The trial did not have NHS Ethical Approval. In fact, it was never applied for -
The decision was made not to apply for NHS ethical approval to recruit through the NHS
(section 6.2) because sufficient numbers of participants were recruited outside of NHS services. Furthermore the process is lengthy and can be difficult to obtain for trials of homeopathy (Viksveen, http://etheses.whiterose.ac.uk/11875/). It is disputable whether this influenced recruitment of a representative sample. One the one hand it may have contributed to
recruitment of hard-to reach participants, since those satisfactorily engaged with usual care
do not look elsewhere, whilst those joining the STAR cohort may have been motivated by a
feeling of unmet need. On the other hand it restricted access to specific target groups of ‘at
need’ children such as the ‘looked after’ children under the care of Sheffield City council.
The question of whether NHS ethical approval was a pre-requisite for a study of ADHD was
resolved (section 8.2), but raised interesting questions and was not a clear-cut decision. The
question centred on response to the Medicines Health Authority (MHA) algorithm: “Will
your study involve research participants identified from, or because of their past or present
use of services (adult and children’s health care within the NHS and adult social care)”. RIS
stated that “the STAR study only recruited children where the carers self-reported that their
child has received a diagnosis of ADHD. The diagnosis itself could have come from an NHS
service, but it may have come from elsewhere (e.g. a health service in another country) and hence the participants have not be identified from, or because of, their use of the NHS specifically”. The STAR management team concurred with this. The ADHD population intersects with, and impacts on many publicly funded systems and services, of which health care is only one, such as social care, the criminal justice system and education. However, NHS clinicians maintain that all children with ADHD are under the care of the NHS and therefore NHS ethical approval is required. Furthermore, care within other services tends to include NHS care.
RIS = University of Sheffield Research and Innovation Services. NHS ethical approval should happen within 60 calendar days if there are no problems with the trial submission. To quote from the protocol -
Homoeopaths are registered with one of the four main
bodies representing homoeopaths in the UK. Nutritional
therapists are registered with the British Association of
Applied Nutrition and Nutritional Therapy and are members of the Complementary and Natural Healthcare Council. All therapists are CRB checked, complete an on-line
NSPCC child protection course (https://www.nspcc.org.uk/what-you-can-do/get-expert-training), attend a 1-day
training course on risk and receive guidelines in management of ADHD and serious adverse events.
Homeopaths and nutritional therapists are not legally recognised as health professionals. They are treated as medically unqualified lay-persons.
There is more -
Application to advertise the project was made to Sheffield Parent Carers, an independent,
local authority funded group of 1,000+ carers of children with disabilities including 150+
with ADHD. They agreed to post an advertisement in their newsletter and send an email to
all members registering a child with ADHD.
Sheffield city council Multi Agency Support Teams (MAST) and the research office for children’s services were applied to. MAST were too busy to consider the application, but the
city council felt the trial met their concerns regarding appropriate management of safeguarding, data protection, and consenting children (Appendices 9 & 10). They requested
that literature refer to ‘carers’ rather than ‘parents’ which was done. They were particularly
positive about the trial design because children would not be offered the possibility of
something they may not get. However, when the STAR project was presented to their
‘Looked after children’ committee (chaired by an NHS CAMHS paediatrician) the committee
considered that NHS ethical approval was a pre-requisite.
Family Action Sheffield were approached. Sheffield City council contract Family Action Sheffield to run 10-week parenting programmes and conduct home visits for newly diagnosed
ADHD families. Permission was gained from national Family Action to advertise the trial to
families they work with. Two weeks after the STAR project started recruiting there was a
breach of protocol, whereby a Family Action worker erroneously handed out flyers within
CAMHS: Family Action workers sometimes work alongside NHS staff in NHS premises, but
since NHS ethical approval had not been obtained, recruitment should not have occurred
during combined sessions or on NHS premises. It was made clear to Family Action workers
that the study does not have NHS REC approval.
The breach of protocol resulted in a challenge to the STAR project recruitment strategy. It
was claimed that NHS approval is required for all children diagnosed with ADHD. This was
refuted by ScHARR research ethics committee, University of Sheffield Research and Innovation services, and the chair of the steering committee, who all confirmed that NHS ethical
approval was not a pre-requisite (see discussion section 9.1.1).
NHS ethical approval is not legally required by the Medicines for Human Use (Clinical Trials) Regulations 2004 but not seeking is poor practice at best. The ethics of paediactric trials are different from those involving adults - because children can not consent. It can be argued that the NHS should be regarded as a gatekeeper for children under their care.
This NHS guidance on trials involving children is helpful. Whilst not mandatory -
Children and young people should be involved in the decision-making process whenever possible. You should ensure that they receive information about your trial, which is understandable to them.
There is something strange in the pilot study as well -
The first version of the pilot trial conceived one arm as a trial of polyunsaturated
fatty acids (PUFAs). When the University of Sheffield Research and Innovation services (RIS)
were applied to, they recommended contacting the Medicines Health Regulatory Authority
(MHRA) in case this arm might be considered a Clinical Trial of a Medicinal Product (CTIMP)
and therefore require MHRA approval. The MRHA did indeed deem that the PUFAs were
being tested as a medicinal product. Therefore to ensure that the study would not be classified as a CTIMP, with all the additional bureaucracy that would entail, the PUFA arm was
substituted with ‘treatment by a nutritional therapist’.
There is guidance. A strict interpretation of the Regulations 2012 would class homeopathic remedies used in the trial as Investigational Medicinal Products. UK law treats homeopathic remedies as medicines. Thus it seems very likely that the pilot study is a CTIMP and an application to the MHRA would have been necessary.
What was the pilot study supposed to do?
This thesis addresses the question: “is the Trials within Cohorts (TwiCs) design feasible to
generate evidence about the effectiveness of interventions for ADHD?”
TwiCs stands for "Trials within cohorts" - which is an invention of Relton (a more detailed explanation can be found here). It uses a comparison of nutritional therapy and homeopathy as adjunctive treatments for ADHD to test this. There was a "treatment as usual" control group.
But this is not how the study is being communicated to the homeopathic community et al. It is presented as a trial of homeopathic treatment for ADHD.
Recruitment and retainment issues
As the section on NHS ethical approval shows, recruitment to the study was per force restricted. This is expanded on -
Recruitment from nationally-funded ADHD facilities such as special schools, secure units, NHS based facilities, and children engaged with support services was not successful. Nor was it possible to recruit from the NIHR-funded Yorkshire and Humber CLAHRC ADHD health tracker cohort. Either NHS ethical approval would have had to be obtained, or there was minimal take up from advertisement, or the process of obtaining the approvals required was too lengthy and onerous. Nor was permission received to recruit from the Newcastle University autism spectrum database (ASD-UK).
Parents were recruited by a number of other routes. As already mentioned, the Sheffield branch of Family Action were used but so where a number of other routes -
As no NHS approval was obtained, the
STAR project recruited through a broad variety of non-NHS sources such as local authority
based organisations, schools, university based events and listings, clinically relevant support
groups, clinically relevant conferences, and social media.
There is a website and a Facebook page. A flyer was sent out that contains roughly the same information. Note that none of these are explicit in what treatments are actually being offered (although the Facebook page does a long time after initial recruitment). A questionnaire (either paper or online) was completed by carers which determined eligibility to the trial. If eligible, a letter was sent to carers for themselves and the child to sign and return - effectively this would be the consent.
Informed parental consent and at the very least assent from the children would be required to participate the pilot study. Yet -
Homeopaths reported that carers needed explanations about what to expect from a homeopathic remedy, sometimes found the different approach difficult to grasp, but were often
intrigued. They reported that homeopathic remedies were well adhered to.
Difficult to grasp? The letter sent to carers who completed the questionnaire is unrevealing of what homeopathy actually is. It directs them to this on the SoH website. But it can not be expected that someone will type in that link on a computer to view the information and even if the information was read, is it possible to give informed consent based on what is essentially marketing material? To quote part of it -
Homeopathy is based on the principle that you can treat ‘like with like’, that is, a substance which causes symptoms when taken in large doses, can be used in small amounts to treat similar symptoms. For example, drinking too much coffee can cause sleeplessness and agitation, so according to this principle, when made into a homeopathic medicine, it could be used to treat people with these symptoms. This concept is sometimes used in conventional medicine, for example, the stimulant Ritalin is used to treat patients with ADHD, or small doses of allergens such as pollen are sometimes used to de-sensitise allergic patients.
False comparison, especially in the case of Ritalin and ADHD - the use of certain stimulants is to deal with attention deficit, not activity levels. Allergen immunotherapy is very different from the purported mechanism of homeopathy. No mention is made of the non-existence of any real evidence base for the efficacy of homeopathy, let alone homeopathy. This is unlikely to satisfy the requirements of the Regulations 2004.
The nutritional therapy letter states -
Nutritional therapy is individually tailored supplements, information, and advice about
nutrition to help ADHD. This means you might be given some supplements considered helpful for ADHD, some information about foods which might be aggravating
your child’s ADHD, and an individually tailored plan with some menu suggestions.
Considered helpful by who? Supplements would be helpful for those with dietary deficiencies, but nutritional therapists can not diagnose them. The evidence for supplement use and dietary changes for ADHD is very poor. This is not mentioned. But at least there is some plausibility for dietary interventions for ADHD.
This level of information would not have been acceptable in an NHS approved trial. To quote variously from the UK policy framework for health and social care research issued Health Research Authority -
Where consent is sought: a. potential research participants should be provided, normally by the
research team, with the information they need to help them decide
whether they wish to take part in research or not, and should be given
reasonable time to reach their decision. The information should be
provided in a suitable format. Unless otherwise justified (e.g. by feedback
from public involvement), the information should include a concise
explanation of relevant research evidence and research in progress that
shows why the proposed research is justified;
And
Proportionality should be applied to the provision of information to potential
research participants. The more research deviates from established practice
or otherwise detrimentally affects the balance between the anticipated risks
and benefits, the greater the amount of information that needs to be provided
to potential participants. By the same token, the closer the research is to
standard practice, the less need there is to provide patients and service users
with detailed and lengthy information. For instance, pragmatic trials looking at
the effectiveness of routinely used standard treatments should be facilitated
so that patients can be recruited in a way that complies with the law but does
not unduly burden either patients or the care professionals seeking their
consent.
Schedule 1, Part 4 CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR of the Regulations 2004 contains -
8. No incentives or financial inducements are given—
(a)to the minor; or
(b)to a person with parental responsibility for that minor or, as the case may be, the minor’s legal representative,
except provision for compensation in the event of injury or loss.
The pilot study reveals that £10 vouchers were given to certain carers -
After discussion with the steering committee and approval from the ethics committee (amendment number 4, Table 16), an incentive was added. From 28/4/16 onwards,
on receipt of CQs, participants were sent a £10 Boots voucher in a card thanking them for
being part of the STAR project. Vouchers were also sent to those who had previously returned CQs. This improved the return rate to 72% (section 7.4.1).
This would appear to be in breach of the Regulations 2012.
Who was involved?
In September 2016 five homeopaths were recruited from Sheffield or nearby and saw participants at Wellforce clinic, Sheffield, Western House consulting rooms, Barnsley, or in participants own homes. Homeopaths did not have particular experience with ADHD, however,
3/5 had experience of working with challenging families. All were registered with the Society
of Homeopaths.
In January 2017 the study started recruiting participants from across the UK requiring online consultations. Since two homeopaths did not want to conduct on-line consultations and
three were inexperienced in conducting on-line consultations (no experience, or just one
experience), three more homeopaths, experienced in conducting on-line consultations,
were recruited from a Complementary Therapies clinic in Marlow, Buckinghamshire, of
whom one (myself) had experience of treating children with ADHD, whilst two had experience of working with challenging families.
It is possible narrow down the homeopaths involved. Some have been previously mentioned by this blog. The Wellforce homeopaths are -
Annie Williams (offers Emotional Freedom Technique - EFT)
Gill Upham (did offer CEASE at one point)
June Dinwoodie (offers herbalism)
Krys Chandler
The homeopath at Western House is Jackie Raw. Marlow Homeopathy are
Elizabeth Courtis (who uses the Asyra machine and unspecified allergy & food intolerance testing, likely using the machine)
Jo O'Flanagan (who offers Craniosacral Therapy - CST)
Tim Lloyd
Vicki Steedman (who offers CST)
Kay Willis (another Asyra user)
Fibert used to work there too.
It is unknown where the nutritional therapists came from or who they are but it is reported that they were all members of BANT and thus also fall under the Complementary and Natural Healthcare Council (CNHC). Nutritional therapies sometimes offer other therapies. Some are know to use the Asyra machine for example.
There was a "management committee" consisting of just Fibert and Relton. There was a "steering committee" additionally comprised of -
Prof David Daley (Nottingham University) (Chair)
Prof Mike Campbell (Medical Statistics, ScHARR, UoS)
Dr Tessa Peasgood (Health Economics and Decision Science (HEDS), ScHARR, UoS)
Dr Liz Williams (Human Nutrition, Oncology, UoS)
Catherine Witzmann (Doncaster NHS) - who is likely an occupational therapist with Doncaster CAHMS
Gill Badby (parent representative, Sheffield NHS)
Heather Wingfield (parent representative)
Competence and Safeguarding Issues
From what can be worked out, no medical professional was involved in this pilot study. To quote from UK policy framework for health and social care research issued -
Principle 2: Competence All the people involved in managing and conducting a research project are
qualified by education, training and experience, or otherwise competent under
the supervision of a suitably qualified person, to perform their tasks.
This blog has long made the case that the treatment of autism is beyond the competence of any homeopath. The same would also apply to ADHD. It is also the case of some of the children also had ASD. That a homeopath is registered with the Society of Homeopaths means very little.
Nutritional therapists are not dieticians (who are regulated) or nutritionists. Nutritional therapists are notorious for bad (even dangerous) advice and selling expensive tests and supplements of little or no value.
It is questionable whether homeopaths or nutritional therapists would be able to recognise an adverse reaction, mainly because of their lack of knowledge but also because of their sometimes bizarre beliefs. Detoxification is an obvious example common to both.
Worse, there is "Adverse events in homeopathy and homeopathic aggravations" (a document found in the appendices of the pilot study) which states -
No serious adverse events [re use of homeopathy] have been reported (ECCH 2009). The adverse events most commonly reported include: headaches, tiredness, skin eruptions, dizziness, diarrhoea or loose stools, and aggravations of patients’ pre-existing symptoms (Dantas & Rampes (2000).
Mild and transient aggravations of patients’ pre-existing symptoms, usually associated with increased feelings of wellbeing, are commonly referred to as ‘homeopathic aggravations’ in the homeopathy literature. They occur relatively soon after taking a homeopathic medicine and are normally considered favourable and part of patients’ curative process (Endrizzi et al. 2005, Thompson et al. 2004). Such aggravations occur more commonly with a particular homeopathic protocol to be used in this trial (CEASE, Smits, 2010).
"Aggravations" have been discussed before (here and here). As homeopathy has not been demonstrated to have any effect, these symptoms are caused by something other than homeopathic remedies. More worrying is that the document is couched in terms purely of reporting the incident to the management committee. No mention is made of seeking medical assistance.
Fibert may have been a Special Educational Needs (SEN) teacher but that was many years ago. Whether she has any relevant experience in training lay persons in the current best practice of management of ADHD is unknown.
The amount and type of safeguarding training required is debatable. The safeguarding document in the appendices is fairly cursory. CEASE advocates medical neglect and some homeopaths, supporters and their organisations have trouble acknowledging this (it is irrelevant that CEASE doesn't seem to have been used). It is not only the inability to recognise CEASE as neglect but not recognising other treatments as neglect or directly harmful that is a concern. In the case of the pilot study, yes, the concern is (partly) mitigated by the children receiving treatment as usual and thus being under the care of the NHS, attending school and possibly having involvement with Social Services. They are exposed to multiple professionals with extensive safeguarding training.
What is clear is that some of the homeopaths did struggle -
Homeopaths said that on average, trial participants had more serious symptoms compared
with their private clients. They expressed frustration at missed consultations, difficulty contacting participants, and the influence of life events. They felt that their intervention was at
times “a drop in a turbulent ocean”. The therapist who dropped out said that “treating these
children makes me feel incompetent, it’s hard not to take missed appointments personally”.
Homeopaths commented that at times they found it difficult to identify a suitable individually-tailored homeopathic remedy. They said that separating the child’s story from the carer’s story was sometimes difficult since information was delivered by carers, some of whom
had traumatic life histories themselves. They found that the symptoms of those children
who were on medication were subdued, which was problematic because prescription relies
on accurate observation of symptoms. They felt that the child’s behaviour was sometimes
inhibited in the consultation room.
The interaction between ADHD medication and homeopathic remedies was sometimes a
concern for homeopaths, participants and/or their GPs or consultants. Several participants
either stopped or didn’t start homeopathic treatment on the advice of their doctors. Some
participants changed conventional medications during homeopathic treatment which homeopaths reported made analysis of change due to homeopathic remedy difficult. And two
participants wanted homeopathic treatment specifically to manage the side effects of conventional medication.
That could be read in a number of ways but it is suggestive that the homeopaths were out of their depth. The implication that homeopathy can not treat when a patient is on medication (suppression of symptoms) is troubling. Would the homeopaths suggest medication is stopped?
The picture is slightly different with the nutritional therapists.
Like homeopaths, nutritional therapists expressed frustration at participants who repeatedly missed consultations, and/or didn’t follow advice, and commented on the difference between trial participants and their private clients: “frequent changes to plans (cancellations
the day before or 'forgetting' appointments) can be extremely frustrating and obviously
happen far more often than with my usual clients, which took some getting used to”. Another therapist said, “I feel like a supplement pharmacist or I stroke the carers”. Therapists felt
that much depended on the carer’s attitude: “if mum has decided it won’t work, it does not
stand a chance”.
Participants often had poor diets consisting of junk food, sweets, fizzy drinks, and other sugary products. Children, particularly teenagers, bought sweets on the way home from school,
which carers could not monitor. Some carers felt unable to implement dietary advice.
Therapists felt that restrictive diets and sensory issues of those with co-occurring ASCs was a
problem that often needed working around. They felt that the nutritional intervention was
just one cog in a complex wheel with confounding factors which often interfered with
treatment. One therapist said “Sometimes nutrition seems unimportant compared to what
I've been hearing about (violent criminal behaviour, trouble with police etc)”.
Although initial consultations were face-to-face, subsequent ones tended to be via other media such as Skype. Whilst this isn't so much of an issue with nutritional therapy, it is with homeopathy - how does "accurate observation of symptoms" occur?
Was CEASE therapy used?
Fibert's entry on the CEASE therapy website says -
She then conducted a consecutive case series of children with ADHD as a component of an MSc at Goldsmiths, University of London where CEASE methodology made a significant difference to the outcome of these cases. She is currently running a clinical trial in the same area as part of PhD studies at Sheffield University, where again CEASE is being used in most cases.
But this was written before the trial had been given ethical approval!
The study says -
Before the trial began, all therapists who were going to deliver the therapies attended workshops run by the PI. The workshops trained them in management of ADHD and how to recognise and respond to any serious adverse events (Appendices 9 & 10). All therapists completed the on-line Sheffield safeguarding children child protection course (Safeguardingchildrentraining@sheffield.gov.uk). Homeopaths were given training in a specific homeopathic methodology for treatment of exposure to environmental toxins, which had been found to be useful in the case series (Fibert, Relton, Heirs, & Bowden, 2016).
That this is CEASE is confirmed by -
Some extra training provided in: CEASE methodology, NSPCC child protection, and ADHD management
But then there is this -
Homeopaths attended several workshops preceding participation in the trial concerning
specific methodologies for treating ADHD cases (section 6.5). It is common for homeopaths
to attend courses as part of their continuous practitioner development (CPD) so this was not
necessarily a deviation from usual practice, although the courses were paid for as part of the
research, which is. However, none of the homeopaths utilised the methodologies they were
trained in during these courses, preferring to use the methods they normally used. Recruitment of future homeopaths will not offer this extra training as it was not cost effective and
reduced the pragmatism of the intervention, but will try to recruit homeopaths who have
already incorporated the techniques into their routine practice.
If CEASE was used, it would have been by Fibert. It is unknown if Upham was involved in the pilot study.
The intention to use CEASE is very clear though.
Supply of Products
This blog does labour the point that most homeopathic remedies are not registered with the MHRA. They have the status of unlicensed medicines. There are strict controls on the supply of unlicensed medicines. The direct supply to consumers is forbidden but exemptions for pharmacists do exist. These exemptions do not apply to medically unqualified homeopaths, either in terms of supply to them or supply by them to trial participants. As described above, a REC can not give approval to a trial that involves illegality. Fibert is a member of the SoH. There is an onus on her as a member to abide by their Code of Ethics which has a requirement to abide by law and there is this but it is relatively recent, wrong (supply, not sales) and totally ignored by the SoH.
Assuming the use of homeopathic products in treatment of ADHD does constitute a CTIMP, charging for them at any point in the supply is illegal under the Regulation 2004.
The situation with products used in nutritional therapy is very complicated. Some are absolutely illegal, but it is not clear if they were used in the pilot study.
Results etc
What the trial is doing is comparing Treatment as Usual versus Treatment as Usual + homeopathy versus Treatment as Usual + Nutritional Therapy. It should be obvious why this is problematic.
Fibert says -
This thesis addressed the research question: Is the TwiCs design suitable to assess the effectiveness of interventions to improve outcomes for ADHD? A small-scale test of the design
and measures was conducted to answer the question, and the results suggest that the TwiCs
approach to pragmatic trial design, with some modifications to its implementation, is feasible and appropriate for trials testing interventions for children with ADHD.
So, in reality, no, the TwiCs design was not suitable if it required modification. It becomes something else if modified. This might seem a quibble over methodology but as Fibert's thesis hinges on the validity of the TwiCs approach, it could be argued that there is a significant failure.
Forgetting the point of her thesis, do the results say anything? Are they compelling? Do they suggest a way forward via medically unqualified persons? No. Marginal parent reported results assessed by a non-clinician. With obvious bias.
Apparently, a reasonable request can obtain the raw data. It depends on who on the gatekeeper of the data is. I'll ask. For a friend. That's not going to end well.
Funding and potential conflicts of interest
The funding for the trial comes from the HRI. They are briefly discussed here. Over time, HRI have allocated £127,623 to Fibert's research - £3,113 for the case series and £124,510 for the pilot study. Where the money for the pilot study came from is unknown.
The cost of running the STAR pilot trial, excluding an investigator’s salary, was less than £50,000.
So, over the course of the study, Fibert would have received £75k or more in the way of a stipend from the HRI. It is unknown whether she was also practicing as a homeopath during this period or had any other additional income.
The allocation was funds to the pilot study was made in two parts. One in financial year 2012/13, the other in 2013/14. Clare Relton was a trustee of the HRI until 20/02/2014. This money was designated as "restricted funds" - it can only be used for the purposes it was donated for. Thing is, originally more money was allocated. Some of the funds were transferred to systematic reviews by Robert Mathie. So either the restrictions were not absolute or the donor(s) agreed to the transfer. It is also the case that the funds were allocated before ethical approval was granted for the pilot study - it would be foolish to specify restrictions on funds that were so specific as to not allow re-allocation of funds if the pilot study had not received approval.
How much say the trustees had in the allocation of the funds is unclear but there is an obvious potential for conflict of interest. Charity Commission guidance is very clear. HRI say that there wasn't one.
Most "therapy centres" operate on the principle of self-employed therapists renting room from the centre rather than being employees of the centre. As Relton is a director of Wellforce, unless Wellforce chose to waive/reduce rental costs for sessions conducted there, she could have received a (small) financial benefit.
Also the pilot study reveals that a small number decided to carry on with homeopathic treatment. Where is unclear.
Intention to continue/expand
The pilot study talks about the desire to continue the study and increase the size of the cohort. This story on the SoH website states -
“We’re looking to recruit 400-500 more families to the cohort. Let us know if you can contribute or if you know anyone who might be able to help,” said Philippa, whose interest in the field was inspired by her previous work with children with special needs as a teacher and parent educator.
From above, it would seem that Fibert wants to recruit homeopaths who use CEASE.
Investigations
It will come as no surprise that the University of Sheffield when concerns were raised regarding this pilot study initiated an investigation. This is believed to be ongoing - no outcome has been as yet communicated.
The MHRA have been requested to review the trial protocol to determine whether approval was required. As yet the issue of the supply of homeopathic remedies used in and whether they are investigatory medical products has not been raised.
Both Sheffield City Council and Sheffield Children's NHS Foundation Trust have been informed. It is unlikely that either would mount investigations themselves.
Conclusion
The fundamental question is whether ethical norms apply in a situation where very low risk therapies are used as an adjunct to treat as usual? If the answer is no, then, all of the above is redundant.
If the answer is yes, violations of those norms has occurred.
Any REC really should have considered whether Fibert is qualified to be principle investigator, provided supervision and, worse, a provider in the trial given her obvious bias. The intention to use CEASE should have been considered too. Fibert's links to HRI may or may not be relevant.
It took several years to get to the point of recruiting for the pilot study. Applying for NHS approval would not have added much in the way of delay. It's difficult not to come away with the impression that it wasn't sought because of the possibility of it not being granted.
The most important thing is that no more recruitment occurs.
Slightly amusing aside
Fibert believes that homeopathy is "under attack", etc -
Considerable resources are employed by a small group of very effective detractors in the UK
to influence public, media and government opinion against homeopathy. They largely refer
to two biased documents: a meta-analysis by Shang et al. (2005) which fails sensitivity analysis (Lüdtke & & Rutten, 2008); and a House of Commons technology report (House of
Commons Science and Technology Committee, 2010) which is based on Shang et al, and was
dismissed by the department of health in an early day motion. Nevertheless detractors have
succeeded in creating an environment where debate and media coverage is one sided and
limits the acceptability and publication of any positive homeopathy results generated.
Fibert simply repeats myths popular in UK homeopathy. The Department of Health said that commissioning of homeopathy was a matter for local NHS bodies. The Early day motion had nothing to do with them. This is touched on in this post.
For example, I co-authored a systematic review of homeopathy for depression which was
initially accepted by sub-editors of a well-known journal but then rejected by the editor. He
provided a negative opinion piece and a blog to justify the journal’s stance that homeopathy
is not an effective treatment for any health condition. In other words, only articles informing
the journal’s interpretive stance were acceptable. In another incident, I was interviewed on
BBC Oxford describing my research, whereupon a well-known sceptic blogger complained to
the BBC, who responded to his complaint by assuring him that homeopathy will never again
be discussed without the prior proviso that it does not work.
It would appear this blog post upset Fibert. False balance is a difficult concept for homeopaths as is scientific/medical consensus. This blog has a tiny audience.
