"Even when the clinical evidence isn’t there"

[Sean]

“Even though doctors value randomized clinical trials and evidence-based medicine, they are powerfully influenced by ideas about how diseases and treatments work. If doctors think a treatment should work, they come to believe that it does work, even when the clinical evidence isn’t there.”

http://harvardmagazine.com/2013/03/a-cardiac-conundrum

 

[PhoenixDown]

Thanks for the link.

“There was a firestorm of controversy,” Jones says. “There was lots of money, institutional power, and lots of lives at stake

Funny how you can get away with mentioning those things in the context of heart disease, but if you mention them in the context of CFS, ME, or Fibromyalgia then you're a "conspiracy theorist". Interesting double standard,

 

[golden]

I was shocked to read somewhere that 85% of allopathic meficine has no scientific evidence base whatso ever!

I had to pause and reflect upon that for considerable time.

That means only around 15% is scientific (in the way the common person would expect the word scientific to mean)

Also 60% or more of allopathic drugs are only working at a placebo level.

It really is peculiar.

 

[Sean]

Also 60% or more of allopathic drugs are only working at a placebo level.

Just to make life interesting, we can't even assume that the placebo effect has much significance on real world outcomes.

http://www.ncbi.nlm.nih.gov/pubmed/20091554

In other words, the majority of allopathic drugs don't work in any way at all, not even as placebo effect modulator.

Completely useless all round.

Now, if the placebo effect in the real world is insignificant, then the significance of the flip side of that putative psychogenic process – the nocebo effect, which is theorised by psychogenists to be the primary driver of CFS – is in serious doubt too.

I think that is the politest way I can say it.

 

[golden]

http://www.whale.to/a/evidence_based.html

I was just looking at this link.

I do think placebo and nacebo exist though.

personally, i would be overjoyed if i activated my placebo - people have done this with cancer etc i have read.



equally when people are given a negative diagnoses from the white coats in the sky - there is substantial evidence that they die on que - even when they discovered they made an error in diagnoses and it was only just a minor ailment!

 

[golden]

I have just realised there are different types of 'placebo' and 'nacebo'

The head of glaxo smith kline acknowledged most drugs do not work a few years ago. But its worse than that because they are a toxic substance and have side effects.

It really does get complicated. hmmmmmm

 

[peggy-sue]

The placebo/nocebo effect does exist.
The only difference between them is one outcome is beneficial, while the other isn't. The principle is exactly the same.

 

[Sean]

The placebo/nocebo effect does exist.

Even if the effect exists, there is no good evidence it makes any difference to clinical outcomes.

The placebo/nocebo effect is vastly over rated.

 

[peggy-sue]

But it still has to be accounted for in experimental controls.

Homeopathy depends entirely on the placebo effect - as does acupuncture.
But I reckon homeopathy and acupuncture are vastly over-rated.

 

[golden]

http://www.newscientist.com/mobile/article/mg18524911.600-13-things-that-do-not-make-sense.html

I was reading this on placebo - this is one type of placebo no. 1

and then i went onto no.4 in which a scientist tried to show homeopathy a placebo - however failed with some very interesting results!

 

[golden]

I am certain i am missing your main point Sean. I feel hazy on the subject.

different types of placebo....

1) the 'sugar pill' - no active ingredients in
2) The colourful bitter pill provided by a Doctor - no active ingredients in
3) A tablet with active ingredients in - but which only works at best at placebo levels

why is this? is it because the side effects cause it to perform worse than a placebo eg: headache tablets cause headaches and anti-depressants can cause depression....

Then there is Homeopathic Medicine which can be liquid but to add to confusions is actuall also administered in sugar pillules...

some people believe these are placebo and others say they have been trialled against a placebo and can out perform a placebo.

4) then there are surgical placebos. eg. terminal cancer has been operated on in surgery and because the patient was told all cancer had gone - then they were cured.

5) then there is self induced placebo - this must surely be activating the bodies own powers to heal itself.

6) there is also hypnotic placebo - activated purely by the power the doctor has over you - either positive or negative.

i think some types of placebo are overated - but the mystery of other types of placebo are massively underated....

eg: the person just cured themself of heart failure - oh thats kust placebo.

i find myself asking after all that - what is placebo?

 

[MishMash]

Placebo and the over-reliance on mice models. Two major reasons why medical findings turn out to be bogus. Mice are mice. Much more often than not their systems react extremely different than humans'. MS has been cured numerous times in genetically engineered mice. All "cures" have failed miserably when applied to people.

Mice Fall Short as Test Subjects for Humans’ Deadly Ills: NY Times

For decades, mice have been the species of choice in the study of human diseases. But now, researchers report evidence that the mouse model has been totally misleading for at least three major killers — sepsis, burns and trauma. As a result, years and billions of dollars have been wasted following false leads, they say.
The study’s findings do not mean that mice are useless models for all human diseases. But, its authors said, they do raise troubling questions about diseases like the ones in the study that involve the immune system, including cancer and heart disease.

“Our article raises at least the possibility that a parallel situation may be present,” said Dr. H. Shaw Warren, a sepsis researcher at Massachusetts General Hospital and a lead author of the new study.
The paper, published Monday in Proceedings of the National Academy of Sciences, helps explain why every one of nearly 150 drugs tested at a huge expense in patients with sepsis has failed. The drug tests all were based on studies in mice. And mice, it turns out, can have something that looks like sepsis in humans, but is very different from the condition in humans.

Medical experts not associated with the study said that the findings should change the course of research worldwide for a deadly and frustrating condition. Sepsis, a potentially deadly reaction that occurs as the body tries to fight an infection, afflicts 750,000 patients a year in the United States, kills one-fourth to one-half of them, and costs the nation $17 billion a year. It is the leading cause of death in intensive-care units.
“This is a game changer,” said Dr. Mitchell Fink, a sepsis expert at the University of California, Los Angeles, of the new study.

“It’s amazing,” said Dr. Richard Wenzel, a former chairman at the department of internal medicine at Virginia Commonwealth University and a former editor of The New England Journal of Medicine. “They are absolutely right on.”

Potentially deadly immune responses occur when a person’s immune system overreacts to what it perceives as danger signals, including toxic molecules from bacteria, viruses, fungi, or proteins released from cells damaged by trauma or burns, said Dr. Clifford S. Deutschman, who directs sepsis research at the University of Pennsylvania and was not part of the study.

The ramped-up immune system releases its own proteins in such overwhelming amounts that capillaries begin to leak. The leak becomes excessive, and serum seeps out of the tiny blood vessels. Blood pressure falls, and vital organs do not get enough blood. Despite efforts, doctors and nurses in an intensive-care unit or an emergency room may be unable to keep up with the leaks, stop the infection or halt the tissue damage. Vital organs eventually fail.

The new study, which took 10 years and involved 39 researchers from across the country, began by studying white blood cells from hundreds of patients with severe burns, trauma or sepsis to see what genes were being used by white blood cells when responding to these danger signals.

The researchers found some interesting patterns and accumulated a large, rigorously collected data set that should help move the field forward, said Ronald W. Davis, a genomics expert at Stanford University and a lead author of the new paper. Some patterns seemed to predict who would survive and who would end up in intensive care, clinging to life and, often, dying.

The group had tried to publish its findings in several papers. One objection, Dr. Davis said, was that the researchers had not shown the same gene response had happened in mice.

“They were so used to doing mouse studies that they thought that was how you validate things,” he said. “They are so ingrained in trying to cure mice that they forget we are trying to cure humans.”
“That started us thinking,” he continued. “Is it the same in the mouse or not?”

The group decided to look, expecting to find some similarities. But when the data were analyzed, there were none at all.

“We were kind of blown away,” Dr. Davis said.
The drug failures became clear. For example, often in mice, a gene would be used, while in humans, the comparable gene would be suppressed. A drug that worked in mice by disabling that gene could make the response even more deadly in humans.

Even more surprising, Dr. Warren said, was that different conditions in mice — burns, trauma, sepsis — did not fit the same pattern. Each condition used different groups of genes. In humans, though, similar genes were used in all three conditions. That means, Dr. Warren said, that if researchers can find a drug that works for one of those conditions in people, it might work for all three.

The study’s investigators tried for more than a year to publish their paper, which showed that there was no relationship between the genetic responses of mice and those of humans. They submitted it to the publications Science and Nature, hoping to reach a wide audience. It was rejected from both.

Science and Nature said it was their policy not to comment on the fate of a rejected paper, or whether it had even been submitted to them. But, Ginger Pinholster of Science said, the journal accepts only about 7 percent of the nearly 13,000 papers submitted each year, so it is not uncommon for a paper to make the rounds.

Still, Dr. Davis said, reviewers did not point out scientific errors. Instead, he said, “the most common response was, ‘It has to be wrong. I don’t know why it is wrong, but it has to be wrong.’ ”

The investigators turned to Proceedings of the National Academy of Sciences. As a member of the academy, Dr. Davis could suggest reviewers for his paper, and he proposed researchers who he thought would give the work a fair hearing. “If they don’t like it, I want to know why,” he said.

They recommended publication, and the editorial board of the journal, which independently assesses papers, agreed.
Some researchers, reading the paper now, say they are as astonished as the researchers were when they saw the data.

“When I read the paper, I was stunned by just how bad the mouse data are,” Dr. Fink said. “It’s really amazing — no correlation at all. These data are so persuasive and so robust that I think funding agencies are going to take note.” Until now, he said, “to get funding, you had to propose experiments using the mouse model.”

Yet there was always one major clue that mice might not really mimic humans in this regard: it is very hard to kill a mouse with a bacterial infection. Mice need a million times more bacteria in their blood than what would kill a person.

“Mice can eat garbage and food that is lying around and is rotten,” Dr. Davis said. “Humans can’t do that. We are too sensitive.”

Researchers said that if they could figure out why mice were so resistant, they might be able to use that discovery to find something to make people resistant.

“This is a very important paper,” said Dr. Richard Hotchkiss, a sepsis researcher at Washington University who was not involved in the study. “It argues strongly — go to the patients. Get their cells. Get their tissues whenever you can. Get cells from airways.”

“To understand sepsis, you have to go to the patients,” he said.

 

[Esther12]

Ta Fire.

People love stories. Curses.

 

[Esther12]

Sorry if this is a bit OT, but it seemed a bit relevent, so I thought I'd add it to the thread

http://news.yahoo.com/psychologists-confront-rash-invalid-studies-152250031.html
Psychologists Confront Rash of Invalid Studies

By Tia Ghose, LiveScience Staff Writer | LiveScience.com – 11 hrs ago

In the wake of several scandals in psychology research, scientists are asking themselves just how much of their research is valid.
In the past 10 years, dozens of studies in the psychology field have been retracted, and several high-profile studies have not stood up to scrutiny when outside researchers tried to replicate the research.
By selectively excluding study subjects or amending the experimental procedure after designing the study, researchers in the field may be subtly biasing studies to get more positive findings. And once research results are published, journals have little incentive to publish replication studies, which try to check the results.
That means the psychology literature may be littered with effects, or conclusions, that aren't real. [Oops! 5 Retracted Science Studies]
The problem isn't unique to psychology, but the field is going through some soul-searching right now. Researchers are creating new initiatives to encourage replication studies, improve research protocols and to make data more transparent.
"People have started doing replication studies to figure out, 'OK, how solid, really, is the foundation of the edifice that we're building?'" said Rolf Zwaan, a cognitive psychologist at Erasmus University in the Netherlands. "How solid is the research that we're building our research on?"
Storm brewing
In a 2010 study in the Journal of Social and Personal Psychology, researchers detailed experiments that they said suggested people could predict the future.
Other scientists questioned how the study, which used questionable methodology such as changing the procedure partway through the experiment, got published; the journal editors expressed skepticism about the effect, but said the study followed established rules for doing good research.
That made people wonder, "Maybe there's something wrong with the rules," said University of Virginia psychology professor Brian Nosek.
But an even bigger scandal was brewing. In late 2011, Diederik Stapel, a psychologist in the Netherlands, was fired from Tilburg University for falsifying or fabricating data in dozens of studies, some of which were published in high-profile journals.
And in 2012, a study in PLOS ONE failed to replicate a landmark 1996 psychology study that suggested making people think of words associated with the elderly — such as Florida, gray or retirement — made them walk more slowly.
Motivated reasoning
The high-profile cases are prompting psychologists to do some soul-searching about the incentive structure in their field.
The push to publish can lead to several questionable practices.
Outright fraud is probably rare. But "adventurous research strategies" are probably common, Nosek told LiveScience. [The 10 Most Destructive Human Behaviors]
Because psychologists are so motivated to get flashy findings published, they can use reasoning that may seem perfectly logical to them and, say, throw out research subjects who don't fit with their findings. But this subtle self-delusion can result in scientists seeing an effect where none exists, Zwaan told LiveScience.
Another way to skew the results is to change the experimental procedure or research question after the study has already begun. These changes may seem harmless to the researcher, but from a statistical standpoint, they make it much more likely that psychologists see an underlying effect where none exists, Zwaan said.
For instance, if scientists set up an experiment to find out if stress is linked to risk of cancer, and during the study they notice stressed people seem to get less sleep, they might switch their question to study sleep. The problem is the experiment wasn't set up to account for confounding factors associated with sleep, among other things.
Fight fire with psychology
In response, psychologists are trying to flip the incentives by using their knowledge of transparency, accountability and personal gain.
For instance, right now there's no incentive for researchers to share their data, and a 2006 study found that of 141 researchers who had previously agreed to share their data, only 38 did so when asked.
But Nosek and his colleagues hope to encourage such sharing by making it standard practice. They are developing a project called the Open Science Framework, and one goal is to encourage researchers to publicly post their data and to have journals require such transparency in their published studies. That should make researchers less likely to tweak their data.
"We know that behavior changes as a function of accountability, and the best way to increase accountability is to create transparency," Nosek said.
One journal, Social Psychology, is dangling the lure of guaranteed publication to motivate replication studies. Researchers send proposals for replication studies to the journal, and if they're approved, the authors are guaranteed publication in advance. That would encourage less fiddling with the protocol after the fact.
And the Laura and John Arnold Foundation now offers grant money specifically for replication studies, Nosek said.

 

[Sean]

But it still has to be accounted for in experimental controls.

The possibility of placebo effect certainly has to be controlled for, no argument there. Placebo arm should be a minimum requirement for all clinical studies, where possible.

My point is that if a significant generic placebo effect was going to show up in randomised placebo-controlled clinical trials, it should have shown up in that review/meta-analysis I linked to above. But it didn't, and that has serious implications about the significance of placebo/nocebo effect, or lack of it.

And if there is no significant effect, then I would strongly argue that removes the central theoretical justification for the psychogenic model of CFS.

 

[golden]

The possibility of placebo effect certainly has to be controlled for, no argument there. Placebo arm should be a minimum requirement for all clinical studies, where possible.

My point is that if a significant generic placebo effect was going to show up in randomised placebo-controlled clinical trials, it should have shown up in that review/meta-analysis I linked to above. But it didn't, and that has serious implications about the significance of placebo/nocebo effect, or lack of it.

And if there is no significant effect, then I would strongly argue that removes the central theoretical justification for the psychogenic model of CFS.

A priori is the first thing to root out.

For example the assumption that scientifically tested medicine yields better clinical results than other medicines.

Then I wonder which placebo is being trialled? For example different coloured and sized pills yield differing results. If the pill is bitter it works better than sweet or pleasant. If the pill is administered by a doctor it will work better than a pill administered by a Nurse.

So we maybe trialling a drug - we may test like for like in the drug and the placebo. A yellow drug and a yellow placebo.

But what if a purple placebo would do better than the yellow drug? what if a top specialist of which there are only 5 in the world flew in and administered the placebo and yielded better results than the yellow drug?

The drug companies were fed up with the placebo percentage and so they calculated in the first drug trial all those who were 'susceptible' to the placebo and filtered them out. They did the trial again and profoundly - the same percentage of placebo rate occurred - thats whackey....

I have not studied what the psychologists say of M.E. and placebo - probably more rubbish

 

[golden]

All Animal Experiments are useless. It is total propaganda.

Even in 1912 Dr. Wolfgang Bonn wrote in the Medical Journal:

'The constant spread of the vivisectionist method has achieved but one thing: to increase the scientific torture and murder of human beings. We can expect this increase to continue for it would be the logical consequence of animal vivisection'

http://www.whale.to/a/ruesch4.html

So you begin by testing on animals after artificially inducing an illness.

The results on animals are promising. So the go ahead is given for human trials. The human trials fail - sometimes causing cancer, death or child deformities.

Scenario 2 - So we test on animals and the results are very bad - cancer, death etc.

So we go ahead as per scenario 1 and begin the human trials.

Why? because, the vivisectors argue, animals are not humans and what happens to animals has no relevance to what happens in humans.

So, whilst anima
l experiments are a huge money maker - they actually hinder science and medicine.

Whilst drugs are on the market that cause cancer in animals, there are drugs on the market which have been apprpved as safe in animals and had disastrous effects in humans. This is also why 50-60 plus drugs are removed from the market each year because they are dangerous.

Dr. Hadwen Trust has some interesting observations on this.

Over three quarters of animals experimented on have no anaesthetic. And I cant help but wonder of the type of person who can do this and equate it with the fact that human babies were also given no anaesthetic when they qere operated on up until parents found out in 1986. The scientific belief was that babies did not feel pain. They poked them with pins and concluded the cries were random or some other such psychological knowledge.

Again, anyone who has nursed a baby with teething troubles or colic knows a baby feels pain - and yet doctors insisted on doing open heart surgery on babies with no pain relief.
It is beyond my comprehension.

There was a doctor that rushed through some scientific tests to prove that babies did feel pain and so the medical practices changed after 1986.

 

[golden]

I have been searching for this fascinating story of surgical placebos.

There was a man called Wright who had cancer and was given water which melted his tumours....

The stats in these articles rate placebo at 30-40% and upto 90% .

http://www.wrf.org/alternative-therapies/power-of-mind-placebo.php



I also found it interesting that the placebo chemotherapy making 30% of patients loose their hair ...

 

[jimells]

... human babies were also given no anaesthetic when they qere operated on up until parents found out in 1986. The scientific belief was that babies did not feel pain.

There was a doctor that rushed through some scientific tests to prove that babies did feel pain and so the medical practices changed after 1986.

There seems to be no end to the cruelty and ignorance of the medical 'profession'. Even though babies are now recognized to feel pain, I have to wonder how many male infants are still subject to genital mutilation without anaesthetic.