"pharma/alternative medicine/superstitious nonsense"

[Astro]

xxxxxxxxx

So now we have a 170 page book that tells us how to cure all diseases except rabies and aids.

Oh did you find the book on the internet?

However, peer reviewed clinical trials are published in medical journals. If there was any evidence that homeopathy actually works it would get published. I did a quick search and came up with this interesting study - this is particularly interesting to me as I spent 3 years in research at the same University. The study looks at mosquito bites treated with a homeopathic remedy a placebo that is the same without the homeopathic component and no treatement. The conclusion was that there was no difference between the homeopathic remedy and placebo. The most telling thing was that the placbo was better than no treatment - and so was the homeopathic remedy. That is because, IMHO the placebo and the homeopathic remedy were identical.

it was a gel though. The best thing for insect bites is - well I'm not qualified to say.

The odd thing is that a link to this reference comes from a homeopathy website. They are actually using this kind of evidence to support homeopathy!

Maybe it's because they want to be seen as being open to these sort of clinical trials?

So they proved that toxic substances have the same toxic effect 150 years after the last time they were observed as having that toxic effect? I hardly think that could be a surprise to anyone. It doesn't, however, 'prove' anything except that the substance is toxic.

It's a pretty long leap of logic from there to assume that using a massively diluted solution of the same substance will cure that disease, don't you think?

Hippocrates - 470-400 BC - (The Father of Medicine) first wrote on curing with 'similars'
Similia similibus curentur - let like be cured with like.

He wrote of 2 methods of healing - by 'contraries and by 'similars'
His observations on cure by 'similars' were not followed by the medical proffession,* except that country people have used this principle sucessfully in their own folk medicine.

*In the late 19th century and early 20th century Homeopathic hospitals were opened in Bristol, liverpool, glasgow, Tunbridge wells and London (Royal Homeepathic Hospital, Quenns Sq. W1 - the Royal family use homepathy).

In 1946 when the NHS was established, homeopathy was included as an officially approved method of treatment.

Anyone can put anything on their card - anyone who has to fake a qualification in that way obviously has self-esteem issues. I'd be more scared if they went for 'MD' or 'MRCS' (although, at least that shows they think they're smart).

I think you mean RSHom, by the way...

[Andy McGregor]

it was a gel though. The best thing for insect bites is - well I'm not qualified to say.

Why stop now? You seem to be making a case for homeopathy as if you know about it. That your case is weak is an understatement. So far the only clinical evidence that's been offered on this site is evidence that I've found - and that evidence proved that a homeopathic remedy did not relieve the symptoms of mosquito bites - so far we've covered mosquito bites (ineffective), aids (ineffective) and rabies (ineffective).

Is there any actual placebo controlled, evidence from a properly designed study that shows a homeopathic remedy can offer a better prognosis than placebo?

[Astro]

Why stop now? You seem to be making a case for homeopathy as if you know about it. That your case is weak is an understatement. So far the only clincal evidence that's been offered on this site is evidence that I've found - and that evidence proved that a homeopathic remedy did not relieve the symptoms of mosquito bites - so far we've covered mosquito bites (ineffective), aids (ineffective) and rabies (ineffective).

Is there any actual placebo controlled, evidence from a properly designed study that shows a homeopathic remedy can offer a better prognosis than placebo?

I know some, it's great for first aid when you have little kids.

In know way am I qualified to give out advice.

I was just trying to add a little knowledge to the debate, as i do believe it works, but I'm not trained, and I'm not a scientist, nor am I linked in with medicine in any way.

I don't know about any specific clinical evidence.

What you really need is a Homepath on the forum to answer your questions.

I did try!

[Chef]

I was just trying to add a little knowledge to the debate, as i do believe it works, but I'm not trained, and I'm not a scientist, nor am I linked in with medicine in any way.

Unfortunately you are not able to add any knowledge to the debate you are only able to offer opinion and do not seem able to understand the difference between knowledge and opinion.

You believe it works and that is enough. If any big pharma company tried to offer any medicine with only the belief that it worked a) no health provider would buy it and b) no one would ever believe them ever again.

Big pharma are required by law to provide data from large scale, multi national, double blind (where neither the doctor or the patient knows which contains the drug and which is placebo) clinical trials. This data is analysed and collated by companies that are paid by the pharma industry (a bit like getting an MOT for your car - just because you are paying for the test doesn't mean you will get the answer that is most convenient). What the data shows is what the data shows and there is no hiding from it. If it shows that the material is not effective or safe enough then tough luck big pharma - the hundreds of millions of pounds that you spent has all been wasted.

A lot of modern medicines had their starting points in nature. Willow bark for aspirin. Poppies for morphine. Snake venom for blood pressure regulators. Digitalis from poisionous plants. Incidently most of this shows that understanding the actions of poisons give a useful avenue to medcines, but you have to understand it and then prove it.


All we are asking of alternative "medicine" is that it be proved to the same standards as you require of big pharma. If your therapy is proved then it becomes a medicine otherwise it is merely a part of a belief sytem

[Barry Shnikov]

Harris Coulter is not a doctor, and he's not a trained scientist either. His tertiary education was 'Russian studies' and 'political science', and his doctoral thesis (in what subject one can only guess) was on the history of homeopathy.

He also appears to be a bit barking - apparently his book AIDS and Syphilis-the hidden connection says that AIDS is really only syphilis, that HIV does not compromise immune systems, and furthermore that (as I understand it) healthy people having nothing to fear from an HIV infection.

This from someone who (I think it's safe to say) has never done an experiment on a pathogen in his life.

I don't say it's utterly impossible that he could have written an informed and unbiased book about clinical testing of alternative medicines, but I think the probability is somewhere about that of finding a bandstand on Mars.

[Barry Shnikov]

It works on the principle of less is more.

I understand what the principle is, but it doesn't work on that principle, nor on any other (except placebo).

There isn't 'less' in a homeopathic remedy, there is 'none'. That's a fact. Those few people who have used the scientific method to demonstrate that homeopathy works have had to concede that there is nothing of the 'active ingredient' left in the remedy. They have therefore been reduced to arguing that the water (or whatever medium) retains a 'memory' of the active ingredient with which it has been in contact, and that the water therefore has a curative effect.

This of course is patently stupid. If this 'water memory' were a real phenomenon, water would retain a memory of all the kidneys it has passed through, all the fish, all the lead pipes, all the feces that have been dissolved in it, and so on and so on.

The one experiment which appeared to confirm the 'water memory' effect was shown, upon closer investigation, to be a sad instance of confirmation bias (the experiment involved a lady researcher counting numbers through a microscope; unfortunately she already knew which petri dishes contained the 'homeopathic' results and which the 'placebo' results, and she was (presumably) unconsciously seeing 'more' in the homeopathic petri dishes. When she was given dishes where she did NOT know which was which, the apparent discrepancy disappeared and there was no statistical significance to report.

There is no doubt that if you exclude all useful evidence homeopathy appears to work; it seems to be effective. But that appearance is due entirely to anecdotal evidence. Anyone with any knowledge of the incredible complexity of the human bio-system knows that there are too many variables for anecdote to be anything but a preliminary indication of a potential remedy.

Plus, you need to understand the enormous power of placebo. Early experiments showed (I cannot remember the details) that a particular surgical intervention was ineffective; because when the surgeon simply made an incision and sewed it up, without carrying out the rest of the procedure, both sets of patients experienced approximately the same relief from their symptoms.

Somebody experiencing relief from their symptoms after homeopathic treatment cannot know themselves whether the relief is caused by the treatment, or whether they have imagined it. To some extent, as long as they are experiencing relief, who cares whether they are imagining it or not? But you can't expect to give other people the same treatment with the same success until you have determined whether the relief is real or not.

In one sense, I don't care whether homeopathy exists or not. If it makes people feel better, it might be a good thing. The trouble is, most supporters of homeopathy have no boundaries - they think the whole thing stands up like the theory of relativity and consequently there are people spending disgraceful amounts of money on distilled water and pure sugar and other people may be dying or suffering pain because they went to a homeopath and not a doctor. Every time I hear about NICE saying that the price of a drug is out of proportion to its clinical effectiveness and therefore it won't be available on the NHS, I seethe with despair at the money wasted on homeopathic hospitals which could be spent on proven treatments.

What's the homeopathic treatment for haemophilia, by the way?

[Barry Shnikov]

Do you have a more direct link Barry?

To what? the blogosphere fuss about homeopathic treatment of holidaymakers in malaria regions?

[Barry Shnikov]

Hippocrates - 470-400 BC - (The Father of Medicine) first wrote on curing with 'similars'
Similia similibus curentur - let like be cured with like.

He wrote of 2 methods of healing - by 'contraries and by 'similars'
His observations on cure by 'similars' were not followed by the medical proffession,* except that country people have used this principle sucessfully in their own folk medicine.

In 1946 when the NHS was established, homeopathy was included as an officially approved method of treatment.

Might as well quote Socrates on how to get good television reception.

They did not even have a working theory of disease in those days. The derivation of that word itself shows the depths of our forefather's ignorance (in the proper sense = not knowing) of sickness: dis - ease. The state where a body is not 'at ease' with itself - because the humours are out of balance. George Washington was killed by two doctors who, despite the fact that he was probably suffering from nothing more than a slight viral fever - flue or a cold - took something like 6 pints of blood from him in 48 hours.

Why did they do that? Because the ancient greek doctors said that certain types of 'dis-ease' were caused by an excess of blood - they had no idea what blood was for, what it does in the body - and so if there's an excess of blood, well by god we must get rid of that excess somehow.

Please don't expect us to take seriously anything said in ancient greece about illness and treatment. Hippocrates is only important because of what he said about how doctors should practise medicine.

Yes, the NHS was saddled with a homeopathic arm. Why? Because a deluded upper-class conservative MP who believed - on the same absence of evidence as you - insisted on it (no doubt trying to curry favour with the Royals!) It wasn't a decision made by either doctors or scientists, so it has no effect on our debate as to whether homeopathy is a true phenomenon.

[Andy McGregor]

I know some, it's great for first aid when you have little kids.

-snip-

I did try!

Thank you for trying

I'm afraid you've been hoodwinked but homeopathy. The people who are arguing against homeopathy are mostly trained scientists. Most of us are sceptical of anything that hasn't been tested properly or anything involving pseudo-science. There is no scientific basis for homeopathy and there is no evidence that it works. Arguments that homeopathy is better than placebo are completely unsupported by anything other than anecdote.

[JiveLad]

Again I am not really sure what you are trying to say here Jivelad.

Are you trying to say that all medicines from big pharma have not undergone clinical testing or are you saying that have undergone clinical testing but that those tests were not rigorous?

Which is it and what information do you have that makes you believe that?

Are you stating here and now, and publically, that you never have nor ever will take drugs made by big pharma, because you believe that have not been clinically tested?

Clearly the tests are not rigorous - if so, why are so many big drugs later withdrawn? Rigour to me means that it has been tested over a sufficient period of time (clearly not the case with statins for example) - and done in a scientific way (clearly not the case with big pharma - see link below for example).

Another area of growing complexity is the interplay of different drug regime combinations. When patients are taking 5 or 6 different drugs at the same time, what testing is done across all the possible combinations?

You can take your pick of any number of drug scandals from big pharma. Interesting to see the latest report on Vioxx which hit the wires a few hours ago:

Bloomberg.com: Worldwide

Quote: "``was marketing masquerading as science,''

[Chef]

Clearly the tests are not rigorous - if so, why are so many big drugs later withdrawn? Rigour to me means that it has been tested over a sufficient period of time (clearly not the case with statins for example) - and done in a scientific way (clearly not the case with big pharma - see link below for example).

The clinical trials are quite extensive before the product is launched. Even after the product is launched data is still gathered so the collection and analysis of data doesn't end once the product is launched. In a patient group of 15,000 people two people have heart attacks during the six month trial on your drug and one person on placebo (you only find this out when the double blind study is decoded). Is the extra person that has a heart attack caused as a result of being on your drug or a purely random event? The data from 15,000 people will not be able to tell you. Data from 8 million patients might.

Is it your proposition that all the sufferers of, say, Parkinsons disease in the entire world have to be medicated for 10 years before we can know is the treatment is 99.9999999% safe?

The criteria is different for different diseases. If you have a disease like diabetes then you are likely to be on medication for many years and many drug side affects are not tolerable for that disease. If you have cancer then you are likely to be on medication for a shorter time (being either cured or dead) and you are probably willing to suffer more severe side effects considering the effects of untreated cancer. This is inevitable for cancer drugs since the drugs are only slightly more toxic to cancer cells than they are to healthy cells.

People were smoking for many decades (some doctors even telling people that it was good for them) until enough data was available from the population to link lung cancer to smoking - not helped by the long time between starting smoking and the onset of the disease. People still smoke today even with all they know about the affects.

Another area of growing complexity is the interplay of different drug regime combinations. When patients are taking 5 or 6 different drugs at the same time, what testing is done across all the possible combinations?

Well I will leave you to work out the maths. About 35,000 drugs - pick every combination of 5 drugs out of those and then recruit 15,000 patients to test them for interactions over a period of 5 years. You might run out of available humans on the planet. As we understand more about how the human body works on a chemical and biological level we can use that knowledge to understand that affecting one system with a drug may have affects in another system (knowledge leads to understanding and that leads to a theory) and we can specifically look for interactions between two or more diseases or drugs (theory requires experimentation to test that theory).

That should cut the number of humans required to test the theory down to a managable number.

As a little aside. I sometime get asked why drug companies don't make drugs for children. My reply goes along the lines of asking these parents if they would want a tested or untested drug. Always they say that they wanted one that is tested. I tell them that the metabolism and immune systems of adults and children are quite different and almost all drugs are tested in adults and are therefore not licensed for use in children so to be licenced for use in children they would need to be clinically tested in children. That is just what we want they always say. Fine, I say, who is going to volunteer their own babies and children for the testing programme. There never have been any volunteers at this point.

You can take your pick of any number of drug scandals from big pharma. Interesting to see the latest report on Vioxx which hit the wires a few hours ago:

Bloomberg.com: Worldwide

Quote: "``was marketing masquerading as science,''

Well there are never going to be any drug scandals from homeopathy is there. Are they ever going to collect any data from double blind, peer reviewed multi national clinical trials that can be analysed for possible side effects? The world awaits - in the meantime they are just keeping the patient amused while nature gets the job done.

Am I still right in assuming that you will never take a drug from big pharma?

A leading member of SHAC (stop hundingdon animal cruelty) spent 30 years screaming and threatening staff at anyone remotely connected to pharma and telling everyone that we have all the cures we need from nature. The moment she got breast cancer she eagerly took up all those animal tested big pharma drugs that she could. Just like calling the police facist bastards until somone is attacking your house with an axe and then you desparately want them around.

[Andy McGregor]

Clearly the tests are not rigorous - if so, why are so many big drugs later withdrawn? Rigour to me means that it has been tested over a sufficient period of time (clearly not the case with statins for example) - and done in a scientific way (clearly not the case with big pharma - see link below for example).

Another area of growing complexity is the interplay of different drug regime combinations. When patients are taking 5 or 6 different drugs at the same time, what testing is done across all the possible combinations?

You can take your pick of any number of drug scandals from big pharma. Interesting to see the latest report on Vioxx which hit the wires a few hours ago:

Bloomberg.com: Worldwide

Quote: "``was marketing masquerading as science,''

We are all aware of the occasional failures of drug companies. The good news about Vioxx is that it has been withdrawn. That withdrawal was due to the on-going vigilance of the medical profession and the manufacturer.

What I'd prefer JiveLad to do is give us some evidence, any at all, that homeopathic remedies work. It is very easy to knock drug companies and it is very easy to knock the established practice of medicine by citing the occasional failure. However, this is, yet again, arguing from the particular to the general. In general, the objectives of drug companies and the objectives of the medical profession are to provide effective treatments that have minimal side-effects.

Come on JiveLad, we all agree that there are occasional failures of drug companies and medics. Let's put that to one side while you tell us about how effective homeopathy can be in the treatment of real diseases? Rather than trying to prove how good homeopathy is by saying how bad the competition has been I'd like to hear why you think homeopathy is so good. No anecdotes, no one-patient stories, no pseudo-science, please. Just hard evidence where patients with real diseases had them cured by homeopathy. People are treated in this way every day. There must be some data, somewhere that shows it actually works. If there is no data, in the face of so much treatment we can draw only one conclusion.

Tell us about the success of homeopathy with real patients, not the theory. Come on JiveLad, do you think you can do that?

[JiveLad]

We are all aware of the occasional failures of drug companies. The good news about Vioxx is that it has been withdrawn. That withdrawal was due to the on-going vigilance of the medical profession and the manufacturer.

What I'd prefer JiveLad to do is give us some evidence, any at all, that homeopathic remedies work. It is very easy to knock drug companies and it is very easy to knock the established practice of medicine by citing the occasional failure. However, this is, yet again, arguing from the particular to the general. In general, the objectives of drug companies and the objectives of the medical profession are to provide effective treatments that have minimal side-effects.

Come on JiveLad, we all agree that there are occasional failures of drug companies and medics. Let's put that to one side while you tell us about how effective homeopathy can be in the treatment of real diseases? Rather than trying to prove how good homeopathy is by saying how bad the competition has been I'd like to hear why you think homeopathy is so good. No anecdotes, no one-patient stories, no pseudo-science, please. Just hard evidence where patients with real diseases had them cured by homeopathy. People are treated in this way every day. There must be some data, somewhere that shows it actually works. If there is no data, in the face of so much treatment we can draw only one conclusion.

Tell us about the success of homeopathy with real patients, not the theory. Come on JiveLad, do you think you can do that?

Not sure when I have ever mentioned or posted anything about homeopathy.

Can you please quote your source.

(Then we'll get back to big pharma).

[Andy McGregor]

Not sure when I have ever mentioned or posted anything about homeopathy.

Can you please quote your source.

(Then we'll get back to big pharma).

Sorry, my misconception, you are responding to a thread titled "pharma/alternative medicine/superstitious nonsense". If you are attacking "big pharma" I'd be interested to hear what you do support. I'd assumed, from the title of the thread, that you were supporting "alternative medicine/superstitious nonsense". Do I take it from this that you believe in no treatments at all?

We really need Gav to post supporting evidence for "alternative medicine/superstitious nonsense".

[JiveLad]

Sorry, my misconception, you are responding to a thread titled "pharma/alternative medicine/superstitious nonsense". If you are attacking "big pharma" I'd be interested to hear what you do support. I'd assumed, from the title of the thread, that you were supporting "alternative medicine/superstitious nonsense". Do I take it from this that you believe in no treatments at all?

We really need Gav to post supporting evidence for "alternative medicine/superstitious nonsense".

Hi Andy - that's ok. My main target is 'big pharma' - and the problems they create. Of course, not everything they have done is bad or unethical - however there are major problems. And having seen some of the issues in a number of pharma companies for which I have worked in Sales & Marketing it really did change my view.

In terms of "what do you support" - I'm not sure I understand the question. If we are going to have a deeper discussion about the philosophy of Western based medicine - that is fine - and I can provide you with some contrasting ideas and approaches to a symptom-cause-drug kind of approach.

In terms of the "occasional" problems - well, this is a list of safety based withdrawals in 2005 alone:

n Azaribine
(1970/1975/1976)
psoriasis treatment/serious blood clots
n Ticrynafen
(1978/1979/1980)
blood pressure reduction/liver toxicity
n Benoxaprofen
(1980/1982/1982)
pain relief/liver toxicity
n Zomepirac
(1979/1980/1983)
pain relief/fatal allergic reaction
n Nomifensine
(1979/1984/1986)
antidepressant/hemolytic anemia
n Suprofen
(1979/1985/1987)
pain relief/acute kidney failure
n Encainide
(1984/1986/1991)
irregular heartbeat/fatal arrhythmia
n Temafloxacin
(1990/1992/1992)
antibiotic/kidney failure
n Flosequinan
(1991/1992/1993)
congestive heart failure/increased deaths
n Fenfluramine
(1967/1973/1997)
appetite suppression/heart valve disease
n Terfenadine
(1983/1985/1998)
antihistamine/fatal arrhythmia
n Bromfenac
(1995/1997/1998)
pain relief/liver toxicity
n Mibefradil
(1996/1997/1998)
blood pressure reduction/serious drug-drug interactions leading to muscle damage and fatal arrhythmia
n Grepafloxacin
(1997/1997/1999)
antibiotic/fatal arrhythmia
n Astemizole
(1985/1988/1999)
antihistamine/fatal arrhythmia
n Cisapride
(1991/1993/2000)
heartburn/fatal arrhythmia
n Troglitazone
(1996/1997/2000)
diabetes/liver toxicity
n Alosetron
[Remarketed in 2002 with restricted distribution]
(1999/2000/2000)
irritable bowel syndrome/ischemic colitis, severe constipation
n Cerivastatin
(1996/1997/2001)
cholesterol reduction/muscle damage leading to kidney failure
n Rapacuronium
(1998/1999/2001)
anesthetic/severe breathing difficulty
n Etretinate
(1985/1986/1999)
psoriasis/birth defects
n Levomethadyl
(1993/1993/2003)
opiate dependence/fatal arrhythmia
n Rofecoxib
(1999/1999/2004)
pain relief/heart attack, stroke
n Valdecoxib
(2001/2001/2005)
pain relief/skin disease
n Natalizumab
[Remarketed in 2006 with restricted distribution]
(2004/2004/2005)
multiple sclerosis/brain infection
n Technetium (99m Tc) fanolesomab
(2000/2004/2005)
diagnostic aid/cardiopulmonary arrest
n Pemoline
(1969/1975/2005)
ADHD/liver failure

(Source: FDA).

I guess it comes down to your definition of "occasional".

[Chef]

I guess it comes down to your definition of "occasional".

I guess it does come down to your definition of "occasional". A drug company that I knew something about 10 years ago was being sued by 9 patients because they said that they suffered pins and needles in thier hands and they were sueing the pharma company for $15 million each in compensation. If you were one of the 13 million people treated with this drug in the US over the last 10 years then you might not see this as a problem but if you were one of the nine people who were suffering from constant pins and needles in your hands then it would be a very real tragedy. Sure there were 973 patients in the USA that year who were suffereing the same symptoms who had never been prescribed the drug nor who had worked with vibrating machinery so there was some argument as to whether the drug was responsible for these peoples symptoms. Never the less the case had to be tested in the court.

The point is is that data is collected and analysed and drugs are withdrawn/ammended as the result of adverse data.

Somthing I heard on the news yesterday morning was that pharma companies spend twice as much on marketing as they do on research and development. That shocked me and made me think that humankind may now have discovered all the drugs needed for all the diseases that we have and perhaps we should now stop if we have got to the point where so much efforts is put into pursueing market share. But then, I am a scientist and know nothing about marketing so I sort of think about it as a non job.

I understand that you have a problem with big pharma and believe that it causes problems.

My two questions for you are

Does it cause more problems than it solves? ie does the risk outweigh the benefits in your opinion?

What do you propose as an alternative?

[JiveLad]

The point is is that data is collected and analysed and drugs are withdrawn/ammended as the result of adverse data.

Eventually - that may happen. Not without a struggle in many cases.

I refer you to the previous report I quoted Bloomberg.com: Worldwide

- and the concept of "seeding trials" (aka marketing trials - so it is somewhat out of the hands of the clinical researchers - or at least, managed and motivated from a different perspective).

Of course "seeding" is a marketing concept well used in other industries. What has been happening over the last few years has been that Big Pharma have been recruiting high profile Marketeers from other industries (eg. Pepsico) who then bring with them some of those discplines. I wonder if some of the practices are appropriate to a supposedly 'ethical' industry like this. It creates all sorts of conflicts of interest when it comes to the reporting and managing of adverse events, as the Vioxx experience is showing.

[Chef]

Of course "seeding" is a marketing concept well used in other industries. What has been happening over the last few years has been that Big Pharma have been recruiting high profile Marketeers from other industries (eg. Pepsico) who then bring with them some of those discplines. I wonder if some of the practices are appropriate to a supposedly 'ethical' industry like this. It creates all sorts of conflicts of interest when it comes to the reporting and managing of adverse events, as the Vioxx experience is showing.

I share your concerns about this sort of thing. I am a scientist within a big pharma company and I understand the dangers both to the public and to the industry of this sort of attemts to put spin on adverse results. IMHO it helps no one at all.

Typically if you look at a big pharma stock market valuation (price of shares x number of shares) and then look at the book value of every physical asset they own then it turns out that about 98% of a comapnies value lays in its knowledge and patents - or at least how much value investers believe that intellectual property is worth.

If a company starts hiding adverse data or even worse - lying, then it calls into question the value of all of the knowledge and patents that that company holds. It is not inconcievable that company behaving in an unethical manner could face the prospect of losing 98% of its stock market valuation.

The risks of not being utterly open and honest about clinical data are so huge that it is not worth the risk.

On the other hand that openess is also openess can also unjustly hurt you. A recent independant analysis indicated there there was an increased risk of heart attack with a drug. In a flash doctors across the world stopped prescribing it, profits dropped by $600 million per year. A wise precaution but analysis of all data for all drugs for treating this disease showed that they all carried exactly the same risk. So you choice was to have a 35% chance of dying from the disease if not treated or a 0.0000027% of dying from a heart attack over the same five year period.

It turned out that the drug itself had no more risk that any other treatment and was a major benefit to people with the disease. But taking a hit of $600 million of profits would destroy most companies (and quite a few banks). However patient safety always comes first because patients are people not items on a balance sheet.

[Andy McGregor]

Somthing I heard on the news yesterday morning was that pharma companies spend twice as much on marketing as they do on research and development. That shocked me and made me think that humankind may now have discovered all the drugs needed for all the diseases that we have and perhaps we should now stop if we have got to the point where so much efforts is put into pursueing market share. But then, I am a scientist and know nothing about marketing so I sort of think about it as a non job.

As someone who has worked in this area of "non-job" for most of my working life I must admit that I'm surprised the spend is twice as much as on R&D. I think this may apply more to the USA than the UK. I've only worked in Sales and Marketing in the UK. Therefore I can only comment about the UK. In the UK in recent years there has been a trend towards a reduction in sales and marketing expenditure in drug companies - especially in sales with the numbers of representatives being reduced massively.

Of course the sales of a drug, no matter how they are created, do not make a difference to the chances of an active producing unwanted effects - it either causes them or it doesn't. However, as Chef said, the more you sell of anything, the more patients will use it and the more chance there is of a pattern of unwanted effects being observed.

I would say that the number of drugs withdrawn shows that the industry is doing it's job and taking note of unwanted effects. As Chef said, it is impossible to know what the very uncommon effects, if any, will be until a product is marketed and used by a huge number of patients. The pre-marketing studies can pick up the common or even uncommon unwanted effects - but there will sometimes, thankfully rarely, be an unwanted effect that is very uncommon or arises after many years of use. It's all to do with "confidence limits" as referred to by statisticians. They choose a sample size that gives them a level of confidence about side-effects.

[HelenB]

Another area of growing complexity is the interplay of different drug regime combinations. When patients are taking 5 or 6 different drugs at the same time, what testing is done across all the possible combinations?

The clinical trials are quite extensive before the product is launched. Even after the product is launched data is still gathered so the collection and analysis of data doesn't end once the product is launched. In a patient group of 15,000 people two people have heart attacks during the six month trial on your drug and one person on placebo (you only find this out when the double blind study is decoded). Is the extra person that has a heart attack caused as a result of being on your drug or a purely random event? The data from 15,000 people will not be able to tell you. Data from 8 million patients might.

{snip}

Well I will leave you to work out the maths. About 35,000 drugs - pick every combination of 5 drugs out of those and then recruit 15,000 patients to test them for interactions over a period of 5 years. You might run out of available humans on the planet. As we understand more about how the human body works on a chemical and biological level we can use that knowledge to understand that affecting one system with a drug may have affects in another system (knowledge leads to understanding and that leads to a theory) and we can specifically look for interactions between two or more diseases or drugs (theory requires experimentation to test that theory). {snip}

Every trial collects data about other concomitant medications and medical history of the patient that gets entered into this database which helps to build up safety data.

I'm the bod who goes out to hospitals to check that the patients who enter the study (by giving consent) are treated according to the strict protocol and that all events/medications/medical history recorded in the patient notes are reported to the pharma company so I know this data is collected (I've checked plenty)

Oh, and on a side note, yes there's been some withdrawals. Some don't even make it past preclinical work, or Phase I. Surely that's proof of the system in place to ensure patient safety

p.s. You forgot to mention all the drugs that have been approved.