Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

C A S T and Narrative Fallacy

Also posted over at Paramedicine 101. Go check out the rest of what is there.

CAST (The Cardiac Arrhythmia Suppression Trial)[1] was a large scale randomized placebo controlled trial. This was to determine which of the antiarrhythmics would be able to claim the title as the most effective life saving drug on the planet. CAST was one of the most important EMS studies ever done. And CAST wasn’t even an EMS study.

Moricizine vs. encainide vs. flecainide to see what saves the most lives.

Which drug won?

We’re not there, yet.

The experts understood the pathophysiology. They knew how to fix it.

What did the experts see as the problem, pathophysiologically?

After a heart attack, many people will have some extra heart beats. Beats apparently originating in the part of the heart damaged by the heart attack. These are most commonly called PVCs (Premature Ventricular Contractions). 2 PVCs are circled in red below. They are also called VPBs (Ventricular Premature Beats) or even FLBs (Funny Looking Beats), but most commonly PVCs.

After a heart attack (MI or Myocardial Infarction), people with plenty of PVCs (post-MI PVCs) will experience SCA (Sudden Cardiac Arrest) at a higher rate than other people who have had heart attacks, but do not have post-MI PVCs.

That much is accepted. In extrapolating from this. They concluded that if patients with frequent post-MI PVCs were more likely to have SCA, they could prevent SCA by preventing the post-MI PVCs.

Sounds reasonable.

It is reasonable. The problem is that they never tested the theory on a large enough group of people, until CAST, to demonstrate how well the theory worked. At the time, these drugs became the top selling drugs. Sales-wise, they were the Prozac and Viagra of the time. They were a hugely profitable part of the drug market. Yet there was no evidence that they saved lives. Only theory. Only pathophysiology. CAST was designed to show how good they were at saving lives.

Preventing post-MI PVCs is pretty easy. Improving survival is a little more complicated.

Why did people accept that fewer post-MI PVCs is the same as improving survival?

The top electrophysiologists were in agreement about how the heart works. Based on their research showing higher mortality with frequent post-MI PVCs, they told people that this was the best way to save lives.

After a patient had a heart attack, they would record an ECG that showed post-MI PVCs, such as the ECG below.

Then they would give patients the medication. As the medication began to work, the post-MI PVCs went away.

Obviously much better. This is proof that the heart is better and the patient is healthier.

Actually, if the ECG is the face that the heart shows us, this is just a form of Botox for the face of the ECG. We are making it look as it did before the heart attack. Remember, this was just for patients who had a heart attack – post-MI PVCs. The problem is that the antiarrhythmic medications interfere with the conduction system to make the post-MI PVCs disappear. The result of that tinkering is not limited to making the PVCs go away. Some of the other effects are still unclear.

The results of earlier studies were clear that the antiarrhythmic medications made the post-MI PVCs go away. This was viewed as a success. This was only a success at treating a surrogate end point. A surrogate end point is often studied, because it does not require as large a study group as an experiment that is set up to show a difference in meaningful outcome.

What is meaningful outcome?

Survival with a good quality of life.

When we look at all of the drugs that are used in cardiac arrest, we are looking at drugs that have been shown to be effective, at least a little bit, but only at improving surrogate end points. Surrogate end points are appropriate for initial studies, but with widespread use of a treatment, we need to look at meaningful outcomes.

In cardiac arrest, epinephrine is great at getting a heart to beat again (ROSC, or Return Of Spontaneous Circulation). Unfortunately, getting a pulse back, but dying in the hospital, is not a good outcome.[2] Having the heart rate go from zero to 200 may not not be the best way to calm down a heart that has just experienced SCA, possibly due to overstimulus. This is one of the reasons for the introduction of vasopressin. Vasopressin is less of a stimulant to the heart, less of a cocaine-like jolt to the heart.

In EMS we used to give nifedipine in hypertensive crisis,[3] because it lowered the blood pressure. It really lowered the blood pressure. The problem was that we were treating a surrogate end point.

Oxygen[4] is another treatment that many of us give just because of surrogate end points. We seem to be trying to get 110% out of the SpO2, rather than treat the patient. We have not done enough research to know when oxygen is harmful. Hypothermic resuscitation is believed to work by preventing post-resuscitation damage from oxygen.

These are examples of narrative fallacy that were compounded by trusting surrogate end points.

So which drug was best at preventing SCA?

Right up until they stopped the study, the doctors believed that all of them were preventing SCA.

As it turns out, post-MI PVCs do not cause SCA. Post-MI PVCs are indicators of a heart that is more likely to have one, or more, SCAs than hearts without post-MI PVCs.

Getting rid of the post-MI PVCs is no more effective at fixing the heart, than Botox is at making the patient younger. They just make things look better.

Post-MI PVCs are bad and making them go away is good. We are becoming more and more tolerant of PVCs and the patients with post-MI PVCs are not dropping like flies.

In hypertensive crisis, we must lower the pressure right away before we get to the ED. A more controlled lowering of the blood pressure in the ED seems to avoid making the patient worse.

Oxygen. More is better. Perhaps oxygen should be treated as if it is a drug, since oxygen is a drug. Perhaps we should figure out when to give a lot of oxygen, when to give a little oxygen, and when to withhold oxygen.

In CAST the patients receiving the study drugs encainide and flecainide were more than 3 times as likely to die as the patients receiving placebo. These life saving drugs were more than three times as likely to kill the patient.

Three times as deadly as what?

Three times as deadly as placebo.

The title as the most effective life saving drug on the planet, in this case, went to the placebo.

CAST was a study that showed how the top experts, the highest in the hierarchy, can be so sure that they are saving lives that they end up causing more harm than benefit. The greater harm was due to the life saving treatments the experts were promoting.

After the fact, there was a lot of concern about how the experts could have been so wrong. The reality was that these experts didn’t understand the pathophysiology as well as they thought they did.

But why did people listen?

Seeing is deceiving. No more PVCs. What more do you need to know?

Narrative Fallacy –

Narrative Fallacy I

How did this happen? – Research

Narrative Fallacy II

CAST and Narrative Fallacy

C A S T and Narrative Fallacy comment from Shaggy

Some Research Podcasting Comments

Shaggy Comments on Some Research Podcasting Comments.

Spine Immobilization in Penetrating Trauma: More Harm Than Good?

EMS EdUCast – Journal Club 2: Episode 43

Education Problems, Autism, and Vaccines


[1] Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial.
Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al.
N Engl J Med. 1991 Mar 21;324(12):781-8.
PMID: 1900101 [PubMed – indexed for MEDLINE]

Free Full Text Article from N Engl J Med with links to Free Full Text PDF download

CONCLUSIONS. There was an excess of deaths due to arrhythmia and deaths due to shock after acute recurrent myocardial infarction in patients treated with encainide or flecainide. Nonlethal events, however, were equally distributed between the active-drug and placebo groups. The mechanisms underlying the excess mortality during treatment with encainide or flecainide remain unknown.

[2] Medications for Arrest Rhythms
2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 7.2: Management of Cardiac Arrest
Free Full Text Article from Circulation with links to Free Full Text PDF download

To date no placebo-controlled trials have shown that administration of any vasopressor agent at any stage during management of pulseless VT, VF, PEA, or asystole increases the rate of neurologically intact survival to hospital discharge. There is evidence, however, that the use of vasopressor agents favors initial ROSC.

[3] Should a moratorium be placed on sublingual nifedipine capsules given for hypertensive emergencies and pseudoemergencies?
Grossman E, Messerli FH, Grodzicki T, Kowey P.
JAMA. 1996 Oct 23-30;276(16):1328-31. Review.
PMID: 8861992 [PubMed – indexed for MEDLINE]

Over the past 2 decades, nifedipine in the form of capsules has become widely popular in the treatment of hypertensive emergencies. . . . Given the seriousness of the reported adverse events and the lack of any clinical documentation attesting to a benefit, the use of nifedipine capsules for hypertensive emergencies and pseudoemergencies should be abandoned.

[4] The Oxygen Myth?
Bryan E. Bledsoe, DO, FACEP
JEMS.com Another Perspective
2009 Mar 5

The effects of aging are often due to oxidative stress. Also, some diseases such as atherosclerosis, Alzheimer’s disease, Parkinson’s disease, and others have been linked to oxidative stress and free radical induction. Thus, the evolving thought is that, in some conditions, high concentrations of oxygen can be harmful.


Homeopathy Week – Shouldn’t it be Diluted?

A blog is having fun with the idea of Homeopathy Week. While I would approach the whole idea as something that should be diluted down to nothing, this blog appears to think that if dilution is the cure favored by homeopaths, maybe ridiculous exposure is the solution to homeopathy.

Homeopathy Week!

I like it.

Homeopathy is making a big deal about hay fever. Probably because allergies are seasonal. In other words, they go away on their own. The homeopath can claim that the natural decrease of the pollen count leading to a a resolution of the hay fever symptoms is all his/her idea. A regular miracle worker.

There is one site that is claiming that they have a more interesting cure for hay fever.

Hay fever ‘could be cured by sex’ (Telegraph.co.uk)

I don’t know if that is a cure, but it certainly might distract from the symptoms.

The study might progress something like this:

Excuse me. We are surveying people about their hay fever.

I’m busy having intercourse. I don’t want to talk about hay fever.

Another hay fever victim saved by sex.

Not exactly the best research, but it is comparable to what is available supporting alternative medicine.

Homeopathy really is ridiculous.

Just be careful you don’t overdo it. Homeopathy might be toxic at larger doses of nothing.

Remember to always pay your homeopath in keeping with homeopathic principles – just a penny will do. The penny retains the memory of all of the other money that it has been with.

Late Update – Don’t miss this critical Homeopathy Warning!


Anti-Science Explained

This quote really does seem to get to the heart of the problem with anti-science people. They do not dislike science, as long as . . . well read the quote –

The more I see of the world [looks pensively out of window] the more it strikes me that people seem to want more science, rather than less, and to deploy it in odd ways: to abrogate responsibility; to validate a hunch; to render a political or cultural prejudice in deceptively objective terms. Because you can prove anything with science, as long as you cherry pick the data and keep one eye half closed.[1]

It does not matter what type of anti-science. I would love to elaborate on this, but why ruin a good thing.


^ 1 Reefer Badness
March 24th, 2007
Ben Goldacre
Saturday March 24, 2007
The Guardian


Piracy on the High Court

On May 28, 2009 the High Court demonstrated that the Mafia has nothing on the ability of the High Court to commit High Crimes.

Pirate Extraordinaire Sir David Eady (Justice X) decided to enforce an order of Omerta on Simon Singh.

What did Simon Singh do that was so bad, that he has been attacked by pirates? He told the truth. When it comes to truth, Great Britain is the modern equivalent of the Barbary States. There is a great jihad against the truth in Britain. They will send their hired thugs to enforce this gagging. At least the United States has no such law to punish the truth. The truth has been an accepted defense since the John Peter Zenger kangaroo trial in New York. A trial that was won by the defendant through jury nullification.

We have all heard the saying, The truth shall set you free. Well, that does not apply in Britain. The opposite is true. If you tell the truth, and somebody does not like the truth, you may end up broke. Maybe the British interpretation is The truth shall set you free of your possessions so that we can protect the most vile frauds.

Just what did Simon Singh do?

What truth could be so horrible that a court would punish him?

Did he make nasty comments about Kermit being green?

What was so unpardonable a truth?

Simon Singh wrote an article in the Guardian. He wrote about an aspect of alternative medicine unicorn medicine that even many of the unicorn therapists do not defend. He pointed out that the British Chiropractic Association preaches this fraudulent disregard for the health of their patients. Since the motto of the British Chiropractic Association is Abandon all ethics, Ye who enter here, a little word – bogus for example – should not bother anyone. Since their treatment can be lethal, they have to stop all criticism. No matter how minor. No matter how honest. No matter that honesty is in the interest of the public welfare.

Here is the offending paragraph. The penultimate word is the truth that will make a fortune for lawyers and allow the health menace that is the British Chiropractic Association to claim they were wronged. Kind of like, You call that rape. We do far worse to people we claim to help. Not another word, or we’ll rape you the old fashioned way.

You might think that modern chiropractors restrict themselves to treating back problems, but in fact they still possess some quite wacky ideas. The fundamentalists argue that they can cure anything. And even the more moderate chiropractors have ideas above their station. The British Chiropractic Association claims that their members can help treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying, even though there is not a jot of evidence. This organisation is the respectable face of the chiropractic profession and yet it happily promotes bogus treatments.

To me, the word that is out of place is respectable. How can Simon Singh use that word in the same sentence as the name of the shakedown artists, the British Chiropractic Association? See what you get for being polite?

But how do we know that these treatments are bogus?

Here is the paragraph that follows:

I can confidently label these treatments as bogus because I have co-authored a book about alternative medicine with the world’s first professor of complementary medicine, Edzard Ernst. He learned chiropractic techniques himself and used them as a doctor. This is when he began to see the need for some critical evaluation. Among other projects, he examined the evidence from 70 trials exploring the benefits of chiropractic therapy in conditions unrelated to the back. He found no evidence to suggest that chiropractors could treat any such conditions.

Where’s the problem? He used the term bogus, but Simon Singh defined what he meant in the same article. Only an idiot could misunderstand that, or someone being bribed.

Yes. That is true. The only reasons to not label these treatments as bogus would be if one believes in unicorn medicine (maybe not idiocy, but massive gullibility), being bribed, or having one’s family held hostage until the decision is handed down. On the other hand, this is England. England wants to return to the swashbuckling days of piracy. They now encourage libel tourism. For a price of course. If you are going to sell your soul, you might as well be paid well for your perfidy. Maybe Britain will try to replace Nigeria as the home of SPAM.

Dear esteemed Sir. I, Sir David Eady, most humbly beseech you to allow me to bring an important financial matter to your attention . . . .

As a justice, raping the innocent all day, I Sir David Eady, find it difficult to go home and do the same to the wife and kids. That’s why I use Viiagra. When all they will do is lie there and think of England, it keeps me raping until the little buggers are a bloody pulp.

As you can see, there is a great future for Sir David Eady.

“No nation, ancient or modern, ever lost the liberty of speaking freely, writing, or publishing their sentiments, but forthwith lost their liberty in general and became slaves.” John Peter Zenger

Think about that, Not-So-Great Britain.

What can be done about the British anti-honesty laws?


And here are articles on this topic by the big media:

The Independent Silenced, the writer who dared to say chiropractice is bogus

The Times Review of libel law called for by comedians

The Guardian online Science writer Simon Singh to appeal against chiropractic libel judgement

Nature news Science writer will appeal libel case ruling

Times Higher Education Singh plans to appeal ruling in libel case

Wall Street Journal Britain Chills Free Speech

The Daily Telegraph online Stephen Fry and Ricky Gervais defend science writer sued for libel

The Daily Mail online Celebrities back writer sued by chiropractors for saying unproven treatment is ‘bogus’

Respectful Insolence I really admire skeptical English bloggers and commentators…

Respectful Insolence Simon Singh appeals Judge Eady’s bogus libel ruling

Bad Science A characteristically amateurish and socially inappropriate approach to pitching an article

Jack of Kent BCA v Singh: An Astonishingly Illiberal Ruling

The Quackometer Bogus Law

Here is a chart comparing the costs of libel litigation in different European countries from The Quackometer. This should have been done with the bars going sideways, to highlight the way the British libel laws make honest people walk the plank.

Click here to read and sign the statement.


Complete Heart Block Confusion

Also posted over at Paramedicine 101. Go check out the rest of what is there.

Here is part of the problem I see with getting people to understand heart blocks. The first thing that is noticed is sometimes what looks normal and comforting. We do not go looking for problems, even though in EMS, we are not supposed to be called for things that are not problems. We are setting ourselves up for making the problem worse. Here is the unmarked copy of Adam’s Complete Heart Block ECG.

When I would show strips like this to people in ACLS (mostly nurses, some doctors, some respiratory, occasionally a paramedic), the first thing someone would comment on is the least important, most misleading part of the strip. The single instance of the normal looking PR interval. Some people see the normal PR interval and assume that all of the PR intervals are normal, just difficult to identify. This is the wrong approach.

This is one of the reasons I keep highlighting the importance of science in EMS.

What does science have to do with this?

The approach of science is to examine research with the attitude of trying to find where there are problems. Falsifiability. Science is about performing research, then publishing it with the expectation that others will look for the problems with the study. And not being mad at those who find flaws in the research. The critic is not the one who made a mistake. That does not mean that the critic would be able to do research as well as the researcher being criticized, but that has nothing to do with science.

Research is validated only when no significant problems can be found with the research.

So what does this have to do with EMS and ECG reading?

We too easily dismiss a patient’s complaint as bogus, when we have not assessed the patient thoroughly enough. If you see the normal PR interval, have you identified this as a healthy rhythm?

Certainly not. We need to keep looking for problems until we have ruled out the potential problems. Many times that is impossible in EMS, but it does not stop some medics from dismissing a patient’s complaint as bogus. This is not good medicine.

Here is the same ECG, but I have marked the normal PR interval on this blatant heart block with a circle. The three beats on top of each other are the same beat, just presented in different leads, so this is three instances of just one normal PR interval. I have also drawn a line over the changing PR intervals. Looks like a pattern.

The PR intervals over the ECG do seem to form a pattern. Longer, longer, longer, repeat. Has Adam missed, right after posting a music video on the topic, a Wenkebach block – a 2nd degree type 1 heart block?

There does seem to be the progressive lengthening of the PR interval. What about the dropped beats? In order to compare the R to R interval in a way that makes this a bit clearer, I copied each pair of beats, after the first pair, and placed the copies under the first pair of beats. I drew a line down the middle of each of the first 2 beats and tried to line up all of the others with those lines. Is there any lengthening of the R to R interval that would indicate a dropped beat?

Click on the image to make it bigger.

I don’t see any significant difference. Without any dropped beats, this cannot be Wenkebach. Longer, longer, longer, repeat. Wenkebach is longer, longer, longer, dropped. The number of longers is not always three. It could be two, or four.

There is a slight variation in the R to R interval. A variation that is more than just my lack of cut and paste skill. Does this variation mean that these beats are not controlled by the ventricles? No.

The vagus nerve is often the culprit in heart rate variability. The vagus nerve is not supposed to connect to the ventricles. However vagal innervation is not the only reason for heart rate variability. Some patients also will have the vagus nerve attached to their ventricles.

This is a nice example of a Complete Heart Block. The terminology is something that cardiologists may not approve of, but I think this is adequate for EMS use. The understanding of the concept is much more important than the terminology.


The Jenny McCarthy Song

Respectful Insolence has The Jenny McCarthy Song posted. Outstanding.

Great writing and singing by the amateur scientist.

A love song from measles and other preventable diseases – to Jenny Killer McCarthy, since she is the savior of these diseases.

She has medical expertise,
Because she is a Mom.
I know what you’re saying,
So has Susan Smith.[1]
And she drove her car in a lake,
When it was full of her kids.

Almost as evil as Jenny – only in a good way, which is not like Jenny. 😉

HT: Of Mule Dung and Ash

For some good information on The Truth About The Evils Of Vaccination, go to AntiAntiVax. One page with a lot of information.


^ 1 Susan Smith


Anti-Science and Killing and EMS

Rogue Medic,

Why do you keep writing about homeopathy and vaccines and other stuff that doesn’t have anything to do with EMS?

Anti-Science is Anti-EMS. Here is one example of how anti-science kills.[1] This was not some serious medical condition that is a mystery to conventional medicine. The medical condition was – eczema.

How does eczema, a skin condition, become so bad that it leads to septicemia. Septicemia is a serious medical condition, but not one that is a mystery to conventional medicine. Eczema should not progress to septicemia in an otherwise healthy child. This was an otherwise healthy child.

On the few occasions that they did follow conventional medical advice, Gloria would improve, but they would soon revert to homeopathic remedies and she would continue to deteriorate.[2]

So they did get conventional medical treatment for their daughter. This is the fault of conventional medicine.

They only took her to a real doctor to get her well enough, so that they could go back to treating her with their anti-science treatment.

Hmm. The parents use conventional medicine and the daughter gets better. Since there is no cure for eczema, it is a chronic condition, the parents go back to the homeopathy to manage the eczema and she gets worse. The parents again use conventional medicine and the daughter again gets better. Since there is still no cure for eczema, the parents go back to the homeopathy to manage the eczema and she gets worse.

Lather, rinse, repeat. Just as it says to do on the label for the eczema/dandruff shampoo.

Lather the health out of their daughter.

Rinse the homeopathy away, temporarily.

Now that she is healthy again, lather the health back out of her.

Well, her father is a doctor. I’m sure he knows what he is doing.

He is a doctor of homeopathy.

Becoming a doctor requires a lot of time studying science.

There is no science in homeopathy.

A doctorate in homeopathy is an oxymoron. This is the equivalent of President Clinton having a doctorate in Celibacy. This is nothing but delusional thinking.

The parents, who each had university degrees and postgraduate qualifications, instead sought help from other homeopaths and natural medicine practitioners,[3]

I suppose they are the equivalent of Jenny Killer McCarthy, just with more classroom time.

This just is further proof that it is not the amount of the education, but the quality of the education. If you attend classes and pay your tuition, some schools will give you a degree, because they would feel guilty if they didn’t. When the degree is in homeopathy, there is no quality to assess.

Practical examsDude, you are like totally succussing[4] too hard, Dude.

Knowledge base (like cures like[5]) – I need a beer to cure my hangover, Dude. Hair of the dog is the only thing that works.

If they were to use homeopathy to try to send someone to the moon, they could instantly claim success. All they have to do is just dilute the trip to the point where the person never even has to leave Earth. The inverse of Zeno’s dichotomy paradox.[6] Homeopathy is amazing. Nothing is Everything. The illogic is perfect.

Late addition 5/05/09 19:49 – from The Macho Response[7] – Health service warns against homeopathic whooping cough remedy.[8] A dead baby. Apparently this is due to choosing homeopathic vaccination over a real vaccination.

How does this relate to EMS?

Original cartoon

Recently I wrote about the Trendelenburg Position,[9] which is an EMS treatment with as much scientific basis as homeopathy. In spite of the lack of evidence to support this as a real medical treatment, there are people who insist that it works because they just know it works. To suggest otherwise would be to suggest that they have been wasting their time, or even worse, harming patients. Rather than deal with this rationally, they take an extra-strong dose of Cognitive DissonanceTM. No homeopathic doses, when it comes to fooling yourself and harming your patients.

You’ve just got to believe in it. Because if you know what you are doing, you can’t continue this patient abuse.

But we can’t just do nothing.

You aren’t doing nothing, just because you are not providing a treatment, that might be harmless, but also might be harmful. One thing the treatment is not – helpful, at least not helpful to the patient. It is helpful to the continuing cognitive dissonance of the paramedic.

Assessment is a treatment. Assessment is essential.

Transport is a treatment. In these cases, transport is also essential.

Doing something, just for the sake of doing something, is horrible patient care.

Doing something, just for the sake of doing something, is patient abuse.

But if the patient dies, I need to feel like I did something. I can’t just stand there and not do something.

What if doing something is what is killing the patient?

Updated 9/14/2012 at 01:15 for formatting and links.


[1] Homeopathy Kills a Child
Respectful Insolence

[2] Dead baby’s parents ignored advice: QC
Harriet Alexander Court Reporter
May 5, 2009
The Sydney Morning Herald

[3] Dead baby’s parents ignored advice: QC
Same article as above.

[4] Dilution and succussion

[5] Law of similars

[6] Zeno’s dichotomy paradox

[7] Homeopathy Does It Again: Baby Dead At 4 Weeks Old – Much Too Young To “Believe”
The Macho Response

[8] Health service warns against homeopathic whooping cough remedy
ABC News (The Australian Broadcasting Corporation)
March 19, 2009

[9] Springtime for Witchcraft in Wake County
Rogue Medic
Tue, 28 Apr 2009

TM Cognitive Dissonance
How to harm people with a clear conscience. Fool yourself.


A Comment on Dr. Reuben’s Fraudulent Science and Patient Care

In response to Dr. Reuben’s Fraudulent Science and Patient Care, there is a comment by Walt Trachim of Life in Manch Vegas, his words are in bold and the other quotes have footnotes.

I read about this “doctor”‘s misdeeds – what was he even thinking? Or was he?

There has been a lot of speculation about this, but right now Dr Scott S. Reuben isn’t talking.

Did he believe that he knew what worked better than everyone else? Therefore he felt comfortable faking the research, because he just knows what the truth is? This is the way many of the anti-vaccinationists, homeopaths, naturopaths, and other pseudoscience people act. This is not really pseudoscience. It is anti-science.

One way to see this difference between true science and anti-science is to observe the response to adversity. Dr. Wakefield has been exposed as a fraud, but his true believers start protesting that it is a conspiracy to frame him. You do not see that here. With true science, fraud is seen as a bad thing, not something to be defended. With anti-science, it is all fraud, so they defend the most vile acts.

True science is about looking for mistakes in one’s work, figuring out why it was wrong, and trying again. The goal is not to appear perfect, but to make progress toward the truth. Anti-science is about maintaining an image of perfection at all costs. Including the lives of patients.

Faking science is not at all science. It is the opposite of science. Science is a process designed to eliminate prejudices. If the reason Dr. SS Reuben was faking studies was that he believed he knew better than everyone else, he was wrong. If that was Dr. SS Reuben’s reason, he clearly demonstrated that he does not have a clue about science. Science is designed to remove our prejudices, not to reinforce them.

If we believe something and a scientific study reinforces that belief, that does not mean that other beliefs we have on the same subject will also be correct. It just means that the result of that study appears to agree with what we believed. Nothing more. All of our other beliefs still need to be tested. There is no reason to presume that a person will continue to be right, just because they appear to have been right once, or twice, or a dozen times.

Everybody makes mistakes. Some people admit their mistakes some of the time. The record of human beings on this is not at all good.

Science makes mistakes, as do scientists, but science is self-correcting. Well done science will identify its mistakes. Science does not have pride, or any other feeling that would get in the way of admitting a mistake. Science is just the pursuit of the truth. Whatever the truth is.

This case of fraud is something the anti-science people have been ecstatic over, but they are just demonstrating that they do not understand science. It is true, that this went on for too long before it was discovered. It is true that this was not discovered by further testing demonstrating the falsehood of the research. Dr. SS Reuben was such a dominant researcher in the field, that people took it for granted that he was doing good work. Honest work. Those who had their doubts, and there had to be some, do not appear to have had anything to do with uncovering this fraud. But they were there, and they were raising the right questions.

Pfizer, however, said in a statement Monday that Reuben’s fabrications do not mean all research on the pain benefits of Lyrica and Celebrex should be discounted.

“Celebrex’s use for the management of acute pain in adults is supported by a significant body of clinical trial data other than Dr. Reuben’s research,” the company said. “The clinical trials that led to the aproval of Lyrica did not include Dr. Reuben’s research.”[1]

One interesting part of this is that the FDA label[2] does not contain links to the actual studies used to provide the information they use. The studies are listed as DPN 1 and DPN 2 (Diabetic Peripheral Neuropathy), PHN 1, PHN 2, and PHN 3 (Postherpetic Neuralgia), E 1, E 2, and E 3 (Epilepsy), and F 1 and F 2 (Fibromyalgia). While the label does briefly describe the studies and show some graphs, that is the extent of the information provided. No authors are listed. No PubMed ID, no link to even an abstract.

It is not unreasonable to believe that these studies had nothing to do with the FDA approval of pregabalin, since they do not fall into his area of research, even though he did a lot of research on pregabalin.

The retractions came after an internal investigation by Baystate turned up evidence of widespread fraud in Dr. Reuben’s research. Jane Albert, a spokeswoman for Baystate, said the inquiry was undertaken after an internal reviewer at the medical center had raised questions last year. Ms. Albert said the hospital’s investigation raised “no allegations concerning any patient care. This was focused on academic integrity.”

Dr. Reuben is on medical leave from his position as chief of the acute pain service at Baystate, Ms. Albert said.[3]

“no allegations concerning any patient care. This was focused on academic integrity.” This is not somebody worth listening to. How does this not concern patient care? All of this affects patient care.

Medical leave? That could lead to endless speculation.

Rumors of a problem with Dr. Reuben’s research have been circulating among academic anesthesiologists for a year, according to people familiar with the matter.

“Interestingly, when you look at Scott’s output over the last 15 years, he never had a negative study,” said one colleague, who spoke on the condition of anonymity. “In fact, they were all very robust results—where others had failed to show much difference. I just don’t understand why anyone would do this or how anyone could pull this off for so long.”[3]

The continual good results should have raised questions long before a year ago. The anonymous colleague does not seem to understand that this is a clue to fraud.

One of the pillars of support for combining celecoxib and pregabalin was a 2006 study in Anesthesia and Analgesia—for which Dr. Reuben has been a reviewer—by Dr. Reuben and colleagues that found the approach effective in patients undergoing spinal surgery. That paper has been withdrawn. “If we take out [those] data in spinal,” Dr. Chelly said, “you really don’t have any evidence that the combination is working.”[3]

If you look at the very long list of journal articles that I included in my last post, some of what has not been removed have just one author – Dr. Scott S. Reuben. How do you not have major questions about those? Others are review articles. Having the doctor, who may be the most prominent in the field, write a review article is not unusual. This is the doctor expected to be most familiar with the research in the field. After all he wrote most of it. Apparently from scratch. The problem here is that he will be providing the final word for many who read about potential treatments. A review article is supposed to take all of the available research and place that research in perspective.

So, why are these not on the list of problem publications?[list in previous article]^
3/17/09 02:23 I finally got this to link correctly. 🙂

Update on the role of nonsteroidal anti-inflammatory drugs and coxibs in the management of acute pain.
Reuben SS.
Curr Opin Anaesthesiol. 2007 Oct;20(5):440-50. Review.
PMID: 17873597 [PubMed – indexed for MEDLINE]

Chronic pain after surgery: what can we do to prevent it.
Reuben SS.
Curr Pain Headache Rep. 2007 Feb;11(1):5-13. Review.
PMID: 17214915 [PubMed – indexed for MEDLINE]

COX-2 inhibitors in sports medicine: utility and controversy.
Buvanendran A, Reuben SS.
Br J Sports Med. 2006 Nov;40(11):895-6. Epub 2006 Sep 1. No abstract available.
PMID: 16950884 [PubMed – indexed for MEDLINE]

Still, the people commenting about this seem to have ignored the signs that science has been starting to recognize the problem. A bit slow, but these are a start.

Even more interesting is a review article with this catchy title. Reduction of opioid-related adverse events using opioid-sparing analgesia with COX-2 inhibitors lacks documentation: a systematic review.[4] The authors looked at research in the area that Dr. Reuben is supposed to be dominant.

We identified 55 potentially relevant trials (7—61) of which 29 were subsequently excluded. One study was a duplicate publication (48), one study was not double-blind (20), another study did not evaluate pain 0—24 h postoperatively (24), one study had a sample size in the COX-2 group less than 10 patients (37), and three trials were written in Turkish or Japanese, respectively (28, 38, 58) (Fig. 1). Furthermore, the drug name of supplementary analgesic was not mentioned in three studies (36, 46, 54), supplementary analgesics could be either an opioid or a non-opioid in seven studies (8, 11, 13, 40, 55, 60, 61), reduction in supplementary analgesic use was not evaluated in seven studies (9, 10, 32, 33, 39, 49, 53), and not documented (no significant difference between study groups) in another five studies (15, 19, 25, 34, 41).

Thus, a reduction in supplementary opioid consumption was documented in 26 trials. Of these, seven trials did not include appropriate data on opioid-related adverse events (14, 16, 21, 31, 35, 52, 59) and were therefore subsequently excluded.

Eventually, 19 randomized trials including 26 comparisons, in which significant opioid-sparing with COX-2 inhibitors was documented (Tables 1 and 2), remained for analysis of recorded opioid-related adverse events.[5]

3 of only 4 papers by Dr. SS Reuben. These were reviewed as just a fraction of the research on the topic. His papers were rejected as inadequate at a much higher rate than all of the other papers 3/4 vs 36/55. The reviewers of this paper did not appear to find his research to be very useful or very important in Dr. SS REuben’s area of expertise.

This suggests to me that things were already beginning to fall apart for Dr. SS Reuben. If I can easily find previous articles indicating problems with his research, and I don’t get paid to pass gas, then the anesthesia community had to be close to exposing this fraud even without the audit by Baystate Medical Center.

Dr. Dunn said he was a co-author with Dr. Reuben of one study, but because he collected the data on that paper himself, the results have not been challenged. However, he said, the nature of the fraud was surprisingly simple—and difficult to detect. “You can see how easy it was to get away with,” he said. “If someone comes to you and says, ‘Here are data on seven patients,’ how do you say, ‘No, I didn’t see you treat those patients’? You assume that a physician would have the integrity not to lie in this way.”[6]

The most alarming aspect of the episode for him, Dr. Dunn said, was that as a skeptic of multimodal analgesia, he would frequently find himself in debates with Dr. Reuben about the approach. During one of those exchanges, Dr. Reuben presented his colleague with a study whose data were so convincing that Dr. Dunn began to doubt his stance. That paper, he recently learned, was on the list of articles to be retracted. “I was appalled that someone could take a paper based on fraudulent work and try to change my practice,” he said.[6]

That is just more evidence, to me, that practicing anesthesiologists were noticing that Dr. SS Reuben’s theories had problems. Dr. SS Reuben would probably say something like, You can’t throw the baby out with the bath water, but that has always been a meaningless phrase, one commonly used to justify fraud.

Back to Walt Trachim’s comment:

From personal experience I can speak volumes about the importance of pain control. If it’s not handled adequately or appropriately, the patient can become a train wreck. And if the anesthesiologist is practicing using information which came from this clown, then he shouldn’t be practicing medicine.

I wouldn’t go that far. An anesthesiologist should be assessing and reassessing the patient’s pain. Treatment of pain is by titration. The initial dose is the only one that is based on mg/kg (milligrams per kilogram). All further doses are based upon the response to previous doses.

Multimodal anesthesia is not a bad idea. In EMS, I have added a benzodiazepine to an opioid to manage the patient’s pain. Usually this is due to running out of opioid, but the combination can be effective for patients who do not get much relief from opioids. Unfortunately the combination of opioid and benzodiazepine also seems to increase the incidence of respiratory depression – at least if you pay any attention to all of the warning labels on these medications. When I have given this combination, I have not had this problem with any of my patients.

Fortunately I had an anesthesiologist who knew what he was doing. Good thing…

Not every anesthesiologist sees through the problems of these studies. That does not make the anesthesiologist a bad anesthesiologist. Not managing pain effectively? That is much more likely to make someone a bad anesthesiologist.

In a post on the topic of pain, to wander a bit off topic, but stay on pain management. At Street Watch, there is a post Empty Shoe, that gets a good discussion going on EMS pain management.

There is also a discussion of the Dr. SS Reuben fraud at Bad Science. Medical scumbag’s masterclass in fraud.


^ 1 Former member of Pfizer speaker bureau accused of research fraud
Thu. March 12, 2009; Posted: 05:04 PM

^ 2 pregabalin (Lyrica)
FDA label
Clinical Studies

^ 3 Fraud Case Rocks Anesthesiology Community
Mass. Researcher Implicated in Falsification of Data, Other Misdeeds
Issue: March 2009 | Volume: 35:3
Anesthesiology News

^ 4 Reduction of opioid-related adverse events using opioid-sparing analgesia with COX-2 inhibitors lacks documentation: a systematic review.
Rømsing J, Møiniche S, Mathiesen O, Dahl JB.
Acta Anaesthesiol Scand. 2005 Feb;49(2):133-42. Review.
PMID: 15715611 [PubMed – indexed for MEDLINE]
Corrected link 3/18/09 23:24

^ 5 Reduction of opioid-related adverse events using opioid-sparing analgesia with COX-2 inhibitors lacks documentation: a systematic review.
Same study as above.

These are the studies by Dr. SS Reuben that were excluded due to inadequacies:

Not on the list of articles being pulled from the journals:
19. An evaluation of the safety and efficacy of administering rofecoxib for postoperative pain management.
JoshiW, Connelly NR, Reuben SS,Wolckenhaar M, Thakkar N.
Anest Analg 2003; 97: 35—8.

Not on the list of articles being pulled from the journals:
21. The preemptive analgesic effect of rofecoxib after ambulatory arthroscopic knee surgery.
Reuben SS, Bhopatkar S, Maciolek H, Joshi W, Sklar J.
Anesth Analg 2002; 94: 55—9.

#6 on the list of articles being pulled from the journals:
24. Evaluation of the safety and efficacy of the perioperative administration of rofecoxib for total knee arthroplasty.
Reuben SS, Fingeroth R, Krushell R, Maciolek H.
JArthroplasty 2002; 17: 26—31.

And the one that met their criteria is #4 on the list of articles being pulled from the journals:

31. Postoperative analgesic effects of celecoxib or rofecoxib after spinal fusion surgery.
Reuben SS, Connelly NR.
Anesth Analg 2000; 91: 1221—5.

^ 6 Routine Audit Uncovered Reuben Fraud
Missing IRB Info Led To Discovery of Fabricated Data
Issue: March 2009 | Volume: 35:3
Anesthesiology News