"There is a categorical lack of clinical evidence to support the use of statin therapy in primary prevention."

Via Stan the Heretic:

There is a categorical lack of clinical evidence to support the use of statin therapy in primary prevention. Not only is there a dearth of evidence for primary cardiovascular protection, there is ample evidence to show that statins actually augment cardiovascular risk in women, patients with Diabetes Mellitus and in the young. Furthermore statins are associated with triple the risk of coronary artery and aortic artery calcification.

Don't Trust The Authorities

Milgram a fraud?

… In the fifty years since publication of Milgram’s first journal article the obedience research continues to be cited as evidence of an enduring psychological truth: inside all of us is a Nazi concentration camp guard waiting to be called into service. Yet my archival research and examination of primary sources and that of other scholars contradicts this claim.

Milgram himself was privately aware of the methodological weakness of his research and struggled with many of the issues about the validity of experiments and their generalisability beyond the lab. Privately Milgram reflected that his work was more art than science, and described himself as a “hopeful poet.” …

Positive Psychology? Smelling Bull.

Nick Brown Smelled Bull (via)

Doctors Who Mislead – Are There Any Other?

"I have apologized for some of the earlier reporting because I think, you know, we've been terribly and systematically misled in this country for some time," Gupta told Piers Morgan on CNN. "And I did part of that misleading."

http://www.usatoday.com/story/news/nation/2013/08/11/sanjay-gupta-marijuana-debate/2636043/

No sweat, Gupta, I expect nothing but false and misleading words from an medical doctor – so do carry on spreading your misleading words.

It's not that I hate science – as a matter of fact, science is the only way to discover the true nature of our reality, and I dearly love science. It is just the scientists…

Most scientists seem to have forgotten that the matter of the game is to find out how reality works, and not to advocate their ill-thought-out biases, and go claiming everywhere that this is "science". (And in the case of marijuana that is true for both sides of the debate – plenty of wishful thinking going around.)

Especially the field of medicine and medical research is a cesspool in my not so humble opinion. You could go an shoot every second medical doctor and shoot every second medical researcher (plus all journalists reporting on medicine), and no ill effect would be noticeable in the general population.

"Simple" Thermodynamics and "Common Sense"

David Berreby – The Obesity Era: (via)

… Moral panic about the depravity of the heavy has seeped into many aspects of life, confusing even the erudite. Earlier this month, for example, the American evolutionary psychologist Geoffrey Miller expressed the zeitgeist in this tweet: ‘Dear obese PhD applicants: if you don’t have the willpower to stop eating carbs, you won’t have the willpower to do a dissertation. #truth.’ Businesses are moving to profit on the supposed weaknesses of their customers. Meanwhile, governments no longer presume that their citizens know what they are doing when they take up a menu or a shopping cart. Yesterday’s fringe notions are becoming today’s rules for living — such as New York City’s recent attempt to ban large-size cups for sugary soft drinks, or Denmark’s short-lived tax surcharge on foods that contain more than 2.3 per cent saturated fat, or Samoa Air’s 2013 ticket policy, in which a passenger’s fare is based on his weight because: ‘You are the master of your air ‘fair’, you decide how much (or how little) your ticket will cost.’

… As the Mayor of New York, Michael Bloomberg, recently put it, defending his proposed ban on large cups for sugary drinks: ‘If you want to lose weight, don’t eat. This is not medicine, it’s thermodynamics. If you take in more than you use, you store it.’ (Got that? It’s not complicated medicine, it’s simple physics, the most sciencey science of all.)

Yet the scientists who study the biochemistry of fat and the epidemiologists who track weight trends are not nearly as unanimous as Bloomberg makes out. In fact, many researchers believe that personal gluttony and laziness cannot be the entire explanation for humanity’s global weight gain. Which means, of course, that they think at least some of the official focus on personal conduct is a waste of time and money. …

It is like the question "Why are some subway cars full of people?" and the answer "Because more people entered the subway cars than left it."

Don't trust any "common sense" explanations with regards to nutrition or health. I now lost 12 kilograms weight in the four month since April 2013. Yes, I eat less – but more importantly I eat no dairy, I eat no cereal grains, I radically reduced the consumption of seed oils and PUFAs (poly unsaturated fatty acids) and I now radically reduced the consumption of sucrose ("sugar") and fructose (to the point that I at the moment even don't eat the supposedly "healthy" fruits). I eat saturated fats from coconut fat, I eat meat, I eat potatoes (preferentially fried) and I eat salad. So fuck you very much Mr. Bloomberg, and fuck you very much Mr. evolutionary psychologist – since when do have animals have to have "willpower" to stay non-obese?

Consider, for example, this troublesome fact, reported in 2010 by the biostatistician David B Allison and his co-authors at the University of Alabama in Birmingham: over the past 20 years or more, as the American people were getting fatter, so were America’s marmosets. As were laboratory macaques, chimpanzees, vervet monkeys and mice, as well as domestic dogs, domestic cats, and domestic and feral rats from both rural and urban areas. In fact, the researchers examined records on those eight species and found that average weight for every one had increased. The marmosets gained an average of nine per cent per decade. Lab mice gained about 11 per cent per decade. Chimps, for some reason, are doing especially badly: their average body weight had risen 35 per cent per decade. Allison, who had been hearing about an unexplained rise in the average weight of lab animals, was nonetheless surprised by the consistency across so many species. ‘Virtually in every population of animals we looked at, that met our criteria, there was the same upward trend,’ he told me.

I say, it is more and more seed oil (supposedly "healthy"), with its high content of PUFAs (as well supposedly "healthy") that is making animals obese (including the human animals).

Peer Review – Not Worth The Paper

Amazing:

The present investigation was an attempt to study the peer-review process directly, in the natural setting of actual journal referee evaluations of submitted manuscripts. As test materials we selected 12 already published research articles by investigators from prestigious and highly productive American psychology departments, one article from each of 12 highly regarded and widely read American psychology journals with high rejection rates (80%) and nonblind refereeing practices.

With fictitious names and institutions substituted for the original ones (e.g., Tri-Valley Center for Human Potential), the altered manuscripts were formally resubmitted to the journals that had originally refereed and published them 18 to 32 months earlier. Of the sample of 38 editors and reviewers, only three (8%) detected the resubmissions. This result allowed nine of the 12 articles to continue through the review process to receive an actual evaluation: eight of the nine were rejected. Sixteen of the 18 referees (89%) recommended against publication and the editors concurred. The grounds for rejection were in many cases described as “serious methodological flaws.” A number of possible interpretations of these data are reviewed and evaluated.

(via WUWT)

Atopic Dermatitis ("Neurodermitis") Caused By Dairy and Eggs?

Another chronic skin condition which is possibly caused by (pasteurized) milk and dairy: Atopic Dermatitis ("Neurodermitis").

The German weekly "Der Spiegel" had this to report in August 2011 (translation mine):

… After Nina Meier's odyssey through doctors offices and many treatments, the turn came with a few words: "Abstain from cow's milk and eggs," advised a general practitioner. "I said to myself, shit, I'll simply try it," says Meier. "It can't get any worse." For one week the symptoms got worse - but then came the turning point. "I could rub off my skin like scabs, underneath new skin came to light. After the old skin had gradually peeled off, it was fine."

Since then she has never been in treatment for their eczema again. With regards to dermatologists she is now skeptical. Nina Meier says she had trusted doctors too much and "ignored nutrition during the search for the cause, because the doctors said nutrition did not play a role". Meanwhile, she can tolerate even a little bit of cow's milk or egg. "And even if my body reacts, I won't get no stressed anymore. Because I now know the cause." …

http://www.spiegel.de/panorama/gesellschaft/jahrelange-fehltherapie-gefangen-in-der-eigenen-haut-a-780722.html

The entire article in "Der Spiegel" is a truly horror story of her various treatments by "evidence based" medical industry – at least it has an happy end for her. What about the countless others who are stuck in this ordeal?

So after Acne, Aphthous Ulcers, Behçet's and Psoriasis, I can add this to my growing list. Why is it the skin, that is the "target"? What is the common mechanism here? I'm sure it will be fascinating to read the mechanism, once medical science will find it out in a couple of decades… I sure hope I live that long.

90% Of Preclinical Cancer Research Is Not Reproducable

Oh my:

In their Comment article 'Raise standards for preclinical cancer research', C. Glenn Begley and Lee Ellis (Nature 483, 531–533; 2012) refer to scientists at Amgen who were able to reproduce findings in only 11% of 53 published papers. Several correspondents have asked for details of these studies, which were not provided in the article.

The Amgen scientists approached the papers' original authors to discuss findings and sometimes borrowed materials to repeat the experiments. In some cases, those authors required them to sign an agreement that they would not disclose their findings about specific papers. Begley and Ellis were therefore not free to identify the irreproducible papers — a fact that the Comment should have mentioned.

Nature, like most journals, requires authors of research papers to make their data available on request. In this less formal Comment, we chose not to enforce this requirement so that Begley and Ellis could abide by the legal agreements.

The scientists at Amgen could not have implemented their study had they reserved the right to reveal the outcome for individual papers. The Comment highlights important systemic problems in preclinical cancer research, which we felt appropriate to communicate to our readers, even though the authors could not disclose the studies in question.

I Guess "Case Studies" and Anecdotes *CAN* Be Usefull Afterall

1 Boring Old Man:

The scheme boxed above [about RCTs, randomized controlled trials], while initiated as a protective maneuver, is actually designed to detect smaller differences – differences that might not even be apparent without the statistical rigor described. One would hardly need more than my one case of terminal congestive heart failure treated with Ethacrinic Acid to know that drug was a powerhouse diuretic – dangerously powerful. The same is true of Digitalis, Insulin, and Prednisone. They don’t work statistically. They just work. The same would be true of Thorazine which is closer to a sledge-hammer than something subtle requiring statistical proof. The issue with all of these drugs is about their safety, not their efficacy. So the coming of the clinical trial technology greatly expanded the ability to detect much more subtle levels of efficacy.

What frustrates me is that medical science (in the form of pharma-trials) is chasing ever smaller effect sizes (Statins, anyone?) while at the same time ignoring what could be gained be removing evolutionary novel foods from nutrition – something like the Paleo Diet, that "just worked" for me. It did not work "statistically", but it "just worked", just like flipping a switch.

Why can't they take MS patients (for example) and put them on elimination diets, where you remove one component from the diet and see what it does? Have one arm of the study where you remove dairy, one arm where you remove grains, one arm where you remove dairy and grains, and so on – there are other possibilities. Or do this with Behçet's and dairy?

I feel like medical science is stuck, unable to ask the right questions anymore, unable to question what is right and what is wrong with all that knowledge they have gathered. The only way to get themselves "unstuck" would to question everything. Are (whole) grains actually healthy? Is dairy actually healthy? Is an increased consumption of PUFAs actually healthy? If not, for which groups of patients with what diseases? Or are there even problems with these foods that affect everybody negatively?

Until the medical science starts questioning whether the foundation of nutrition is really what the medical mainstream thinks it is, until then medical science will remain stuck.

If only

From time to time one can hear the lament from the ME/CFS community:

"If only we had the money and the attention other diseases receive!"

Well, 1 Boring Old Man tells us how it looks like in other diseases:

This represents a massive medicaide fraud [TMAP] and over $50 M of NIMH money [STAR*D, IMPACTS, CO-MED, and EMBARC] chasing a mediocre idea about how to make some mediocre drugs less mediocre that failed at every turn. It’s an outrageous waste of valuable resources that makes one wonder if anyone at the NIMH even looks at the books.

Vegetable Oils, PUFAs, Omega-6? Don't eat it.

If you need any more evidence that seed oil (aka "vegetable oil") is bad for your health, here it is:

Use of dietary linoleic acid for secondary prevention of coronary heart disease and death: evaluation of recovered data from the Sydney Diet Heart Study and updated meta-analysis
…
Advice to substitute polyunsaturated fats for saturated fats is a key component of worldwide dietary guidelines for coronary heart disease risk reduction.

However, clinical benefits of the most abundant polyunsaturated fatty acid, omega 6 linoleic acid, have not been established.

In this cohort, substituting dietary linoleic acid in place of saturated fats increased the rates of death from all causes, coronary heart disease, and cardiovascular disease.

An updated meta-analysis of linoleic acid intervention trials showed no evidence of cardiovascular benefit.

These findings could have important implications for worldwide dietary advice to substitute omega 6 linoleic acid, or polyunsaturated fats in general, for saturated fats. 

To sum it up: The advise of the past decades for a "heart healthy" not only has no health benefits, it actually creates the problem it perpetuates to fight.

Don't eat vegetable oils, because vegetable oils cause disease.

Eat saturated fat, because saturated fat does not cause disease.

I know this will make most doctors unhappy, but hey: go fuck yourselves. Handing out murderous advise for decades? If people find out, there'll be a shortage of pitch-forks, I hope – one can dream, right?

(via)

[Update] Stan the Heretic an his take on the matter:

…
This high multiple factor seems to be confirm by the data from Table 5 indicating that for every 5% PUFA increase (in absolute energy%) the All cause mortality, the Cardiovascular disease mortality and the Coronary heart disease mortality increased by 31%, 35% and 26% respectively (relative risk factor).

This implies a proportionality factor of about 5-7. That is, for every 1% added Poly-Unsaturated Fatty Acids ( PUFA) in absolute calories % of the total, cardiovascular mortality INCREASED by 5 to 7%. This is big news!
…

[Update] Chris Kresser on the same topic.

Fuck That.

David Healy - Time to abandon evidence based medicine?

• You can't trust trial data
• You can't trust reviews (not even Cochrane Reviews)
• Real significant problems (e.g. increased suicides on Prozac) can be "statistically not significant"
• Data is hidden
• Evidence vs. Evident: Large controlled trials are needed to weed out the drugs that don't work – drugs that "really" work show their effects in small trials. If you need 10,000 people to show an effect, something is fishy.
• If alcohol were a novel substance, a (hypothetical) trial could be made that would show that alcohol works as an anti-depressant drug
• In this (hypothetical) "alcohol as anti-depressant drug" example, one could even get alcohol as drug to be included in the NICE-guidelines
• One (hypothetical) 6 week (!) trial alone (!) could "prove" that the economy would save lots of money by putting people on alcohol for depression
• And this (hypothetical) one 6 week trial would be enough "prove" that doctors would insist that patients should take this drug for life(!), because the condition is life-long
• If a drug causes symptoms (e.g. more suicides), which the disease can also produce, then a control trial can not answer that question for you
• Clinical trials are not the answer:
  1. If both the illness & the drug cause a problem
  2. If the clinical population is heterogenous (if the underlying condition is unknown)
  3. If the researchers don't know what they are doing
  4. Clinical trials cannot provide patient level answers
  5. Clinical trials do not reveal cause and effect
• Doctors will defend prescription drugs – and hereby delay investigation into adverse effects by 15 or more years

And all that is not even including the carnage done by quacks…

Fuck that.

We have all these amazing medical, technological and scientific advances, which should put us in a position to fight diseases in a way that would make all the Pasteurs and all the Enders' and all the Salks and all the Sabins of past times green with envy. Where is the evolution in medicine? Why does it seem to me that we are stuck in a dead end?

The medical profession does well with clearly defined illness – say HIV/AIDS – that, if left untreated, lead to clearly measurable, visible adverse outcomes. But things like depression? MS? T2DM? In all likelihood, the treatment may lead to worse outcomes than if the illness is left untreated.

And this hits me at the moment. My doctor is willing to try out medication for my ME/CFS and therefore I'm currently looking into what agonist drugs are available to stimulate the alfa 2A receptor which is shown to be involved in at least subgroup of patients. Besides

• the almost total lack of scientific interest in ME/CFS by the medical commuity that leads to a situation where every person with ME/CFS is going from one "personal drug trial" to the next because guiding trial data is non-existent,
• besides not having any certainty whatsoever what actually the pathology is in my case (besides some personal indication that the alfa 2A receptor might be involved for me as well),
• besides not knowing if a stimulation with an Ad2A agonist is actually the right thing to do, if it is the Ad2A in my case,
• and besides not knowing what the actual (vs. claimed) spectrum of adverse reactions of these drugs is,

besides that I am totally at loss whether the supposed alfa 2a agonists actually do what the pharmaceutical industry claims they do.

Should I give Guanfacine a try? Or rather Tizanidine? Maybe Xylazine? What about Lofexidine?  Is Brimonidine only for occular hypertension?

I know, let's play guinea pig! And if one doesn't work, or makes me awful, then we try the next! Oh boy, what fun.

I feel like I might go to a pharmacists, and at gun point take any random medication and try that – and not be worse off…

But it sure is nice to see a psychologist like David Healy sharing his good insight into the problems of his profession and giving his best to address them properly.

David Gorski on Nutritional Science

Long read, some problems in science (and Gorski surely sees only a selection of those), and much food for thought (ha!).

This figure caught my eye:

All results for salt, pork, olive and bacon are on one side of Relative Risk = 1, however with some results coming close to it? Come on, WTF! This smells like publication bias! And then there is milk and onion and beef and sugar and carrot. Just look at them! And don't get me started on tea…

Looks like some of the results are more a mirror of prevailing biases, than a result of inquiry into reality.

Gary Taub on Big Sugar

Gary Taub on Big Sugar:

… Following the Montreal conference, the ISRF disseminated a memo quoting Errol Marliss, a University of Toronto diabetes specialist, recommending that the industry pursue "well-designed research programs" to establish sugar's role in the course of diabetes and other diseases. "Such research programs might produce an answer that sucrose is bad in certain individuals," he warned. But the studies "should be undertaken in a sufficiently comprehensive way as to produce results. A gesture rather than full support is unlikely to produce the sought-after answers."

A gesture, however, is what the industry would offer. Rather than approve a serious investigation of the purported links between sucrose and disease, American sugar companies quit supporting the ISRF's research projects. Instead, via the Sugar Association proper, they would spend roughly $655,000 between 1975 and 1980 on 17 studies designed, as internal documents put it, "to maintain research as a main prop of the industry's defense." Each proposal was vetted by a panel of industry-friendly scientists and a second committee staffed by representatives from sugar companies and "contributing research members" such as Coca-Cola, Hershey's, General Mills, and Nabisco. Most of the cash was awarded to researchers whose studies seemed explicitly designed to exonerate sugar. One even proposed to explore whether sugar could be shown to boost serotonin levels in rats' brains, and thus "prove of therapeutic value, as in the relief of depression," an internal document noted. …

Warning: Article is spread over three "pages".

Cervantes on the Medical-Pharmaceutical-Industry

Cervantes on the Medical-Pharmaceutical-Industry:

The Senate finance committee has found that [the Medtronic corporation] paid -- get this, it's not a typo or an extra zero -- hundreds of millions of dollars to doctors to pretend to be the authors of articles they drafted, edited and approved praising its product InFuse. Senator Max Baucus says, "Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has." Indeed. The editors of Spine Journal weigh in: "If surgeons had known that the lead authors of the 13 original studies on InFuse had received payments ranging from $1.7 million to $64 million [sic!] from Medtronic and that its marketing employees were co-authors and co-editors, would they have been as eager to use InFuse on their patients?"

That's all well and good but BMJ fails to name the names of those "physicians." They are all cruising along with high powered appointments and continuing to publish.

Look AHEAD trial stopped

Look AHEAD trial stopped
Eat less, move more, have your heart attack on time!

With apologies for lack of any attention to the blog recently (which may be set to continue for some time) but this snippet just had to get passed on. This link from Karl:

http://www.theheart.org/article/1458351.do

More info here

http://www.nih.gov/news/health/oct2012/niddk-19.htm

And the glowing anticipation of success here from the planning stage:

https://www.lookaheadtrial.org/public/home.cfm

Pubmed gives a series of genuine success stories from the early days on all sorts of parameters. But the cardiovascular end points show how utterly useless these interventions are long term.

However the massive omission, from the quick look I've managed, is of any intention to report the all cause mortality. It seems very likely to me that more people died in the intervention group than in the usual care group, but p was > 0.05.

Call me a cynic, but I think they stopped the trial because they could see where that p number was heading. Has anyone seen a body count from anywhere in the trial?

Also, what might the outcome have been if the intervention group had been repeatedly bullied, harassed and indoctrinated to maintain a normoglycaemic, low grade ketogenic diet for 13.5 years? Say to an HbA1c of around 5%?

Ha ha ha bloody ha.

Peter

[Update]: And Seth Roberts on the topic.

Hobbesianism in the pharmaceutical Industry

Ben Goldacre:

Question: Do you think there are any pharmaceutical companies that stand out in terms of transparency of trial results? And at the other end of the scale, are there any companies that consistently fail to publish negative trials?

Ben Goldacre: No. I have no reason to believe that any one is any better than the other. If you have bad regulations, incoherently enforced, then everybody does what they have to do, to succeed in the marketplace.

Of what reminds me that, that "everybody does what they have to do, to succeed in the marketplace"?

"That which is now to be expropriated is no longer the labourer working for himself, but the capitalist exploiting many labourers. This expropriation is accomplished by the action of the immanent laws of capitalistic production itself, by the centralisation of capital. One capitalist always kills many."
-- Karl Marx on the primitive accumulation of capital

"Je ein Kapitalist schlägt viele tot."
-- Karl Marx über die ursprüngliche Akkumulation

Yes, the "expropriation of many capitalists by few capitalists", everybody has to do what he has to do to succeed – aka Hobbesianism.

Science is human – and some humans behave badly

Ed Yong discusses human science:

Over the last year, I’ve written several pieces about problems in psychology – namely, an overwhelming skew towards positive results, a lack of replications to check if they are correct, and a disturbing number of cases of misconduct. But of course, psychology is not alone here. These problems are pervasive in science, and it’s important to discuss them.

Doctors without Science

Seth Roberts at his best:

Extremely Disappointing Facts About Doctors

The gist of Unaccountable: What Hospitals Won’t Tell You … by Mart Makary, a med school professor at Johns Hopkins, is that doctors have failed to regulate themselves. Nobody else regulates them, so they are unaccountable. In many ways, Makary shows, bad behavior (e.g., unnecessary treatment, understating the risks of treatment) is common. Hospitals hide how bad things are. Makary mostly discusses surgeons — he’s a surgeon — but gives plenty of reasons to think other specialties are no better.

The book is one horror story after another. At one point, Makary quit medical school. He was disgusted and appalled by seeing doctors — his teachers — push an old woman to consent to an operation she didn’t want and didn’t need. She refused, again and again, but the doctors kept pushing. Makary objected. He was ignored. Finally she agreed. The operation killed her.

I know Peter Attia as a co-founder, with Gary Taubes, of the recently formed Nutritional Science Initiative. Makary met him when Attia did a surgery residency at John Hopkins Hospital. Attia had seen a doctor about back pain and had been told he needed surgery. They operated on the wrong side, causing damage that prevents Attia, an excellent athlete, from playing most sports. Eventually Attia left medicine. He felt “modern medicine was too frequently dishonest with patients, at times understating risks and overtreating patients as a matter of reflex” — “as a matter of reflex” meaning “as a matter of course”, i.e., usually. And Johns Hopkins Hospital is one of the better hospitals in America. “Almost everyone I talk to has a story about a friend or a family member who was hurt, disfigured, or killed by a medical mistake,” writes Makary. He has six such stories, including his grandfather and his brother. His grandfather died from unnecessary surgery.

…

The Big Pharma Conspiracy

Ben Goldacre at his best:

When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was "both shaken and enraged about the criticism, that could not be recognised". It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can't see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.

Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif's third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt "intimidated and harassed" by Lif's behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.