, and patients usually have good recall of the events of the dream although there ability to describe them varies with age. Also, unlike after night terrors, children with nightmares tend to achieve full wakefulness and have difficulty falling back asleep because of residual distress. There is an absence of symptoms such as flushing and sweating on awakening, but kids may have some mild increased heart rate, and excessive body movements during the nightmare are uncommon because of REM sleep inhibition.
Nightmares occur in a large percentage of children, and often can interfere with sleep and lead to parental awakening. Stress in general, and traumatic events can induce nightmares, so it shouldn’t be surprising that nightmares are more common in kids with PTSD. Similar to night terrors in this regard, poor sleep and anxiety can increase the incidence of nightmares. Unlike night terrors, there are some medications that can also increase the risk. Nightmares tend to peak between 5 and 10 years of age and then significantly decrease in incidence.
Reassurance is also in order with nightmares, and improved sleep hygiene. Simple techniques such as night lights and avoiding any potentially overstimulating television before bed can help, as can relaxation strategies. But with very frequent and severe events, there is potential association with anxiety disorders so a referral to mental health or a developmental-behavioral pediatrician may be necessary.Nightmares, night terrors and psychotic experiences
The study making the rounds this month is a prospective birth cohort study using data from the Avon Longitudinal Study of Parents and Children (ALSPAC). A longitudinal cohort study, as opposed to a cross-sectional study, follows a group of subjects without a condition and who share common characteristic over time, sometimes even decades, to investigate various exposures or risk factors and their possible link to the development of a condition. The common experience of the cohort used for this study was being born in 1991 or 1992, and in or around Bristol, England. 6,796 children (3,462 girls, 50.9%) who completed a psychotic experiences interview made up the subject pool.
Although prospective cohort studies can be very helpful in telling if a certain risk factor, such as heavy smoking, plays a causal role in the development of lung cancer for example, they aren’t as effective as the randomized controlled trial. But they are a solid epidemiological tool even if there is some increased risk of missing a confounding variable. Of course RCTs aren’t always appropriate. Imagine assigning a study group to smoke a certain amount of cigarettes each day, or having a random assignment to the “no vaccines” arm of a trial. Only IRBs made up of family members and meeting in your basement would approve a study like that.
An advantage of a prospective cohort study is determining potential risk factors for a condition by following subjects over long periods of time. And when information is collected frequently over time, there is less need to rely on potentially biased recall of information. As with any prospective design, subjects can drop out, die, or disappear. And longitudinal cohorts running for decades take time and money, but are often worth it because of the improved reliability over studies that look back retrospectively or involve samples of subjects taken at one moment in time.
The authors compared subsets within the cohort, in this case children whose mothers reported frequent nightmares between age 2.5 and 9 years, to children who did not have frequent nightmare episodes during that period, and then 12-year-old children who self-reported nightmares, night terrors, or sleepwalking during the previous 6 months to those who did not. All of the children were asked about psychotic experiences at age 12 years. The goal of the authors was to examine any link between these parasomnias and psychotic experiences.
According to the authors, potentially confounding variables such as sex, family adversity, emotional or behavioral problems, IQ and potential neurological problems were accounted for, but I think some glaring potential confounders were missed. After analyzing the data, they concluded that “Nightmares and night terrors, but not other sleeping problems, in childhood were associated with psychotic experiences at age 12 years. These findings tentatively suggest that arousal and rapid eye movement forms of sleep disorder might be early indicators of susceptibility to psychotic experiences.” I appreciate their use of the word “tentatively”.
Also, the study does not tell us what having psychotic experiences at age 12 means in regards to future risk of mental health problems. The same authors, using the same cohort data set, actually addressed this in a 2013 study published in the American Journal of Psychiatry. In that paper they found a very poor positive predictive value of non-clinical psychotic experiences at age 12 years. Only 1.7% of 12-year-old subjects reporting psychotic experiences went on to meet criteria for a psychotic disorder at age 18 years. Sadly, only half of the 1.7% had received any mental health services.
Mothers were interviews roughly every 16 months between age 2 and 9 years, which seems like plenty of time for there to be some error in recall to creep in but it could be worse. Children whose mothers reported only one period of nightmares were 16% more likely to have psychotic experiences at age 12 years. Kids with 3 or more periods of nightmares were 56% more likely. Of the 12-year-old children asked about recent parasomnias, those with nightmares were 3.5 times more likely to have psychotic experiences while those reporting night terrors had twice the risk. The specific psychotic experiences they asked about were hallucinations, interrupted thoughts, and delusions and only 4.7% reported having one.
As I said in the intro, this study is interesting but I’m not sure if it adds much to what we already know. And naturally much of the news coverage is over-hyped and at times comes across as implying that somehow nightmares and night terrors might play a causal role in psychotic experiences in older kids, which is completely unfounded. There is also the implication that psychotic experiences at age 12 are a good predictor of psychiatric illness. The authors are absolutely not making that claim. But if this gets parents and healthcare professionals to pay a little more attention to sleep hygiene and pediatric mental health, I’m okay with that.
I feel like if a mother approached a pediatrician about her child having persistent severe nightmares or night terrors, especially if they had aged out of the typical peak years, most of us would consider the possibility that something more was going on, and not just mental illness. We would get a feel for the home and school situation and ask about risk factors for abuse, neglect, exposure to violence and poor sleep hygiene. We would also review potential worrisome indications for mental health issues. And I’d like to think that we would make the appropriate referral if necessary. But I don’t think that we should approach nightmares in the overwhelming majority of young children as a sign of mental illness.
Of course the major issue with pediatric mental health in this country is the abysmal lack of pediatric mental health in this country. There is often nowhere for poor kids to go for care, and often long waits for even those with money. Many get to the point of suicidal ideation or self-harm having never been evaluated. Suicide is an all too common cause of death in teens. Many don’t enter the system until they are forced to sleep in an emergency department for 3 days while waiting for a bed in an inpatient psychiatric facility.
Not surprisingly, the apparent relationship between parasomnias and psychotic experiences was stronger in the 12-year-old subjects who were currently having parasomnias. We already know that there is an association between stress and anxiety with parasomnias, and mental illness, or maybe just worrying about mental illness, certainly could be a strain. Many adolescent patients with schizophrenia for instance will self-medicate with marijuana. Marijuana can cause psychotic experiences. Some kids with schizophrenia are missed because their symptoms are blamed on the pot. As stated above, parasomnias almost always resolve by the time children are this age, so it stands to reason that there might be more to the situation at that point.
I realize that the authors attempted to account for potential psychosocial confounders, but this was based on self-report. I imagine that there might have been some under-reporting of some potential confounders, like marijuana use perhaps, or perhaps even under-reporting of psychotic symptoms. These children weren’t evaluated by a psychiatrist or other mental health professional. They just answered a list of questions.
We also know that there is a genetic predisposition at play with parasomnias, particularly night terrors. This also appears to be the case with many psychiatric conditions. This supports a possible link between the two issues. We also know that poor sleep is a factor in parasomnias. Sleep deprivation also plays a role in a variety of neuropsychiatric complaints. This wasn’t accounted for in the study questions. Neither was the possible use of illicit drugs, which could play a role in both conditions.
Psychotic experiences are actually fairly common in the 9-12 years age group according to the largest systematic review/meta-analysis to date. A median of 17% of kids in that age range compared to 7.5% of kids aged 13 to 18 years. They occur in about 5% of adults. Most kids who have these experiences in early adolescence won’t have them a few years later. Unfortunately, according to the authors of this review we should think more broadly because early psychotic symptoms may be a risk factor for much more than future psychosis. It should probably be considered a warning sign for future depression and other psychopathology. Still, most kids who have some thought interruptions or a hallucination or two at age 10 won’t go on to have any psychiatric condition. It probably represents some remnant of what would have been considered normal behavior a few years earlier.
I hope that parents won’t be losing sleep over their child having a nightmare or a night terror, or even bunch of them. The main author, Professor Dieter Wolke, stated in the press release, and I agree, that “We certainly don’t want to worry parents with this news; three in every four children experience nightmares at this young age. However, nightmares over a prolonged period or bouts of night terrors that persist into adolescence can be an early indicator of something more significant in later life.”Conclusion
Sleep is an extremely important and often overlooked component of health in all age groups. But it is particularly important in kids because of the long-term implications of early sleep deprivation on development and a variety of other conditions. Pediatric healthcare professionals should be asking parents about their children’s sleep and be prepared to offer solutions for common sleep problems.
There may be a link between some sleep problems in kids, in this case nightmares and night terrors, and self-report of psychotic experiences in young adolescents. But it remains unclear what this means in regards to future diagnosis of true psychiatric illness. I don’t think that the study in question really should change what we do, and it should not lead to increased parental anxiety. Parents have enough to worry about.
There are a number of risk factors, such as family history and early environment, that serve as red flags for potential psychiatric illness in kids. Some of them also likely play a role in difficulties with sleep and the occurrence of parasomnias. And in some kids mental illness itself likely does cause sleep problems. It isn’t beyond possibility that some children with mental illness will present with a complaint of severe or persistent nightmares or night terrors. We should always consider the possibility of mental illness and ask the appropriate follow-up questions.