"Misinformed consent" rears its ugly head in Pediatrics

I've written about the concept of "misinformed" consent with respect to the anti-vaccine movement. To summarize, "misinformed consent" is a perversion of the concept of informed consent in which cranks claim to be championing true informed consent (and, by implication, that opponents have not) when in fact they are presenting a scientifically unsupportable assessment of the risks and benefits of an intervention. In the case of vaccines, anti-vaccine activists play up the risks of vaccines far beyond what science supports, attributing to them, for instance, risks of autism, autoimmune disease, and a veritable laundry list of diseases, conditions, and syndromes while at the same time downplaying the many, many benefits of vaccines. In other words, the "informed" in "informed consent" very much becomes "misinformed."

Unfortunately, it's not just the anti-vaccine movement that's touting misinformed consent. it's pretty much the entire "alternative medicine" movement. Worse, they're even managing to promote their arguments in the very pages of influential peer-reviewed journals, such as Pediatrics. I'm referring to an article I came across in a recent issue of Pediatrics entitled Informed Consent: Advising Patients and Parents About Complementary and Alternative Medicine Therapies. One of the co-authors is Michael H. Cohen, JDA, MBA, who has been discussed over at Science-Based Medicine on more than one occasion and who maintains a blog (CAMLaw) that I check out from time to time that is unrelentingly hostile to science-based medicine and pro-woo. In this article, he and his co-authors advocate, in essence, using laws regarding informed consent to force doctors to "inform" their patients about "complementary and alternative medicine" (CAM) to pediatric patients, using the example of a child undergoing chemotherapy and suffering from nausea. The story is, from the beginning, slanted in the most heart-tugging, manipulative way that the lawyers can get away with in a peer-reviewed journal:

The parents of 6-year-old Jake, a young boy with medulloblastoma, are distressed by the nausea and vomiting he is suffering as a result of chemotherapy. His chemotherapy-induced nausea and vomiting (CINV) occur spontaneously and are also being triggered by sights, sounds, and smells for up to 2 weeks after a course of chemotherapy. His parents believe that this is preventing him from eating properly and that the psychological toll of the adverse effects of treatment are limiting his ability to combat the cancer. They ask Jake's oncologist about other options to alleviate his nausea. He has tried dimenhydrinate and dexamethasone in addition to ondansetron, but like metoclopromide, they have not provided Jake with sufficient relief. Jake's oncologist recommended that he continue with nabilone, a synthetic cannabinoid; however, Jake refuses to continue this drug, because it makes him feel dizzy and anxious. Disappointed, his parents resign themselves to the possibility that Jake might not find relief from his CINV.

While communicating online with other families of patients with cancer, Jake's parents discover that a consensus panel through the US National Institutes of Health (NIH) has recognized the effectiveness of acupuncture for alleviating CINV.1,2They ask their oncologist about it, but his response is noncommittal. Jake's parents take him out on intermittent passes from the hospital to an acupuncturist in the community. They are delighted to see that his nausea and vomiting are much improved after each acupuncture session. Jake begins to regain his appetite, gains weight, and generally has a better sense of well-being.

Jake's parents are upset that their physician, whom they believe also had access to information outlining the potential benefits of acupuncture, did not tell them that it was potentially a safe and effective treatment option for CINV. When they describe their son's improvements after acupuncture, their physician dismisses them as a "placebo effect." Jake's parents are concerned that the physician instead offered antiemetic medications that, from their point of view, only created more problems and unnecessary adverse effects

Of course, the physician is completely correct in describing the apparent response as almost certainly being placebo effect, but in the article the science-based view is presented as close-minded and biased, not to mention uncaring, with the physician in the vignette above (whether real or made up) coming across as either ignorant of something that might have alleviated the child's suffering or uncaring in his dedication to science- and evidence-based medicine.

It's pointed out that the law on informed consent varies in various states and nations, which is true enough. Some take a more patient-centered view of informed consent requiring physicians to disclose what a "reasonable" patient might want to know. Others take a more profession-centered view, mandating informing patients of what a reasonable health care professional would consider necessary to disclose. The authors then write:

...it has been suggested that when there is a genuine difference of opinion within the medical community and the treating physician does not support the alternative, there is still a duty to tell the patient about it and why the doctor considers it inappropriate.25,28 Some cases have shown a narrower view, holding that the treating physician is only obligated to disclose options that in his or her reasonable medical judgment are appropriate for the patient.31,32 This distinction may make little difference in practice because, as one court noted, when there is more than one medically reasonable treatment and the risk/benefit analysis engaged by the alternatives involves different considerations, then "a reasonable person would want to know about the alternatives and would want the assistance of the doctor's risk/benefit analysis of the various possible treatments... ."

The authors note that neither Canadian nor U.S. legal scholars have been able to identify a case where physicians or other "conventional" health care providers have been found liable for not informing a patient about CAM or not advising a patient to undertake CAM. I was actually relieved to learn this, because, given the tone of the article up to this point I was expecting that the authors would have dredged up at least one such case. It is also noted, however (and rather ominously), that:

...disclosure obligations evolve over time. As the evidence for a particular therapy (whether conventional or CAM) grows and it becomes more accepted in the medical literature, clinicians' duty to disclose information about them can be expected to expand accordingly as well.

What follows next is a group of lawyers, bioethicists, and woo-friendly physicians laboring mightily to argue that there is a real effect of acupuncture on chemotherapy-induced nausea and vomiting that is anything more than placebo. They cite a 14-year-old NIH Consensus Statement on Acupuncture that is exhibit A in the deficiencies of evidence-based medicine and how it doesn't take into account basic science and prior plausibility, relegating them to the lowest rung of the evidence hierarchy. As I've explained (as have others), this problem comes into play for extremely implausible medical treatments like homeopathy and, yes, acupuncture. They then cite the most recent Cochrane Review on CINV, which is actually far less glowing about the potential usefulness of acupuncture than the NIH consensus statement was.

It's actually a fairly useful Cochrane Review in that the systematic review and meta-analysis, if anything, was far less supportive of acupuncture for CINV than this Pediatrics article suggests. If you look at the pooled numbers, the first thing you will notice is that the effect sizes reported tend to be all very small, with 95% confidence intervals that barely miss overlapping 1.0 for effect sizes and lots of p-values of 0.04; i.e., barely reaching statistical significance. In the case of such results, I always question whether "statistically significant" actually equals "biologically significant" or "clinically significant." Given the effect sizes noted, I remain...skeptical. At best. And that doesn't even take into consideration the extreme biological implausibility of acupuncture, particularly for conditions other than pain. One can't also help but notice that the general quality of the studies pooled is pretty poor. Several of them don't even include a sham acupuncture control group, for instance. In the acupressure studies, most did not include a placebo control. Taken in its entirety, this Cochrane review is relatively unconvincing. And, of course, it calls, as nearly all of these Cochrane reviews do, that "more research is needed."

There is a very clear agenda behind papers like this, and that agenda has nothing to do with science. The agenda to which I refer that these CAM advocates are promoting is no less than using the law to provide legitimacy to various implausible CAM modalities that science has not provided. The strategy is explicit, too. It isn't hidden. It isn't even all that disguised. They want nothing less than to use the laws regarding informed consent to force physicians to have to "disclose" various CAM therapies to patients. The next step will be to mandate referrals. Indeed, in a companion article by the same authors in the same issue of Pediatrics (which I might just blog tomorrow) in the same issue of Pediatrics implies just that.

Of course, readers of this article probably have no idea what Michael Cohen's true agenda is. As Kimball Atwood has pointed out, Cohen was very involved in the American Association for Health Freedom, a group dedicated to convincing the government to legitimize various implausible medical claims through political influence rather than science. Indeed, some of Cohen's other writings are downright scary, such as this essay entitled What is the Matrix? A Radical Look at Medico-Legal Reform, in which he likens health care law and health care to the Matrix. For example, get a load of this passage:

Controlling fraudulent practitioners is seen as a public good, therefore licensure and credentialing rules, prohibitions against fraud, and the like are seen as virtuous, light-bearing beacons in the social order rather than as manifestations of evil. Yet the dark forces of fear, jealousy, and control often govern licensing laws and bodies; this includes intra-professional turf battles, legislative line-drawing in scope of practice conflicts, and medical boards' attempts to revoke licensure and discipline practitioners for deviating from conventionally agreed norms. The godly art of medicine and the best intentions of honest caregivers can be obscured if not buried by the maze of legal rules governing the profession and the ever-present fear of professional liability.

This maze is the Matrix. The Matrix controls healing.

Health and healing can involve the highest of which a human being is capable. Near-death experiences, encounters with angels, and events that touch the individual's interior castle and border on mysticism-hese experience manifest 'light,' in the sense of coming closer to that which is Supreme at the edges of our consciousness. How would an enlightened civilization, composed of enlightened citizens, govern its own evolutionary movement toward the highest possible level of healing? What role would law play? Would the absence of regulation, instead of its pervasiveness, bring peace-a kind of regulatory lacuna? Would legal structures be able to handle the notion that healing involves mind, body, emotions, and spirit, but also such other dimensions of the human experience as inter-species communication and greater sense of earth-consciousness (Gaia)?


Unfortunately, Michael Cohen has managed in a short ten years to go from writing bizarre passages like the one cited above (which, trust me, was not taken out of context, as you can determine for yourself if you don't believe me) to coauthoring articles like the one in Pediatrics that I've been discussing. His intent is clear. He wants to use the concept of informed consent as a bludgeon to force practitioners to offer CAM therapies to their patients as an "alternative." At its core, this strategy is nothing more than the same strategy that anti-vaccine activists have been using. It's more "misinformed consent."


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This sounds to me like the "informed consent" of the counseling centers for women who are going to have abortions - the ones that claim abortion leads to breast cancer and depression without there being any scientific evidence for those claims.

It's agenda, plain and simple, and it's disgusting that people push agenda onto those who are vulnerable to believe it.

Once physicians start mentioning the CAM alternative as a part of their duty of informing the patient, the next step by these people would probably be to make a statistical report saying that "upwards of 80% (or any such number) of physicians recommend such and such CAM treatment" in a bid for legitimacy.
They would also make us look like hypocrites when speaking out against CAM, saying that we recommend it to our patients (leaving out the "mentioning it as a part of legal formality").

There are treatments that have been sufficiently evaluated and have demonstrated safety and efficacy such that they constitute âstandard of careâ treatments. Every treatment that is not a âstandard of careâ treatment has not been demonstrated to be safe and effective.

What constitutes non-medical malpractice is doing something other than what is the âstandard of careâ. There are infinitely many non-standard of care treatments for every condition. It can't be the âstandard of careâ to inform patients about every single non-standard of care treatment and then tell them why it is not standard of care.

What CAM proponents need to do is not slime their way into medical practice via legal threats, but via demonstrating that their CAM treatment is safe and effective than any other treatment so it becomes not "CAM" but "standard of care Medicine".

I do believe there's a mistake, Orac. You seem to have quoted Mike Adams in that last section, and not Cohen.

I always question whether "statistically significant" actually equals "biologically significant" or "clinically significant

We had that drilled into our heads back in school. Just because you find a significant difference of 2 g in the weight of fish in one lake vs another lake because you weigh 10,000 fish from each lake does not mean the statistical significance equals biological significance.

By Daniel J. Andrews (not verified) on 09 Nov 2011 #permalink

So what would be a good counter-offense? Do we individually write or email the Journal of Pediatrics, requesting that our viewpoints be "considered" for inclusion in the the "comments" section of the next issue?

It seems to me that the CAM lawyer gets to write and article for the Journal and the Pediatrics journal should also review our commentary in reply and print some of the opposing comments.

When I did an extended nursing internship through a major university-affiliated cancer treatment department, at the end of my nursing training, I used to "suggest" chewing slowly some dry saltine crackers to eliminate the nausea and queasiness. Many patients tried it and some derived considerable relief.

Would the absence of regulation, instead of its pervasiveness, bring peace-a kind of regulatory lacuna?

Here's a little experiment for Mr. Cohen. Examine the state of health care and quality of care and the safety/risk of remedies offered in, oh, let's say the pre-1906 era. Compare that to the safety/risk of remedies that are used today.

If he wishes to go back to the days of patent medicines, where some remedies had some slight benefit, most remedies did nothing to treat the illness and many were quite harmful, by all means, he's welcome to it. Just move to some little island somewhere to set up his own Shangri-la.

@ Todd W: Mr. Cohen has no intention of moving away from his livelihood here in the United States, where he is the hired-gun legal mouthpiece of the CAM industry.

Why on earth would a cancer specialist recommend more "needles" to a parent whose child is undergoing cancer treatment? Why would a parent who understands the child's developmental age and abilities, even consider inflicting additional pain and discomfort on their child by the placement of needles along "meridians" to alleviate treatment-related discomfort?

I think it is high time that pain specialist from childrens hospitals weigh in, about this.

Interesting how it is that when you don't have the data to support your position you need to call in the lawyers! Where have we seen that before?

Of course this fits right in with linguistic manoeuvring- calling your woo-meistery something it's not, like "medicine"- and political lobbying- getting legislatures to sanction your particularly egregious usage of pseudo-data since nobody else will; right now, it appears that various alt med advocates are attempting to ride upon the coattails of the Occupy Wall Street movement- in style as well as substance. AoA regularly posts information about the Canary Party. LHK calls for political action. Her co-author calls for legal action. Alt med advocates fondly remember how the chiropractors "stuck it to the AMA"; they also regularly confuse scientific rejection of their idiosyncratic belief system with the abrogation of their *civil* rights.

Smoke, mirrors, legalese, and PR. Stuff like this makes me so morose I shall leave out my quip about the Matrix. Use your imagination.

By Denice Walter (not verified) on 09 Nov 2011 #permalink

lilady--might I suggest a Letter to the Editor? A condensed version of this very column, perhaps, Orac?

By Cynical Pediatrician (not verified) on 09 Nov 2011 #permalink

@ Cynical Pediatrician: Just a few questions....

I don't have access to the Pediatric Journal, it is behind a pay wall.

Could you provide the essence of their "Comments Editor" policy, including the name of the actual "Comments Editor" and their instructions (email or snail mail) for submitting a letter for inclusion in their next monthly issue?

Thanks so much.

Incredible quote! That Matrix analogy and name-dropping for Gaia (Gaia? Seriously?)is seriously crazy. (Really? Did I just read that? Yes I did. He said Gaia.)

I am beside myself. This is seriously across the woobicon.

Lilady, I suggest sending the folks at Pediatrics a link to article 4 from Mr. Cohen's website, so they can ask themselves if they just read a grown man write that healing came from Gaia-consciousness with a straight typeface.

By Scott Cunningham (not verified) on 09 Nov 2011 #permalink

Try this link regarding submissions: http://pediatrics.aappublications.org/site/misc/Author_Instructions_201…

How to Submit Reader Responses for consideration as eLetters:
1. Locate the article online using the "Current Issue" link (via www.pediatrics.org)
2. In the content box to the right of the article, click "Submit an eLetter"

Go to the main page (www.pediatrics.org), click "eArchives", look for 2011 November, Supplement 4. You should be able to at least get to the abstract and the eLetters link from there. This is the only way to submit letters, but some do get flagged for print publication.

Interestingly, every article in the Supplement appears to have been written by these same authors. Not something you see too often. Haven't gotten around to reading my copy yet, so can't comment otherwise on the content.

By Cynical Pediatrician (not verified) on 09 Nov 2011 #permalink

The kettle once again calls the pot black. Whoever or whatever orac is, one thing is clear, orac is a master of slanted if not slanderous reporting. Mainstream medicine is without fault, irregardless of evidence. Criticisms originate from crazy misinformed people period, end of discussion. That is subjective orac. That is useless orac.
Orac won't mention lawsuits against Pharma, and will twist information until it suits orac's ideology. orac is a waste of space.

You don't need to be a subscriber to submit an eLetter. If you go to the abstract there is a place to click to submit an eLetter.

Ross Coe,
Evidence needed.

By Mephistopheles… (not verified) on 09 Nov 2011 #permalink

Mr. Coe, you have returned! Now could you please tell us why Roald Dahl's oldest daughter was unable to tell us about her reaction to measles? I have been waiting for that answer since I first asked you here.

Please don't run away again, just answer the question.

@ross coe

Thanks for your fine example of unabashed ad hominem. I had a laugh at your stupidity.

@Ross Coe:

recently blinded studies have demonstrated that accupuncture (the type of alternative practice mentioned in the example) is no better than placebo. To a rational, caring person recommending someone waste money on something that would work just as well as thinking happy thoughts (which is free) is abhorrent. A professional whose biggest goal is to heal and make whole is not going to want to send parents chasing after dubious treatments with no guaranteed outcome. They will only be comfortable offering treatments which have demonstrable improvement through testing. Why do you find that objectionable?

Strangely, science and evidence-based medicine NEVER guarantees 100% cure, because their tests have never given them a single treatment that offers one. They will instead offer you the best they know about and, if you ask, tell you how good it was or let you read a patient leaflet which summarizes research findings.

There are very few lawsuits on alternative practitioners because the desperate people who seek them out, when they find yet another treatment that doesn't work, just move on to the next one without considering the fact that they may have been taken advantage of. I know this because I've watched my husband spend well over $1000 trying to "cure" me with things that sometimes didn't even make sense.

He is not "twisting" anything, but rather pointing out an alarming trend where unscientific treatments are being pushed into mainstream medicine through legal maneuvering rather than through testing to prove them safe and reliable.

ross coe's google-fu is poor too

Ross Coe:

You seem to be making a very standard logical inference error which we see time and again on the part of apologists for quackery CAM:

Premise #1: Big Pharma is tainted (lawsuits, demonstrated corruption, thalidomide, whatever turns your crank)

Premise #2: ????? (maybe a miracle occurs?

Conclusion: Quackery CAM works.

As you can see, unless the second premise can be filled in with acceptable evidence, the conclusion simply does not follow from the first premise.

So does this work in other cases of consent? Is it misinformed consent if you don't make sure your special friend is aware of all other hypothetical options? Even their douche ex- with that douche haircut above his douche face?

Whoever or whatever orac is . . .

It's no secret. He's an oncologist, works at an academic medical center, does NIH-funded research, cares for patients. Actually knows what he's talking about. His real name and more specific biographical facts are also not actually a secret but we play along here and pretend that they are, just for yucks.

Thank you all for your advice about accessing the E-Supplement website to submit a comment. Unfortunately, I cannot post anonymously or with a 'nym...and you all know my reasons for protecting my name.

I did, however, do some more checking on the internet about Michael H. Cohen and his "affiliations" as listed on the abstract...I also check the "affiliations" of his four co-authors:

Joan Gilmour is an attorney and professor at a law school in Toronto. The other four co-authors are MDs affiliated with hospitals in Canada.

Michael H. Cohen lists his affiliation (at the time the article was accepted for publication) at the Fenton Nelson law firm, Los Angeles, California. This is a major law firm specializing in representing hospitals and health insurance companies.

Mr. Cohen is no longer affiliated there...I know because I spoke with the office manager. He now has his own law firm which, according to his website, represents alternative "practitioners", "supplement" manufacturers and every other type of woo purveyors.

Perhaps...now that he has left the large prestigious law firm and opened his own practice...future articles that he submits to the Pediatric E-Supplements websites may not be accepted.

@ Cynical Pediatrician: You are correct every one of the E-Supplement articles are co-authored by Mr. Cohen and his small coterie of co-authors; apparently it is the Woo Medicine branch of Pediatrics. I also checked out the long list of printed supplements that are sent out with the printed version of Pediatrics. None of the printed supplements dating back to 1953 on forward to 2011, are woo articles.

One more question...Why didn't he disclose his affiliation (blogmeister) with the CAMLaw website?

Irregardless, really. That was the best word you came up with. Try a few minutes on M-W.com

@ Agashem: Perhaps when Sid Offal the fire science "expert" comes posting again, we should ask him to define flammable and inflammable.

"Near-death experiences, encounters with angels, and events that touch the individual's interior castle and border on mysticism-hese experience manifest 'light,' in the sense of coming closer to that which is Supreme at the edges of our consciousness."

And, with woo-based treatment, you'll have lots of opportunities to observe near-death experiences among your friends and family, just like in the good old days before that icky allopathic medicine was foisted upon us. Unfortunately these near-death experiences will mostly go on to become death experiences, also just like in the good old days.

I'm OK with this, as long as the homeopaths, naturopaths and other CAM practitoners provide the risks, benefits and alternatives available in allopathic medicine.

Ross coe:
> orac is a waste of space.

Why do you think Orac allows your comments to remain posted here, while anti-children blogs censor any posts that talk about the benefits of vaccines? Is it that Orac hasn't figured out how to delete posts, or is it that he is confident enough to allow people to decide for themselves whether you or he is more reliable?

HaHa! That would be cruel, kind of like asking him to sit in the corner of a round room! ;)

Maybe the acupuncture "worked" just because the acupuncturist's office is a nice change of pace from staying in the hospital with beeping lights, antiseptic odors (or worse), PA system blaring...

Even so, taking an immune-compromised child out of the hospital to be exposed to other patients' ailments and possibly unsterilized needles doesn't sound like a wise idea.

@Andrew (29)

He's poisoning the well. Orac premoderates all the rational, well-argued pro-CAM comments and leaves people like Ross Coe, so we all think CAMsters are idiots.

It's the only rational explanation.

Mr. Coe has a habit of jumping into a thread, posting some nonsense and never coming back. He did come back once in the thread I posted a question to him after he assumed that Olivia Dahl could not explain what happened to her sounded like autism. Please don't give away what measles did to her, I really want Mr. Coe to tell us what happened to her.

@Andrew F: "He's poisoning the well. Orac premoderates all the rational, well-argued pro-CAM comments and leaves people like Ross Coe, so we all think CAMsters are idiots.

It's the only rational explanation."

Or maybe Ross Coe is paid by Big Pharma to make antivaxxers look worse?

6 year old Jake gets acupuncture, despite the studies that always show acupuncture is no better than sham acupuncture (ie worthless) even for cancer therapy nausea and vomting and sham acupuncture esp toothpicks, has fewer complications

Because of the suppressed immune system and sloppy acupuncture technique, he gets a group A strep necrotizing fasciitis that leads to increased vomiting, aspiration, respiratory failure and intubation. Despite aggressive debridement, including amputation, he dies of multiorgan system failure, primarily vomiting induced aspiration ARDS.

Oh, says the acupuncturist, it wasn't my doing.

Been there, done that.

@Andrew F: Occam's Razor (popular variety) argues that the simpler version is that none of the CAM people have the rationality and arguing capabilities of a salmon.

By Man Called True (not verified) on 11 Nov 2011 #permalink

@Mark Crislip

Thank you, sir.

All I can do is repeat "been there, done that."

Jake's parents take him out on intermittent passes from the hospital to an acupuncturist in the community. They are delighted to see that his nausea and vomiting are much improved after each acupuncture session. Jake begins to regain his appetite, gains weight, and generally has a better sense of well-being.

Maybe going places with his parents makes him feel better. Did they try taking him out to a park, or a movie, or lunch before this acupuncture thing?

By Tsu Dho Nimh (not verified) on 14 Nov 2011 #permalink

I've always wondered about the medical legal ramifications of misinformed chiropractic advice.One of my 17mo old patients was hospitalized for two weeks with pertussis.She,of course, had not been immunized at the advice of mom's chiropractor.Why does no one ever think of starting legal action against their chiropractor or naturopath.This can't possibly be the only case in the country of CAM misinformation.
Actually, now that I think of it what about Wakefield,no lawsuits from kids hurt by his falsifying information? I don't get it?

By G Vazquez (not verified) on 14 Nov 2011 #permalink

@ G Vazquez: I assume you are talking about children whose parents have "opted out" of vaccinations. Perhaps the reason why they don't seek legal redress might be because they sought the advice of a non-medical alternative practitioner, over and above the advice of a pediatrician.

I wonder if you know how the parents feel about their decision now that their child needed hospitalization? We have discussed this extensively on this blog and I really don't know of any cases, where parents have sued under the circumstances you describe.

You mentioned Wakefield. The twelve kids were referred to him by lawyers who sought to "make the case" against the manufacturers of vaccines...it was a legal maneuver. The parents themselves subjected their autistic children to unnecessary invasive painful medical procedures.

I think it's worth making a distinction between MISinformation and DISinformation. Misinformation is when someone perpetuates a falsehood unaware that it is false. Idle gossip is one example of a source of misinformation. Disinformation, on the other hand is when someone perpetuates information that they know to be false, and do so intentionally to promote ignorance for the speaker or others to capitlize (read: prey) on. An example of a source of disinformation would be a snake-oil salesman peddling a quack medicine. Orac's targets, in other words. There are far too many charlatans in this world and it pleases me to see that someone like Orac is working to enlighten more people so that they may successfully avoid being duped by swindlers and quacks.

By Steve Chisnall (not verified) on 19 Dec 2011 #permalink