UK medicines regulation is now officially non-scientific

[Blue Wode]

Another two signatures added to the Statement of Objection.

John Hewitt, here’s your “A Habit of Lies - How Scientists Cheat” link:
http://freespace.virgin.net/john.hewitt1/

And here’s your short autobiographical sketch
http://www.sexandphilosophy.co.uk/author.htm

 

[Deetee]

Please everyone keep submitting your objections and comments to Chris Tyler on the Sense about Science link Asolepius gave.

To register your concerns:
· Sign this statement (click on the link at the bottom of the pdf) and send in your comments
· Contact medics and scientists and urge them to do the same

As Asolepius says, this will be debated in the House of Lords on the 26th October, and although this will not immediately change anything, it will serve as a marker of general concern and get things on the public record.

Those of you who have already registered your objections will have received an email from Chris. Included is this bit:

The next stage is to make sure that everyone who should know about these regulations does. In preparation for the debate on 26th, to make a fully comprehensive case on these regulations, we want comments from EVERYONE who is concerned with the role of evidence in medicine. Please continue to publicise the EBM statement on our web site, contact us with suggestions and write about it in newsletters etc. If you are a member of an institution that could respond do let us know so that we can coordinate approaches, since some are already vocal on the issue.

 

[Mojo]

I took a look at this press release and I cannot see what you expect anyone to do. Homeopathic medicines are just water and you cannot ban the sale of water you can only say that it is ineffective as a medicine. I am sure the purveyors of these things, like those who sell cosmetics, use careful phrasing to stay within the law, so they can't be banned.

Did you actually read the press release or any of the discussion of it?

For the first time since Product Licences of Right were issued in 1971, companies will be allowed to include information about the treatment and relief of minor, self-limiting conditions based on the use of the product within the homeopathic tradition. For example, labels may indicate that a product may relieve the symptoms of common colds and coughs, hay fever or chilblains.

The purveyors of these things will be allowed, within the law, to make medical claims for their products without having to provide any evidence that they are in fact effective. That is what the issue is here.

 

[John Hewitt]

The purveyors of these things will be allowed, within the law, to make medical claims for their products without having to provide any evidence that they are in fact effective. That is what the issue is here.

Yes, I did read it and I have the feeling you are being excessively precious. Nobody has ever demonstrated, or will ever demonstrate, that homeopathic medicines are worth anything - they are only water. Do you really think you can ban something that harms nobody and clearly gives many people comfort?

If you ban their sale as medicines, they will be sold as medicaments or as remedies or whatever other phrasing can be constructed. What else will you ban because "Sense about Science" have no sense. Will you ban contributions into church offertory boxes because you are an atheist? Can I ask for a ban on deodorant sprays because, when I use them, women don't chase after me in the supermarket? Things should be banned only when harm can be demonstrated.

You seem anxious to ban whatever you don't believe and to build some kind of peer reviewed New Atlantis. The reality you are not facing up to is that cultures that claim to be utopias are, in fact, dictatorships and that is what I object to here. On the face of it, the rules proposed by that press release would harm nobody and would comfort many. I would say to scientists, do your own job and put the facts to people, then allow them to make their own decisions.

You can have my signature whn you can demonstrate that homeopathy, given under those rules, causes anyone any harm.

 

[Badly Shaved Monkey]

John

Are you happy that NHS money is spent propagating the lie that is homeopathy?

You appear to be highly concerned about your vision of truth in science. Are you happy about the stamp of official approval that is progressively being applied to homeopathy by the health regulatory authorities? Do you not think that has a corrosive effect on public understanding of science?

You also seem to be labouring under a misapprehension. It would be hard to epxlicitly ban homeopathy, but the subject under discussion is resisting its adoption by the UK health system.

 

[asthmatic camel]

You can have my signature whn you can demonstrate that homeopathy, given under those rules, causes anyone any harm.

Homeopathic remedies don't harm anyone, how could they when they contain no active ingredients? The danger is that people choose them instead of proven therapies and expert medical advice; official endorsement increases the risk of this happening.

And it does happen. One high profile case was Spike Milligan's wife, who decided to dismiss conventional medicine in favour of homeopathy. At one stage, the homeopath confidently declared that Mrs. Milligan was cured. Pity she died a few months later, isn't it?

 

[Asolepius]

To John Hewitt

Firstly, welcome to the forum. As the OP on this thread I feel obliged to explain a few things.

Here is a hypothetical scenario. Those responsible for these new regulations might claim that no harm is done because only `mild self-limiting conditions' are allowed to be on the labels. A distinguished medical expert might ask whether constipation would be one of those. Naturally the reply would be "Of course". The distinguished medical expert might then say "I suppose you realise that one of the first signs of bowel cancer is constipation?". Now many other products are marketed for constipation, but the difference is that they work. If they don't work, there is most likely something more serious. The danger of homeopathy is that it encourages people to abandon rational thought that might save their lives.

There is a vastly wider issue at stake than just health. The UK and the USA recently went to war, resulting it was reported this week in the deaths of some 600,000 people in Iraq alone. Please don't quibble about the numbers, you only have to look at the news to see the extent of the daily slaughter. It emerged very quickly that the evidence supposedly justifying the war was absent. Moreover, in the UK two public enquiries exonerated the government, and considered that the British Prime Minister had no obligation to verify the evidence for weapons of mass destruction in Iraq. This demonstrates the disdain with which evidence is treated in the highest echelons of government.

What the present scandal over homeopathy is about is not really whether it works or not. We all agree here that it doesn't - you do as well. Even the MHRA agrees with that. It quite clearly stated that homeopathic products "have difficulty in establishing efficacy in clinical trials". In its very next sentence, the MHRA agreed to accept `non-scientific data'. In other words, it is prepared to accept lies about homeopathy, but it won't accept anything other than scientific data for any other products.

Do you really think that government sponsored lying is good for society - or even tolerable? You might respond by saying "Get real, governments always lie". This is perfectly true. They tell more lies than truth. Just because it's the norm does not make it right. You might also say "Why bother? It's a losing battle". Maybe you are right there as well, but believe me, I will go to my grave a guilty man if I don't try. Read my sig line.

 

[Mojo]

You can have my signature whn you can demonstrate that homeopathy, given under those rules, causes anyone any harm.

The point is not whether homoeopathy does any harm; it is whether it does any good.

Do you think that the manufacturers of homoeopathic "medicines" should be allowed to claim that their "medicines" can be used to treat particular conditions in the absence of any evidence that their "medicines" are effective in treating those conditions?

To make this a little easier for you, I'll ask you a second question. I'd like you to answer both, please.

Do you think that pharmaceutical companies should be allowed to claim that their products can be used to treat particular conditions in the absence of any evidence that their products are effective in treating those conditions?

 

[Mojo]

Nobody has ever demonstrated, or will ever demonstrate, that homeopathic medicines are worth anything - they are only water.

So why do you think it is OK for the manufacturers of homeopathic "medicines" to make therapeutic claims about their products? Do you think that vendors should be allowed to give misleading descriptions of the products they are selling? Do you think it is OK for second hand car dealers to wind back the odometers on the cars they're selling and claim that the cars have done less miles than they actually have?

If, as you say, "nobody has ever demonstrated, or will ever demonstrate, that homeopathic medicines are worth anything" do you think that the purveyors of these "medicines" should be allowed to claim that they are worth something?

Should people be allowed to lie in order to sell a product?

 

[Asolepius]

.....and I will add my other favourite quotation from Burke:

All that is necessary for the triumph of evil is that good men do nothing.

John Hewitt advocates doing nothing. This is why evil happens. Does anyone really think that Pandora's box still has its lid on?

 

[Cynric]

If you ban their sale as medicines, they will be sold as medicaments or as remedies or whatever other phrasing can be constructed.

That's how they are presently sold, and I doubt anyone here has any problem with that. It's lamentable that people are not persuaded by good argument, certainly, but they are free to do as they please and believe what they will. Government-sanctioned misinformation is another matter.

Things should be banned only when harm can be demonstrated.

And things should only be officially licenced as medicine if benefit can be demonstrated.

You seem anxious to ban whatever you don't believe and to build some kind of peer reviewed New Atlantis. The reality you are not facing up to is that cultures that claim to be utopias are, in fact, dictatorships and that is what I object to here. On the face of it, the rules proposed by that press release would harm nobody and would comfort many. I would say to scientists, do your own job and put the facts to people, then allow them to make their own decisions.

A little OTT perhaps?
If you consider the requirement for scientific evidence of the efficacy of medicines to be onerous, do you perhaps think the MHRA should be disbanded altogether?

 

[asthmatic camel]

.....and I will add my other favourite quotation from Burke:
John Hewitt advocates doing nothing. This is why evil happens. Does anyone really think that Pandora's box still has its lid on?

Some of us are hiding beneath the lid, occasionally sniping at the serpents and other uglies.

 

[Mojo]

Do you really think that government sponsored lying is good for society - or even tolerable? You might respond by saying "Get real, governments always lie". This is perfectly true. They tell more lies than truth. Just because it's the norm does not make it right. You might also say "Why bother? It's a losing battle". Maybe you are right there as well, but believe me, I will go to my grave a guilty man if I don't try. Read my sig line.

I'm sure that the irony of the author of a document called "A Habit of Lies - How Scientists Cheat" defending the right of homoeopaths to lie about their products is not lost on most of the people reading this thread.

 

[John Hewitt]

Here is a hypothetical scenario. Those responsible for these new regulations might claim that no harm is done because only `mild self-limiting conditions' are allowed to be on the labels. A distinguished medical expert might ask whether constipation would be one of those. Naturally the reply would be "Of course". The distinguished medical expert might then say "I suppose you realise that one of the first signs of bowel cancer is constipation?". Now many other products are marketed for constipation, but the difference is that they work. If they don't work, there is most likely something more serious. The danger of homeopathy is that it encourages people to abandon rational thought that might save their lives.
<snip>
What the present scandal over homeopathy is about is not really whether it works or not. We all agree here that it doesn't - you do as well. Even the MHRA agrees with that. It quite clearly stated that homeopathic products "have difficulty in establishing efficacy in clinical trials". In its very next sentence, the MHRA agreed to accept `non-scientific data'. In other words, it is prepared to accept lies about homeopathy, but it won't accept anything other than scientific data for any other products.

Do you really think that government sponsored lying is good for society - or even tolerable? You might respond by saying "Get real, governments always lie". This is perfectly true. They tell more lies than truth. Just because it's the norm does not make it right. You might also say "Why bother? It's a losing battle". Maybe you are right there as well, but believe me, I will go to my grave a guilty man if I don't try. Read my sig line.

I can see two positive reasons for bringing these people into the NHS. The first is to provide a channel for those patients who do have serious problems. The second is to provide well but worried patients with placebos, something that Doctors have prescribed forever. When I was little they were commonly called "tonics." They taste(d) like patients felt a "medicine" should taste and had a long list of dreadful sounding ingredients at minute concentrations. Patients will always want such things and the attention that goes with them. I think it is better to provide them within the system than have patients going outside for them.

We are not talking about the Iraq war and evidence is treated with disdain within science just as much as outside it. In this case, you are ignoring the evidence that the placebo effect is real and the evidence that some patients need attention rather than treatment. Very often, alternative therapists are providing just those things and if the NHS can save the time of its serious physicians by these techniques then that is good.

The NHS is not lying about homeopathy, neither is the government. Perhaps they think, as Burke might have said, that it is a mistake to keep on doing something that we know doesn't work.

 

[Asolepius]

I can see two positive reasons for bringing these people into the NHS. The first is to provide a channel for those patients who do have serious problems. The second is to provide well but worried patients with placebos, something that Doctors have prescribed forever. When I was little they were commonly called "tonics." They taste(d) like patients felt a "medicine" should taste and had a long list of dreadful sounding ingredients at minute concentrations. Patients will always want such things and the attention that goes with them. I think it is better to provide them within the system than have patients going outside for them.

I think you misunderstand what is happening here. The subject of this discussion is not about making homeopathy available on the NHS. It is about licensing. The regulation of medicines is far from perfect, it sometimes fails, but it is at least based on the need to support a claim with evidence. I tend to avoid the word `proof', because there are no absolutes in medicine, only varying degrees of uncertainty. The purpose of the MHRA is to protect the public by minimising uncertainty. What is momentous about the present fiasco is not just that uncertainty is now tolerated, but positively encouraged.

We are not talking about the Iraq war and evidence is treated with disdain within science just as much as outside it. In this case, you are ignoring the evidence that the placebo effect is real and the evidence that some patients need attention rather than treatment. Very often, alternative therapists are providing just those things and if the NHS can save the time of its serious physicians by these techniques then that is good.

This argument is as old as the hills and as badly eroded by logic. It's also incredibly old-fachioned. We are supposed to be moving away from paternalistic medicine, whereby the physician takes the attitude of "There there, I know what you need, but you don't need to know anything about it". This is a condescending and insulting mindset. No, I am not in any way denying that the placebo effect is real. After 30+ years in clinical science I'm very well aware of that. The problem with it is, that to use it doctors are obliged to lie to patients. It's a widespread fallacy that doctors prescribe placebos. They don't, it's illegal. What you are recommending has enormous ethical and legal implications. We are far better off researching how the placebo effect works and using the knowledge to design better treatments.

The NHS is not lying about homeopathy, neither is the government. Perhaps they think, as Burke might have said, that it is a mistake to keep on doing something that we know doesn't work.

You need to do a bit more research. For a start, the NHS is not the MHRA. But while we are on the subject, the NHS Direct website admits that there is no evidence that homeopathy works. Actually this has very recently been updated as a result of many of us protesting at the misleading information it was providing before. At the same time as admitting this, the NHS continues to spend millions on homeopathy. Do you think that is honest?

I am quite shocked at your degree of cynicism and disdain for science. It's not perfect either, there are many abuses and errors, but it's better than fantasy. Why don't we tell people there are fairies at the bottom of their gardens that will grant them their wishes for good health?

 

[tkingdoll]

I'm going to simplify this even further for John:

Makers of homeopathic remedies want their products to be licenced as medicines without having to provide evidence that they work.

Then, once licenced, they will sell the 'medicines' to the unsuspecting public as though they do work.

The public will buy the medicine believing it works as well as other, proven medicines, and take it for real symptoms of real illnessess. If their illness is real, they will not get better, they may get worse, and they may die.

A licence is an endorsement of a medicine. The public trust that what they are buying contains something that will help them in the way the labelling describes. Homeopathic remedies will be licenced and labelled with specific claims to effiacy which are not proven and not true.

It's a con. Let's not tolerate cons.

 

[asthmatic camel]

John Hewitt, are you, perchance, involved in the production or sale of homeopathic "remedies"? Or are you merely a good, old-fashioned troll? I think we should be told.

 

[John Hewitt]

I think you misunderstand what is happening here. The subject of this discussion is not about making homeopathy available on the NHS. It is about licensing. The regulation of medicines is far from perfect, it sometimes fails, but it is at least based on the need to support a claim with evidence. I tend to avoid the word `proof', because there are no absolutes in medicine, only varying degrees of uncertainty. The purpose of the MHRA is to protect the public by minimising uncertainty. What is momentous about the present fiasco is not just that uncertainty is now tolerated, but positively encouraged.


<snip>

You need to do a bit more research. For a start, the NHS is not the MHRA. But while we are on the subject, the <snip> nhs website admits that there is no evidence that homeopathy works. Actually this has very recently been updated as a result of many of us protesting at the misleading information it was providing before. At the same time as admitting this, the NHS continues to spend millions on homeopathy. Do you think that is honest?

I am quite shocked at your degree of cynicism and disdain for science. It's not perfect either, there are many abuses and errors, but it's better than fantasy. Why don't we tell people there are fairies at the bottom of their gardens that will grant them their wishes for good health?

I am not a believer in talking round in circles and I think I have said my piece on this matter.

My main point is that public policy will never and can never be based solely on scientific evidence. We live in a social world composed of people whose primary logic is not objective or scientific. It is both inevitable and proper that public policy will be significantly swayed by the general public's own perceptions. The public's choice of placebo may change but for now, I would let the NHS prescribe these things.

I will close with a few statements which you can agree with or not as you will.

1. Doctors have always prescribed placebos and, since, I have never heard of any doctor being prosecuted for this act, its legality, or otherwise, seems to me immaterial.
2. I have my own research programme which, as indicated in my web site, is bioepistemic evolution and its implications; researching the administrative structure of the British health service is not part of that programme and, accordingly, I respectfully decline your suggested research project.
3. I am not at all disdainful of properly conducted science - in my judgment science is the best source of objective knowledge available to human beings.
4. That is why I do not like to see science sullied; that is why I am disdainful of some scientists who, in my opinion, are demonstrably either incompetent or deceitful, or both, and whose professional opinions seem to be driven purely by self-interest; that is why I am disdainful of the manifest trash, the "garden fairies," that those people present as "quality controlled" science and that is why I am disdainful of scientific institutions, and I mean most scientific institutions who, fully knowing about the behaviour of such staff, respond to protests about it with indifference and with cover ups.
5. Finally, I am concerned by organizations such as "Sense about Science." I suppose I should be glad to see their efforts at maintaining high scientific standards but, on the other hand, they do represent exactly the same institutions that engage in these cover ups and that leaves some real doubts in my mind. I would have more confidence in the elevated scientific standards of such bodies if those standards did not vanish in a puff of platitudinous rhetoric whenever questions were asked about their own, or their institutes', behaviour.

 

[Mojo]

The public's choice of placebo may change but for now, I would let the NHS prescribe these things.

The issue being discussed in this thread is that the MHRA is allowing the manufacturers of "these things", which you have admitted are worthless, to make claims about conditions they can treat.

If you think that the manufacturers of homoeopathic remedies should be allowed to tell lies, why are you so outraged about the idea of scientists telling lies? Why the double standard?

 

[Cynric]

4. That is why I do not like to see science sullied; that is why I am disdainful of some scientists who, in my opinion, are demonstrably either incompetent or deceitful, or both, and whose professional opinions seem to be driven purely by self-interest; that is why I am disdainful of the manifest trash, the "garden fairies," that those people present as "quality controlled" science and that is why I am disdainful of scientific institutions, and I mean most scientific institutions who, fully knowing about the behaviour of such staff, respond to protests about it with indifference and with cover ups.

This is what's so confusing and engaging about your contribution to the debate. Your righteous indignation aimed at bad scientists who allow politics and careerism to corrupt their objectivity does not apparently translate to homoeopaths. Their efforts to promote their trash hypotheses (despite the mountain of evidence against them) by political lobbying, celebrity endorsement and appeals to antiquated authority, should be anathema, surely?

You seem to reserve more venom for flawed scientists than outright frauds.