Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
More boring politics, but it matters. The two main recommendations of this Pittilo report are that
- Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine should be subject to statutory regulation by the Health Professions Council
- Entry to the register should normally be through a Bachelor degree with Honours
For the background on this appalling report, see earlier posts.
A very bad report: gamma minus for the vice-chancellor
The Times (blame subeditor for the horrid title), and some follow up on the Times piece
The Health Professions Council breaks its own rules: the result is nonsense
Chinese medicine -acupuncture gobbledygook revealed
Consultation opens on the Pittilo report: help stop the Department of Health making a fool of itself
Why degrees in Chinese medicine are a danger to patients
The Department of Health consultation shuts on November 2nd. If you haven’t responded yet, please do. It would be an enormous setback for reason and common sense if the government were to give a stamp of official approval to people who are often no more than snake-oil salesman.
Today I emailed my submission to the Pittilo consultation to the Department of Health, at HRDListening@dh.gsi.gov.uk
The submission
I sent the following documents, updated versions of those already posted earlier.
- Submission to the Department of Health, for the consultation on the Pittilo report [download pdf].
- What is taught in degrees in herbal and traditional Chinese medicine? [download pdf]
- $2.5B Spent, No Alternative Med Cures [download pdf]
- An example of dangerous (and probably illegal) claims that are routinely made by TCM practitioners [download pdf]f
I also completed their questionnaire, despite its deficiencies. In case it is any help to anyone, this is what I said:
The questionnaire
Q1: What evidence is there of harm to the public currently as a result of the activities of acupuncturists, herbalists and traditional Chinese medicine practitioners? What is its likelihood and severity?
Harm
No Harm
Unsure
Comment
The major source of harm is the cruel deception involved in making false claims of benefit to desperate patients. This applies to all three.
In the case of herbal and TCM there is danger from toxicity because herbal preparations are unstandardised so those that do contain an active ingredient are given in an unknown dose. This is irresponsible and dangerous (but would not be changed by the proposals for regulation).
In addition TCM suffers from recurrent problems of contamination with heavy metals, prescription drugs and so on. Again this would not be the business of the proposed form of regulation.
Q2: Would this harm be lessened by statutory regulation? If so, how?
Yes
No
Unsure
The proposed form of regulation would be no help at all. The HPC has already said that it is not concerned with whether or not the drug works, and, by implication, does not see itself as preventing false health claims (just as the GCC doesn’t do this). False claims are the responsibility of Trading Standards who are meant to enforce the Consumer Protection Unfair Trading Regulations (May 2008), though they do not at present enforce them very effectively. Also Advertisng Standards. The proposed regulation would not help, and could easily hinder public safety as shown by the fact that the GCC has itself been referred to the Advertisng Standards Authority.
The questions of toxicity and contamination are already the responsibility of Trading Standards and the MHRA. Regulation by the HPC would not help at all. The HPC is not competent to deal with such questions.
Q3: What do you envisage would be the benefit to the public, to practitioners and to businesses, associated with introducing statutory regulation?
Significant benefit
Some benefit
No benefit
Unsure
This question is badly formulated because the answer is different according to whether you are referring to the public, to practitioners or to businesses.
The public would be endangered by the form of regulation that is proposed, as is shown very clearly by the documents that I have submitted separately.
In the case of practitioners and businesses, there might be a small benefit, if the statutory regulation gave the impression that HM and TCM had government endorsement and must therefore be safe and effective.
There is also one way that the regulation could harm practitioners and businesses. If the HPC received a very large number of complaints about false health claims, just as the GCC has done recently, not only would it cost a large amount of money to process the claims, but the attendant bad publicity could harm practitioners. It is quite likely that this would occur since false claims to benefit sick people are rife in the areas of acupuncture, HM and TCM.
Q4: What do you envisage would be the regulatory burden and financial costs to the public, to practitioners, and to businesses, associated with introducing statutory regulation? Are these costs justified by the benefits and are they proportionate to the risks? If so, in what way?
Justified
Not Justified
Unsure
Certainly not justified. Given that I believe that the proposed form of regulation would endanger patients, no cost at all would be justified. But even if there were a marginal benefit, the cost would be quite unjustified. The number of practitioners involved is very large. It would involve a huge expansion of an existing quango, at a time when the government is trying to reduce the number of quangos. Furthermore, if the HPC were flooded with complaints about false health claims, as the GCC has been, the costs in legal fees could be enormous.
Q5: If herbal and TCM practitioners are subject to statutory regulation, should the right to prepare and commission unlicensed herbal medicines be restricted to statutorily regulated practitioners?
Yes
No
Unsure
I don’t think it would make much difference. The same (often false) ideas are shared by all HM people and that would continue to be the same with or without SR.
Q6: If herbal and TCM practitioners are not statutorily regulated, how (if at all) should unlicensed herbal medicines prepared or commissioned by these practitioners be regulated?
They could carry on as now, but the money that would have been spent on SR should instead be used to give the Office of Trading Standards and the MHRA the ability to exert closer scrutiny and to enforce more effectively laws that already exist. Present laws, if enforced, are quite enough to protect the public.
Q7: What would be the effect on public, practitioners and businesses if, in order to comply with the requirements of European medicines legislation, practitioners were unable to supply manufactured unlicensed herbal medicines commissioned from a third party?
Significant effect
Some effect
No effect
Unsure
European laws,especialliy in food area, are getting quite strict about the matters of efficacy. The proposed regulation, which ignores efficacy, could well be incompatible with European law, if not now, then soon. This would do no harm to legitimate business though it might affect adversely businesses which make false claims (and there are rather a lot of the latter).
Q8: How might the risk of harm to the public be reduced other than by orthodox statutory regulation? For example by voluntary self-regulation underpinned by consumer protection legislation and by greater public awareness, by accreditation of voluntary registration bodies, or by a statutory or voluntary licensing regime?
Voluntary self-regulation
Accreditation of voluntary bodies
Statutory or voluntary licensing
Unsure
I disagree with the premise, for reasons given in detail in separate documents. I believe that ‘orthodox statutory regulation’, if that means the Pittilo proposals, would increase, not decrease, the risk to the public. Strengthening the powers of Trading Standards, the MHRA and such consumer protection legislation would be far more effective in reducing risk to the public than the HPC could ever be. Greater public awareness of the weakness of the evidence for the efficacy of these treatments would obviously help too, but can’t do the job on its own.
Q10: What would you envisage would be the benefits to the public, to practitioners, and to businesses, for the alternatives to statutory regulation outlined at Question 8?
It depends on which alternative you are referring to. The major benefit of enforcement of existing laws by Trading Standards and/or the MHRA would be (a) to protect the public from risk, (b) to protect the public from health fraud and (c) almost certainly lower cost to the tax payer.
Q11: If you feel that not all three practitioner groups justify statutory regulation, which group(s) does/do not and please give your reasons why/why not?
Acupuncture
Herbal Medicine
TCM
Unsure
None of them. The differences are marginal. In the case of acupuncture there has been far more good research than for HM or TCM. But the result of that research is to show that in most cases the effects are likely to be no more than those expected of a rather theatrical placebo. Furthermore the extent to which acupuncture has a bigger effect than no-acupuncture in a NON-BLIND comparison, is usually too small and transient to offer any clinical advantage (so it doesn’t really matter whether the effect is placebo or not, it is too small to be useful).
In the case of HM, and even more of TCM, there is simply not enough research to give much idea of their usefulness, with a small handful of exceptions.
This leads to a conclusion that DH seems to have ignored in the past. It makes absolutely no sense to talk about “properly trained practitioners” without first deciding whether the treatments work or not. There can be no such thing as “proper training” in a discipline that offers no benefit over placebo. It is a major fault of the Pittilo recommendations that they (a) ignore this basic principle and (b) are very over-optimistic about the state of the evidence.
Q12: Would it be helpful to the public for these practitioners to be regulated in a way which differentiates them from the regulatory regime for mainstream professions publicly perceived as having an evidence base of clinical effectiveness? If so, why? If not, why not?
Yes
No
Unsure
It might indeed be useful if regulation pointed out the very thin evidence base for HM and TCM but it would look rather silly. The public would say how can it be that the DH is granting statutory regulation to things that don’t work?
Q13: Given the Government’s commitment to reducing the overall burden of unnecessary statutory regulation, can you suggest which areas of healthcare practice present sufficiently low risk so that they could be regulated in a different, less burdensome way or de-regulated, if a decision is made to statutorily regulate acupuncturists, herbalists and traditional Chinese medicine practitioners?
Yes
No
Unsure
As stated above, the.only form of regulation that is needed, and the only form that would protect the public, is through consumer protection regulations, most of which already exist (though they are enforced in a very inconsistent way). Most statutory regulation is objectionable, not on libertarian grounds, but because it doesn’t achieve the desired ends (and is expensive). In this case of folk medicine, like HM and TCM, the effect would be exactly the opposite of that desired as shown in separate documents that I have submitted to the consultation.
Q14: If there were to be statutory regulation, should the Health Professions Council (HPC) regulate all three professions? If not, which one(s) should the HPC not regulate?
Yes
No
Unsure
The HPC should regulate none of them. It has never before regulated any form of alternative medicine and it is ill-equipped to do so. Its statement that it doesn’t matter that there is very little evidence that the treatments work poses a danger to patients (as well as being contrary to its own rules).
Q15: If there were to be statutory regulation, should the Health Professions Council or the General Pharmaceutical Council/Pharmaceutical Society of Northern Ireland regulate herbal medicine and traditional Chinese medicine practitioners?
HPC
GPC/PSNI
Unsure
Neither. The GPC is unlikely to care about whether the treatments work any more than the RPSGB did, or the GCC does now. The problems would be exactly the same whichever body did it.
Q16: If neither, who should and why?
As I have said repeatedly, it should be left to Trading Standards, the MHRA and other consumer protection regulation.
Q17:
a) Should acupuncture be subject to a different form of regulation from that for herbalism and traditional Chinese medicine? If so, what?
Yes
No
Unsure
b) Can acupuncture be adequately regulated through local means, for example through Health and Safety legislation, Trading Standards legislation and Local Authority licensing?
Yes
No
Unsure
(a) No -all should be treated the same. Acupuncture is part of TCM
(b) Yes
Q18.
a) Should the titles acupuncturist, herbalist and [traditional] Chinese medicine practitioner be protected?
b) If your answer is no which ones do you consider should not be legally protected?
Yes
No
Unsure
No. It makes no sense to protect titles until such time as it has been shown that the practitioners can make a useful contribution to medicine (above placebo effect). That does not deny that placebos may be useful at times. but if that is all they are doing, the title should be ‘placebo practitioners’.
Q19: Should a new model of regulation be tested where it is the functions of acupuncture, herbal medicine and TCM that are protected, rather than the titles of acupuncturist, herbalist or Chinese medicine practitioner?
Yes
No
Unsure
No. This makes absolutely no sense when there is so little knowledge about what is meant by the ” functions of acupuncture, herbal medicine and TCM”.Insofar as they don’t work (better than placebo), there IS no function. Any attempt to define function when there is so little solid evidence (at least for HM and TCM) is doomed to failure.
Q20: If statutory professional self-regulation is progressed, with a model of protection of title, do you agree with the proposals for “grandparenting” set out in the Pittilo report?
Yes
No
Unsure
No. I believe the Pittilo report should be ignored entirely. The whole process needs to be thought out again in a more rational way.
Q22: Could practitioners demonstrate compliance with regulatory requirements and communicate effectively with regulators, the public and other healthcare professionals if they do not achieve the standard of English language competence normally required for UK registration? What additional costs would occur for both practitioners and regulatory authorities in this case?
Yes
No
Unsure
No. It is a serious problem, in TCM especially, that many High Street practitioners speak hardly any English at all. That adds severely to the already considerable risks. There would be no reliable way to convey what was expected of them. it would be absurd for the taxpayer to pay for them to learn English for the purposes of practising TCM (of course there might be the same case as for any other immigrant for teaching English on social grounds).
Q23: What would the impact be on the public, practitioners and businesses (financial and regulatory burden) if practitioners unable to achieve an English language IELTS score of 6.5 or above are unable to register in the UK?
Significant impact
Some impact
No impact
Unsure
The question is not relevant. The aim of regulation is to protect the public from risk (and it should be, but isn’t, an aim to protect them from health fraud). It is not the job of regulation to promote businesses
Q24: Are there any other matters you wish to draw to our attention?
I have submitted three documents via HRDListening@dh.gsi.gov.uk. The first of these puts the case against the form of regulation proposed by Pittilo, far more fluently than is possible in a questionnaire.
Another shows examples of what is actually taught in degrees in acupuncture, HM and TCM. They show very graphically the extent to which the Pittilo proposals would endanger the public, if they were to be implemented..
32 Responses to One month to stop the Department of Health endorsing quacks: the Pittilo questionnaire
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The questionaire is a foregone conclusion style one.
I shall take time to submit my own response & should have already so done.
The way these things seem to work – someone with vested interests punts out a “consultation” designed to sideline opposition. Most people, like me, are busy with daily pressures and don’t notice and don’t respond to the consultation. The consequences are no benefit to anyone except the propsers.
I know I’ve been too laid back in not responding & I would encourage anyone who follows DC’s web site to respond to the “consultation” asap. We rely too much on DC to reply on our behalf.
David, thank you for an excellent response.
Have you had any acknowledgement that they got your submission? I emailed my response on 29th August, and have had no acknowledgement that they have received my message.
My experience with e-mailing the Dept of Health is that you have to very very persistent.
Keep on and on sending them e-mails askiing if they received your submission, always using the ‘reply receipt’ option.
The other problem I (and others) have had is that they sometimes send replies in obscure formats which are impossible to read. With one lot of correspondence I had to e-mail them at least seven times before they finally sent a pdf attachment. Unsurprisingly, when it arrived the reply was less than adequate and did not answer my questions at all, so more time wasted follwoing it up.
But when you don’t hear from them, don’t give up. We pay their wages after all!
And I echo Andrew’s request: please everyone respond in depth to this report. I also suggest sending a copy of your response to your MP. Just make lots of noise about this rubbish.
Truth can influence only half a score of men in a century while falsehood and mystery will drag millions by the nose.
Aristotle
On filling in the questionaire some time ago I made the foregone conclusion nature of the questions a point in my replies both individually and overall at the end. I was polite but scathing and told them that it indicated I was wasting my time since it implied they had already made up their minds.
I will await the results but am prepared to complain long and loud about the nature of the ‘consultation’ if necessary.
Lindy,
Thanks for the suggestions. I re-emailed my response this morning, asking for acknowledgement, and got a response this afternoon.
Just sent my (8 page!) response in, and have done the consultation, for what it isn’t worth. I may also send a copy of my response to the Scottish parliament directly, since the consultation is on behalf of them too.
I finally got around to throwing in my tuppenceworth. Thanks for the reminders, DC! I found the questionnaire completely infuriating, especially the way it conflates the interests of the public with practitioners and businesses as if they are all happily in harmony. If the subject of the consultation was crime (and in a way it is, of course) would they stress the benefits and burdens for burglars and crowbar manufacturers?
Hello, DC bloggers.
My apologies for the length of time it has taken me to write you, here, after my posts last year. I am inundated with patients who have been mis-treated and badly diagnosed within the NHS.
I had have 5 new patients in the last 3 days. All of them had been either mis-diagnosed, dismissed by their GPs when they had serious concerns about their health, or had been admitted to A & E with serious complaints only to have been sent home by doctors who spoke very little english and weren’t interested in the patient’s medical history.
But all that is an aside to what I have to say to you tonight. I see you have all been campaigning against the Statutory Regulation of herbalists in the UK after the DoH put forward its consultation document last month.
I have a few simple things to say to you. If you do not support the Statutory Regulation of Medical Herbalists, you face over 1000 registered practioners in the UK going underground to practice their trade without any supervision. The National Institute of Medical Herbalists will fold as will the College of the Practitioners of Phytotherapy. Herbalists will continue to practice without tinctures made under Good Manufacturing Practice, and they will make most of their own products rather than those provided by excellent companies like Proline, Kingham, Panacea, Avicenna, Herbal Apothecary, and Organic Herb Trading Company who have the facilities to distill and pack in a clean environment.
We will be no longer required to provide proof of our Continuing Professional Development, nor will we be required to provide proof of our qualifications in Pharmacology and Toxicology, Clinical Medicine, Clinical Diagnosis, or Botany. Those people who call themselves ‘naturopaths’, who have certificates from unrecognized programmes all over the UK will have the same right to treat people with hedgerow medicines as those of us who have studies biomedical science for 3 or 4 years.
I think you are all making a very big mistake. You do not want to drive herbalists to the ground to practice, unsupervised, on the general public. We should be properly regulated by the HPC.
I beg you to support the regulation of Medical Herbalists by the Health Professions Council, so that people who are qualified to issue plant medicines to the public are regulated properly by a major body.
The alternative is the American model, where herbs and supplements (BAH!) are offered as dietary advice. This is what you will get if you continue on this course.
People will continue to seek out alternative treatments. Whether you want them to be of quality is up to you.
I wish you all the best,
NAWD
Dear All,
One more thought, this evening. As a part of my job, I do First Aid at many Music Festivals all over the UK. I deal with people who are on very serious drugs from Methadone to Mephadrone. I deal with people on ‘legal highs’ who don’t know where they are, to people on LSD, Ketamine, Cannabis, Ecstasy, MDMA and other entheogens, who need serious medical care. I disapprove of the use of all of these drugs, but they are readily available at any music festival in the UK.
I take care of these people. I give them tea, talk to them, take care of them. I work with them when they are hallucinating, ill, and, sometimes, suicidal. I carry them out of rivers, and check whether they have serious medical conditions. It is one of the most rewarding things I do as a medical herbalist and First Aider.
If you drive herbalism underground, the herbal industry will become as rotten as the drug industry. It will make billions of pounds but not be regulated. Young people will be able to buy drug analogues under auspice of them being ‘legal’ when legal practitioners of Herbal Medicine are not able to practice.
Think very carefully about whether you would like the 60 million pound per annum herbal trade to be regulated or whether you would like it to be just an underground free-for-all.
To me the choice is quite clear. We must support the Statutory Regulation of Medical Herbalists to protect the public. Please support us. The work we do is worthwhile.
All the best to you,
NAWD
A final thought on this subject.
I will continue to practice, whether or not Statutory Regulation takes place.
I will treat people who come to me, because I have taken the Hippocratic Vow to do so.
I would like to use medicines made under standards of Good Manufacturing Practice.
Whether I can or cannot use these medicines is up to everyone who writes in to the DoH on this consultation. Otherwise, I just have to go out in my garden and make what is available.
The choice is yours.
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@notawitchdoctor
Why do you choose to hide behind a false name?
@notawitchdoctor
The tone of your posts, both here and previously, worries me a lot.
What comes through to me in such comments is a very worrying arrogance and a kind of paternalist assumption of authority and infallibility:
This is, I am afraid, the Siren Song of deluded quacks down the ages, and you need to take a hard look at yourself.
You have regularly told us that you trained for four years in biomedical sciences, and that you are a “proper healthcare practitioner” with professional standards. Yet you seem to have learned nothing about the humility, and admission of your own possibly (likely?) fallibility, that is required of real doctors.
People, including doctors, make all sorts of errors of logic – of which thinking you automatically know better than anyone else is one. One of the key reason why “evidence based medicine” movements, and synthesis of evidence, are needed is precisely to counterbalance such tendencies.
Dear notawitchdoctor,
How will avoiding SR drive herbalists underground? If the DH opts for the status quo option, then herbalists will still be able to practise under section 12(1) of the Medicines Act 1968. Have you actually read the consultation document?
Frankly, you’re deluded about the number of herbalists practising in the UK & I’m not sure how the lack of SR legislation is going to lead to the collapse of the organisations & suppliers you mention. I think you’ve been supping too long at the breast of the EHTPA. Try forming a few opinions of your own instead of using the off-the-shelf variety provided by ‘stakeholders’…
There is no warfare as fierce as the internecine war between different sects of within alternative medicine. Some herbalists are as strongly opposed to the Pittilo proposals as I am, though for quite different reasons. As of today, 1718 herbailsts have voted against the proposals. My old friend Ann Walker seems to want the best of both worlds.
Perhaps it will be best to leave Anti-D an Notawitchdoctor to fight it out between themselves,
“Alternative TO medicine”, not “Alternative medicine”, please!
DC, ‘internecine war’ is a bit dramatic – I call it a difference of opinion…
Anti-D
Well try this. Chiropractic wars. Part 3: internecine conflict
That’s a pretty vigorous difference of opinion. The fascinating thing is that it illustrates rather nicely the common analogy between magic medicine and religious beliefs. Protestants seem to hate catholics more than they hate atheists. Odd really.
@Michael Kingford Gray: Because the internet is full of very strange people, some of whom have serious psychological issues. I can be easily found on Google and I like to think that my family and I are safe from people with grudges. If the internet were safe, I’d be happy to post my name and the name of my business. I’m not hiding, I’m protecting myself and my business from crazy people.
@Dr. Aust: I’ve always worried you. You’ve said so many times.
Quote: ‘What comes through to me in such comments is a very worrying arrogance and a kind of paternalist assumption of authority and infallibility: ‘I am a healer! My patients need me! I must continue in my calling! I don’t care what other people say!’
I am the least arrogant herbalist I know. I am most concerned about my patients. I am not a ‘healer’. I am, like any other healthcare practitioner, a facilitator. People come to me. I recommend lifestyle changes, and I make a prescription. Whether people comply with this is up to them. I have, recently, diagnosed 3 people with severe conditions, that GPs and specialists did not pick up because they do not read each others notes. In each case, the GP or specialist was impressed that I was able to spend enough time with the person to see the whole picture. We are all working together, now, to give these people the best care we can give them.
And I do care what other people say. I read the BMJ, many pharmacological and medical journals, and I try to keep up to date on the frontline treatments for any number of conditions. I’m a proud defender of the NHS, which I worked for for a number of years.
However, I do take with a grain of salt the opinions of men with too much time and broadband width on their hands. And if you accuse me of a paternalist assumption of infallibility, I invite you to spend some time with Foundation I doctors. They take the cake, really.
@Anti-D: Quote ‘How will avoiding SR drive herbalists underground? If the DH opts for the status quo option, then herbalists will still be able to practise under section 12(1) of the Medicines Act 1968. Have you actually read the consultation document? Frankly, you’re deluded about the number of herbalists practising in the UK & I’m not sure how the lack of SR legislation is going to lead to the collapse of the organisations & suppliers you mention. ‘ Unquote
I have indeed read the consultation document and answered it. I think that you don’t understand the whole picture because you don’t understand the EU legislation that’s due to come online at the end of 2010, and the connection that that legislation has to the current consultation. Catch up, you’re falling behind.
And I’m certainly not deluded about the numbers of Medical Herbalists practicing in the UK. The NIMH has over 750 members and the CPP has about 170. Some of these (like myself) overlap, but the general number is hovering about 1,000. And there are over 150 graduates due to graduate this year.
We will not be able to continue to practice under the 1964 and 1996 laws because 3rd party production of medicines under GMP will be outlawed under the EU directive unless we are statutorily regulated. We will lose a huge number of remedies and many wonderful rpoducers of herbal tinctures will go out of business. So we will onyl be able to practice if we roam the countryside looking for herbs to boil up in our own kitchens. I’d much rather buy herbs distilled and macerated in a clean environment with GMP. Personally, I’d like to see them standardised.
@Dr. Colquhoun: Those herbalists are the ones who want to continue to make medicines in their kitchens, who are opposed to standardisation, who don’t want to prove their continuing professional development, and who hate the idea that we might move into the 21st century as practioners: complete with clinical testing, standards, clean facilities for production, and proper training.
I’m not quite sure why you oppose my stance, as, since we have had so many conversations, I am advocating the regulation, standardisation, and proper supervision of Herbal Medicine.
And, I am not at war with those who oppose regulation. As far as I am concerned they are an annoying throwback to the 19th century that we must ignore until they go away. The younger generation of herbalists has the upper hand. We will see it out.
I stand by what I said. We must be statutorily regulated for the protection of the public. Anything else is, simply, allowing the real quacks to call themselves properly trained plant pharmacologists. If you cannot see that then I look forward to the columns in the future……
All the best to you all,
NAWD
@NAWD
I’m very happy to agree that you are one of the most reasonable herbalists I’ve met. I accept your enthusiasm for putting herbalism on a sound scientific basis.
But I still disagree with you about regulation, in the form that is being proposed by Pittilo. That is because his proposals will achieve none of the things that you want. There is no mention of standardisation (the real Achilles heel of herbalism) and the little question of whether it works on not. The only effect of this form of pseudo, box-ticking “regulation” will be to endorse the sort of witch doctory that you so sensible oppose.
Please don’t allow your wish for real, effective, regulation lead you to support the Pittilo proposals. If they are eccepted, your aims will be set back for many years.
Dear NAWD,
The following is the ‘3rd party production’ legislation you mention:
Article 5
‘1. A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order,
formulated in accordance with the specifications of an authorised health-care
professional and for use by an individual patient under his direct personal responsibility’.
Click to access 2001-83-EC.pdf
Could you please explain how this will lead to a loss of ‘a huge number of remedies and many wonderful poducers of herbal tinctures will go out of business’?
Remember that the THMPD comes into force in 2011 (not 2010) and puts in place your beloved GMP standards for suppliers of direct to practitioner herbal remedies, but its main target is OTC herbal remedies. It replaces section 12(2) of the Medicines Act 1968. The THMPD has nothing to do with SR.
One other thing: PA membership numbers do not equate to herbalists in practice.
NAWD wrote
The FY1 hubris – usually an over-reaction to getting past the initial terror that they won’t be able to do anything – is a well-recognised stage that almost all of them grow out of, NAWD, I suspect you know this. And of course one of the reasons solo practitioners are rather frowned upon in conventional medicine is that having close colleagues interacting with you (or even correcting you) helps prevent people getting too messianic.
If I’ve misjudged the tone of your comments, apologies – but really, read over the ones of yours I quoted above and ask yourself how you think they come over.
Dear All,
thank you for your interesting and concise responses to my posts.
@ David Colquhoun: I have no choice but to support the current drive toward SR. I believe it will drive many of those herbalists uninterested in SR into not practicing and bring those of us who are dedicated to scientific study of plant pharmacology into a position where we might even get permission and funding to do proper trials on constituents of herbal medicines. It’s a ray of hope for those of us who believe that plant medicines have something to offer as an adjunct to pharmaceuticals.
@Anti-D: The third party legislation is especially important for a practitioner like myself who relies on good-quality herbal medicines made by a third party for their practice. I refuse to give my patients things I have made myself (I can do this, but I haven’t got clean facilities, testing facilities, clean bottles, sterile environment). If this legislation comes into practice, I will have to make most of the medicines I use myself. This is a huge waste of my time and unsafe for my patients. I also use third-party materials like creams, pessiaries, and capsules that are not reasonable for me to make in bulk on my premises. As it stands, I can phone one of a few good companies here in the UK and have something made to order in a clean environment and give them to my patients with confidence. If that EU legislation goes through, I will have to make all of these treatments myself. In my kitchen. It doesn’t bear thinking about.
@Dr Aust: I agree in theory with what you say, but my experience in the NHS must make me cautious. Foundation doctors are ridiculously arrogant, but I have also met and been treated by Consultants who have never lost their swagger. They are among the most arrogant people I have ever met in a clinical setting. I have met a few dedicated, incredibly wonderful surgeons, but I could count these on one hand.
GPs surgeries are much more often about business and dividing money than GPs helping each other to be better practitioners. One of the GPs at my local surgery nearly killed my husband. He wouldn’t recommend that my husband be admitted to hospital for gallstones because my husband was not Fat Female Fertile Fair and Forty. My husband was subsequently rushed to hospital without the GPs okay and had 22 gallstones and his gallbladder removed. He had a gallstone lodged in his bile duct and was nearing abdominal infection when he was finally admitted to hospital.
I had a consultation this week with a woman who has suffered (very badly) with joint problems since she was about 8 years old. After my consultation, I did a short bit of research, and it is my feeling that she has had undiagnosed Ehlers-Danlos syndrome for her whole life and she has never been diagnosed by an NHS doctor. Mainly because she grew up in India and hates the NHS system. She has refused to go and get a diagnosis. She has come to me for treatment and I am morally obliged to help her with her condition. This is not hubris or anger, it’s simply wanting to help someone.
What I do is not quackery. I respect your opinons. I am trying very hard to be the best healthcare practitioner I can be. It would be much better if I could rely on you (who are scientists and healthcare practitioners) as colleagues rather than the current alternative.
All the best to you,
NAWD
Dear NAWD,
Your interpretation of the ‘3rd party’ legislation seems to me driven by a very active imagination. Have you written to the MHRA to check whether your fantasies correlate to their version of reality?
@Anti-D
This is what the EHPTA, the NIMH, and the CPP understand to be the case as regards the legislation that comes on line in 2010-2011.
I have no fantasies on the subject, I am working on the information I have received from these organisations and my own readings of the materials posted on the internet. If you feel I am wrong, then I accept you have a dissenting opinion. I wonder…. have YOU written to the MHRA to find out what the legislation means, or are you fishing for a particular answer from me?
All the best,
NAWD
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Dear NAWD,
Indeed I have. I wrote to Judith Thompson on 9 October and, as is usual with the MHRA, have not yet received a reply. I have copied my email below for your information:
Dear Judith,
I hope you can clarify a number of issues regarding the above piece of legislation as it affects practitioners of herbal medicine. As you may be aware there is a DH consultation regarding the statutory regulation (SR) of herbalists currently in progress. The effect of section 5.1 of Directive 2001/83/EC (without the enactment of SR and the associated ‘authorised health-care professional’ status) is being interpreted, by a number of organisations & individuals, to be the complete disruption of herbal supplies.
Could you please let me know how the MHRA would interpret the nature and scope of section 5.1 of Directive 2001/83/EC for herbalists were SR not be in place by 2011? How does the MHRA define a ‘bona fide unsolicited order’ in the context of section 5.1? How does the MHRA define ‘formulated’ in the context of section 5.1? What type of herbal medicinal products can be considered to be ‘formulated’ in the context of section 5.1? How would herbalists and their suppliers be materially affected by section 5.1 of Directive 2001/83/EC were SR not in place? The wording of section 5.1 appears to require interpretation on a case-by-case basis, would you agree?
All help with regard to this matter will be gratefully received, etc…
@Anti-D
Thanks very much for that. I look forward to her reply with interest.
I note the deadline for submissions has been extended to 16th November 2009 because of the postal strike.
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