tylenol deficiency and other headaches…

Posted on Wednesday 20 May 2015

There’s obviously more to say about Wunderink, but I wanted to stick in a few front burner items first:
The Globe and Mail
by ADRIANA BARTON
May. 17 2015

If serotonin is the “happy chemical,” then boosting our serotonin levels should keep depression at bay. After all, low serotonin brings on the blues, right? But the truth is, depression is not a serotonin deficiency. The idea that depression is caused by low serotonin levels is based on flimsy evidence dating to the 1950s. Pharmaceutical companies promoted the low serotonin story to sell Prozac and related antidepressants. They marketed a myth.

Today, the serotonin fallacy is as ingrained as the notion that drinking orange juice wards off a cold. Many of us still believe we are raising our serotonin levels to lift depression using wildly popular drugs known as selective serotonin re-uptake inhibitors, or SSRIS. But psychiatrists now say it is unlikely these drugs treat depression by simply increasing serotonin. While antidepressants help many patients, researchers have only a hazy idea of how they work. The consensus is that depression is a complex disorder with hundreds of potential underlying causes, said Dr. Roger McIntyre, head of the mood disorders psychopharmacology unit at the University Health Network in Toronto. “There’s really no scientific case to say that people who have depression have a deficiency in body and brain serotonin levels.”

The medical journal BMJ put the spotlight on the low serotonin doctrine in a recent editorial published in April and written by Dr. David Healy, a professor of psychiatry at Bangor University in Wales. Blockbuster sales of antidepressants such as Prozac are based on the marketing of the serotonin myth, Healy wrote. He added that pharmaceutical companies misled the public into putting too much faith in SSRIs.

Scientists never confirmed whether SSRIs raise or lower serotonin levels. “They still don’t know,” Healy said. Many of his peers suggest that Healy is not a respected figure in psychiatry, in part because of his stance that older tricyclic antidepressants are better than today’s Prozac-type drugs. His colleagues maintain that SSRIs are safer if taken in overdose than older antidepressants, and caution that patients should not switch medications based on Healy’s views. Nevertheless, most psychiatrists agree that depression is not a matter of serotonin levels being up or down. The role of serotonin in depression is best described as a “dysregulation” of the serotonin system, McIntyre said.

The serotonin system regulates aspects of behaviour, thought processes and mood. But it also interacts with other brain systems that may be involved in depression. Modern antidepressants block the re-absorption of serotonin in the brain. When researchers discovered that SSRIs helped depression in some patients, they concluded that low serotonin must be the cause of the disorder. But the assumption was no more valid than the notion that “having a headache means that your Tylenol levels are low,” McIntyre said. McIntyre described psychiatrists as being “guilty of exuberance” when they framed depression as a low serotonin problem.
David Healy’s editorial has gotten lots of play…
Maybe it was the just right time to put the Serotonin Myth to rest. Whatever the reason, it is long past due. And McIntyre’s line in this piece, ‘the assumption was no more valid than the notion that “having a headache means that your Tylenol levels are low,”‘ is an instant classic!

But on the darker side of the street:
AllTrials
18 May 2015
hat tip to Ferrell…  
The Guardian
by Sarah Boseley
18 May 2015

The long-fought battle for greater transparency in human drug trials is facing a major setback after a legal challenge against full disclosure from within the pharmaceutical industry. The Health Research Authority, which authorises trials and works to ensure the safety of patients taking part, has proposed that all drug trials must in future be registered. A judicial review has now been brought by a leading clinical trials company, challenging the plans for reform.

In the past, some drug companies have airbrushed out bad results by not publishing them, which could result in a drug appearing to work better and more safely than it does in reality. Many scientists, campaigners and health bodies have applauded the HRA’s proposals, which recently include a requirement on those running trials to ensure all previous studies they were involved in have also been registered – to try to bring historical data to light.

But Richmond Pharmacology, a company which conducts clinical trials on behalf of major pharmaceutical firms, has received permission to bring a judicial review of the HRA’s plans. Sense About Science, one of the organisations behind the AllTrials campaign for clinical trials transparency, says it is appalled that the issue is to be brought before the courts. “It is shocking that a company is using court action to try to stop transparency,” said Síle Lane, director of campaigns. “Hidden and unregistered trials are compromising patient care, and, rightly, causing public outrage.

“The HRA has really led the way with its proposals to check that clinical trials aren’t kept hidden during the trial approval process. Hundreds of members of the public, patients, researchers, doctors and pharmacists have told the HRA that this is exactly what it should be doing. They want the HRA to help right the injustice done to the thousands of patients who have taken part in clinical trials that have been kept hidden. I find it deplorable that one company is trying to stop that”…

The campaigners want to ensure that negative results are just as available as those from trials that succeeded in showing a drug was beneficial. From antidepressants such as Seroxat to the flu drug Tamiflu, it has been publicly argued that some drugs have worrying side effects or work less well than the published data suggests. Richmond Pharmacology said it was not at liberty to comment at the moment, because the case was in the hands of its lawyers.
Things never go as smoothly as we’d like, and I suppose that this kind of thing is to be expected, but it takes its toll. The Abbvie/Intermune assault on Data Transparency with the EMA was a setback that took some of the fire out of the EMA’s Program. And this feels like "here we go again" [Company Challenges UK Clinical Trial Transparency Rules].
  1.  
    May 21, 2015 | 12:44 AM
     

    Here is an analogy as to why hiding the results of trials skews the effectiveness.

    Hypothetical situation:
    I claim to have a way of playing blackjack that will beat the house. My way of playing blackjack is a trade secret. I want people to invest in my way of playing blackjack and I assure them that I can beat the house. They understandably want some data to show that.

    I run experiments by going to Las Vegas and playing against the house. If I report to my proposed investors that I have done this 25 times and won 5 times then they are not likely to see my way of playing blackjack as a good investment. That is, my way of playing blackjack works only if I am lucky.

    If, however I conceal the 20 times I have lost, reporting to my proposed investors that I have gone to Las Vegas 5 times and won 5 times, then they are likely to see my way of playing blackjack as a good investment. However, by doing this I am lying to them and fraudulently misleading them into a bad investment.

    This is what a pharmaceutical company is doing when they run multiple studies and conceal ones that are not positive. It is fraudulently misleading people, insurance companies, and governments into investing their their health and money in a treatment that is effective only if the recipient of the treatment is lucky.

    Please note that this is an analogy only. I do not claim to have any way of playing blackjack that can beat the house.

  2.  
    James O'Brien, M.D.
    May 21, 2015 | 4:49 AM
     

    You can’t beat it anymore since Vegas changed the rules. If you played by the strategy of Beat the Dealer or the MIT Blackjack Club 25 years ago, you had about a 51.5 to 48.5 advantage. Back when double and single decks were dealt through and you could double or split anything. Anyway I digress. Never thought I’d miss the mafia who were more sporting than the hotel chains.

    It’s not just pharma doing this, we see spiked negative studies in all fields of science and spiked financial losses in all forms of finance. AGW research won’t be published nor peer reviewed if it doesn’t support the dominant paradigm. Quantitative easing in essence is fraudulently keeping 4 trillion dollars worth of low yield overpriced loans off the books much like Enron did with it’s hide the loss strategy. It’s great until it blows up.

    Even something as basic as the unemployment rate…they don’t count people who have given up. Basically writing off human capital. Then cheering the low number as a measure of success.

    This is what happens when you raise a generation where everyone gets a trophy and academic careerism trumps objectivity. How many scientists out there are really trying to actively disprove their pet theory? Which is what a good scientist does.

    By the way, this is why I am not a fan of professionals or any group of people in power agreeing all the time ignoring bad data. It turns into logrolling. There was a bipartisan consensus that CRA and the housing bubble was a good idea. If only someone had the guts to not suffer fools in advance.

    Pharma is an easy target, but this is a widespread problem in all of society.

  3.  
    May 21, 2015 | 5:19 AM
     

    Roger McIntyre is pushing “chemical imbalance version 2” with “The role of serotonin in depression is best described as a “dysregulation” of the serotonin system.”
    He has reason to do so: from Medscape disclosure 19.02.2014 “Roger S. McIntyre, MD, FRCPC, has disclosed the following relevant financial relationships: Served as an advisor or consultant for: AstraZeneca Pharmaceuticals LP; Bristol-Myers Squibb Company; Lilly; GlaxoSmithKline; Janssen-Ortho Inc.; Lundbeck, Inc.; Merck & Co., Inc.; Organon Pharmaceuticals USA Inc.; Pfizer Inc; Shire. Served as a speaker or a member of a speakers bureau for: AstraZeneca Pharmaceuticals LP; Lilly; Janssen-Ortho Inc.; Lundbeck, Inc.; Merck & Co., Inc.; Pfizer Inc. Received grants for clinical research from: AstraZeneca Pharmaceuticals LP; Lilly; Janssen-Ortho Inc.; Lundbeck, Inc.; Pfizer Inc; Shire.

    Chemical Imbalance, Version II (taken from an astute MIA blogger, Philip Hickey)
    1. Psychiatry never promoted a simple chemical imbalance theory.
    2. But psychiatry did promote a complicated chemical imbalance theory.
    3. The complicated chemical imbalance theory is plausible.
    4. There are chemicals involved in depression. [This is non-contentious. Brain chemicals are involved in literally everything humans do, think, and feel, from the simplest eyeblink, to writing great works of art, and everything in between.]
    5. It’s useful to emphasize that brain chemicals are involved in depression, in order to convince people that depression is a serious problem that can’t be conceptualized in ordinary human terms.
    6. But we can’t use the term “chemical imbalance” any more because it’s been outed as a hoax.
    7. We need a new phrase that will mean essentially the same thing.

    This is equally NONSENSE – it simply says “chemistry is part of everything, so it MUST be wonky” and there’s NO evidence for “a dysregulation”.

    Again, not saying folks don’t suffer, nor that SSRIs etc don’t “do stuff” but these chemical imbalance falsehoods are proven harmful.

    By the way in helping patients by debunking these falsehoods I’ve been saying for years that “when paracetamol helps your headache, is it correcting a paracetamol imbalance?” to show the utter logical nonsense of this myth.

    And btw I am a psychiatrist, an old fashioned doctor for whom INFORMED CONSENT is central, along with DO NO HARM. Whitaker and Cosgrove’s book focusses on “significant social injury, and in particular, a societal lack of informed consent regarding the use of psychiatric drugs, and the pathologizing of normal behaviors in children and adults.” Very true, important.

    Our profession is clearly abrogating its responsibilities to our patients by not loudly and clearly debunking these harmful myths.

  4.  
    Steve Lucas
    May 21, 2015 | 6:36 AM
     

    Joseph,

    This is exactly the example used in my undergraduate and graduate programs to explain gaming or Monte Carlo theory. Today I believe the term is chaos theory.

    The take away was that you cannot beat the house when they control the table.

    Steve Lucas

  5.  
    AA
    May 21, 2015 | 7:01 AM
     

    On a related note, I was reading the Amazon reviews for Tryptophan as I was considering trying it for sleep. Yes, I know that there are many downsides to this so please no comments on what I was thinking about doing. 🙂

    But I was stunned in reading the comments about how many people believed in the low serotonin theory and how they felt this substance miraculously bought their levels to the correct balance. So Dr. Pursey and others, thank you for your efforts in debunking these myths.

  6.  
    James O'Brien, M.D.
    May 21, 2015 | 8:54 PM
     

    Another example of academic cherry picking of data and this isn’t driven by pharma money but ideology:

    http://www.businessinsider.com/paul-krugman-shifts-chart-to-show-non-existant-correlation-2015-5

    These are not problems unique to psychiatry.

    BTW I’m not completely on board with the idea that pushing serotonin dysregulation was fraudulent. Basically anything medical presented to the public is to some extent dumbed down even concepts like “good cholesterol”. Again, if we’re going to beat up psychiatry for this, we have to beat up neurology for pushing the idea in migraines. And everyone else too. Stress ulcers were widely accepted until Helicobacter was discovered.

  7.  
    Winge D. Monke, Ph.D.
    May 22, 2015 | 11:36 AM
     

    Thanks for looking into McIntyre, Rob P. I wondered.

    Barton took some talking points from Science Media Center’s “expert reactions” to Healy’s recent BJM article.

    Did they make much sense here?
    http://www.sciencemediacentre.org/expert-reaction-to-editorial-on-serotonin-and-depression/

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