Download Lectures on Biostatistics (1971). Corrected and searchable version of Google books edition
Download review of Lectures on Biostatistics (THES, 1973).
labels
The absurdness of allowing statutory regulation of herbal medicines, both Western and Chinese has already been pointed out here, in Government lends credibility to quacks and charlatans, and by Andrew Lewis in “How to Spot Bad Regulation of Alternative Medicine“
The harm done by the government’s endorsement of herbal products could be ameliorated if they were labelled honestly. The labelling is a matter for the Medicines and Healthcare products Regulatory Authority (MHRA), and for a while I have been writing to the head of the MRH, Kent Woods, and to Richard Woodfield (head of MHRA herbal medicine policy), in an attempt to work out their reasons for not telling the consumer the simple truth.
A similar (but even worse) problem arises in the labels that have been allowed by the MHRA for homeopathic pills. That has been discussed in Pseudo-regulation: another chance to save the MHRA from looking idiotic . The matter is not yet decided, but on past performance, I’m pessimistic about whether the MHRA will listen to scientists.
The Traditional Herbal Registration (THR) scheme allows herbal medicines that are registered on this scheme to be sold if they are safe, and have been in use for 30 years. There is need to supply any information whatsoever about whether they work or not. That itself is very odd, given that the MHRA’s strap line says
"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe."
In the case of herbals, the bit about ensuring that medicines work has been brushed under the carpet.
A typical dishonest label
Take "Echina Cold Relief". The Traditional Herbal Regulation document specifies the label.
Note, first of all, the therapeutic claim in the brand name itself. This is blatant practice for most herbals and appears to be unregulated. The label says
|
It is my contention that most people would interpret this label as a claim that the tablets would have a beneficial effect on the symptoms of "common cold and influenza type infections". The impression is reinforced by the government stamp of approval on the package. The MHRA tell me that no tests have been done to discover how shoppers interpret these words. They should have been done.
|
|
Why is there nothing on the label that tells the plain, unvarnished truth? Perhaps something like this
"There is no evidence that this product works for the indications mentioned".
Or
"Clinical trials have shown this product to be ineffective for xxx "
or, at a minimum
"The MHRA kite mark does not imply that this product is effective".
Some Evidence
Echinacea is a generous choice of example because, unlike most herbs, there is a bit of evidence about its effectiveness. A Cochrane review says
Sixteen trials including a total of 22 comparisons of Echinacea preparations and a control group (19 placebo, 2 no treatment, 1 another herbal preparation) met the inclusion criteria. All trials except one were double-blinded. The majority had reasonable to good methodological quality. Three comparisons investigated prevention; 19 comparisons investigated treatment of colds. A variety of different Echinacea preparations were used. None of the prevention trials showed an effect over placebo. Comparing an Echinacea preparation with placebo as treatment, a significant effect was reported in nine comparisons, a trend in one, and no difference in six. Evidence from more than one trial was available only for preparations based on the aerial parts of Echinacea purpurea (E. purpurea).
“It seems that some preparations based on the herb of Echinacea purpurea might be effective for this purpose in adults, while there is no clear evidence that other preparations are effective or that children benefit. Side effects were infrequent but rashes were reported in one trial in children.”
The US agency NCCAM has spent over a billion dollars on testing various sorts of alternative treatment, and has failed to find a single useful treatment, They say
"Two NCCAM-funded studies did not find a benefit from echinacea, either as Echinacea purpurea fresh-pressed juice for treating colds in children, or as an unrefined mixture of Echinacea angustifolia root and Echinacea purpurea root and herb in adults."
So the evidence is a mess. There is no evidence that Echinacea can prevent colds, and, at the very best, it might shorten slightly the time for which cold symptoms last. The most likely interpretation of the mixture of contradictory results, many negative trials with a handful of small positive effects, is that for practical purposes, echinacea is useless. There is NO treatment known that affects the duration of a cold to any useful extent.
I wrote to Kent Woods in February 2011
|
Hello
Sorry to bother you again, but recent events have caused me to think about a rather fundamental question, and I have never seen it discussed in any official documents. I suspect it needs to be answered at the highest level. Question, Do you make any distinction between (a) herbs that have unknown efficacy (most of them). and (b) herbs that have been shown in good trials to have no useful effect (like echinacea)? It is one thing to say “traditionally used for …” when you don’t know whether it is true or not. It is quite another thing to say “traditionally used for. . . ” when you know it is untrue No such distinction seems to be made at the moment. Is that because the distinction has never been considered by the MHRA? Or is it because it has been considered, but dismissed as unimportant? Or is it considered important but you are prevented from doing anything about it (and, if this is the case, what prevents you?) Best wishes |
His reply was, essentially, that herbs come in so many different forms that they can’t all be tested so it is never possible to say that a herb “does not work to any useful extent”
|
. . . Based on our experience of regulating herbal medicines, we think it unlikely for the foreseeable future that there would be available for particular herbs a comprehensive body of published studies that meet medicines regulatory standards and cover systematically the numerous possible permutations as to type of extract, plant species and part of plant. Consequently, it is unlikely that evidence would be available for MHRA to know that a traditional herbal product did not have efficacy. In summary, you suggest an interesting scenario the handling of which would be worthy of further consideration in the event of major advances in the range and quality of clinical trials of herbal medicines – but for the foreseeable future we would see the dilemma as largely a theoretical one.
Regards Kent Woods
|
This strikes me as a cop-out. It amounts to saying that it’s impossible ever to say that a treatment us useless. If NICE took the same view, no medicine would ever be ruled out as having no useful effect.
Then I asked about a press release from the MHRA, dated 18 March 2011.
|
Hello It says (my emphasis)
Since the main sort of information that people want about a medicine is whether it works, and you have explicitly ruled out any information about that, the description "informed choice" seems to me to be exaggerated to the point of dishonesty. This raises another question. Many people think that the wording that you approve is deceptive. can you tell me whether you have yet done tests to discover whether or not the average consumer interprets your wording as suggesting effectiveness? This was raised (apropos oh homeopathics) with Kent Woods at the SciTech enquiry and they were assured such tests had been done. Still nobody has seen the result of such tests. Please will you let me know if they have been done, and, if they have, what the results were? if they have not been done, why not? Best regards |
The legal requirement
In response to my letter, Richard Woodfield said
"Specifically on the question of wording affecting efficacy, we have to comply with the requirements of the herbals Directive which specifies the required product information about the traditional basis of the registration. We have not user tested the required statement in the Directive.
"
The European Herbals directive 2004/24/EC [download it] does make it mandatory to include the words used by the MHRA
“In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication( s) exclusively based upon long-standing use.”
Telling the truth on the label
I asked the MHRA whether there was any legal reason why they could not add the following notice to the wording required by the European Directive. I had to ask the question several times before I got a straight answer, but the answer eventually turned out to be that there is no legal reason that bars honest labels. Eventually Richard Woodfield told me there was no legal reason.
|
Dear Prof Colquhoun There is no specific bar in the European Directive that would definitely preclude requiring additional statements that were consistent with the Directive. Obviously one would have to look at the specifics of what was proposed.
The main bar is that of Government policy. Under the previous Administration when the scheme was set up there was a strong policy of avoiding gold plating of European legislation – and this would clearly be a case of gold plating. Under the new Government that policy of avoiding gold plating has been strengthened further. And added to that there is now a presumption that wherever possible Directives should be transposed by “copy out” of the text rather than elaborating upon the requirements of the Directive.
The onus would be on those seeking gold plating to demonstrate that it was necessary. In the present absence of evidence of significant detriment under the THR scheme to consumers who for example choose to take a THR to help with a condition such as mild indigestion we have no present plans to propose the introduction of a form of retrospective gold plating of this legislation. As recognised in your last email, I think that is about as far as we can usefully comment on the issue for the time being. Regards
Richard Woodfield |
So, at last we have the answer. And pretty pathetic it is. “Gold-plating” is a term that is used by the anti-European lobby to describe the process of not simply implementing European law but making it more strict that is essential. In this case, I would claim that making the label honest was the opposite of gold-plating, The European law is obviously designed to encourage the herbal industry by disguising the lack of evidence for the herbs. The MHRA should correct that deficiency but has declined to do so.
Safety
The herbal medicine business, especially the Chinese Traditional medicine, is riddled with impure, contaminated and sometimes lethally toxic rubbish. Of course it is right that the public should be protected from this. Probably it is a job that should be done by Trading Standards officers, but sadly they have shown themselves time and time again to be incompetent and unwilling to enforce the law when it comes to false health claims. The MHRA make a reasonably good job on this front, but that is no reason for them to endorse misleading labels. Statutory regulation by the HPC will do nothing to help: on the contrary it will endorse courses that teach dangerous nonsense.
The Herbal Medicines Advisory Committee
The MHRA’s Herbal Medicines Advisory Committee should have resisted this misleading labelling, but they do not seem to have not done so (it’s hard to tell because the published minutes are totally free of any useful information). The chairman of that committee is Professor Philip A Routledge OBE MB BS MD FRCP FRCPE. If I had been in his position, I would have resigned. I believe that he has let down honest science, and potentially endangered patients by not insisting on honest labels. I do hope that this was not a result of pressure from the Prince of Wales. We know he has lobbied Kent Woods and Philip Routledge. Incidentally, Routledge is president elect of the British Pharmacological Society. Quackery has crept in even there.
What can be done
There us no reason why, even now, the MHRA could not change the labels to something honest. I expect the government is pressing them to support the herbal industry, and big business usually wins over regulators (as with banks).
Freedom of choice by consumers was mentioned several times by the MHRA. That’s fine. Nobody wants to ban echinacea. The whole point of labels is to ensure that it is informed choice. Labels that mislead do not help anyone. They hurt the consumer and they are disastrous for the reputation for integrity of the MHRA.
We should keep up the pressure on the MHRA. Here are a couple of my recent efforts, on BBC Breakfast TV.
The second interview was joint with Dick Middleton. It should have been made clear that Middleton is a pharmacist who is technical director of Schwabe Pharma, a company that sells expensive herbal pills, so has a vested financial interest in disguising the lack of evidence for efficacy,
Follow-up
1 May 2011. The new herbal regulations have come into effect. Radio 5 put me up against the herbal industry representative, Michael McIntyre (chair of the European Herbal & Traditional Medicine Practitioners Association). I was pleased to get the chance to debate directly with him, because he has been misrpresenting the evidence for years. See, for example, Some truly appalling reporting of science by the BBC. and Government lends credibility to quacks and charlatans. I was able, at last, to ask him directly, which herb had the best evidence for its efficacy. He repeatedly refused to answer: “I’m not going to get into detail”. Eventually he resorted to the argument that herbalists treat people not diseases. I pointed out that the MHRA-approved labels list all sorts of diseases. No response. He then misquotes Sackett, who did NOT say that experience was as good as RCTs.
McIntyre goes on to misrepresent the BMJ Clinical Evidence paper which, he says, shows that 46% of all treatments are not proven to be effective. It is hard to be believe that McIntyre is really unaware that a large proportion of those that were not shown to be effective are CAM treatments, herbal medicine and the like. Professor John Garrow has pointed this out (see, also Healthwatch). Either he doesn’t read the literature or he deliberately misrepresents it.
Then a caller came in to swear that Chinese Medicine had cured his prostate problem and his wife’s hair. Of course he hadn’t any idea of how is prostate would have progressed if he hadn’t taken the Chinese medicine. Luckily for him, he didn’t have prostate cancer (the people who take Chinese medicine for cancer are probably dead so they can’t appear on the radio). These people are difficult to deal with without appearing rude, by saying they are gullible and deceived. I tried. Interestingly McIntyre did not leap to the defence of Chinese herbs.