"Scientific" double blind placebo controlled trials

I find this thread interesting because double blind placebo trails had been dumped a long time ago as being unethical.

Double blind trails are important and still go on, but the use of placebos fell away because of the methods the big pharma were using to place placebos. It was an out and out scandal that placebos were being used in the USA on blacks, and later in developing countries.

Therefore in drug trials the use of placebos actually has human rights implications.

So if there is a stardard for placebos or not....... They are not used as much in drug development as some would like us to believe.

I would urge anyone who is interested reasearch is conducted to read some of the white papers to see how things are actually done. I think this is also more important when a lot of public health policy decisions are being made on the outcomes of meta research.

If as supporters of CAM we are going to argue against our critics, it's best not to misrepresent them as they do us.

Myarka.

I find this thread interesting because double blind placebo trails had been dumped a long time ago as being unethical.

Since when Myarka? It is not so very long since I was at college and these were cited as the 'gold standard' for scientific trials!

Double blind trails are important and still go on, but the use of placebos fell away because of the methods the big pharma were using to place placebos. It was an out and out scandal that placebos were being used in the USA on blacks, and later in developing countries.

Therefore in drug trials the use of placebos actually has human rights implications..

I quite agree!

I would urge anyone who is interested reasearch is conducted to read some of the white papers to see how things are actually done. I think this is also more important when a lot of public health policy decisions are being made on the outcomes of meta research..

Could you point me in the direction of some of these white papers please?

If as supporters of CAM we are going to argue against our critics, it's best not to misrepresent them as they do us.

Absolutely! I do however believe Natural News (Mike Adams) does his research well - and I was pointing the reader in his direction.

Since when Myarka? It is not so very long since I was at college and these were cited as the 'gold standard' for scientific trials!

Both the Belmont report (USA), and the Hensinki agreement (Europe) laydown guidelines for ethical research. The view is that placebos should only be used where there is no existing treatment.

Could you point me in the direction of some of these white papers please?

The trip database references all this work, just search on the subject you're interested in and it will take you to the research:

HTH,
Myarka

Unfortunately, it is widely perceived that placebos are not used because they show up the true lack of value of many interventions.

Who would volunteer to be untreated for cancer for the sake of science? But if we don't leave some people untreated, how do we know that the therapy is really helping people and not actually killing them? The answer is we don't.

The last trial of a vaccine against inert placebos was for BCG, and the outcome was that with the actual vaccine you were more likely to get tuberculosios.

Hence, when they test modern medication, they always test it against another medication, it may appear effective against something worse than useless. Vaccines are tested against other vaccines, and against the whole toxic coctail in a vaccine but without an 'active' ingredient'. So if a vaccine for flu is more effective against an injection of toxic rubbish, then it is deemed useful. Of course they don't test effectiveness anymore, just whether antibodies are present, which is not a good correlate for actual 'immunity', but good enough to sell billions of dollars' worth. So this is flawed on several levels, but that's another story.

But cynicism about big pharma's intentions aside, if placebos are unethical because that would be denying treatment to participants of a study, that logically assumes that the drug they are testing must be better than nothing. The trouble is, that if they don't test them against a placebo, how do they know? If they begin by assuming that a drug will always be more effective to the extent that it should not be tested against placebo, then we can assume anything. At that stage we're into the realm of pseudoscience and foregone trial outcomes, which is no way to do science.

if placebos are unethical because that would be denying treatment to participants of a study, that logically assumes that the drug they are testing must be better than nothing. The trouble is, that if they don't test them against a placebo, how do they know?

Actually, there are a number of situations in which mainstream medicine considers placebo-controlled trials to be unethical.

The classic example is heart-attack victims. If twenty victims arrive in A&E over a week, it would obviously be unethical to divide them into two groups and use a fake defibrilator on half of them.

The risks involved in controlled trials have to be balanced against the lives that will be saved when the treatment is found to work (or not). All trials in the western world are subject to stringent ethical guidelines.

I myself have taken part in a clinical trial, and one in which there were fatalities. I still feel comfortable about the risk to which I was subjected.

(If anyone wants my advice, using [url]Mike Adams[/url] as the main source for a medical claim deserves nothing but laughter in response. I mean this most respectfully.)

Your classic example is not a good example. In a critical emergency, it's hard to see how you can make things worse, when faced with almost certain and imminent death, doing nothing is usually the worst option. There is some evidence of this. Even so, people do choose no treatment sometimes for a heart attack, and live, so who are we to knock their choice?

When it comes to chronic and terminal disease, there is plenty of scope to make the situation far far worse than it already is. The trouble is, we don't know that people aren't dying sooner and in more pain because of some treatments, because there are no controls for comparison.

Emergency medicine is what medicine is particularly good at, I'm afraid that this is not an argument that transfers easily to chronic or terminal illness, we are using many dangerous treatments without being able to quantify the benefit.

I'm intrigued about your experience of a medical trial: there's a certain inconsistency in your thinking. If it's okay to risk dying from an experimental treatment, why is it so much worse to risk death from no treatment at all?

Placebos, nocebos and multiple personalities

The placebo effect is one that is frustrating for pharma researchers. I can't remember where I read it, but I understand that many drugs have not been able to produced because the placebo effect was either the same or better.

It’s time placebos were taken seriously and really studied for their own sakes and the medical profession recognises the huge effect our thinking has on our bodies and the responses to medicated and non-medicated drugs. (I know of several people who have been given drugs they have not believed in - one chap accidentally drunk some liquid hallucinogenic from a soft drink bottle during a party, but when he realised what was happening he was able to stop the effect)

Here's a fascinating example of placebo surgery from a television documentary a few years ago:

[DLMURL] http://video.google.com/videoplay?docid=3632381798967472933 [/DLMURL]

Another area where there is a huge amount of data on the mind-body connection is here:

The effect of nocebos also deserves urgent consideration, especially as their use is promoted in some advertising by the pharma companies.

The Nocebo Effect: Placebo's Evil Twin

The nocebo phenomenon: concept, evidence, and implications for public health.

…Within minutes the arm the boys believed to have been exposed to the poisonous tree began to react, turning red and developing a bumpy, itchy rash. In most cases the arm that had contact with the actual poison did not react." (Gardiner Morse, "The nocebo effect," Hippocrates, November 1999, Hippocrates.com)

…Accordingly, they experienced breathing problems, and some had full-blown asthma attacks. They were then given the same saline spray, but this time they were told it was a helpful medicine -- and they recovered. Note that the patients didn't just think their airways were constricting -- they really were.

This author was someone who was looking at spiritual healing but it applies to the study of the mind-body effect as well.

The time has come when it is an urgent necessity that science should look at the pattern of life as a whole, taking every factor into account and excluding nothing from its inquiry... Firstly, science must approach the problem in the spirit of relativity rather than of Newtonianism; it must look for patterns, with a readiness to recognise whole patterns, rather than for force-laws. It will no longer start with the presumption that certain events cannot happen, or must not happen, or ought not to happen, in the old force-law terminology; it will rather be content to ask simply whether the event did happen, or does happen, and if so, of what particular pattern it is the evidence. It will be on the look-out particularly for the evidence of faint patterns emerging into sudden prominence... Relativity rules nothing out a priori; it is not concerned with rules, it observes patterns - and if it sees them it does not shut its eyes.
The Resurrection Pattern by Geoffrey Hoyland (1947)

Judy

Just read an article written by a former research scientist David Hamilton on :

Ironically, my research into the power of the mind, began while I was an R&D scientist with one of the world’s largest pharmaceutical companies – making drugs. I became fascinated with the placebo effect. That’s where 100 people get the drug and 100 get the placebo (dummy drug). Sometimes you find that around 70-80% of people get better on the drug but around 50-60% get better on the placebo because they believe they’re getting the drug. Certainly, those types of figures are real for some of the types of drugs I worked on – heart drugs and anti-hypertension drugs (for lowering blood pressure). People often quote the placebo effect as 35%. This is not entirely correct. It varies greatly from one condition to the next, and also with the nature of the medical trial, the appearance of the drugs and placebos (colour, shape, size, and even smell), and even the personality of the healthcare professionals administering it. Sometimes it’s low – 30% - but other times it’s high – 70%. You may be familiar with the fact that the placebo effect of most antidepressants accounts for 81% of the drug’s effectiveness. Similarly, an enthusiastic doctor maybe able to heal 80% of his patients with placebos, where a less enthusiastic doctor may only be able to heal 40% with the same placebos. The point is that there exists a capacity to heal and much of this depends upon your thoughts and beliefs. The power is within you!

Dr David R Hamilton gained a first – class honours degree in chemistry, specializing in biological and medical chemistry before going on to be a scientist in the pharmaceutical industry in 1995. Since 1999 he has worked as a motivational speaker and as a college lecturer in both chemistry and ecology. He has been featured on TV and radio and been the subject of national newspaper articles.

RP

I think one thing - and one only - becomes very clear in discussions around this issue. It's that mind and body are fundamentally connected. It seems that the scientific commmunity tends to regard the placebo effect as a problem - as if people are somehow being 'unreasonable' in allowing a 'fake drug' to cure them... I wonder when the penny will drop for them that we do not have a body - we are a bodymind. Our approach to healthcare needs to reflect that.

But of course those of us who aren't pumping clients full of GlaxoSmithKline's finest are all quacks, aren't we? :rolleyes: It would be quite funny if it wasn't so tragic.

I agree with you Richard!

Just found the link to this info I found very interesting and mentioned earlier:

Judy

I agree with you Richard!

Just found the link to this info I found very interesting and mentioned earlier:

Judy

Interesting article, thanks. Some drugs are sometimes very effective for some people with some conditions. Drug companies obviously want to turn 'some' into 'all' - and meanwhile alternative approaches that might be just as effective (and perhaps cheaper!) get ignored or dismissed as hokum. And the concept of holistic well-being gets short shrift, because it's actually subversive. IMHO society as it is currently structured is wholly incapable of permitting us to truly look after our integrated physical, emotional and psychological needs as a fundamental priority in our lives.

There are some fundamental problems with evidence based medicine. The main one that I see is that it is allowed to bypass the scientific method. In that I mean that pieces of isolated and unrelated data obtained in quite different contexts can be put together to form a theory, much as pixels on a screen can make an image.

Theory formation in science has always begun with testing an hypothesis, if we miss out that stage we lose the connection to real-world experience of human over generations. When there is a mismatch, the hard work begins of explaining it. EBM proponents grant themselves permission to ignore this task altogether.

When many peices of unrelated data come together, what is formed in not a theory at all, but another hypothesis, that itself requires testing in its wholeness.

So when a piece of research says that bumblebees ought not be able to fly, the task begins of explaining the mismatch. Sometimes it's necessary to look to the method of research and see what went wrong. It's not good enough to say that bumblebees are wrong. But this is what many medical researchers frequently do.

I agree, kvdp.

I always thought that the proper scientific approach was that test results should be consistently repeatable for a hypothesis to be accepted as theory. If X then Y - with no exceptions. This simply doesn't hold for pharmaceuticals - many drugs do not work on many people.

I think one thing - and one only - becomes very clear in discussions around this issue. It's that mind and body are fundamentally connected. It seems that the scientific commmunity tends to regard the placebo effect as a problem - as if people are somehow being 'unreasonable' in allowing a 'fake drug' to cure them... I wonder when the penny will drop for them that we do not have a body - we are a bodymind. Our approach to healthcare needs to reflect that.

But of course those of us who aren't pumping clients full of GlaxoSmithKline's finest are all quacks, aren't we? :rolleyes: It would be quite funny if it wasn't so tragic.

Richard- I think you will find very few scientists or doctors who do not agree that the body and mind are a single system, with feedback on several levels. The point under discussion is blinding and placebo control in the specific context of drug trials. There would be no point in testing a new drug against a placebo if there already exists a drug which is more effective than placebo.
Saying "Headaxe(TM) cures headaches better than Polo Mints" would hardly be a ringing endorsement.
"Headaxe has been shown to cure headache better than Aspirin, with lower gut inflammation ." is a useful observation.

The placebo effect is "a problem" for science in the sense that we don't know how it operates and many people are trying very hard to find out.
Gravity is a problem in that sense too.

It would be easy for Glaxo et al to produce sugar placebo pills, mark them up to a ridiculous profit margin and claim they cure 40-50% of all headaches via placebo effect, as they perhaps might. It would scarcely be ethical -though it's hard to see how it would differ from what Boots do using homoeopathic sucrose and lactose pillules which are analytically indistinguishable from pure sugar.

You are absolutely right that understanding how the placebo effect works - and why it does not work in every case- is important research and is an area where I would hope to see a Nobel won in the next decade.

SoapySam, there's a huge problem with getting further and further away from the benchmark with each succsssive trial, and that is known as 'the compounding of errors'.

Even with the best will in the world, the effect of compounding errors can turn night into day and yes into no after only a few tests against tests against tests.

As for selling sugar pills and labelling them as therapeutic because of 40% effectiveness that's known to be due to placebo; why is it so much more ethical to be selling dangerous toxins that don't work, on the basis of a testing system that's known to be full of flaws? It's not.

SoapySam, there's a huge problem with getting further and further away from the benchmark with each succsssive trial, and that is known as 'the compounding of errors'.

Then the test design is wrong.

Even with the best will in the world, the effect of compounding errors can turn night into day and yes into no after only a few tests against tests against tests.

If you test for a desired property, I don't see why you would get further from achieving it with every test. Can you give an example of what you mean?

As for selling sugar pills and labelling them as therapeutic because of 40% effectiveness that's known to be due to placebo; why is it so much more ethical to be selling dangerous toxins that don't work, on the basis of a testing system that's known to be full of flaws? It's not.

It isn't and I don't think anyone suggested it was. Two wrongs do not cancel, however.

The placebo effect is "a problem" for science in the sense that we don't know how it operates and many people are trying very hard to find out.
Gravity is a problem in that sense too.

It would be easy for Glaxo et al to produce sugar placebo pills, mark them up to a ridiculous profit margin and claim they cure 40-50% of all headaches via placebo effect, as they perhaps might. It would scarcely be ethical -though it's hard to see how it would differ from what Boots do using homoeopathic sucrose and lactose pillules which are analytically indistinguishable from pure sugar.

You are absolutely right that understanding how the placebo effect works - and why it does not work in every case- is important research and is an area where I would hope to see a Nobel won in the next decade.

A VP of GlaxoSmithKline admitted that 90% of drugs do not work on 30-50% of people. It is clear that the placebo effect is a signficant factor in the efficacy of medications. What I object to is scientists, doctors & pharamceutical companies dismissing alternative medicine as snake-oil, when in actual fact their own products are no more scientifically sound (universally repeatable).

A VP of GlaxoSmithKline admitted that 90% of drugs do not work on 30-50% of people.

Do you have a link for that, Richard? It's certain people's response to drugs varies widely among individuals.

It is clear that the placebo effect is a signficant factor in the efficacy of medications.

Indeed - and we need to understand exactly why so we can use it.

What I object to is scientists, doctors & pharamceutical companies dismissing alternative medicine as snake-oil, when in actual fact their own products are no more scientifically sound (universally repeatable).

The difference of course is that they are actually testing their products, whereas much alternative medicine is not adequately tested at all.
What's unacceptable is when they fiddle the data analysis to make their stuff or techniques look good. Even worse is when they sue for libel anyone who points out the error of their ways.
[DLMURL] http://libelreform.org/news/473-bbc-news-nmt-libel-case-intensifies-for-cardiologist [/DLMURL]

Do you have a link for that, Richard?

It was widely reported in the press at the time. The entry in Wikipedia states:

In December 2003, Allen Roses, the then worldwide vice-president of genetics at GlaxoSmithKline, admitted that most prescription medicines do not work on most people who take them. "The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people."

Just noticed an interesting article on the home page of Healthy Pages:

I think the placebo works pretty much like a homeopathic medication. The person takes the pill with the intention of a particular healing result, such as killing bacteria or calming inflammation, so that is what happens.

I thought this was an interesting article on 'the decline effect' and scientific testing.

I've just read a friend's blog and the topic today is placebos, so I thought I'd resurrect this thread and add the link. [url]Do the positive and negative of placebos and nocebos point to thought as king in healthcare concerns?[/url]

There's a video to watch and links to a couple of articles too. This is from an observation about one of them:

The article, called Mind over meds - patients can weaken painkillers’ punch by negative thoughts - by Benjamin Carlson, in Rupert Murdoch’s iPad newspaper The Daily – starts out with the line: “Told that a powerful painkiller would not bring relief, subjects in a new study from Oxford University felt the “nocebo” effect – as much pain as if they hadn’t been given the drug at all.” Lead researcher Irene Tracey was quoted as saying “We not only overrode all the goodness of the positive expectation, we overrode the goodness of the drug itself.”

To which one might gently add the query…or does such an experiment even point towards the fact that there is no intrinsic goodness in the drug itself? Is it possible that what these kinds of experiments are probing and proving is that all the effects that drugs appear to have are actually the evidence of the impact of educated belief on the body?

Judy

I find this thread interesting because double blind placebo trails had been dumped a long time ago as being unethical.

I've also come across people in such experiments, currently, where the most obvious experimental flaw comes immediately to light. So obvious, it's like the little boy saying that the king has no clothes on. The group who are not receiving the placebo but actual treatment (when neither group is really told the actual drug will make them feel bad) can have tremendously bad side-effects, such as from chemo, of course. It's very clear from quick and numerous side-effects which people are getting the real drug, and many of them actually call a halt (when there's no surety the operation hasn't worked fine anyway and they may be OK).

I doubt in these experiments that placebo subjects would get psychologically-induced side-effects as the effects are extremely bad, yet virtually no warning is given about them (there's no "set up" you might say).

V

Who would volunteer to be untreated for cancer for the sake of science? But if we don't leave some people untreated, how do we know that the therapy is really helping people and not actually killing them? The answer is we don't.

I'm aware of experiments which I suppose are ethical. After operation, when all cancer may be removed and chemo would not normally be administered unless it's seen to return, then 80% (for some reason) are given chemo anyway, and 20% a placebo. The observed results are then the %s of cases from each group in which the cancer returns.

But it does mean that potentially 'cured' people are volunteering to have awful side-effects for years to come, possibly for no reason.

V