Dept of Health replies to enquiries on MRSA/HCAI infection control and prevention - bacteriophage (phage) therapy, UV light, ventilation, air decontamination, essential oils, silver-impregnated wound dressings, medical grade Manuka honey dressings, bioactive fabrics, natural biocides etc..
Further independent research at http://www.relax-well.co.uk/summary.html.

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Reply from the Department of Health: 22.9.05 including the new situation re. phage therapy
The three original questions from Designs For Wellbeing: 30.08.05
Reply from the Department of Health 8.3.05 re. alternative methods of spelling MRSA!
Reply from the Department of Health: 9.6.05 re. alternative methods for combating MRSA

Reply from the Department of Health 15.06.05 re. phage therapy
Reply from the Department of Health 20.06.05 re. phage therapy
Reply from the Department of Health 21.06.05 re.UV equipment and ventilation
Visual aid from Designs For Wellbeing 19.02.06 re. sunlight, UV equipment, ventilation and air decontamination
Another visual aid from Designs For Wellbeing 31.12.06 re. sunlight, UV equipment, ventilation and air decontamination
Message to the Department of Health 6.12.06 about a new book
Reply from the Department of Health 5.1.07 re Recent publication which draws attention to the beneficial effects of sunlight
Reply from the Department of Health 15.07.05 re. phage therapy
Reply from the Department of Health Chief Nursing Officer and Chief Medical Officer 20.07.05 re. one of your letters
Reply from the Department of Health: 22.9.05 including the new situation re. phage therapy
Our ref: DE00028507
 
 Dear Ms Filby,
 
Thank you for your further email of 30 August to the Department of Health about several matters.  This has been passed to me for reply.
 
The Government is aware that many people find complementary and alternative medicine (CAM) helpful in alleviating the symptoms of certain illnesses, especially those illnesses for which orthodox medicine does not appear to offer a complete answer.  The Government also appreciates the fact that the public is increasingly making use of complementary medicine treatments and products.  However, the Department of Health does not maintain a position on individual therapies.
 
You may find the results of the Herbal Medicine Regulatory Working Group (HMRWG) of interest.  The HMRWG was jointly established by the Department of Health, the Prince of Wales’ Foundation for Integrated Health and the European Herbal Practitioners Association (EHPA) to develop recommendations for the statutory regulation of herbal medicine.  You can find a report of the findings at the following address: http://www.advisorybodies.doh.gov.uk/herbalmedicinerwg/index.htm

In the UK, as in the rest of the EC, medicinal products which are placed on the market are required to have marketing authorisations (formerly product licences) in accordance with the Medicines For Human Use (Marketing Authorisations) Regulations 1994 (S.I.1994/3144).  Amongst other things these provide that, unless exempt, no medicinal product shall be placed on the market unless a marketing authorisation has been granted in accordance with Community provisions by the licensing authority or the European Commission.  It is an offence to sell, supply or advertise a medicinal product that does not have a marketing authorisation.

A "medicinal product" is defined in Article 1 of Council Directive 2001/83/EC and this definition is now part of UK law as a result of S.I.1994/3144.  The definition is:

"Any substance or combination of substances presented for treating or preventing disease in human beings.

Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological function in human beings is likewise considered a medicinal product ".

In broad terms, when classifying a product, the Medicines and Healthcare products Regulatory Agency (MHRA) looks at the way the product is presented (especially any claims) and at its function, that is, its effects (when administered) on human physiology.

Although, in general, medicinal products cannot be placed on the market unless a marketing authorisation has been granted, Regulation 1 (3) of S.I. 1994/3144 allows some medicinal products to be supplied by certain individuals without the need for that product to undergo the normal licensing procedures.  Certain categories of products are medicinal but exempt from the requirement to have a marketing authorisation.  Schedule 1 of S.I. 1994/3144 provides that a relevant medicinal product may be sold or supplied by a registered pharmacist, to fulfil a prescription given by a doctor or dentist.

The legislation requires that the manufacturer of the product has a Manufacturers (Specials) Licence or that the importer of the product has a Wholesale Dealers Import Licence.  The holder of a Wholesale Dealer's Licence may purchase the product from the holder of the Wholesale Dealer's Import Licence but he may not advertise or otherwise promote sales of the unlicensed product.

It is entirely possible that the wound dressings you mention are devices.  In fact, MHRA officials are aware of CE marked silver-impregnated wound dressings which are available in the UK, but believe that the Manuka honey products are neither licensed nor CE marked as devices.  If the Manuka honey cream is a medicinal product, it should, therefore, only have been imported and prescribed as an unlicensed medicinal product (as above).  However, there are no similar regulations covering devices.

To turn to your point about UV equipment and ventilation, I contacted officials at the Department's Infection Control Team on your behalf and was assured that they have nothing further to add to the previous information the Department provided. 

With regard to your question about phage therapy and European law, decisions concerning the funding of treatment are the responsibility of individual Primary Care Trusts (PCTs).  It is for PCTs in partnership with Strategic Health Authorities (SHAs) and other local stakeholders to plan, develop and improve services for local people.  The Department recognises that health services are better when management is devolved to the frontline.  Within the framework set out in the NHS Plan and other policy documents, PCTs with their specialised knowledge of the local community are able to manage, develop and improve local services more effectively.

I hope the information I have provided is helpful.

Yours sincerely,



Shelley Wilson
Customer Service Centre



----- Original Message -----
From: Grace Filby
To: dhmail@dh.gsi.gov.uk
Sent: Tuesday, August 30, 2005 9:09 AM
Subject: enquiry

...please would the DoH answer these questions for me? Thank you very much.

1.

How can it be that natural, holistic methods for infection control such as sterile Manuka honey wound dressings and cream, or silver-impregnated wound dressings are now approved for use by the DoH and NHS- but they do not have the authorisation of the MHRA? Please clarify this. Is it not necessary?

2.

Can the DoH continue to justify their statement to me that “consequently the use of UV treatment or changing ventilation is unlikely to have a significant impact”? (This was the view of an MRSA Policy Adviser in June).

Actually I have found that many international experts consider that the reverse is more likely. It is standard practice e.g. in research labs and path labs to use portable UV lamps to disinfect contaminated surfaces. UV lamps are even routinely built into fume cupboards. UV equipment may be expensive but it could save lives and a huge drugs bill if local directors of infection control and prevention are reminded that this option is available.


3.

Since bacteriophage therapy is now approved in Poland by their Bioethics Committee for HAIs and MRSA etc., please can you confirm that since Poland is part of the EU, the UK could use phage therapy under EU law - at least as an option to the conventional antibiotics. Could our NHS patients be offered the option to travel to Poland? - the treatment is so successful.

I look forward to hearing from you at your earliest convenience.



Grace Filby (Ms)
Designs For Wellbeing
Further information: www.relax-well.co.uk
01737 271588


----- Original Message -----
From: @dh.gsi.gov.uk>
To: <Grace Filby>
Sent: Tuesday, March 08, 2005 5:46 PM
Subject: Response to your query to the Department of Health Customer Service Centre - our ref : DE6009240




Our ref: DE6009240





Dear Ms Filby,

Thank you for your email to the Department of Health about the change of
spelling from methicillin to meticillin. Your email has been passed to me
for reply.

I can confirm that meticillin and not methicillin is now the standard name
for this generic antibiotic in Great Britain. This is due to the risk of
errors in international prescribing from country to country without a
uniform standard. The UK used to conform to a system called 'British
Approved Names' (BANs), but there was an element of confusion with this
when prescribing abroad for non-British health professionals. It was
recommended by the Medicines Commission that the UK adopt the international
standard, known as 'recommended International Non-proprietary Names'
(rINN), to avoid confusion.

I have provided a link to the relevant press release below:

http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4075150&chk=k96yFB

I hope this information is helpful.

Yours sincerely,

>>>>
Customer Service Centre






---- Original Message -----
From: < @dh.gsi.gov.uk>
To: <Grace Filby>
Sent: Thursday, June 09, 2005 10:37 AM
Subject: Response to your query to the Department of Health Customer Service Centre - our ref : DE6015540

Our ref: DE6015540

 


Dear Ms Filby,

Thank you for your email of 7 June about alternative methods for combating
meticillin resistant Staphylococcus aureus (MRSA). Your email has been
passed to me for reply.

The Government is always interested to hear of effective new healthcare
products and ideas. However, you will understand that the Department
cannot endorse specific items. Before a new product or idea could be
introduced to the NHS, there would need to be an evidence base that it did
prevent infection, and did not have any adverse effects on patients. As
you know, to help the NHS make such assessments, a rapid review process has
been convened by the Health Protection Agency (HPA) to review proposals
designed to aid hospital infection control.

The Rapid Review Panel (RRP) reviews proposals received or identified by
the Department to prevent or control HCAIs. 78 item reports are currently
displayed on the Health Protection Agency's website and are the results of
four RRP meetings. You mentioned that the ideas you discussed are outside
the remit of the RRP, but in the report below, it does have a heading under
'air decontamination products' called 'Fresh Air-UV Air Filter'. If you
have not already seen them, these reports can be accessed at:
http://www.hpa.org.uk/infections/topics_az/rapid_review/reports.htm.

In March, then Health Minister Melanie Johnson said: "The scientific
literature indicates that essential oils can help control
healthcare-associated infections, including methicillin-resistant
staphylococcus aureus [MRSA].
The department has allocated £3m to research into healthcare associated
infection and has recently issued a call for research proposals."
Therefore, you may wish to send detailed information, particularly the
results of external studies including clinical trials, to:

The Inspector of Microbiology and Infection Control
The Department of Health
Room 357C
Skipton House
80 London Road
London
SE1 6LH

Although common sense suggests there is an association between cleanliness
and HCAIs including MRSA, we do not have a strong scientific evidence base
to prove the link. The Department of Health is therefore working to
improve not just cleanliness, as you mentioned, but also infection control.

The Government is making considerable research investment in the area of
bacteriophages. The database of the Biotechnology and Biological Sciences
Research Council (www.bbsrc.ac.uk) lists 105 grants and studentships. In
addition, the Medical Research Council (www.mrc.ac.uk) has funded a project
at the Institute of Child Health, London, to investigate the potential of
bacteriophages for the treatment of staphylococcal infection.

The Department of Health keeps its priorities for research under review.
Priorities for departmental research and development support for the
development of policy are determined through discussion with policy
officials and Ministers. In the NHS priorities are identified through
widespread consultation with those using, delivering and managing services.
They take account of the burden of disease, potential benefits and the
Department's objectives as well as the responsibilities and work of other
funders - including charities.

I can assure you that the Government is committed to tackling all
healthcare associated infections (HCAIs), including MRSA, as a key
priority. Ministers are determined to ensure that the hospitals in which
patients are treated are of a high standard, with well-trained and highly
motivated staff, and that the environment in which patients are treated is
safe.

Unfortunately, not all HCAIs are preventable and many factors contribute to
the problem. For example, more patients who are susceptible to contracting
infections are being treated than ever before, such as patients with severe
or chronic diseases. Advances in treatments that improve patient survival
can at the same time leave them more vulnerable to infections.

You have obviously put a lot of work into your research and I thank you for
taking the time to write to the Government.

Yours sincerely,

>>>>
Customer Service Centre
Department of Health



----- Original Message -----
From: <@dh.gsi.gov.uk>
To: <Grace Filby>
Sent: Wednesday, June 15, 2005 3:37 PM
Subject: Response to your query to the Department of Health Customer Service Centre - our ref : DE6015962


> Our ref: DE6015962
>
>
>
>
> Dear Ms Filby,
>
> Thank you for your further email, dated 13 June, to my colleague, Vanessa
> Starkey, about bacteriophages. This has been passed to me for reply.
>
> Phages are not a new concept in scientific terms. However, their possible
> usefulness in a medical context is limited by the fact that they have
> narrow spectrums and are bacterium specific. That is, a specific phage is
> needed for a specific organism.
>
> As my colleague explained, the Government is currently funding research in
> this field. This research is ongoing and, as yet, has not yielded any
> conclusive results.
>
> I am sorry that neither I nor my colleagues can give you any more
> information on this subject at present. Nevertheless, I hope the
> information I have been able to provide has been of interest to you. Thank
> you for writing to the Department
>
> Yours sincerely,
> > > >
> Customer Service Centre
> Department of Health
>

----- Original Message -----
From: <@dh.gsi.gov.uk>
To: <Grace Filby>
20.06.05

... "I have spoken with the Department's
leading expert on this matter, Professor Brian Duerden, who has confirmed
that there are currently no licensed preparations in this country. As I
mentioned above, research is ongoing."
>
> Yours sincerely,
> > > >
> Customer Service Centre
> Department of Health
>

----- Original Message -----
From: <@dh.gsi.gov.uk>
To: <Grace Filby>
21.6.05

"Inadequate hand hygiene is believed [believed? - Ed.]
to be the main transmission route for MRSA
and consequently the use of UV treatment
or changing  ventilation
is
unlikely to have a significant impact."

Visual aid from Designs For Wellbeing 19.02.06 re. UV equipment and ventilation and air decontamination:
'Is this a significant impact?'
Scientific evidence base via:
http://www.relax-well.co.uk/good_luck.html
FACT:

UV and sunlight kill germs


demonstration

-




Another visual aid from Designs For Wellbeing 31.12.06 re. sunlight, UV equipment, ventilation and air decontamination


Full evidence base via http://www.relax-well.co.uk/Light_Revolution.html



And another visual aid as a stark contrast.



----- Original Message -----
From: Grace Filby
To: DHMail@dh.gsi.gov.uk
Sent: Wednesday, December 06, 2006 10:09 AM
Subject: new book

Dear DoH
 
 
The attached review of a newly published book may be of interest to the DoH.

Please will you bring it to the attention of the Government's specialist advisory committee on antibacterial resistance e.g. Susan McQueen who was commenting on COSHH this week in The Telegraph. Her colleagues would probably want to consider the serious implications regarding the book's message about sunlight being neglected - and the dire need for some immediate changes in policy. http://www.telegraph.co.uk/health/main.jhtml?xml=/health/2006/12/04/nmrsa01.xml
 
The review is also online at www.relax-well.co.uk.
 
 
Yours sincerely
 
 
Grace Filby

----- Original Message -----
From: DHMail@dh.gsi.gov.uk
To: Grace Filby
Sent: Friday, January 05, 2007 2:28 PM
Subject: Response to your Query : - Ref:DE00000168848 - Recent publication which draws attention to the beneficial effects of sunlight.





Our ref: DE00000168848
Dear Ms Filby,
Thank you for your email of 6 December to the Department of Health about a recent publication which draws attention to the beneficial effects of sunlight.  
 
The Department is grateful to you for highlighting this interesting literature.  It has been drawn to the attention of the appropriate policy leads.
The basic work, focusing on the beneficial effects of sunlight, is known to the Department and officials regard it worthy of consideration, although this must of course be balanced with other aspects of what is needed to tackle infection in the healthcare environment.
Thank you again for writing to the Department.
Yours sincerely,
 
>>
Customer Service Centre




----- Original Message -----
From: <@dh.gsi.gov.uk>
To: <Grace Filby>
Sent: Friday, July 15, 2005 10:19 AM
Subject: Response to your query to the Department of Health Customer Service Centre - our ref : DE6018177

> Thank you for your further email, dated 13 July, to the Department of
> Health about phage therapy.
>
> As I explained previously, research into this subject is ongoing and,
> currently, there is no further information available to offer you. After
> thorough consideration of the facts, I am afraid that the Department has
> nothing further to add to previous replies.
>
> I am sorry to have to give a disappointing answer, but we must now consider
> this matter closed.
>
> Thank you for taking the time to write to the Department.
>
> Yours sincerely,
> > > >
> Customer Service Centre
> Department of Health

The Reply from the Department of Health: 22.9.05 including the new situation re. phage therapy is at the top of this page.

----- Original Message -----
From: <Christine Beasley>
To: <Grace Filby>
Sent: Wednesday, July 20, 2005 3:14 PM
Subject: Re: one of your letters


Dear Ms Filby

Thank you for your e-mail to CMO and myself on the subject of measures to
control the spread of MRSA. I am responding on CMO's behalf as well. As you
know, it is one of my top priorities to improve levels of hospital hygiene
and reduce the risk of healthcare associated infections (HCAIs).

The most recent information about the measures that are being implemented
can be viewed on a dedicated website at www.dh.gov.uk/reducingmrsa This
includes a new toolkit for hospital trusts, 'Saving Lives: a delivery
programme to reduce Healthcare Associated Infection including MRSA'.
Existing guidance already covers the provision of treatment in isolation
from other patients where appropriate.

I would like to assure you that we are actively setting out to improve the
research evidence underpinning infection control practice. The government
has committed £3 million extra to support R&D into healthcare associated
infection. We sought proposals earlier this year to evaluate the impact of
interventions to reduce the risk of HCAIs and are currently considering the
more than 70 proposals received.

The rapid review panel provides a means by which new processes and products
can receive a quick scientific review of their merits. These reviews are
published and disseminated regularly to NHS Chief Executives and Medical
Directors, to advise them of the latest developments and to enable them to
make decisions about purchasing for local implementation. One of the top
rated products, a new two hour test for MRSA, is being trialled at three
NHS trusts.

I hope you will find this information helpful.

Yours sincerely


Christine Beasley
Chief Nursing Officer


From: <Grace Filby>
To: <Christine Beasley><Liam Donaldson>
Sent: 24/06/2005 14:57
Subject: one of your letters


Hello,

A colleague at the Rapid Review Panel has kindly offered your email
addresses so I hope this is acceptable to contact you directly.


I am enquiring about one of your letters online at
http://www.dh.gov.uk/assetRoot/04/11/25/90/04112590.pdf - Mandatory
Surveillance of Methicillin Resistant Staphylococcus Aureus (MRSA)
Bacteraemias.

There are one or two things I'd like to check as part of my research.

1. It says that the DOH is currently implementing a raft of interventions.
Exactly how big is this raft? Is there enough space on this raft yet for
phage therapy, essential oils, vitamin C, garlic, ozone, UV light, clean
air filters/ducting and more (not just asking people to submit proposals
for more research or commercial products to the RRP) because the research
has been done - the evidence has not yet been coordinated and incorporated
into policy reviews.

The following comment is from our local Hospital Trust's Consultant Medical
Microbiologist & Director of Infection Prevention & Control. I think it
indicates that they would like to adopt some more holistic interventions,
but it would be for the Dept of Health to proactively and urgently show
their support for the efficacy and safety of this type of remedy, so that
local policy makers can make informed decisions.
"Our local policy decisions have to be made carefully and justifiably, and
in the light of national evidence-based guidance which, currently, does not
exist for these modalities in this context."
Dr Bruce A.Stewart

Even if the official view by one of the MRSA Policy Officials is that these
"may be beneficial in some circumstances as part of a complete system for
prevention and control" at least that comment made publicly would be a real
constructive step forward, and better than doing or saying nothing helpful
about them. In comparison, it doesn't sound very scientific or
evidence-based when members of the public are merely informed that
"Inadequate hand hygiene is believed to be the main transmission route for
MRSA", as if nothing else matters.


At the moment everything seems to be held up with loads of 'red tape' or
lack of vision. There is plenty of evidence about alternative approaches
out there, and even another suggestion for you about side rooms that you
hadn't even thought of.
I hope you would feel that this would be worth thinking about and I would
be delighted to be invited to explain it to you.
My idea (Patent Office appln. no 0512044.9 Filing date 14-Jun-2005) would
help you make TEMPORARY ISOLATION AREAS without any of the disadvantages
that the 6 top microbiologists are worried about. You are probably familiar
with that correspondence
http://www.timesonline.co.uk/article/0,,59-1509376,00.html.


2. I was rather intrigued and also amused by the very last sentence on page 5:
"This flow of information and bacteria for reference investigation should
continue." Would this be better re-phrased? I thought the Dept of Health
was supposed to be stopping the flow of bacteria?


Kind regards


Grace Filby
www.relax-well.co.uk






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