May 21, 2010

Un método de tratamiento específico del SPP utilizando inmunoglobulina intravenosa (IVIG).

 Noticias
http://www.grifols.com



Grifols cierra un acuerdo con Pharmalink para la compra de los derechos de propiedad intelectual para el tratamiento del
Síndrome Post-polio (SPP) 


Incluye las patentes para Estados Unidos, Europa y Japón de un método de tratamiento específico del SPP utilizando inmunoglobulina intravenosa (IVIG).

Actualmente
no existe ningún medicamento aprobado para el tratamiento del SPP. 
Grifols ha suscrito un acuerdo con la compañía farmacéutica sueca Pharmalink AB para la adquisición de los derechos de propiedad intelectual para el tratamiento del síndrome post-polio (SPP). La adquisición, cuyo cierre se prevé durante las próximas semanas, incluirá las patentes para Estados Unidos, Europa y Japón de un método de tratamiento específico del SPP utilizando inmunoglobulina intravenosa (hemoderivado), además del uso sin restricciones de los datos de los ensayos clínicos realizados por PharmaLink que apoyan este método de tratamiento. Asimismo, también contempla la documentación, el know-how, las licencias en Suecia con en nombre Xepol.

Esta adquisición permitirá a Grifols abrir nuevas áreas terapéuticas en sus 
proyectos de investigación clínica. Para Ramón Riera, vicepresidente de marketing y ventas de Grifols, "explorar el tratamiento del SPP está en consonancia con nuestra misión de desarrollar terapias para grupos de pacientes con enfermedades crónicas poco frecuentes". Actualmente no existe ningún medicamento aprobado para el tratamiento del SPP. 

El síndrome postpolio (SPP) está reconocido como una enfermedad rara y l
a FDA norteamericana ha designado la inmunoglobulina intravenosa (IVIG) como medicamento huérfano para su tratamiento. Por ello, continuar con este proyecto de investigación ofrece nuevas esperanzas a los miles de personas que padecen sus síntomas debilitantes. 

Ensayos clínicos llevados a cabo por PharmaLink sobre el uso de inmunoglobulina para el tratamiento del SPP se han desarrollado utilizando la inmunoglobulina intravenosa (IVIG) de Grifols. Con esta adquisición Grifols tendrá acceso sin restricciones a los datos procedentes de estos ensayos previos y le permitirá investigar a partir de las conclusiones. La adquisición también incluye las patentes para EE.UU., Europa y Japón, que confieren a Grifols los derechos exclusivos sobre el método de tratamiento.
Sobre el Síndrome Post-polio (SPP) 

El SPP suele desarrollarse varias décadas después de superar una infección de polio aguda. El SPP se caracteriza por un incremento de la debilidad muscular, fatiga y dolor musculoesquelético. La progresiva denervación se ha señalado como la causa más importante de pérdida de fuerza muscular asociada a la infección de la polio. Los pacientes con SPP presentan un aumento de la expresión de ARNm para citocinas proinflamatorias en el líquido cefalorraquídeo, lo que sugiere un proceso inflamatorio en el sistema nervioso central. Algunos pacientes con debilidad asimétrica han aumentado el desgaste de articulaciones y músculos, incluyendo los respiratorios. Aunque rara vez es una patología mortal, los síntomas neurológicos y musculares del SPP son permanentes y debilitantes.

La epidemia de poliomielitis tuvo su punto culminante en los países occidentales en torno a 1950. Como la mayoría de las infecciones se produjeron en niños, actualmente existe un gran número de supervivientes de la polio con diferentes grados de deterioro funcional. El Instituto Nacional de Trastornos Neurológicos y Accidentes Cerebrovasculares (NINDS) de EE.UU. considera un intervalo de prevalecía del SPP del 25% al 50% (en supervivientes de infecciones de polio primarias) mientras que la OMS estima una prevalencia del 40%. Asumiendo una prevalencia del 30%, significaría que sólo en los principales países occidentales habría alrededor de 300.000 afectados con este síndrome.


Actualmente no existe un tratamiento farmacológico del SPP. Varios agentes terapéuticos han fracasado en el logro de resultados positivos. Los tratamientos se basan en fisioterapia, ejercicio ligero y el uso de dispositivos de ayuda. Los prometedores resultados del uso de inmunoglobulina pueden dar respuesta a las necesidades de algunos de los pacientes afectados con el SPP. En varios ensayos clínicos dirigidos por un equipo de científicos del Instituto Karolinska (Suecia), la inmunoglobulina ha mostrado resultados significativos en aspectos como el dolor, la capacidad de caminar y la calidad de vida (SF-36) a través de la reducción del proceso inflamatorio en el sistema nervioso de los pacientes con SPP. 

Sobre Pharmalink AB 

Pharmalink es una compañía farmacéutica sueca que desarrolla productos de alto valor añadido para enfermedades poco frecuentes. Pharmalink aprovecha su amplia experiencia en el desarrollo de productos farmacéuticos y la excelencia de la ciencia médica sueca para identificar y desarrollar productos que responden a importantes necesidades médicas no atendidas. Pharmalink ha introducido más de 15 productos farmacéuticos en el mercado.

Su estrategia está basada en la búsqueda de reformulaciones y nuevas indicaciones terapéuticas para medicamentos, lo que minimiza el riesgo en el desarrollo de fármacos. 
La estrategia de la compañía es desarrollar fármacos a través de la realización de pruebas clínicas para nuevas indicaciones terapéuticas y ofrecerlos como medicamentos huérfanos o venderlo a terceros. Pharmalink tiene actualmente dos proyectos en esta fase de desarrollo clínico, Nefecon® y BusulipoTM, y trabaja de forma activa en la concesión de nuevas y prometedores licencias para añadir a su cartera de proyectos. Para más información: www.pharmalink.se
Sobre Grifols 

Grifols es un holding empresarial español especializado en el sector farmacéutico-hospitalario presente en más de 90 países.
 Desde mayo de 2006 cotiza en el Mercado Continuo Español y forma parte del Ibex-35. Actualmente es la primera empresa europea del sector de hemoderivados y el cuarto productor mundial. En los próximos años potenciará su liderazgo en la industria como compañía verticalmente integrada, gracias a las inversiones realizadas. En términos de materia prima,
 Grifols tiene asegurado el suministro de plasma con 80 centros de plasmaféresis en Estados Unidos y desde un punto de vista de capacidad de fraccionamiento, sus instalaciones productivas de Barcelona (España) y Los Ángeles (Estados Unidos) le permiten dar respuesta a la creciente demanda del mercado. No obstante, la compañía se prepara para lograr aumentos sostenidos durante los próximos 8-10 años para lo que ha puesto en marcha un ambicioso plan de inversiones. 

Grifols agrees with Pharmalink to acquire PPS drug development project


Grifols has announced that it has reached an agreement with Pharmalink to acquire intellectual property associated with the treatment of post-polio syndrome. The acquisition is expected to be finalized in the next few weeks and will include documentation, know-how, and Swedish regulatory approvals under the trade name Xepol.  Grifols will also acquire US, European and Japanese patents for a specific PPS treatment method utilizing human immunoglobulin and unrestricted use of existing Pharmalink clinical trial data supporting the treatment method.
Previous clinical trials on the use of human immunoglobulin for the treatment of PPS have been sponsored by Pharmalink using Grifols’ intravenous immunoglobulin.  Grifols’ acquisition of the Pharmalink PPS project will give Grifols unrestricted use of those data and set the stage for Grifols to investigate clinically relevant research questions growing out of prior studies.  The acquisition also includes U.S., European and Japanese patents which will effectively give Grifols exclusive rights to the treatment method.



CODIGO G "14" 
El pasado mes de febrero de 2009 y como resultado de la reunión anual del Comité de Revisión y Actualización de la Organización Mundial de la Salud, (OMS)  que tuvo lugar en Delhi, durante el mes de octubre de 2008, la Clasificación Internacional de Enfermedades, en su versión 10 (ICD-10) ha adjudicado un lugar específico al Síndrome Post-Polio (SPP) clasificándolo bajo el código "G14" y excluyéndolo del código B91  (Secuelas de poliomielitis), en el que antes ese organismo lo consideraba abarcado. Más informes www.postpoliolitaff.org

May 17, 2010

The WHO’s polio challenge


The WHO’s polio challenge: From inspiration to exhilaration

Canadian leading global battle against disease finds reasons to hope that the tipping point is near


André Picard
From Monday's Globe and Mail
Published on Sunday, May. 16, 2010 7:18PM EDT
Last updated on Monday, May. 17, 2010 3:09AM EDT
The World Health Assembly – the forum through which the World Health Organization is governed by its 193 member states – will be meeting in Geneva from Monday through May 23. Among the issues they will discuss is stepping up efforts to eradicate polio. The plan to eliminate the disease was first hatched in 1988, but has stalled in recent years. Bruce Aylward, the Canadian epidemiologist who co-ordinates the WHO global polio eradication program talks with The Globe.
In a word, how would you characterize polio eradication efforts to date – frustrating, inspiring, exhilarating?
Frustrating would not be the word. Inspiring would be closer to it. Exhilarating is what I hope to feel five years after.
But there seem to be so many obstacles.
Sure, there are challenges. Take northern Nigeria: There are real problems, but they’re not about polio eradication per se, they’re about making a quantum leap in the delivery of public services like health care. Take northern India: We’ve run into problem, problem, problem. But, again, it’s about applying modern science to breaking the back of an ancient virus. We’re either over, at or inches from the tipping point but we don’t know yet; we’ll know in six months.
If things are going well, why do we need a new plan?
The context is that, two years ago, the world assembly looked at the eradication program and said: ‘We’re deeply alarmed by the situation in Nigeria, and the fact that the last four countries [Nigeria, India, Pakistan, Afghanistan] seemed stalled in their efforts.’ So it asked for a new strategy. We suspended our five-year plan and developed a one-year plan.
So how is the new plan?
There are four elements: 1) A recognition that, in Asia and Africa, the immunity thresholds you need to stop the virus are different – they are 10-15 per cent higher in Asia, especially northern India, than in sub-Saharan Africa. 2) We learned that polio can survive in smaller populations and geographic sub-populations than scientists ever thought. 3) We have recognized that the routes of international spread of polio are largely predictable. 4) The last piece of the strategy involved the vaccine itself. Since 2005 we’ve used new vaccine – type 1 and type 3 – and they’ve worked really well. But we’ve seen a Ping-Pong effect: You get type 1 under control and type 3 pops up, and vice-versa. So now we’re going to systematically use bivalent vaccines that work well against both remaining viruses.
Are you confident this will get you over the hump?
Just five months into 2010, we’re seeing really good results. At this time last year, we had 300 cases of polio in Nigeria; this year, we have two. In northern India, in the states of Bihar and Uttar Pradesh we have not had a single case in four months.
But you have a big outbreak in Tajikistan, which has been polio-free for a long time. It’s like a hydra – cut off one head and two more appear.
It’s almost like a hydra, but it’s not: To kill a hydra you have to cut off all the heads at once. With polio, the challenge is different, it’s finding the weak point in the hydra. If you look at a map of the world, every dot you see that is a case of polio originates from eight states in northern Nigeria and two states in northern India. If you stop polio there, there will be no other outbreaks.
But the voices saying “eradication can’t work” are growing louder.
There are two groups that control whether or not eradication will get finished. First, there are the countries where infection is still endemic, in particular India and Nigeria. The other group is the G8. That’s because 50-60 per cent of the funding for the initiative comes from the G8. The day they decide ‘we’re not behind this program,’ that will be the end of eradication. The good news is that neither group is saying ‘No.’ On the contrary.
What message would you like to deliver about polio eradication to the G8 meeting in Canada?
They embraced a bold initiative on public health: to get rid of polio and to eliminate inequity in public health. After 10 years of a major investment, they are finally seeing a dramatic result in polio: months and months with very little virus in northern India and northern Nigeria. This is their chance to finish the job.

May 16, 2010

Surgery


Surgery

Like everybody else, people with polio might need surgery one day. Because of the history of polio extra precautions are needed. Patients with PPS may display altered respiratory function, chronic pain syndromes, cold intolerance, risk of aspiration, and altered sensitivity to anesthetic agents.
Take time to research the operation, the need for it, the consequences and to prepare adequate and informed post-op options for best recovery.
Surgeons can be very enthusiastic and positive about an operation, but might not have any experience with operating people with polio.
It is very important to talk with the surgeon about what the polio did to your body and the complications the disease brought on you. It might be a good idea to go to your rehabilitation doctor first. He knows or can find out what the consequences of polio are on your physical anatomy, muscle strength and ability. Ask what the impact of the operation is on your functionality and what the best way is for rehabilitation after the surgery. Ask your rehabilitation doctor if he will contact the surgeon and discuss your case.
If, after talking everything over with the surgeon, you have doubts about him doing the surgery, go for a second opinion with another surgeon.

Talk to the anaesthetist beforehand about your polio history. Do this especially if you had difficulty with breathing or swallowing in the acute phase of the polio infection. He can then decide to do detailed respiratory evaluation tests and arrange the narcotics according to the outcomes.
If you have scoliosis, spinal anaesthesia might be difficult.
Talk about the positioning on the operation table, this might prevent more complaints afterwards.
Often it is very cold in the operating theater, ask for extra warm blankets.
Discuss what sort of pain medication is best for you after the surgery.
There is not a lot of significant published information on this subject, but 2 helpful resources are:

"Post Polio Syndrome and Anesthesia" by David Lambert MD et al, University of Manitoba, Winnipeg, Canada in the Sept 2005 issue of Anesthesiology (Vol. 103, No. 3, pp 638-644. See at:http://journals.lww.com/anesthesiology/Fulltext/2005/09000/Postpolio_Syndrome_and_Anesthesia.29.aspx
Post Polio Health International: Dr Selma Calmes, see at: www.post-polio.org/ipn/anes.html

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“Post Polio Syndrome – Management and Treatment in Primary Care”


Post Polio Syndrome – Management and Treatment in Primary Care



The Post Polio Support Group in Ireland has published a book entitled “Post Polio Syndrome – Management and Treatment in Primary Care”. Written by medical professionals, including a doctor, physiotherapist, occupational therapist and speech therapist it allows polio Survivors to discover more about their condition, diagnosis and treatment. Although only published in English it is free to download and reproduce with due acknowledgement being given. To discover more go to http://www.ppsg.ie/publications_postpolio.html

P O L I O – STRIKING A SECOND TIME IN LIFE ?

The article (Polio - Striking a Second Time in Life?), reproduced by kind permission of Dr. Peter Brauer, is given in EnglishFrench (Français), Dutch & German (Deutsch)

By Dr. Peter Brauer
When the World Health Organisation (WHO) declared Europe as free of polio on the 21st June 2002, this was, no doubt, the most welcome result of a successful world-wide vaccination campaign to eradicate a disease that had been nearly forgotten. Except for the victims and a handful of medical doctors hardly anybody remembers anything about it. Therefore it comes as a huge surprise when tens of years later patients with a polio history suddenly face new problems very similar or / and different to those experienced in the acute stage of the polio infection , these new symptoms leading inevitably to a progressive deterioration of their already more or less affected state of health. In spite of intensive medical efforts the cause of this cannot be found. Attempts at treatments fail most of the time or even speed up the deterioration. A really truly horror scenario starts for the affected people in trying to find medical help .

For more than twenty years, very gradually, one has come to recognise that polio in its convalescence stage represents an inherent invisible “trap”. The affected and reduced nerve/muscle system is “repaired” to a degree where sufficient training enables it to function and move relatively normally with fewer nerves and muscles. Due to this reduced number they must, even under normal circumstances, work up to 10 times as hard, functioning for years and tens of years at their very limit. Then, eventually, regeneration and recovery abilities fail – pain, exhaustion, fatigue are warning signals, dying of nerves and muscles being the final stage. Important regulatory functions of the brain are affected , such as e.g. breathing.

In this way polio comes back a second time in the form of its own pattern of disease which with its many symptoms can be summarised as “ post-polio syndrome”, abbreviated PPS. The beginning of PPS goes unnoticed until a more serious level of problems occurs , which varies from case to case. As long as this is not recognised nor considered by either the patient or the doctor there is no way of providing any help. If after a number of physical examinations and laboratory tests no other disease can be found many doctors diagnose the patient as having a psychosomatic or imaginary disease and fail to provide the urgently needed treatment. PPS can be treated to a certain point but cannot be healed. If the effects of the old polio infection is not taken into account as being the cause of the problems and therefore the new symptoms misjudged it is inevitable that the wrong treatment leads to disastrous results. Unfortunately a lot of people do not know that they lived through a polio infection because it passed asymptomatic, e.g. flu-like symptoms. Even these people can get PPS, a fact which a lot of medical professionals are quite unaware of.

Doctors need to know about PPS in order to be able to help. But not only does this apply to doctors specialising in different areas of medicine, but also to physiotherapists, rehabilitation centres, to the medical and orthopaedic technology, to people providing health certificates, and last not least to the national health system, insurance companies, pension, health and social security systems.

At present the estimated figure of people suffering from the postpolio syndrome is estimated at 1 Mio people in Europe – the unknown figure is supposed to be much higher. Unfortunately there rarely is a conscious cooperation or networking between all the above areas of health care down to the non-medical staff, and they are therefore not to blame for ignorance. Here the patient is called upon to provide information. In his own interest he should inform himself about his own symptoms and to pass on medical information to his doctor etc. The European Polio Union and their national organisations as well as all their associated self-help and support groups (addresses and links can be found on www.europeanpolio.eu)  will help the patient to the best of their abilities.

ATTENTION: Do not forget immunisation !! Global travelling and migration will necessitate protection by vaccination more than ever, POLIO STILL EXISTS !!!
Author of this article :
Dr. med. Peter Brauer is the scientific adviser to the Polio Group of the Schleswig-Holstein Self-Help Group e.V. and member of the Medical Scientific Advisory Board to the Bundesverband Poliomyelitis e.V. Germany www.polio.sh
We thanks Dr. Peter Brawer for letting us publish and for his support to our organization Post Polio Litaff, Association A.C _APPLAC
          CODIGO G "14" 

El pasado mes de febrero de 2009 y como resultado de la reunión anual del Comité de Revisión y Actualización de la Organización Mundial de la Salud, (OMS)  que tuvo lugar en Delhi, durante el mes de octubre de 2008, la Clasificación Internacional de Enfermedades, en su versión 10 (ICD-10) ha adjudicado un lugar específico al Síndrome Post-Polio (SPP) clasificándolo bajo el código "G14" y excluyéndolo del código B91  (Secuelas de poliomielitis), en el que antes ese organismo lo consideraba abarcado. Más informes www.postpoliolitaff.org

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