Regulation of CAM

davros

From another thread

sextusempiricus:

However we should be grateful that registered bodies are publishing studies to examine the therapy they oversee. At least if its all in the public eye a more critical assessment of these therapies is possible.

willamgrogan:

The problem with the regulation issue is that it also lends credence to the "regulated body". In fact many CAM people are agitating for regulation for this reason.

Surely the correct approach is to regulate it away?

I reckon this question is worth a new thread. It looks like the CAM industry in Ireland is going to get official self-regulation, backed by the Department of Health.

There was a forum on this topic in 2001 hosted by Minister Martin (his speech). The final report of the forum is here [pdf].

Any opinions on the DoH's motive? Is it a move to regulate them out of existence? Or do they genuinely believe in CAM?

ecksor

If they are being put in a position where they can be critically assessed and properly regulated then that's a definite step forward in my view.

Unless a treatment is shown to have negative health effects, then let people throw money away on it if they want, but regulation could make sure that a practitioner doesn't make patently false claims or stop/discourage a person from seeing a doctor with a health complaint? Of course, publish sceptical articles about questionable treatments

davros

Originally posted by ecksor
If they are being put in a position where they can be critically assessed and properly regulated then that's a definite step forward in my view.

That's not the impression I have though. What's proposed is self-regulation so the homeopaths' association will say who is qualified to practise as a homeopath, for example. They are not likely to be very critical.

In theory, such regulation might weed out vendors of Chinese skin creams that illegally contain steroids. But I doubt resources will be allocated for such rigorous testing.

Our best hope might be that the EU allocates funds for proper evaluations of CAM claims and treatments. I've no idea what's coming down the line there but the herbal medicine crackdown is a promising start.

ecksor

Originally posted by davros
That's not the impression I have though. What's proposed is self-regulation so the homeopaths' association will say who is qualified to practise as a homeopath, for example. They are not likely to be very critical.

Well, all I have to go on is the quote that sextusempiricus gave us which said "critical assessment" and mentioned published studies. Are reports conflicting in this regard or (more likely in this country ) are they failing to put their money where their mouth is?

davros

Originally posted by ecksor
Well, all I have to go on is the quote that sextusempiricus gave us which said "critical assessment" and mentioned published studies. Are reports conflicting in this regard or (more likely in this country ) are they failing to put their money where their mouth is?

Sorry, I quoted sextusempiricus out of context. He was talking about the UK.

(Kind of incidentally, I've often wondered why we don't just throw our lot in with the UK on certain things like the licensing of medicines. It's not like our body chemistry is different to theirs.)

williamgrogan

from Michael Martin's speech

Statutory registration will bring benefits to the professions involved by ensuring that only those who are fully trained to professional standards are eligible to practice

How can you be fully trained in say punching holes with a needle in the "energy channels" if they don't exist? Professional Standards in conning people?

I'm thinking of leaving the planet.......... I wonder could I hitch a lift on the next passing comet?

davros

Originally posted by williamgrogan
How can you be fully trained in say punching holes with a needle in the "energy channels" if they don't exist? Professional Standards in conning people?

If you were the minister though, what would you do? You are faced with a completely unregulated industry where the types of bizarre treatments and claims multiply every year. Perhaps you would play along with the industry for a while, get them to happily put limits on themselves first.

Later you would tighten the screws, insisting on expensive clinical trials, regulatory fees and malpractice insurance, all in the name of providing a better service to the patient.

williamgrogan

Perhaps we could try the same with the drug dealers?

Regulate them, tax their profits, set up a heroin advisory clinic, get the IDA interested in exports, then increase their tax rate, insist on higher purity, advertise via the dept. of Health on the dangers etc.

Yea. Maybe?

Are we sure the civil servants know what they are doing? Do civil servants not go to acupuncturists?

Can I ask a silly question? Why isn’t the DPP prosecuting people who claim to heal cancer & sell water that cures asthma? I wonder is it anything to do with votes?

PaulP

Perhaps it all comes down to truth in advertising. If someone claims to be able to cure cancer using 'homeopathic crystals' or some other nonsense then why is it not simple criminal fraud if they have no proper evidence that they can?
We have never been healthier, nor more able to cure and prevent disease. Yet it's interesting that people are more and more convinced that they are 'ill' (self-diagnosed and with lots of hand-waving) and that the very thing that has achived this state of affairs, Western medecine, is somehow either lacking or in some extreme cases the cause of these unspecified illnesses.
These people have too much money and time on their hands and so feel their lives to be empty, ergo they deduce that they must be sick.

sextusempiricus

Having quickly read through the IPA report on regulation the most useful comments come from that archaic but immeasurably important body the House of Lords. This august institution has wisely, in my estimation, put forward the appropriate criteria for regulating CAM therapies. These are,

"1) There is a significant risk to the public from its practice.
2) There is a sufficiently well approved voluntary regulation system and a consensus among its members that statutory regulation is the desired next step for the profession.
3) the therapy in question has a credible evidence base to support its claims "
( my italics)

Those practitioners outside regulation system are likely to be approached by most of the public with a degree of caution, even scepticism. The other side of the coin is official recognition of practices that accept regulation. Regulation may be the referable option. No-one in this thread has mentioned that CAM professional bodies will most probably have a code of ethics and a complaints committees and procedures that can discipline practitioners who breach this code e.g. by striking them off the register. Also practitioners should have professional indemnity and public liability insurance as part of their membership of these bodies. If patients can sue then it seems to me CAM practitioners are going to take detailed histories from clients, keep careful notes and not keep on bringing back patients when their treatments don't work.
Consensus may be a problem. John Nash in an article on Professor Edzard Ernst, Britain's only professor of complementary medicine ( at Exeter university) [in the London 'Times' , 'Body & Soul' p 7, Saturday January 10, 2004] writes,

Nevertheless, his crusade for more scientific rigour in complementary therapies still prompts much suspicion from practitioners and Ernst believes he knows why. "It threatens people. Scientific rigour does not threaten conventional medicine in the same way. If I tell GPs that aspirin is not the wonder drug they think it is, they do not feel under attack because they have a million other treatments to use instead. The acupuncturist has only the needle, the chiropractic has only spinal manipulation, so they feel threatened by rigorous testing."

A few rotten apples risks discrediting the practice of concientious practitioners. Regulation and keeping a tight check on professional standards is, I imagine, likely to override the suspicions of most CAM therapists. I may be wrong.

Regulation may perhaps see these complimentary treatments appearing more often in hospitals and GP surgeries and covered increasingly by by medical insurance. Those that hold the purse strings will no doubt want to see money well spent and if this leads to serious scientific papers (and where possible randomized controlled trials) to assess the efficacy of CAM then in the end the patients may benefit.

ecksor

As a Medic (just going by your profile), what complementary therapies, if any, do you see as probably having some merit behind them? (not looking for an endorsement etc, just an opinion).

davros

Originally posted by PaulP
We have never been healthier, nor more able to cure and prevent disease.

Another way of looking at it is to say that we have never been able to prolong life as much as we can now. So much so that we have run into a whole new set of diseases - the ones that come with old age, like many cancers. By definition, these are the ones we cannot cure since they are the ones that kill us. You might even regard old age itself as a disease and many therapies and treatments are devoted to staving off this inevitability. So as much as we vanquish one illness after another, we simultaneously uncover others that had lain hidden up to that point.

sextusempiricus

Originally posted by ecksor
As a Medic (just going by your profile), what complementary therapies, if any, do you see as probably having some merit behind them? (not looking for an endorsement etc, just an opinion).

To date NONE. When I trained CAM hadn't really become popular. I was trained to be critical and look for the published evidence. Of course that's an aspiration that is not always easy to carry out. Most doctors hopefully all get involved with continuing medical education and regularly read the numerous medical journals arriving in the post. Indeed it will become a requirement of registration that we all keep up to date. Publication of 'Clinical Evidence' in the past few years by the BMJ certainly encourages a critical outlook. Here are thousands of randomised controlled trials on our therapies. Of the 1851 treatments covered in its latest issue (No. 10, Dec 2003) 270 (15%) are rated as beneficial, 392 (21%) as likely to be beneficial, 139 (7%) as trade off between benefits and harms, 96 (5%) unlikely to be beneficial, 88 (4%) likely to be ineffective or harmful, and 866 (47%) , the largest proportion, as unknown effectiveness. This is the treatments, remember, of mainstream medicine. If 3 RCTs give support that ginger helps hyperemesis I'll give it a try. The evidence of trials is often conflicting. On acupressure for example (p1673)

One systematic review including small RCTs found limited evidence that acupressure reduced morning sickness compared with sham acupressure or no intervention. Two further RCTs and two randomised crossover trials found that P6 acupressure reduces duration but not intensity, of nausea and vomiting. However, a small RCT found accupressure bands to be less effective than placebo bands.

This gives you an idea of the contents of 'Clinical Evidence'. Most of it is taken up of course by the drugs we use, many of which have more important interactions and side-effects than St John's Wart. Even this 'herbal medicine' makes its appearance on p1130

'Two systemic reviews in people with mild to moderate depression have found that [it] significantly improves depressive symptoms over 4-12 weeks compared with placebo, and have found no significant difference in symptoms between St John's Wort and prescription antidepressant drugs....The results of the reviews should be interpreted with caution because the RCTs did not use standardised preparations of St John's Wort, and doses of antidepressants varied.'

As I have written in another thread I'll take the claims of CAM more seriously when they subject their therapies to similar rigorous testing. If registration includes serious studies on the efficacy of CAM remedies as promised by Micheal Martin and encourages some kind of best practice standards then I'm in favour of it.

ecksor

I appreciate that viewpoint, but I suppose I was looking for an unsceptical opinion. As in, something which you would perhaps not be comfortable recommending based upon the lack of evidence, but where anecdotal evidence based upon your own observations and patient recoveries would suggest to you that something was worthy of being investigated at least.

However, on reflection, given that you have been identified as a medic that is probably an unfair question to ask in a public forum and I withdraw it.

GuanYin

A colleague of mine looks into CAMs every so often, both for an ongoing problem and for incidental illnesses.

She has both a medical and a research background and screens anything she takes against her knowledge or current literature. I remember talking to her about it a while ago and she does believe that alot of the pharmacology of CAM may be relevant, but that unfortunately unregulated blanket dosage will ultimately mean that many people do themselves more harm than good.

PaulP

Have a look at
http://www.expatica.com/source/site_article.asp?subchannel_id=58&story_id=3606

French psychoanalysts are getting hot under the collar about being regulated

PaulP

There is a related issue of how to evaluate the results of even peer-reviewed papers appearing the the legitimate medical press on non-CAM issues.
Consider this beauty: http://archinte.ama-assn.org/cgi/content/abstract/163/16/1897 . The conclusion is not borne out by the evidence present, because (getting technical) the confidence intervals for the relative risk either contain 1 or nearly 1 (0.99), and a value of 1 means no risk.
There are some general basic rules for imterpreting epidemiological studies which go out the window when human health is being studied, and because of this we are constantly being bombarded with health scares.
The weakening of scientific rigour in relation to non-CAM health questions will open a barn door for the quacks.

williamgrogan

PaulP - could you elaborate? The link didn't seem to tie up with what you said?

PaulP

Which link is in trouble please?

williamgrogan

I can link OK but do not understand your point.

Myksyk

Originally posted by ecksor
Unless a treatment is shown to have negative health effects, then let people throw money away on it if they want

Treatments should be able to demonstrate positive results not just the absence of negative effects. (BTW, 'negative' impacts are notoriously difficult to pinpoint and include for example unwittingly delaying access to proven treatments).

The problem, as others have alluded to, is that regulation/stautory registration will be seen as enough in and of itself, and will not likely increase commitment to producing evidence of efficacy.

In my opinion, only those therapies that produce replicable studies of treatment efficacy should be considered for registration.

It seems the DOHC have got the cart before the horse and are willing to give official State sanction to unproven and often useless therapies because there are so many people practising them, in spite of their startling lack of an acceptable scientific evidence base.

ecksor

Originally posted by Myksyk
Treatments should be able to demonstrate positive results not just the absence of negative effects. (BTW, 'negative' impacts are notoriously difficult to pinpoint and include for example unwittingly delaying access to proven treatments).

Well, right, that's why I mentioned that in the next sentence.

Let me put my position another way. People can and will spend money on whatever they want, because it is their money and it is what they want to spend it on. Personally speaking, if some group of people started telling me that I can't continue with an alternative treatment that I want to receive on the basis that "there's no clinical proof that this is doing you any good" then as far as I'm concerned they can go to hell.

OTOH, I would want to know if the treatment has a poor body of evidence for it, that practitioners were obliged to follow certain standards of practice (including, for example, referring the client to their GP when there is evidence of serious illness and clearly defined circumstances), that they can't misrepresent the evidence for their treatments, etc.

Also, without wanting to go into too much detail, I have gone to GPs on a few occasions and been misdiagnosed and mistreated which ultimately had the effect of unwittingly delaying access to proven treatments. That's not to knock the medical profession, without which I wouldn't be typing this now, merely to say that your point is valid for more than just CAM.

The problem, as others have alluded to, is that regulation/stautory registration will be seen as enough in and of itself, and will not likely increase commitment to producing evidence of efficacy.

In my opinion, only those therapies that produce replicable studies of treatment efficacy should be considered for registration.

And ban practice of the others? That seems very unlikely to happen or even be taken seriously as an option. Otherwise I think that imposing standards can only be a help. I do agree that a meaningless system of registration is worse than nothing since it lends an air of approval, but I think the focus should be on making sure it is done properly.

PaulP

WillianGrogan:

I assume you are referring to the link to the paper on dietary fibre and chronic heart disease (CHD).

Technical explanation: if you take two samples from the same population and measure some quantity, then the two average measured values (from the samples) for the quantity will not be the same. Indeed each is essentially an estimate of the average for the whole population.

So if you measure the same quantity (e.g rate of CHD) for samples from two different populations (e.g. one with high intake of dietary fibre and one with low intake) and get two different averages, it does not automatically mean there is a difference between the two populations for the measured quantity (CHD).

This paper reported two different averages and then proceeded to claim a significant difference in CHD rates between the two populations.

How statisticians determine whether the difference is significant is to use condifence intervals: essentially they can say that e.g. the average CHD rate for a population is e.g. 95% certain to be inside a 95% confidence interval. So for a measured sample average of e.g. 10 the 95% confidence interval might be 7-13.
In this case they are trying to measure relative risks, which is in one case the ratio of the risk of CHD in the population with the lowest intake of dietary fibre compared to the risk for the population with the highest intake. (They estimate the risk by counting the number of cases of CHD).
If there is no difference between the risks then dividing one by the other should give a value of 1. Taking what was said above about confidence intervals, if the confidence interval includes a value of 1 , or a value very close to it such as 0.99 or 0.98, then there is no significant difference. They had figures showing no significant difference but claimed to have found a significant difference and got published in a prestigious scientific journal. Their conclusion is balderdash.


That such rubbish could get published at all is a very bad thing..

Myksyk

Originally posted by ecksor
Let me put my position another way. People can and will spend money on whatever they want, because it is their money and it is what they want to spend it on. Personally speaking, if some group of people started telling me that I can't continue with an alternative treatment that I want to receive on the basis that "there's no clinical proof that this is doing you any good" then as far as I'm concerned they can go to hell.

Couldn't agree more. The focus has to be on the 'sellers' not the consumers. People are free to purchase what they want. I make a point of buying some extravagant and useless gadget at least once a year!!:)



[/QUOTE] And ban practice of the others? That seems very unlikely to happen or even be taken seriously as an option.

Obviously not. This was not mentioned as an option. I was talking about registration. Practitioners of therapies without an acceptable evidence base should not be considered for registration.

ecksor

Originally posted by Myksyk
Obviously not. This was not mentioned as an option. I was talking about registration. Practitioners of therapies without an acceptable evidence base should not be considered for registration.

Ok, but that's most/all of them isn't it? I mean, if they had the sort of evidence that you're talking about in their favour then I feel they'd no longer be considered CAM.

I understand the danger of something been seen as an undue endorsement, but surely the point is to bring in some control rather than to make any comment upon the effectiveness of the treatment.

sextusempiricus

Originally posted by Myksyk
I was talking about registration. Practitioners of therapies without an acceptable evidence base should not be considered for registration.

CAM does in general have little or nothing to support it. But we must consider the risk of harm to a gullible public that could occur in the absence of registration . I have here in mind patients with back pain who may indeed have a spinal cancer such as myeloma or, more commonly, osteoporosis who could be left paraplegic if an alternative practitioner administered injudicious manipulation to the spine. In the UK osteopaths and chiropractors by law have to belong to either the General Osteopathic Council or General Chiropractic Council. These bodies run continuing education for their members and require them to accept a codes of ethics, practice and conduct. Patients can complain to these bodies and moreover sue if they have receved harm from poor treatment. The presence of such bodies does make it more likely that their members will, to avoid litigation as much as for professional satisfaction, ensure that the right history taken and a proper examination, which in the case of backache would include at least a neurological examination of reflexes, and detection of sensory and motor loss.
Perhaps the traditional bone-setter will persist for a little longer but the only answer in the end is a more educated and critical public unwilling to put themselves at risk from the dubious therapy on offer.
Nothing above should imply I support either osteopaths or chiropracters. As a GP I have never referred anyone to them for help. They still have to prove themselves.

PaulP

The assumption being made by proponents of CAM regulation is that this would prevent patients being damaged by some current practitioners of CAM who would not be allowed to practice in the regulated future.
Now there are to questions about any treatment for a medical condition: 1) does it produce a cure or relieve the symptoms and 2) does it do actual damage.

Regulation might partially address point 2). It might prevent a CAM practitioner giving a 'treatment' that itself would damage the patient. But it would do nothing to help those who get worthless CAM treatments for conditions curable by orthodox means and who suffer thereby.


Also: there is a never-ending flow of new forms of quackery. If every CAM form has to be regulated, then this will inevitably prevent new forms being practised, as it takes a while for a new form to become established enough to permit regulation. CAM proponents would object strongly to that.

williamgrogan

Coroner's jury links neck manipulation to stroke death.

A coroner's jury, which concluded that Lana Dale Lewis of Toronto was killed by a chiropractic neck manipulation, has ruled that her death was "accidental" rather than "natural." On September 1, 1996, six days after manipulation of her upper neck, Lewis was admitted to Queensway General Hospital suffering from a stroke. She died from another stroke on September 12. The issue involved was whether her death was due to natural causes (hardening of the arteries) or an injury to an artery caused by the manipulation. For purposes of the inquest, the word "accidental" means "not due to natural causes. As explained by Amani Oakley, the attorney who represented Lewis's survivors:

"An inquest jury in Ontario can only find one of five one-word verdicts: homicide, suicide, accident, natural causes, and undetermined. They cannot actually point the finger of blame to anyone, so it is not open to them to make a finding of 'death from a chiropractic manipulation.' However, they were clearly instructed by the Coroner and other counsel that if they were convinced that the cause of Lana Lewis' stroke was as a result of the neck manipulation, this would be a traumatic origin of the stroke, and their verdict would be 'accident.' If they believed that the stroke she died from was as a result of her lifestyle, health condition, etc., then the verdict would be 'natural causes.' If they were not sure which of the two it was, then their finding would be undetermined."

Among other things, the jury recommended that all patients for whom neck manipulation is recommended be informed that risk exists and that the Ministry of Health establish a database for chiropractors and other health professionals to report on neck adjustments. The jury's report is posted at http://www.chirobase.org/15News/lewis.html The closing arguments will be posted when available.

Regulation would not have saved this woman's life. Spinal manipulation is nonsense in most cases and should be illegal unless carried out by a qualified doctor for a medical reason. I have recently read in a number of sources that one side effect is a stroke.

ecksor

An overview of where chiropractic is at written by the people who run the chirobase website: http://www.acsh.org/publications/priorities/1102/chiro.html

Hobart

Originally posted by williamgrogan
....."An inquest jury in Ontario can only find one of five one-word verdicts: homicide, suicide, accident, natural causes, and undetermined....

My emphasis BTW. Puts your faith right back there in journalism and eh... justice.

sextusempiricus

Originally posted by williamgrogan
Regulation would not have saved this woman's life. Spinal manipulation is nonsense in most cases and should be illegal unless carried out by a qualified doctor for a medical reason. I have recently read in a number of sources that one side effect is a stroke.

I've always been wary of manipulations at least if there is a risk of damage to the spinal cord ( which ends at the 2nd lumbar vertebra, well above where most prolapsed discs occur ). Some doctors and physiotherapists manipulate often using the Cyriax methods although I've never been convinced of their efficacy. These are potentially dangerous techniques and should never be considered on patients with evidence of motor or sensory loss or who might be on anticoagulant therapy. The case of Lana Dale Lewis , who was only 45, is unusual as well as tragic but you shouldn't be so dogmatic in your claim that spinal manipulation is useless and then qualify this assertion with the words 'in most cases'. The jury made no such claim. Its only doubt related to the efficacy of provocative tests prior to high cervical manipulation. The jury indeed suggested further studies to show a relationship between manipulation and stroke. It had further good advicepresumably carried out through the chiropractors' regulatory body . This includes,
1) A standard of practice established in good record keeping and any procedure easily identified ( making further scientific evaluation of the procedure possible ).
2)The establishment of a database where not only chiropractors but doctors and physiotherapists too who manipulate cervical spines can report their manipulations. a separate part of this database would be for the report of adverse events after the procedure.
3)The chiropract professional associations, teaching facilities and regulatory colleges ensure all of their members maintain their skills by taking mandatory upgrade courses.
4) The recommendation that the patient after manipulation stays in the chropractor's office for an appropriate time for observation.
5) Better communication with the patient's doctor. This unfortunate patient may have a history of hypertension, hypercholesterolaemia and atheromatous arteries that might have made a chiropractor more cautious.

It strikes me that, since patients like going to chiropractors, the advice offered by the jury is sensible and is best achieved through a regulatory body .

PS I had one patient who walked into a Dublin Hospital, had an epidural injection and ended up paraplegic. These things happen.