Yes, it’s an answer, but to the wrong question. I have to say that the author Janet Woodcock did a pretty good job at telling the Burzynski sycophants to get lost,which is fine as far as it goes. What I want to know is why the FDA allows a medical scam to continue.

So I thanked Karen for her reply, and pointed out the error. Indeed my original questions were still at the bottom of her email in reply, so I just told her to scroll down. Since then she has said that she has to consult with colleagues, and they still haven’t got back to her – that’s as of 20:00 UK time on 14th December.

Now what is rather annoying is that Dr Lewin, who is responsible for regulatory compliance by clinical researchers, has passed this on to what appears to be the news desk. She has obviously not followed up on the questions that I and many others have asked her. I am clearly not getting very far with the news desk, so I will email Dr Lewin again and set out the questions in bullet points. OK I am not a US citizen, but this issue has a big impact in the UK so there is public interest over here. Her address is constance.lewin@fda.hhs.gov.

However, can any readers who are US citizens please take up the baton? Let’s have lots of you good brave Americans pressing Dr Lewin for answers. Can you lobby your democratic representatives? I for one am not going to be brushed off, and neither should you.

Craig comes across as well read, as he ought to as a university professor, but doesn’t convey to me any fundamentally new concepts. He starts with a wild claim that religious belief is undergoing a resurgence, quite the opposite of my understanding. He says that 30% of philosophy professors are theists, which is hardly relevant to whether any god exists. The people who know how the universe works are scientists not philosophers, and he doesn’t mention them in this context. It’s very well documented that almost all top scientists are non-theists, a fact he ignores. The significant point is that, while religious belief runs at about the same level in all scientists as it does in philosophers, among the most accomplished scientists (ie the ones who know the most) only 7% are believers. Of course, Craig’s gambit is really the discredited `appeal to authority’, but here he has chosen the wrong authority.

His philosophical rhetoric sounds impressive, but throughout he never addresses the matter of evidence. His attempt to poke holes in theoretical physics misses the point totally. The undisputed fact that current theories are incomplete does not in any way strengthen the argument for a god. Does he not understand that the nature of science is the crash testing of ideas? Necessarily there will be lots of ideas and they won’t all, indeed can’t all, be right.

Religious historical figures get lots of coverage, especially Thomas Aquinas. I have studied the latter’s `proof’ for the existence of God and found it logically weak, as again it depends on internal relationships between a set of concepts and doesn’t reach out for evidence (that has been said to be its strength!). Indeed I have just read the `proof’ again and, rather than a tour de force in logical reasoning, it now presents itself to me as remarkably stupid. Aquinas deliberately constructs a contradiction in order to dismiss the possibility that God might not exist.

To recruit William of Occam to Craig’s cause seems a bit cheeky. OK, Occam was a Franciscan monk but however unlikely current theories of the universe are, Occam’s Razor would surely cut out the possibility of the even less likely God? I did warm slightly to his critique of the evolution of many universes, but this must be among the most speculative of concepts and not supported by anything we have observed.

Craig is correct that science is rooted in the concept of causality, but we have to remember that the arrow of time is something that we have deduced because of the way the universe works now. If, as many cosmologists agree, both time and space came into being at the Big Bang, then at that instant there was no arrow of time and no causality as we know it now. It seems crazy to me to try to apply present day concepts to such alien conditions. Time is essentially inseparable from entropy – the only way we can measure time is by reference to it. When entropy achieves its maximum, that will literally be the end of time. At the Big Bang, entropy had not started so there was no time, and hence no causality.

But Craig departs even further from logical thought with his arguments about plausibility. Yes, our universe is extremely implausible, but surely a personal creative intelligence is even less plausible? He falls into the standard believer’s trap of assuming that the deity is beyond challenge or questioning. He makes no attempt at all to speculate as to why his god should ever exist. Had he done so of course, he might have been forced to ask why this god would have created the universe. Was it for the god’s own amusement? If so, he has a strange sense of humour, as he has ever since presided over one horrible natural disaster after another, presumably because he made such a poor job of designing the universe (I am only using `he’ by convention). It seems that Craig’s obsession with causality stops here. This failure makes his discourse appear even more pretentious than it might have done.

Overall, Craig seeks to get the scientific ducks in a row and knock them down one by one, until all that is left is his god. His mistake is in thinking that science is complete, and that there are no more ducks.

It appears that Dennett was given very little time to reply. Even so, I think he could have done a better job. He was more generous to Craig than I think was necessary, but he ended on an important note. He says that whatever we discover to be the truth, it will astound us. We should not speculate on what that truth might be, by applying our preconceptions and prejudices.

Now there are sceptics who refuse to debate with Craig, and for very good reasons. Craig believes in the literal truth of the Bible, for a start. That seems a very odd thing for a philosopher to do. For example, Richard Dawkins discusses at length Craig’s endorsement of the Israelites’ genocide against the Canaanites. It is a truly horrible and disgusting tale, and firstly Graig accepts it as true (it could well be), and secondly justifies it with arcane arguments. He even goes to the unthinkable extent of approving the slaughter of young children. Can the millennia of conflict in the Middle East be at all surprising when there are thought leaders like Craig endorsing massacres on a huge scale?

Such stories paint a picture of Craig as a player of philosophical games, without any personal connection to the claims of religion to provide a moral framework. Indeed, his pronouncements on the Israelites give the impression of a very unpleasant person indeed. I don’t expect him to challenge me to a debate, and if he did I would expect him to win on a point-scoring basis, but I don’t think I would want to be in the same room as him let alone on the same platform.

Constance Lewin, M.D., M.P.H.
Branch Chief, Good Clinical Practice Branch I
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5354
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA

Dear Dr Lewin

Re: The Burzynski Research Institute, 9432 Katy Freeway, Houston, Texas 77055

The activities of this investigational site have attracted attention worldwide. For well over 20 years Dr Burzynski has been administering investigational drugs, which he calls antineoplastons, to patients with very advanced cancers. He charges extremely high fees for entering patients in what he claims are clinical trials. Hitherto none of these `trials’ has met internationally recognised standards of design. Of 61 protocols registered on www.clinicaltrials.gov, 34 are recorded as of unknown status, six have been withdrawn, and only one has been completed. There are only five publications from this investigator on PubMed indexed as clinical trials, but three appear to be reporting on the same study.

In 2009 The FDA issued a warning letter to the Burzynski Research Institute IRB, citing multiple violations. These violations implicated The Burzynski Research Institute itself in various breaches of Good Clinical Practice.  Can you tell me please why the warning letter has not been closed out, and why The Burzynski Research Institute has not received a for-cause inspection by the FDA? In particular, I am wondering how approvals for phase I and phase II trials could have been issued over so many years, when the protocols were so obviously of no real scientific value. For example, protocol NCT00003533 states its objectives as:

• Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable, metastatic, hormone-refractory adenocarcinoma of the prostate.
• Describe response to, tolerance to, and side effects of this regimen in these patients.

The first objective has no scientific aim or predicted outcome. Please explain how the FDA can consider this to be acceptable practice. I am aware that BRI claims antineoplastons to be orphan drugs, but that does not excuse abuse of the scientific method.

To illustrate the level of concern many people have for this matter, I would direct you to a digest at:

http://josephinejones.wordpress.com/2011/11/29/burzynski-blogs-my-master-list/.

Here in the UK, the public is being asked to contribute to fund-raising efforts to pay for the treatment of children by Dr Burzynski. As a professional in clinical research, it is easy for me to see that there is no realistic prospect of success from this treatment. How does the FDA justify allowing this investigator to continue?

Yours sincerely

This will have to go via snail mail as I could not find an email for Dr Lewin. But her phone number is +1 301-796-3397. In any case a paper letter will be less vulnerable to the delete button. What if she got 50 such letters? Get writing.

Well more eminent bloggers than I have done just that. The inestimable Andy Lewis, of Quackometer fame, was among the first to wade in, and has been rewarded with probably the most scurrilous and puerile attack I have ever seen from the pseudoscience fraternity. The non-lawyer Marc Stephens accuses Andy of lying and fraud. OK, let’s see who is telling the truth.

There are 61 protocols on www.clinicaltrials.gov, going back to 1999 when the website started. Of these, one is given as completed, six as withdrawn, 10 actively recruiting patients, and 34 of unknown status. The remainder are shown as not recruiting. A search of PubMed reveals five citations for clinical trials, under the authorship of S Burzynski:

1. Burzynski SR, Kubove E, Burzynski B. Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1. Drugs Exp Clin Res. 1990;16(7):361-9.
2. Burzynski SR, Lewy RI, Weaver RA, Axler ML, Janicki TJ, Jurida GF, Paszkowiak JK, Szymkowski BG, Khan MI, Bestak M. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report. Drugs R D. 2003;4(2):91-101.
3. Burzynski SR, Weaver RA, Lewy RI, Janicki TJ, Jurida GF, Szymkowski BG, Khan MI, Bestak M. Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report. Drugs R D. 2004;5(6):315-26.
4. Burzynski SR, Weaver RA, Janicki T, Szymkowski B, Jurida G, Khan M, Dolgopolov V. Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1. Integr Cancer Ther. 2005 Jun;4(2):168-77.
5. Burzynski SR, Janicki TJ, Weaver RA, Burzynski B. Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma. Integr Cancer Ther. 2006 Mar;5(1):40-7.

None is a controlled clinical trial. They are all case series with no more than 14 patients each. Three of them seem to include the same patients – they are periodic reports on the same study. In publication 5, the authors conclude:

Antineoplastons contributed to more than a 5-year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients.

This is a staggeringly confident assumption of causality, in the absence of any control group.

The abstract for publication 2 states:

The percentage of patients’ response is lower than for standard treatment of favorable PNET, but long-term survival in poor-risk cases and reduced toxicity makes ANP promising for very young children, patients at high risk of complication of standard therapy, and patients with recurrent tumors.

Again, it is impossible for anyone to draw any conclusions as to survival, in the absence of a control group. The abstract does not define `response’, but even so the authors admit that whatever the criterion, the treatment was less effective that standard therapy. Is this all there is to show for 21 years of `research’? Out of 61 protocols we have only seen five publications. Note that there has been nothing for the last five years. So far, we have no evidence (at least as available on PubMed) of any clear benefit. Indeed, one attempt to conduct a properly designed trial ended in disarray because the sponsor (The National Cancer Institute) and Dr Burzynski disagreed on scientific protocols.

But while researching BRI’s claim to have FDA approval for a phase III trial*, I came across more interesting stuff. On 5th October 2009 The FDA issued a warning letter, after a regulatory inspection of the BRI institutional review board (IRB). I should explain that in the USA an IRB is effectively what we call an ethics committee. In this case, BRI has its own IRB, which is supposed to be independent. The primary purpose of the IRB is to protect clinical trial patients from ethical abuses. To summarise the letter, the main violations were:

• Failing to report to the FDA that BRI had dosed human subjects without IRB approval.
• Allowing a study to proceed, despite asking for further pre-clinical toxicology data.
• Allowing a study to proceed without an investigator’s brochure having been submitted (the investigator’s brochure is the detailed summary of all data to date, and is mandatory for all investigational drugs).
• Approving the use of a medical device without assessment of risk.
• Failing to ensure that BRI obtained informed consent from patients or guardians.
• Conflict of interest between BRI and the IRB – the IRB chairman was also an investigator.
• Failing to carry out regular review of ongoing studies.
• Multiple failures to maintain files and documents, including minutes of meetings.
• Co-opting external people onto the IRB, against FDA rules.

Note that the FDA has not issued a close-out letter, hence the IRB has so far failed to remedy these breaches. Yet BRI continues to dose patients with its unproven treatment nearly three years after the inspection. What does the FDA think it is doing? Surely it’s time for a `for-cause’ inspection of BRI itself?

Isn’t it significant that among enthusiasts for pseudoscientific medicine there are so many deeply unpleasant people? For example, I have on occasion crossed swords with the homeopath John Benneth, and have received a threatening phone call from a certain academic who will remain nameless – unless he tries it again. How many real scientists behave like this? OK, I know that Isaac Newton was very nasty to Leibniz, but Newton was exceptional in many ways. Marc Stephens and his ilk always remind me of what little Shakespeare I remember – “Methinks [he] doth protest too much”.

*How is it possible to go to phase III trials without any proof of concept or dose-ranging data?

Dear Dr Bewley (sic – she is Professor)

Thank you for your letter of 2 September 2011.

I am sorry you have had to wait so long for our response. The delay was caused by the fact we have only just received feedback on your queries from the Medicines and Healthcare products Regulatory Agency (MHRA), the body with responsibility for the Advisory Board on the Registration of Homeopathic Products (ABRHP).

I can imagine it would have taken some time to work out how to answer such searching questions.

The MHRA has provided the following information in response to your request that we explain the following:

a) What possible service this Board serves?

The Advisory Board on the Registration of Homeopathic Products (ABRHP) was established in 1994 by the Medicines (Advisory Board on the Registration of Homeopathic Products) Order 1994 (SI 1994/102) as amended by the Medicines (Advisory Board on the Registration of Homeopathic Products) Order 1995 (SI 1995/309) and Medicines (Advisory Board on the Registration of Homeopathic Products) Amendment Order 2006 (SI 2006/2386) pursuant to the powers contained in section 4 of the Medicines Act 1968.

The service that this Board offers is encapsulated in its terms of reference which are:

a. to give advice on safety and quality in relation to any homeopathic medicinal product for human use, in respect of which a certificate of registration has been granted or applied for;

b. to give advice on safety, quality and efficacy in relation to any homeopathic medicinal product for human use:

i) in respect of which a homeopathic marketing authorisation has been granted or has been applied for

ii) in respect of which a licence of right has been granted.

Note: efficacy means acceptability within the UK homeopathic tradition.

I suspect the MHRA is deliberately missing the point here. Susan was really asking what value the ABRHP was providing, not the work it was doing – they are different. But just look at that staggeringly revealing tailpiece. The MHRA unilaterally redefines efficacy. No longer does it have anything to do with evidence, it is based entirely on faith.

b) More specifically, what is the ‘complex scientific expertise’ that is required to understand homeopathy (that has no effect beyond that of a placebo)?

The remit of the ABRHP is to provide advice on homeopathic medicinal products and not homeopathy per se. It gives advice on all aspects of homeopathic medicinal products, including consumer information.

The MHRA is learning from its political masters. When asked a difficult question, just ignore it and answer something else, that hasn’t been asked. The MHRA has asked for `complex scientific expertise’, but on what remains a mystery.

c) How can experts advise about the safety and quality of safety and homeopathic medicines that contain negligible, if any, ingredients?

Applicants submitting an application for a certificate of registration are required to submit dossiers to demonstrate the pharmaceutical quality and safety of the products concerned. Quality and safety dossiers are also required when submitting an application for a homeopathic marketing authorisation in addition to a dossier supporting the use of the product by UK homeopathic practitioners within the indications sought.

The Directive lays down requirements that are the same as for conventional medicinal products. Homeopathic medicinal products are made from starting materials that may be of animal, vegetable, herbal or mineral origin and other chemicals. The quality dossier submitted must provide data on the production and control of the homeopathic stock or starting material, since the nature of homeopathic products is such that tests on the finished product are of limited value with regard to quality control. The quality and control of stocks is therefore of considerable importance in assuring the consistent quality of the finished product.

Hang on a minute, what’s this `Directive’ that has suddenly popped up? Is it  Directive 2001/83/EC as amended by 2004/27/EC? Whatever it is, to say that it ” lays down requirements that are the same as for conventional medicinal products” is demonstrably untrue. All EU and UK legislation excuses homeopathic products from demonstrating any efficacy, as is mandatory for real medicines. The writer’s brain seems to be wired differently from mine – how is the quality of the finished product related in any way to the quality of stocks, when there is no stock in the finished product?

The quality dossier submitted must also provide supporting data on the production and control of the dosage form and due to the low levels of stock present in the dosage form, it is important to ensure that adequate planning and in process controls are applied to the manufacturing process in order to ensure batch to batch homogeneity.

The safety dossier submitted must provide supporting data on the safety of the finished product include (sic) calculations of the concentration of stock in the finished product. Experts advise on the safety of the dosage form and on key safety messages that should be included in the consumer information to ensure the safe use of the product.

Of course, in most cases all they have to show is that they have diluted beyond Avogadro’s number. How hard is that?

d) How the Appointments Commission will handle the fact that professionals with faith based (rather than evidence or science based) beliefs in homeopathy are highly unlikely to be recognised by their peers as eminent members of their profession? Science tells us “that there isn’t anything there”.

Members’ expertise covers a broad range of specialisms in order to enable the ABRH (sic) to fulfill its Terms of Reference as outlined above. The role of each Member is to advise on their own area of expertise. Therefore, Members whose area of expertise is not within homeopathy are not expected to have any knowledge of the theory of homeopathy.

Appendix 1 provides a list of Members and their individual areas of expertise.

The writer has turned the question on its head. Susan was challenging the scientific credentials of homeopaths on the committee. Instead, the writer excuses real scientists from holding bizarre beliefs – how generous!

e) Pharmacognosy has nothing to do with homeopathy. What is the point in requiring an expert in medicines derived from natural sources to advise about products that will no longer be present after multiple dilutions?

Homeopathic medicinal products are not always highly diluted e.g. Euphrasia tincture is traditionally used as eyewash to soothe sore eyes. As discussed above, the quality and control of stocks is of considerable importance in assuring the consistent quality of the finished product. Since many stocks, including Euphrasia, are derived from plants, the expertise of a Pharmacognosist is required.

“Not always..” does not mean “hardly ever..”. The truth is that most homeopathic remedies are diluted beyond Avogadro’s number. This is a classic red herring.

f) What are the benefit and opportunity costs of the taxpayer paying £325 per meeting x 4 members x 11 meetings x 4 years (£57,200) for just part of this committee?

Although 11 meetings are put in the diary only four or five a year are held and this depends very much on the amount of business requiring the Board‘s advice. Board Members are paid a taxable fee of £325 per meeting plus accommodation and travel costs within strict Government guidelines.

And finally, a prime example of evading the question. Susan asked for the benefit and opportunity costs, and quite obviously the writer does not understand the terms, or chooses to ignore them.

I hope this information is helpful and demonstrates the purpose of the ABRHP more clearly. Please let me know if you have any further queries.

Yours sincerely

Andrea Sutcliffe

Chief Executive

Well the letter certainly is helpful, in that it shows how the MHRA regards the public that it serves. It thinks we are idiots. Let me remind you of the MHRA’s mission statement:

We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk free.  Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

Am I in order to say they are lying to us? By redefining efficacy as they have done here, they are very clearly not using `robust and fact-based judgements’. They have been effectively lying to us since 2006, when the new registration scheme was surreptitiously forced onto the statute book. Well I do think I am allowed to say this, because a lie is something that the speaker knows to be untrue, and is intended to mislead. This has been going on for so long that the MHRA can’t possibly be unaware of the truth. By welcoming anti-scientific people into its fold, the MHRA finds itself forced to defend them and ends up misleading the public.

This scandal has been further aired in the BMJ, with a letter authored by Susan and which I was proud to support. It sparked off the usual vitriolic and sometimes personal attacks by various homeopaths. I am always struck by the courtesy which most sceptics employ, and the gutter language that we usually get from the alternative medicine fraternity. Says it all really.

Thank you for your inquiries about evidence based practice. Please accept my apologies for the delay in responding to you. As my colleagues have indicated, the GMC has not issued any advice about complementary and alternative medicine. However, all doctors have a duty to be familiar with and follow our core guidance, Good Medical Practice (2006), which describes what is expected of all doctors registered with the GMC.  Good Medical Practice is guidance, not a statutory code; so doctors must use their judgement to apply the principles to the various situations doctors will face, bearing in mind that they must be prepared to explain and justify their decisions and actions. Specifically, we say that ‘in providing good care [doctors] must provide effective treatments based on the best available evidence’ (paragraph 3c of Good Medical Practice). Doctors must also be satisfied that any drugs or treatment provided serve the patient’s needs. In many cases this is straightforward as the evidence base for particular treatments is clear. Where there is little or no evidence to support a particular treatment, or where there is genuine uncertainty about the evidence base for a particular treatment, doctors need to use their clinical and professional judgement, and, working in partnership with their patient, make a decision about treatment options that will serve the patient’s needs. As a result, doctors will not always only be providing evidence based treatments. We would not wish to stifle all innovation or unconventional approaches or prevent doctors from taking a patient’s wishes into account. However, a doctor who believed that treatment, which would generally be regarded as outside the boundaries of conventional practice, would be of benefit to a patient should always:

• seek advice from at least one experienced colleague or ask a colleague to provide a second opinion.
• keep a detailed record of the decision making process.
• monitor the patient’s condition and progress very carefully, and again keep a detailed record of the patient’s response to the treatment, reverting to conventional therapies if the patient has an adverse reaction.

In addition, our guidance, Consent: patients and doctors making decisions together (2008) requires doctors to give patients the information they want or need to make an informed decision about whether to agree to a particular treatment. This includes information about the ‘purpose of any proposed investigation or treatment and what it will involve’ and ‘the potential benefits, risks and burdens, and the likelihood of success’ of any treatment options offered. Regardless of whether a doctor is providing conventional or alternative treatments, they are expected to follow our guidance and serious or persistent failure to follow the guidance will put a doctor’s registration at risk. We have imposed sanctions on several doctors in relation to their use of complementary and alternative treatments. We are currently undertaking a review of Good Medical Practice (2006) and we can further consider the advice we give on this issue as part of this review. In considering these issues, we are mindful of the recommendations of the Science and Technology Committee Report, ‘Evidence Check 2: Homeopathy’, and the Government’s response to the Inquiry Report. In its response the Government noted that the commissioning of health services by Primary Care Trusts involved a range of considerations including, but not limited to, efficacy and outlined their continued position that local NHS services should continue to have responsibility for deciding what treatments to provide, including treatments such as homeopathy. I hope that you will take the opportunity to be involved in the review of Good Medical Practice by responding to the formal consultation when it is launched in October 2011 (you can keep up to date with developments by visiting www.gmc-uk.org/gmp2012).  I apologise again for the delay in responding to you and hope this written response is helpful in explaining our guidance.

It seems to me that all this took a lot of working out. The policy seems to have morphed from the previous “doctors must follow evidence-based practice at all times” to the present “if doctors don’t follow evidence-based practice, they must tell their patients they are prescribing quackery and they must seek advice from a colleague” (I paraphrase). Would any of us be surprised if that colleague turned out to be another quack?

Coincidentally, I have been having a heated discussion with some homeopaths on Edzard Ernst’s Pulse Today blog. One of those is a GP. Presumably the GMC’s policy has no problem with accommodating the regular prescribing of medicine with no medicine in it, as Dr Andrew Sikorski proudly admits to doing?

One more point. Do take up the invitation to get stuck into the GMC’s consultation. If you belong to a relevant professional body or other group (eg a patient support group), agitate for them to stand up for science in health care.

…there is nothing further for the Department to add on this matter.

In other words, “We are not going to answer your questions so you had better get used to not asking them any more”. Do you detect a note of exasperation? Well I have it on extremely good and very senior authority that ministers are getting rather fed up with what they describe as “hectoring and unhelpful” questions from scientists about evidence in health care. Sorry, I can’t reveal my source, but you know you can trust me. Well it’s good news that we are getting them to notice. I don’t think now is the time to worry about how much sleep Earl Howe and Anne Milton are losing, so the message is, don’t back off.

Thus I have broadened the approach slightly. Firstly, there is the Dept of Health’s response to the NHS Future Forum Report. I homed in on a key statement in the summary:

…we will support clinical commissioning groups to make high quality, evidence-based decisions, with information joining up to support integrated care.

What can this mean? If you search for the word `evidence’ in the whole document you get 19 hits, but what I am really looking for is a clear statement that in this brave new NHS, health care providers are expected to follow evidence based practice. It doesn’t say that anywhere. Read it yourself, if you can stand the repetition and boredom. So I asked the Dept of Health. More than two weeks later I got the reply:

You recently contacted the Department of Health to request further information about a paragraph in the summary box on page 14 of the Government Response to the NHS Future Forum that indicates that the Government will ‘support clinical commissioning groups to make high quality, evidence-based decisions, with information joining up to support integrated care’.

This is expanded in more detail later in the Chapter, at paragraphs 3.74 to 3.90: ‘Information and evidence to support high quality integrated care’.  This section considers, in particular, the information and other tools that will support integrated care and the importance of research and innovation for high quality commissioning.

We will publish an Information Strategy in due course, which will provide more detail about our plans to improve access to and the quality of information, including how commissioning can help to improve the collection and use of information and how we will ensure that information systems work together to support integrated care.

I hope this reply has been helpful.

Well of course it isn’t. Is it beyond the wit of the Dept of Health to say something like this?

We expect clinicians in the NHS to follow evidence based practice in patient care.

Apparently it is, because if they did they really would have to close the homeopathic hospitals. I realised that if I asked another question in writing I would have to wait another two weeks for a reply, so decided to phone the press office. They really didn’t want to talk to me, and referred me to the general enquiries desk. I asked to speak to someone about the NHS reforms, but the lady who picked up the phone felt well qualified to answer herself. So I asked whether evidence based practice by individual clinicians formed part of the NHS reforms, and got the usual flannel about how commissioning would be based on evidence. No, that isn’t what I asked, I said, because I am interested in what the Dept of Health expects of clinicians when they are choosing treatments. This went round in circles for a while, touching on NICE guidance, but I pointed out that NICE has not evaluated a great many treatments that are routinely used in the NHS. The lady then referred me to the NHS Constitution, which she said contains the policy I was seeking. Apparently this sets out the standards of evidence based practice that are expected of clinicians. Well guess what, it doesn’t. The word `evidence’ only appears once in the whole 12-page document. It appears on page 6, in this section:

You have the right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence. If the local NHS decides not to fund a drug or treatment you and your doctor feel would be right for you, they will explain that decision to you.

Of course, `local decisions on funding’ are not in any way the same thing as whether a doctor is prescribing a treatment with no evidence that it works. It isn’t too long a document to scan through it for any wording that might be relevant to evidence based practice, but there is nothing. I tried to explain that they were getting it the wrong way round. I was not concerned about whether commissioning decisions were based on evidence, I was asking what happens when a clinician ignores a lack of evidence. Naturally, I got for the umpteenth time the DoH mantra that “clinical decisions are for clinicians, and it is not for the Department of Health to interfere”. No, I said, I am not asking for the DoH to dictate what doctors must do, I am just asking what the DoH expects of them. Back to the NHS Constitution, which we now know is useless on this topic. I received a mini-lecture on how clinicians were best placed to decide what to prescribe, which is of course something of a generalisation. I could name a good number of registered physicians who obviously ignore evidence based practice.

At the same time I have pursuing a similar avenue with the General Medical Council.  I kicked off with this question to the media office:

This is a media enquiry on behalf of the charity HealthWatch, of which I am a committee member. I am prompted by the government’s response to the NHS Future Forum Report. The government does not make it clear that evidence-based practice will be a component of the NHS reforms. Indeed ministers insist in correspondence that they will not intervene in clinical decisions, which they leave entirely to clinicians themselves. Could we have a statement please on the GMC’s expectation in this regard? To maintain their registration, to what extent are doctors expected to adhere to evidence-based practice? Will the GMC engage with the government to ensure that evidence-based practice is increasingly followed in the NHS?

I got a fairly quick reply:

I would like to refer you to our core guidance for doctors, Good Medical Practice which in paragraph 3c states that a doctor must, when providing care:

“Provide effective treatments based on the best available evidence”.

Doctors should abide by this guidance at all times in their practice.

My interest was piqued by the phrase at all times. So I fired off this:

I am interested in the phrase “Doctors should abide by this guidance at all times in their practice“. This presumably means that doctors who prescribe treatments for which there is no evidence, such as homeopathy, are in breach of their terms of registration? Please clarify. I should mention that the government’s response to the Science and Technology Committee’s evidence check report agreed that homeopathy is not effective.

Also has the GMC contributed to the government’s consultations on the NHS reforms? In particular has the GMC reinforced the benefits to health outcomes of evidence-based practice?

This time the reply took rather longer – 12 days:

Thank you for your email and apologies it has taken me a while to reply. I wanted to check with our Standards team how best to answer your questions.

I bet he did.

The GMC’s role is not to evaluate the effectiveness of treatments but to set standards of good practice for doctors.

Registered doctors have to apply our guidance to the situations they face and act in the best interests of the patient at all times.

Our guidance does not require doctors to use only evidence based treatments, in any form of medical care, but we do expect doctors to do their best to ensure that any treatment they offer is in the patient’s best interests. This will generally mean that any known risks of the treatment are outweighed by the potential benefits to the patient.

We have not issued any advice about complementary and alternative medicine, as this is not within our remit.

The GMC did respond to the government consultation you mention, but focused on revalidation and education in particular. You can read our response here:

http://www.gmc-uk.org/GMC_response_to_DHE_White_paper_Equity_and_Excellence___Liberating_the_NHS_35892333.pdf

So what about this “at all times in their practice”? It has changed to “do their best to ensure that any treatment they offer is in the patient’s best interests”. I have therefore asked whether prescribing a treatment that is known to be ineffective according to the evidence, is in the patient’s best interest. No reply yet after more than a week. If it ever does appear, I’ll post what they say of course, but I am not holding my breath.

So is all this really so difficult? Not apparently for the Medical Council of New Zealand. Its Standards and Guidelines set out clearly and in detail what is expected of a doctor who practices non-orthodox medicine. For example on page 172:

Any registered medical practitioner who embarks on a mode of investigation or treatment of patients that is not based on evidence of effectiveness must also apply the standards that would be applied to orthodox methods. That requires a history and examination sufficient to make or confirm a generally recognised diagnosis; investigations using generally accepted tests pertinent to the patient’s complaint; a diagnosis that reasonable doctors would make; advising the patient of the orthodox treatment options, their risks, benefits and efficacy, as reflected by current knowledge; and recording all of the above in accordance with sound practice.

It also requires the doctor to demonstrate current knowledge and skills in their specialty; act according to the fundamental values of the profession; provide sufficient information to allow patients to make informed choices without misrepresenting information or opinion. Patients must be told the likely effectiveness of a given therapy according to published and accepted information, not subjected only to the doctor’s individual beliefs.

All this is not just words, and the guidance cites a number of fitness to practise hearings, eg:

…the Tribunal wishes to record that Dr X did not provide any meaningful explanation of the condition of ‘electromagnetic sensitivity’ or any credible reason for having diagnosed (the patient) as having it.

and

… Dr X did convey misleading information to give (the patient) the impression PMRT had a scientific validity it did not have…. Some examples are
a. the authoritative manner in which he gave his successive diagnoses;
b. his use of pseudoscientific language; and
c. his claim to use this diagnostic technique (which he claimed was extensively used overseas) ahead of his peers in New Zealand.

This is all well-established stuff, but in March this year the MCNZ consolidated its position with a very clear statement on CAM. My feeling is that if our GMC adopted such standards a great many doctors would find themselves in front of a fitness to practice panel. Is it therefore surprising that UK doctors will lose the right to regulate themselves? Current GMC guidance on Good Medical Practice has not a single word on doctors who use CAM. I am quite clear on how this should work. It is not for the DoH to regulate doctors. But the DoH pays the vast majority, who work in the NHS, so is a very major stakeholder in medical regulation. The DoH should therefore be engaging with the GMC to set out its expectations for good medical practice. Clearly the GMC is not going to take any initiative regarding unorthodox practice, so it is entire logical for the main stakeholder to drive the process. It would be nice to know how much money could be saved by cutting out evidence-free treatments, but the NHS doesn’t record any useful data except for certain defined areas such as homeopathic hospitals. The problem is far wider than that of course, and embraces a lot of well established practice (eg physiotherapy). The DoH issued a consultation on outcomes a while back, and this really should be the stimulus for collecting such data, but no sign of that so far.

Let me remind you of the purpose of this blog, which is to arm you with some tools to support truth and evidence. Nothing will change if not enough people care, so get writing to your MPs. It is extremely easy these days. Get involved with local and national groups, eg HealthWatch, Sense About Science, and The Nightingale Collaboration. If you belong to a relevant professional body, campaign for evidence based standards. Come on in, it’s great fun!

When he pulled out a leaflet on creationism I really lost my rag. He got both barrels – I said that what really irked me was not so much that he believed this rubbish, but that he was indoctrinating this young person with it. I told him it was child abuse and he should stop. He claimed that surely parents had the right to tell their children whatever they liked. I said no they don’t, if they are going to tell them things that are not true and are harmful.

I asked if he had ever read any of the evidence for evolution. He said “I choose not to”. In fact he had not read any science book since school. I asked him why he was coming to me with irrational ideas, when he had not bothered to look at any of the evidence surrounding the debate. He said “Well I respect your beliefs”.

“No no”, I blustered, “you misunderstand all this, it is not about belief, it is about evidence. My belief counts for nothing, only the evidence matters, and the evidence for evolution is so overwhelming that it is no longer considered a theory, it is a fact”.

Well I have summarised a bit, but the whole exchange was only about five minutes. I just hope that I sowed a tiny seed in that developing brain, that will one day germinate into a question about belief and evidence. But I am not very hopeful. I really don’t handle these situations well, they just make me too angry.

The Earl Howe

Parliamentary Under Secretary of State

Department of Health

Richmond House

79 Whitehall

London

SW1A 2NS

6th April 2011

Dear Lord Howe

I appreciated the opportunity to ask you about government policy on health care evidence, at the Institute of Clinical Research conference on 21st March. Of course, such a forum does not provide for detailed debate, so please permit me to explain the reasons for my question.

Whereas homeopathy may well have been uppermost in both our minds, the issue of evidence based practice is of course far wider. There remain substantial areas within the NHS where evidence from high quality studies is weak our even absent. For example, physiotherapy is considered mainstream but has little evidence for many of its techniques. My point is that permitting public funding of obviously useless practices such as homeopathy undermines the effort to deliver better outcomes for patients, by encouraging resources to be wasted on treatments that have no value. Your suggestion that such practices will naturally decline seems unsupported by the facts. Two weeks ago I noticed that a new ‘natural childbirth suite’ has been opened in a hospital on the south. It includes the provision of aromatherapy, a thoroughly discredited practice.

To claim that ministers cannot dictate therapeutic decisions to clinicians is simply not true. Various treatments that have been shown to be effective are not funded on the basis of cost. Yet such practices as homeopathy (I cannot call it a treatment as it does not treat anything) must have zero cost-effectiveness, and you insist on continuing to pay for them. What happens when decisions are delegated without clear standards and guidance was demonstrated by the recent GP commissioning pilot, when money was dissipated on practice overheads and alternative medicine.

As you are responsible for quality, then you will know that in any quality system, top management has to set the standards. Science tells us that clinical evidence delivers quality outcomes for patients. This is where the future of the NHS lies, not by translating post-modernist sociology into health care delivery.

I am copying this letter to my MP and to my colleagues at the charity HealthWatch (not the government’s HealthWatch – we were there first, many years ago). Therefore you should not regard it as privileged or confidential.

Finally, let me thank you for spending time at the ICR event, and I hope that you will have time to reply to this letter directly. I and my colleagues have had too many replies from junior ministers, using exactly the same wording every time.

Yours sincerely

You will see that I had the satisfaction of putting Howe on the spot at the ICR conference, when he gave the usual stuffed shirt political spiel about how wonderful the government is in supporting science. It is not wonderful enough to understand what evidence is. Here is the reply:

Thank you for your letter of ll April to Earl Howe about NHS bodies commissioning complementary therapies. I have been asked to reply. As you may be aware, the House of Commons Science and Technology Committee carried out an examination of the evidence to support the provision of homeopathy on the NHS. The Committee’s report was published on 22 February 2010. Ministers have considered its findings and recommendations and have published a full response.

The Department of Health will not be withdrawing funding for homeopathy on the NHS, nor will the licensing of homeopathic products be stopped. Decisions on the provision and funding of any treatment will remain the responsibility of the NHS locally.

A patient who wants homeopathic treatment on the NHS should speak to his or her her GP. If the GP is satisfied this would be the most appropriate and treatment then, subject to any local commissioning policies, he or she can refer them to a practitioner or one of the NHS homeopathic hospitals.

In deciding whether homeopathy is appropriate for a patient, the treating clinician would be expected to take into account safety, clinical and cost-effectiveness as well as the availability of suitably qualified and regulated practitioners. Neither ministers nor the Department of Health would intervene in such decisions.

I should clarify that ministers do not intervene in therapeutic decisions. The choice of treatments that are available in an area is a matter for local NHS commissioners, and ministers do not override the judgement of clinicians. As you may be aware, the National Institute for Health and Clinical Excellence (NICE) is an independent body which makes decisions on the clinical and cost

effectiveness of products based on thorough assessment of the best available evidence. NICE operates with great transparency and makes exhaustive efforts to involve stakeholders in its appraisal work. It consults widely in the development of guidance, publishes most key documents on its website, and holds its appeal panel hearings in public. NICE also consults stakeholders on the

methods and processes it uses to carry out its work.

Once NICE guidance is published, health professionals, NHS commissioners (and the organisations who employ them) are expected to take guidance fully into account when deciding what treatments should be available. However, NICE guidance does not replace the knowledge and skills of

individual health professionals who treat patients; it is still up to them to make decisions about a particular patient in consultation with the patient. The Department’s response to the Science and Technology Committee report explains the reasons behind its decisions in more detail. You can access the response through the Department’s website: www.dh.gov.uk, by typing ‘Government Response to the Science and Technology Committee report’ into the search bar and following the links.

I note that you have presented your views to your local MP, who can lobby the Government on your behalf on this matter if you would like to see changes to current Government policies.

I hope this reply clarifies the Department’s position on the matter.

Yours sincerely,

Tim Morgan

Customer Service Centre

Perhaps what has rattled me more than anything is not the content, which I largely expected (albeit this version is even worse than before), but that I am not even considered worthy of a rubber stamp from an intellectually challenged junior minister. The message is clear – I am to stop doing this as nobody at the Department of Health is interested. Naturally, I am not going to stop sending letters, but I am now beyond being polite:

Dear Mr Morgan

I am in receipt of your letter of 6th May, which I am sorry to say I found rather insulting. I specifically took issue with earlier correspondence on this matter being met with standardised and meaningless replies, and what do I get? The same standardised and meaningless reply, this time with further illogical statements tacked on. Is this the `Big Society’?

It is demonstrably untrue that ministers do not intervene regarding which treatments are available to patients. NICE guidance has been overruled by ministers on occasions. Let me make crystal clear the matter of cost-effectiveness, which you say clinicians are expected to take into account. There can be no calculation of cost-effectiveness unless effectiveness has been measured. The government has agreed in its response to the Science and Technology Committee report that homeopathy is not effective. Therefore cost-effectiveness must be zero. Presumably it is the Department which expects clinicians to take cost-effectiveness into account. Can the Department therefore not point out to clinicians that this parameter is zero in the case of homeopathy?

The relevance of your words about NICE escapes me, as I did not mention it in my letter. I am well aware of what NICE does, but it has not evaluated any complementary or alternative medicines (CAMs). Indeed the previous government committed to referring CAMs for NICE appraisal, in response to the House of Lords Select Committee report on CAM in 2000. When challenged on this point, the incumbent minister Lord Warner issued a statement claiming that the process had been initiated (I have his letter on file), which was immediately exposed as false. After a whole decade, nothing has been done.

Your letter ignores my central point, which is that homeopathy is simply indicative of a dangerous disregard for evidence. Everything you and successive ministers have said indicates that the Department of Health simply does not care about evidence based practice. How you can consider that your letter “clarifies the Department’s position on the matter” is a total mystery – it is a continuing exercise in obfuscation. I would appreciate being afforded sufficient respect that the points I have made could be answered clearly and directly. Is this too much to ask?

Yours sincerely

I will probably get the usual “this dialogue is at an end” reply.

On the basis of subjective and objective evidence, we contend that an individual’s expectation of a drug’s effect critically influences its therapeutic efficacy and that regulatory brain mechanisms differ as a function of expectancy.

Their use of the generic term “a drug’s effect” is unfortunate. It implies that this applies to all drugs, when it only applies to analgesics on the basis of these data. This over-generalisation was of course carried forward by the BBC’s report, for which this link label was used:

Pessimism ‘stops drugs working’

In an age of dumbing down, this was one of the dumbest I have seen. To be fair, the actual article did state in the title that it was about analgesia, but it presented the whole thing as a totally new finding when it isn’t. Indeed the authors of the paper didn’t acknowledge in the abstract the substantial literature on clinical trials in this field. Maybe they did in the full text, but I can’t read that. Does anyone else have access? I would be interested.

But my major exasperation is reserved for the comment at the end of the BBC article by Professor George Lewith. To say that

“It completely blows cold randomised clinical trials, which don’t take into account expectation.”

is about as wrong as it is possible to be. Now I am quite prepared to consider the possibility that a BBC editor will have got Lewith’s statement completely wrong, but I doubt it will have been that much wrong. Is not the use of a placebo control a way of dealing with expectation? Is not this study a “cold randomised clinical trial” its very self? This from a professor who is employed to run “cold randomised clinical trials”. To claim that one randomised controlled trial (RCT)  in a single therapeutic area invalidates the entire discipline of clinical trials is bizarre and not remotely supported by the evidence. But this study simply doesn’t mitigate in the slightest way against RCTs, because it is an RCT. Sorry, but in case Lewith is reading this I have to make it crystal clear.

It looks a lot like bandwagon jumping to me.