Author: Admin

Dr Sandra Kweder MD, Deputy Director, CDER Office of New Drugs, stated  in response to Terry Gilmete

” We consider your condition to be in the category of serious or life threatening diseases.

Okay, so all of the measures to move things through rapidly, all of the tools that we have here at FDA to try and expedite reviews or expedite development and work with companies to try and encourage them along that would apply to, you know, immediately life threatening cancer, as far as we’re concerned they apply to this condition.

This is a serious condition and I just want to make that clear. We consider it in the same category because there are no approved treatments for this condition and we understand how seriously and severely peoples’ lives are impacted by this disease – by this condition.”

Kim McLeary picked this up saying ” I’m President and CEO of the CFIDS Association of America…….I’m delighted today to hear the clear affirmation from FDA that ME/CFS is considered a serious and life threatening condition and hope that the pharmaceutical and biotech partners on the line will take that as a sign that they should ramp up their efforts to take advantage of the accelerated approval measures that can be utilized or applications under ME/CFS indications.”

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf 

We are delighted to announce the first TV screening of Voices from the Shadows this year. It is being broadcast by 31Digital Community Television Station in Brisbane on Sunday 7th of October 2012. We would like to thank Lesley McLeod, as this has come about entirely as a result of her determined efforts to use the film for educating people in her region.

The screening will take place in NEWRY at the Mourne Country Hotel, Belfast Road, Newry on Tuesday October 2nd at 7-45 pm, although the evening will start at 7.15 with refreshments. Admission and refreshments are free. We are delighted that Dr William Weir will be flying in from London to attend and take a Q & A session after the film. Dr Weir is a Consultant Physician in Infectious Disease with a special interest in ME. He has had a very long involvement with ME patients, both through the NHS and his private clinic, and has been an active member of the John Richardson Research Group. He will be joined by Dr Jay Wiggan a Lecturer in Social Policy at Queens University. Dr Wiggan is currently doing a study of which he says, “Reflecting my expertise in social security and labour market policy the focus is on examining the labour market transitions and experiences of working age people with ME in Northern Ireland claiming or trying to claim various benefits. There has been little research in the last ten years and none of it conducted in NI into how changes in benefit regulations/employment support and job search requirements specifically affects people with ME.”

Joan McParland and the Newry and Mourne ME/CFS Support Group are organising this event.  Please call either of these numbers to book a place – Paul on 07590648161 or Joan on 07712892834 – and check the schedule as this may change slightly with the new arrangements.

Thursday 27th September 2-4pm – at the Robert Burns Centre, Dumfries, Scotland. A free screening organised by the Dumfries and Galloway ME Network.  Patients are invited to an afternoon screening followed by a Q& A session with Dr Nigel Speight – Consultant Paediatrician and  Dr Gregor Purdie – Lead clinician for ME, NHS Dumfries and Galloway. Refreshments will be served. Please ring 01387 264808 to reserve a place and leave your name and phone number. If you later find you are unable to attend then please inform the box office as someone else may be glad of your seat. Please remember that the film is unsuitable for children. This screening will be followed by an event for invited clinicians at a later date. It looks as though there will be a full house with three quarters of the seats already booked, so don’t leave ringing in to reserve your place for too long or you may be disappointed.

The next IACFS/ME Conference (March 2014 in the San Francisco area) will be co-sponsored by Stanford Medical School with the support of Dr Montoya and Dr Lily Chu. This vividly demonstrates how seriously Stanford Medical School, which is ranked 4thin the USA for medical research, is taking research and treatment of ME and CFS patients. Last year the IACFS/ME conference in Ottawa showed a sneak preview of Voices from the Shadows, prior to its premier at Mill Valley Film Festival where Dr Montoya spoke and supported the film in the Q & A session. The Stanford Chronic Fatigue Initiative website lists the film and Dr Montoya’s responses on its Links and Resources page.  Here.

On Thursday 27th September from 2-4 pm the Dumfries and Galloway ME Network invite you to a free screening of Voices from the Shadows at the Robert Burns Center in Dumfries. The one hour film will be followed by a Q&A session with Dr Nigel Speight – Consultant Paediatrician and Dr Gregor Purdie – Lead clinician for ME, NHS Dumfries and Galloway. Refreshments will be served. Please ring the box office to book a place – 01387 264808 – and you will be asked to leave your name and telephone number. Please remember the film is not suitable for children. There are four wheelchair spaces. If after booking you are unable to attend then please inform the box office as someone else may be glad of your seat. The ME Network are following this event with a special evening screening for medical professionals.

The International Association for CFS/ME have produced an excellent Primer for Clinical Practitioners containing guidelines for diagnosing and treating people with ME, or CFS as it is known in the USA and many countries. This is an invaluable resource for doctors, giving a comprehensive view of the many different aspects of the illness.  The Primer gives guidance on making an accurate diagnosis and excluding other conditions which are commonly confused with ME and then covers the management and treatment of the illness, including related conditions such as orthostatic intolerance and cardiovascular symptoms, gastrointestinal problems or multiple chemical sensitivity. One critical aspect is that it discusses post-exertional consequences; the malaise and exacerbation of symptoms or deterioration which can follow any activity which exceeds an individual’s personal energy ‘envelope’. Importantly for patients and doctors in the UK the Primer warns doctors against approaches such as graded exercise therapy which, although widely recommended for chronic fatigue,  has been proved to be not only generally of little use but can be positively harmful when used for treating patients with ME. The Primer is an invaluable tool for doctors and one which I feel patients should download (while making a donation to the IACFS/ME as requested) and take it for their doctors to read. It can be downloaded from the IACFS/ME website here .

‘The Naked Truth about ME/CFS – the clinician’s viewpoint’ – a free study day for professionals is to be held in Washington, Tyne and Wear on Saturday May 19. (It is accredited with three CPD points)

It is being given by members of the Dr John Richardson Research Group – Prof Malcolm Hooper and Dr Irving Spurr with consultant paediatrician Dr Nigel Speight. ‘Voices from the Shadows’ will be screened during the event. For further information please phone 0191 455 6959 There is also info on the ME Association page here.

We are now able to send our PAL DVDs of “Voices from the Shadows” to the USA and Canada. Please note that these are primarily for viewing  on computers (PCs & Macs) because they are not in the standard format for DVD players in the USA. However, as well as computers,  there  are some DVD players which are multi-format and they too will play these DVDs.

Edinburgh ME self-help group are presenting a screening of Voices from the Shadows on Thursday 24th May at 2pm at Cineworld, Fountain Park, Edinburgh. This will be followed by a Q&A session with Dr Vance Spence & Dr Neil Abbot from MERUK and Dr Nigel Speight.  Admission is free and refreshments will be provided. To reserve your place email book@edmesh.org.uk or phone 0845 625 2025  This event is not suitable for children.  www.edmesh.org.uk