By Alice Neville
Kiwi researchers have welcomed a scientific breakthrough that could hold the key to a debilitating condition affecting 20,000 New Zealanders.
A retrovirus discovered by US experts may reveal the cause of myalgic encephalopathy (ME), also known as chronic fatigue syndrome.
And Auckland GP Dr Ros Vallings will be among the first to learn how the findings can help the estimated 17 million sufferers around the world, thanks to the Cathay Pacific/Herald on Sunday High Flyers Awards. The Associated New Zealand Myalgic Encephalopathy Society will use its travel award to send Vallings to a high-powered conference in London next May.
The fifth annual ME/chronic fatigue syndrome conference will focus on the discovery of the XMRV retrovirus in blood samples from ME patients - and possible cures.
Vallings, acknowledged as Australia's leading ME expert and an adviser to the society, said the findings were wonderful news. But she warned they had to be replicated by other independent laboratories to validate them.
She expects to be in a position to bring back the latest knowledge to help Kiwi sufferers. A retrovirus contains DNA that is incorporated into the host cell's DNA strand and replicated, meaning it stays with the sufferer for life.
The Aids virus is a retrovirus, as are some cancer-causing viruses.
That such a serious problem could be the cause of ME may seem an odd thing for sufferers to celebrate, but it means a real understanding of the disease is finally in sight.
When Vallings began working with ME sufferers more than 30 years ago, there was little understanding of the condition.
"Until the last five years or so, people have been sceptical because there is no definite cause and no definite tests,"she said.
"A lot of sufferers look well, so had been mislabelled as having psychiatric conditions, and the term fatigue is very vague."
Attitudes to ME in New Zealand are more advanced than in other countries such as America, where sufferers struggle to have their condition accepted as a legitimate illness, she says.
"We're quite lucky because we're a small country and it's easier to educate the powers-that-be and doctors."
But there is still a "hidden amount of scepticism" here: "Schoolteachers and employers can still be quite difficult because they don't ... More on nzherald.co.nz
Doctor Speedy and ME in search of medical honesty
Monday, November 30, 2009
Saturday, November 28, 2009
Dangerous lead
Thousands of UK workers are being exposed to levels of lead that can cause serious chronic health problems. The Health and Safety Executive knows it, but admits it has “no intention” of doing anything about it. Hazards special report, November 2009
Friday, November 27, 2009
Cleveland Clinic conference puts spotlight on XMRV link with chronic fatigue syndrome
By Angela Townsend cleveland.com
"There are so many more questions than answers," Silverman said. "What is the prevalence in the general population? Is it the cause of human disease? Are CFS patients infected because they're more susceptible to the virus, or is the virus causing the disease? Is this virus a threat to public health or not?"
Silverman, one of the researchers credited with the initial discovery of XMRV, said he would love to gather the group together again, perhaps in a year.
"Every day I'm getting e-mails from scientists wanting the virus for their studies," he said.
These people are mostly virologists looking at other viruses, or researchers looking at CFS and prostate cancer, which also has been linked to XMRV.
Silverman's lab has been trying to fill requests as quickly as possible, sending the virus DNA -- not the live virus -- by mail in a test tube. (The researcher can then insert the DNA into human cells in the lab, which makes the actual virus.)
In the meantime, researchers are working to develop a diagnostic test for XMRV
Thursday, November 26, 2009
Wednesday, November 25, 2009
The Role of Viruses in ME/CFS
The Role of Viruses in ME/CFS, XMRV and the MRC PACE Trial – Margaret Williams – 21st November 2009
"On 8th October 2009 the premier journal Science published a paper online showing a direct link between a retrovirus and ME/CFS (Detection of infectious retrovirus XMRV, in blood cells of patients with chronic fatigue syndrome. Lombardi VC, Ruscetti FW, Peterson DL, Silverman RH, Mikovits JA et al) which caused global reverberations.
However, this was not the first time that a retrovirus had been associated with ME/CFS.
In 1991, using polymerase chain reaction and in situ hybridisation, Dr Elaine De Freitas, a virologist at the Wistar Institute, Philadelphia (which is America’s oldest independent institution devoted to biological research) and Drs Daniel Peterson, Paul Cheney, David Bell et al found such an association (Retroviral sequences related to human T-lymphotropic virus type II in patients with chronic fatigue immune dysfunction syndrome. Proc Natl Acad Sci USA 1991:88:2922-2926). It is notable that co-author Hilary Koprowski is a distinguished virologist and Professor Laureate who was Director of the Wistar Institute from 1957-1991; he is a member of the US National Academy of Sciences and is Director of the Centre for Neurovirology at Thomas Jefferson University.
Before publication, the findings were presented on 4th September 1990 by Elaine De Freitas at the 11th International Congress of Neuropathology in Kyoto, Japan.
Ten days later, on 14th September 1990 Dr Peter White (as he then was) and other members of the Wessely School dismissed the findings: “in the vast majority of CFS cases there is a psychological component. About 75% of CFS sufferers are clinically depressed, according to Peter White, senior lecturer in the department of psychiatric medicine at St Bartholomew’s Hospital in London. White said he believes depression is often a cause, rather than a consequence, of CFS…Les Borysiewicz, a clinical virologist at Addenbrookes Hospital in Cambridge (now Chief Executive of the MRC, having succeeded Professor Colin Blakemore) (said) ‘Whatever causes CFS, it isn’t the virus itself’…Anthony Clare, psychiatrist and medical director of St Patrick’s Hospital in Dublin (now deceased), pointed out that…there have been many ‘fatigue’ diseases with shifting causes: ’Neurasthenia, food allergies, now viruses. Some people would always rather have a disease that might kill them than a syndrome they have to live with’ ” (Science 1990:249:4974:1240).
In their PNAS article that was published in April 1991, De Freitas et al noted that chronic fatigue immune dysfunction syndrome (CFIDS) “may be related or identical to myalgic encephalomyelitis” and examined adult and paediatric CFIDS patients for evidence of human retroviruses (HTLV types I and II). As the CFIDS Chronicle article noted, the Wistar team looked at the peripheral blood DNA to see if they could find messenger RNA (mRNA) encoding for a viral segment of the HTLV-II virus.
At that time, known human retroviruses were the human immunodeficiency viruses 1 and 2 (HIV-1 and HIV-2) which are known to cause AIDS, and human T-lymphotropic viruses HTLV-I which causes lymphoma and HTLV-II which causes leukaemia (Hunter-Hopkins ME-Letter, October 2009). The four segments of the HTLV-II virus are referred to as the env, gag, pol and tax.
After a two year study, De Freitas et al provided evidence for HTLV-II-like infection of blood cells from CFIDS patients (and also to a lesser extent from people closely associated with them). This evidence was further substantiated by patient reactivity to proteins with the molecular weights reported for HTLV-I and HTLV-II antigens.
In their article, De Freitas et al said: “The frequency of these antibodies in CFIDS patients compared with healthy non-contact controls suggests exposure / infection with an HTLV-like agent rare in healthy non-contact people”.
Following the Wistar findings, researchers at the US Centres for Disease Control (CDC) allegedly attempted to replicate De Freitas’ work but failed to do so; this was suggested to be because certain scientists appeared eager to discount any possibility of a retroviral association with CFIDS. De Freitas defended her work and insisted that the CDC investigators had modified her assays, with the result that her work could not be replicated by the CDC.
De Freitas was publicly discredited; her research funding was discontinued and her research abandoned; she was subjected to what appeared to be attempts to destroy her professional reputation. Commenting on the subsequent discovery of XMRV (see below), ME/CFS expert Dr Paul Cheney of The Cheney Clinic was unambiguous: “Her work was unfortunately assaulted by the CDC. Her proposal to fly to the CDC in Atlanta to physically run the assays side by side with the CDC scientists was dismissed by the CDC” (http://cheneyclinic.com/a-retrovirus-called-xmrv-is-linked-to-cfs/538 )."
"On 8th October 2009 the premier journal Science published a paper online showing a direct link between a retrovirus and ME/CFS (Detection of infectious retrovirus XMRV, in blood cells of patients with chronic fatigue syndrome. Lombardi VC, Ruscetti FW, Peterson DL, Silverman RH, Mikovits JA et al) which caused global reverberations.
However, this was not the first time that a retrovirus had been associated with ME/CFS.
In 1991, using polymerase chain reaction and in situ hybridisation, Dr Elaine De Freitas, a virologist at the Wistar Institute, Philadelphia (which is America’s oldest independent institution devoted to biological research) and Drs Daniel Peterson, Paul Cheney, David Bell et al found such an association (Retroviral sequences related to human T-lymphotropic virus type II in patients with chronic fatigue immune dysfunction syndrome. Proc Natl Acad Sci USA 1991:88:2922-2926). It is notable that co-author Hilary Koprowski is a distinguished virologist and Professor Laureate who was Director of the Wistar Institute from 1957-1991; he is a member of the US National Academy of Sciences and is Director of the Centre for Neurovirology at Thomas Jefferson University.
Before publication, the findings were presented on 4th September 1990 by Elaine De Freitas at the 11th International Congress of Neuropathology in Kyoto, Japan.
Ten days later, on 14th September 1990 Dr Peter White (as he then was) and other members of the Wessely School dismissed the findings: “in the vast majority of CFS cases there is a psychological component. About 75% of CFS sufferers are clinically depressed, according to Peter White, senior lecturer in the department of psychiatric medicine at St Bartholomew’s Hospital in London. White said he believes depression is often a cause, rather than a consequence, of CFS…Les Borysiewicz, a clinical virologist at Addenbrookes Hospital in Cambridge (now Chief Executive of the MRC, having succeeded Professor Colin Blakemore) (said) ‘Whatever causes CFS, it isn’t the virus itself’…Anthony Clare, psychiatrist and medical director of St Patrick’s Hospital in Dublin (now deceased), pointed out that…there have been many ‘fatigue’ diseases with shifting causes: ’Neurasthenia, food allergies, now viruses. Some people would always rather have a disease that might kill them than a syndrome they have to live with’ ” (Science 1990:249:4974:1240).
In their PNAS article that was published in April 1991, De Freitas et al noted that chronic fatigue immune dysfunction syndrome (CFIDS) “may be related or identical to myalgic encephalomyelitis” and examined adult and paediatric CFIDS patients for evidence of human retroviruses (HTLV types I and II). As the CFIDS Chronicle article noted, the Wistar team looked at the peripheral blood DNA to see if they could find messenger RNA (mRNA) encoding for a viral segment of the HTLV-II virus.
At that time, known human retroviruses were the human immunodeficiency viruses 1 and 2 (HIV-1 and HIV-2) which are known to cause AIDS, and human T-lymphotropic viruses HTLV-I which causes lymphoma and HTLV-II which causes leukaemia (Hunter-Hopkins ME-Letter, October 2009). The four segments of the HTLV-II virus are referred to as the env, gag, pol and tax.
After a two year study, De Freitas et al provided evidence for HTLV-II-like infection of blood cells from CFIDS patients (and also to a lesser extent from people closely associated with them). This evidence was further substantiated by patient reactivity to proteins with the molecular weights reported for HTLV-I and HTLV-II antigens.
In their article, De Freitas et al said: “The frequency of these antibodies in CFIDS patients compared with healthy non-contact controls suggests exposure / infection with an HTLV-like agent rare in healthy non-contact people”.
Following the Wistar findings, researchers at the US Centres for Disease Control (CDC) allegedly attempted to replicate De Freitas’ work but failed to do so; this was suggested to be because certain scientists appeared eager to discount any possibility of a retroviral association with CFIDS. De Freitas defended her work and insisted that the CDC investigators had modified her assays, with the result that her work could not be replicated by the CDC.
De Freitas was publicly discredited; her research funding was discontinued and her research abandoned; she was subjected to what appeared to be attempts to destroy her professional reputation. Commenting on the subsequent discovery of XMRV (see below), ME/CFS expert Dr Paul Cheney of The Cheney Clinic was unambiguous: “Her work was unfortunately assaulted by the CDC. Her proposal to fly to the CDC in Atlanta to physically run the assays side by side with the CDC scientists was dismissed by the CDC” (http://cheneyclinic.com/a-retrovirus-called-xmrv-is-linked-to-cfs/538 )."
Dr. LUCINDA BATEMEN and CFS
"Almost 20 years ago, when I finished my residency, the Infectious Disease fellows placed a message on the telephone saying, “If you are calling about Chronic Fatigue Syndrome, call Dr. Bateman at this number,” essentially diverting CFS patients away from the state funded university hospital to my new internal medicine practice.
It was a joke—payback--- for the intense interest I had expressed for CFS during my training, about the time the 1988 Holmes case definition was published. My interest was initially fueled by a personal desire to help my sister, who became ill while I was in medical school, but grew as I searched the medical literature, evaluated hundreds of patients, and came to know the illness face to face.
Nine years ago, after 10 years of CFS, my sister developed non-Hodgkins lymphoma. She died at age 51, overwhelmed by an unknown infection following stem cell transplant. Now WPI has reported the presence of XMRV, a discovery that could potentially have changed her fate.
Two decades after diagnosing my first patient, and one decade after opening a CFS clinic, remaining self employed has been the best way to continue a search for answers and to provide a place for patients with CFS.
I have indirectly donated at least a million dollars to the cause of CFS in the form of lost potential income.
I still participate in Medicare and most major insurances and follow a large group of patients with CFS and related illnesses. As a small business owner I can not provide medical insurance for my staff and was myself recently declined individual medical insurance by Blue Cross/Blue Shield. The clinic generally runs in the red and continues as a service to patients in my community.
The effort is subsidized largely by pharmaceutical dollars since I moonlight doing drug research and consulting to pay my clinical staff.
The CDC researchers are still doing epidemiology, deny a viral contribution, and demonstrate little understanding of the clinical subsets that meet the Fukuda CFS Case Definition
The NIH has not matched research funding to the significance and immediacy of the problem.
There is little recognition, interest or expertise regarding CFS at academic medical institutions across the country, including the University of ..."
It was a joke—payback--- for the intense interest I had expressed for CFS during my training, about the time the 1988 Holmes case definition was published. My interest was initially fueled by a personal desire to help my sister, who became ill while I was in medical school, but grew as I searched the medical literature, evaluated hundreds of patients, and came to know the illness face to face.
Nine years ago, after 10 years of CFS, my sister developed non-Hodgkins lymphoma. She died at age 51, overwhelmed by an unknown infection following stem cell transplant. Now WPI has reported the presence of XMRV, a discovery that could potentially have changed her fate.
Two decades after diagnosing my first patient, and one decade after opening a CFS clinic, remaining self employed has been the best way to continue a search for answers and to provide a place for patients with CFS.
I have indirectly donated at least a million dollars to the cause of CFS in the form of lost potential income.
I still participate in Medicare and most major insurances and follow a large group of patients with CFS and related illnesses. As a small business owner I can not provide medical insurance for my staff and was myself recently declined individual medical insurance by Blue Cross/Blue Shield. The clinic generally runs in the red and continues as a service to patients in my community.
The effort is subsidized largely by pharmaceutical dollars since I moonlight doing drug research and consulting to pay my clinical staff.
The CDC researchers are still doing epidemiology, deny a viral contribution, and demonstrate little understanding of the clinical subsets that meet the Fukuda CFS Case Definition
The NIH has not matched research funding to the significance and immediacy of the problem.
There is little recognition, interest or expertise regarding CFS at academic medical institutions across the country, including the University of ..."
Tuesday, November 24, 2009
Pacemaker endocarditis: an important clinical entity
SUMMARY
Pacemaker endocarditis remains a rare but potentially life threatening complication of pacemaker implantation.
This case illustrates a rare cause of pacemaker endocarditis, Serratia marcescens, the management difficulties that can be faced with such organisms, and the potential indolent nature of pacemaker lead associated endocarditis.
A review of the current data for pacemaker endocarditis management suggests that treatment with antimicrobials alone is unlikely to be curative and explantation of the device is recommended in all cases of confirmed pacemaker endocarditis (by echocardiography, in correlation with the patient’s clinical condition and inflammatory markers).
Pacemaker endocarditis remains a rare but potentially life threatening complication of pacemaker implantation.
This case illustrates a rare cause of pacemaker endocarditis, Serratia marcescens, the management difficulties that can be faced with such organisms, and the potential indolent nature of pacemaker lead associated endocarditis.
A review of the current data for pacemaker endocarditis management suggests that treatment with antimicrobials alone is unlikely to be curative and explantation of the device is recommended in all cases of confirmed pacemaker endocarditis (by echocardiography, in correlation with the patient’s clinical condition and inflammatory markers).
In memoriam Wendy Cleal
Woman with ME found dead in her home after fire
A GWENT woman was found dead in her home by a friend, two days after a fire in the house. The body of Monmouthshire massage therapist Wendy Cleal, 46, was found after police were called at 1.20pm on Tuesday when worried friends raised the alarm.
It then emerged that a fire had broken out at the Catbrook house on Sunday night, burning itself out and the tragic death remaining undiscovered until Tuesday.
South Wales Fire and Rescue investigator Matt Jones said the most likely cause of Miss Cleal's death was smoke inhalation after a small fire which extinguished itself.
It is understood that investigations centre around a portable heater found at the house.
Miss Cleal’s sister Janice Love said yesterday her family are “raw and completely in shock”.
She added: “It’s really hard, we’re devastated and Wendy will be badly missed.”
A GWENT woman was found dead in her home by a friend, two days after a fire in the house. The body of Monmouthshire massage therapist Wendy Cleal, 46, was found after police were called at 1.20pm on Tuesday when worried friends raised the alarm.
It then emerged that a fire had broken out at the Catbrook house on Sunday night, burning itself out and the tragic death remaining undiscovered until Tuesday.
South Wales Fire and Rescue investigator Matt Jones said the most likely cause of Miss Cleal's death was smoke inhalation after a small fire which extinguished itself.
It is understood that investigations centre around a portable heater found at the house.
Miss Cleal’s sister Janice Love said yesterday her family are “raw and completely in shock”.
She added: “It’s really hard, we’re devastated and Wendy will be badly missed.”
Monday, November 23, 2009
Asbestos: A shameful legacy
The authorities knew it was deadly more than 100 years ago, but it was only banned entirely in 1999. The annual death rate will peak at more than 5,000 in 2016 – now MPs have a chance to do the decent thing.
By Emily Dugan
They called it "the Barking cough". First it began like any other: a tickle in the chest and slight pain on breathing. Then, within a matter of months, the sufferer was in agony, gasping for air and eventually suffocating to death as a vicious cancer attacked their lungs waiting for the final lingering, inevitable end which might not come for decades.
The legacy of the Cape Asbestos factory in Barking, east London, where asbestos-related cancers continue to kill scores of residents, is a deadly one. Hundreds of people have died since the factory closed in 1968.
The story of Barking's "industrial killing machine" is a story repeated up and down the country where thousands of Britons continue to be blighted by their industrial past. Exposure to asbestos is now the biggest killer in the British workforce, killing about 4,000 people every year – more than who die in traffic accidents. The shocking figures are the grim legacy of the millions of tons of the dust shipped to Britain to make homes, schools, factories and offices fire resistant. It was used in products from household fabrics to hairdryers.
Those most at risk are ordinary workers and their families. Whether it was dockyard workers who unloaded the lethal cargoes, or those in the factories exposed to the fibres, or the carpenters, laggers, plumbers, electricians and shipyard workers who routinely used asbestos for insulation – all suffered. So did the wives who washed the work overalls and the children who hugged their parents or played in the dust-coated streets.
The exposure to asbestos in Britain is largely historical but the death toll is alarmingly etched on our future. Asbestos fibres can lie dormant on victims' lungs for up to half a century; deaths from asbestos in Britain will continue to rise until 2016.
Nor is it confined to Britain. The World Health Organisation says ...
Saturday, November 21, 2009
World AIDS Day 2009 is 1st December 2009
Today there are more people than ever before living with HIV in the UK, but less people report knowing someone with HIV. People with HIV generally look healthy and many do not find it easy to tell other people, so you may not realise if someone you know if HIV positive. To learn more about the different groups of people affected by HIV view the statistics.
Friday, November 20, 2009
Professor Nancy Klimas talks about XMRV and ME/CFS
Dr Nancy Klimas, from the University of Miami, talked about the XMRV retrovirus link with ME/CFS when she was interviewed yesterday on the South Florida Today news programme.
Dr Ellen Goudsmit joins ME Association panel of advisers
The ME Association have appointed Dr Ellen Goudsmit as a consultant on psychological issues. Dr Goudsmit is a registered health psychologist with a background in medical and psychological research.
Dr Goudsmit is a visiting research fellow at the University of East London, and is a co-editor of ME and CFS References, a list of all published papers on ME, CFS and related conditions, compiled for the Melvin Ramsay Archive since 1989. She has been a long time critic of the CBT-model for CFS. She devised the strategy of pacing for ME and introduced the concept of psychologisation (the emphasis on where there is little or no evidence to justify it).
Dr Goudsmit studied clinical psychology and psychophysiology for her Dutch Master’s degree. Her PhD described three studies of people with Ramsay-defined ME and post-viral fatigue syndrome.
In 2009, she was elected a fellow of the British Psychological Society (BPS). She is also a member of the International Association for CFS/ME.
Dr Goudsmit is an advocate for specialist clinics where physicians and other health professionals can choose from an arsenal of interventions depending on the symptoms, circumstances and preferences of the patient. As she was part of the BPS team which scrutinised the NICE guidelines and as she has already analysed the studies on CBT and GET, we hope that we will be able to use her knowledge to provide expert advice on the imminent publication of the PACE trial.
Dr Goudsmit, who was born in Amsterdam, has had ME since childhood. She became a British citizen two years ago.
Dr Goudsmit is a visiting research fellow at the University of East London, and is a co-editor of ME and CFS References, a list of all published papers on ME, CFS and related conditions, compiled for the Melvin Ramsay Archive since 1989. She has been a long time critic of the CBT-model for CFS. She devised the strategy of pacing for ME and introduced the concept of psychologisation (the emphasis on where there is little or no evidence to justify it).
Dr Goudsmit studied clinical psychology and psychophysiology for her Dutch Master’s degree. Her PhD described three studies of people with Ramsay-defined ME and post-viral fatigue syndrome.
In 2009, she was elected a fellow of the British Psychological Society (BPS). She is also a member of the International Association for CFS/ME.
Dr Goudsmit is an advocate for specialist clinics where physicians and other health professionals can choose from an arsenal of interventions depending on the symptoms, circumstances and preferences of the patient. As she was part of the BPS team which scrutinised the NICE guidelines and as she has already analysed the studies on CBT and GET, we hope that we will be able to use her knowledge to provide expert advice on the imminent publication of the PACE trial.
Dr Goudsmit, who was born in Amsterdam, has had ME since childhood. She became a British citizen two years ago.
Thursday, November 19, 2009
Wednesday, November 18, 2009
ME is still not taken seriously ...
http://www.youtube.com/user/hoofbags: "In spite of the overwhelming evidence, the UK NHS still refuses to accept ME as a genuine illness and vehemently will never accept it as such. They will even go as far as torturing children to make their point and warn us no to do the same. "
Common cold may hold off swine flu
A VIRUS that causes the common cold may be saving people from swine flu. If this intriguing idea turns out to be true, it would explain why swine flu's autumn wave has been slow to take off in some countries and point to new ways to fight flu.
"It is really surprising that there has not been more pandemic flu activity in many European countries," says Arnold Monto, an epidemiologist at the University of Michigan, Ann Arbor.
It is really surprising that there has not been more pandemic flu activity in many European countries.
In France, flu cases rose in early September, then stayed at about 160 per 100,000 people until late October, when numbers started rising again. The delayed rise was puzzling, says Jean-Sebastien Casalegno of the French national flu lab at the University of Lyon.
He reports that the percentage of throat swabs from French respiratory illnesses that tested positive for swine flu fell in September, while at the same time rhinovirus, which causes colds, rose (Eurosurveillance, vol 14, p 19390). He told New Scientist that in late October, rhinovirus fell - at the same time as flu rose. He suspects rhinovirus may have blocked the spread of swine flu via a process called viral interference.
This is thought to occur when one virus blocks another. "We think ...
"It is really surprising that there has not been more pandemic flu activity in many European countries," says Arnold Monto, an epidemiologist at the University of Michigan, Ann Arbor.
It is really surprising that there has not been more pandemic flu activity in many European countries.
In France, flu cases rose in early September, then stayed at about 160 per 100,000 people until late October, when numbers started rising again. The delayed rise was puzzling, says Jean-Sebastien Casalegno of the French national flu lab at the University of Lyon.
He reports that the percentage of throat swabs from French respiratory illnesses that tested positive for swine flu fell in September, while at the same time rhinovirus, which causes colds, rose (Eurosurveillance, vol 14, p 19390). He told New Scientist that in late October, rhinovirus fell - at the same time as flu rose. He suspects rhinovirus may have blocked the spread of swine flu via a process called viral interference.
This is thought to occur when one virus blocks another. "We think ...
Tuesday, November 17, 2009
No fruit heads aka CBT Professors allowed ...
Spotted near the National Institute of ignoring Clinical Evidence
Monday, November 16, 2009
What Professor Simon Wessely does not want you to know ...
"Simon Wessely is a British psychiatrist. He is professor of epidemiological and liaison psychiatry at the Institute of Psychiatry, King's College London and head of its department of psychological medicine, as well as Director of the King's Centre for Military Health Research. He is also honorary Consultant Psychiatrist at King's College Hospital and Maudsley Hospital, as well as Civilian Consultant Advisor in Psychiatry to the British Army.[Witapedia] .
What is not repoerted in Witapedia is Simon Wesselys association with the insurance industry..........
You may be aware that there is considerable controversy surrounding the subject of ME/CFS and that patient groups have acquired a reputation for being at loggerheads with a group of UK psychiatrists, collectively known as the Wessely school, who state that ME/CFS is a somatoform/functional disorder (i.e. psychiatric)
Somatoform / functional disorders have no scientific basis whatsoever. By contrast..."
What is not repoerted in Witapedia is Simon Wesselys association with the insurance industry..........
You may be aware that there is considerable controversy surrounding the subject of ME/CFS and that patient groups have acquired a reputation for being at loggerheads with a group of UK psychiatrists, collectively known as the Wessely school, who state that ME/CFS is a somatoform/functional disorder (i.e. psychiatric)
Somatoform / functional disorders have no scientific basis whatsoever. By contrast..."
Interactive Formula 1 Car
The Formula 1 2009 season has seen fundamental changes to the way the cars look and run.
In this interactive guide, you can investigate key changes: the return of slick tyres; the first use of KERS, a new feature to help limit the ecological impact of the sport; a new body shape and changes to the way that the nose, wing and rear wing operate.
Sunday, November 15, 2009
More Evidence of Inflammation in ME/CFS
Margaret Williams, 14th November 2009
In his presentation in Bergen on 20th November 2009, Professor Peter White’s power point slides state about (ME)CFS that maintaining factors include illness beliefs, the search for legitimacy, being on benefits, and the diagnostic label, and that immune or viral measures are NOT involved in the maintenance of the disorder ( http://www.unifobhelse.no/upload/Bergen%20What%20is%20CFS%202009.pdf ).
White’s assertion that immune or viral measures are not involved in the maintenance of the disorder would seem to be a direct denial of the evidence of two of the world’s leading immunologists who specialise in ME/CFS, Professors Mary Ann Fletcher and Nancy Klimas, who recently published yet more confirmatory evidence of immune dysfunction in the maintenance of the disorder (Journal of Translational Medicine 2009:7:96: doi:10.1186/1479-5876-7-96).
Saturday, November 14, 2009
Sir Peter Spencer and the £500m Chinook “gold standard cock-up”
"Sir Peter Spencer and the £500m Chinook “gold standard cock-up”.
Sir Peter Spencer KCB was appointed Chief Executive of Action for M.E. on 30 April 2007. Prior to that he was Chief of Defence Procurement of the MOD, from May 2003.
Further details of Sir Peter’s career at the Ministry of Defence emerged yesterday. The coverage is not flattering, as newspaper headlines suggest:
“Chinook blunders cost MoD £500m”, David Hencke, Westminster correspondent, The
Guardian, Wednesday June 4 2008.
“£500m ‘wasted’ on Chinooks that have never flown”, Michael Evans, Defence Editor, The Times June 4, 2008.
“Chinook fleet sitting idle costs £422m”, By Rosa Prince, Political Correspondent, Daily Telegraph: 11:09 PM BST 03/06/2008.
--------------------------------------------------------------------------------
“MOD accused of Chinook 'cock-up'”, BBC: 2008/06/03 23:42:54 GMT."
Sir Peter Spencer KCB was appointed Chief Executive of Action for M.E. on 30 April 2007. Prior to that he was Chief of Defence Procurement of the MOD, from May 2003.
Further details of Sir Peter’s career at the Ministry of Defence emerged yesterday. The coverage is not flattering, as newspaper headlines suggest:
“Chinook blunders cost MoD £500m”, David Hencke, Westminster correspondent, The
Guardian, Wednesday June 4 2008.
“£500m ‘wasted’ on Chinooks that have never flown”, Michael Evans, Defence Editor, The Times June 4, 2008.
“Chinook fleet sitting idle costs £422m”, By Rosa Prince, Political Correspondent, Daily Telegraph: 11:09 PM BST 03/06/2008.
--------------------------------------------------------------------------------
“MOD accused of Chinook 'cock-up'”, BBC: 2008/06/03 23:42:54 GMT."
No excuses for lying CBT psychiatrists anymore ...
A new computer aimed at lying CBT psychiatrists who are unfamiliar with PCs and the internet has been unveiled.
"The simplified desktop - called SimplicITy - has just six buttons directing users to basic tasks such as e-mail and chat.
The computer comes pre-loaded with 17 video tutorials from television presenter Valerie Singleton ..."
"The simplified desktop - called SimplicITy - has just six buttons directing users to basic tasks such as e-mail and chat.
The computer comes pre-loaded with 17 video tutorials from television presenter Valerie Singleton ..."
GET and CBT HARMFUL FOR ME/CFS
A recent review of the relevant scientific literature shows that the "revalidation therapies" for patients with ME/CFS, which are monopolized by the governmental institutions for example in the UK, Belgium and the Netherlands, are not only not efficient, but also aggravate the condition of many patients.
Despite several major scientific breakthroughs, ME/CFS is still described in the popular media as a medically unexplained disorder. Psychotherapy (cognitive behavioral therapy) and graded exercise therapy (GET) are declared to be the only possible therapies.
A thorough analysis of the current medical scientific literature and international patient surveys, however, shows that CBT/GET is not only ineffective for the majority of the ME/CFS patients, but also potentially very harmful.
Scientific studies and large-scaled patient surveys have shown that treatments with CBT/GET seriously deteriorate the condition of many patients with ME/CFS.
The work capacity decreased as well!
The review also explains why GET and exercise do aggravate characteristic complaints, like “fatigue”, pain, neurocognitive problems (e.g. concentration and memory).
Pre-existing biological aberrations, e.g. inflammation, oxidative stress, and dysfunctional ion channels, will be amplified by a minor exertion, like walking or reading a book … and by “rehabilitation therapies” like CBT/GET.
Despite several major scientific breakthroughs, ME/CFS is still described in the popular media as a medically unexplained disorder. Psychotherapy (cognitive behavioral therapy) and graded exercise therapy (GET) are declared to be the only possible therapies.
A thorough analysis of the current medical scientific literature and international patient surveys, however, shows that CBT/GET is not only ineffective for the majority of the ME/CFS patients, but also potentially very harmful.
Scientific studies and large-scaled patient surveys have shown that treatments with CBT/GET seriously deteriorate the condition of many patients with ME/CFS.
The work capacity decreased as well!
The review also explains why GET and exercise do aggravate characteristic complaints, like “fatigue”, pain, neurocognitive problems (e.g. concentration and memory).
Pre-existing biological aberrations, e.g. inflammation, oxidative stress, and dysfunctional ion channels, will be amplified by a minor exertion, like walking or reading a book … and by “rehabilitation therapies” like CBT/GET.
Friday, November 13, 2009
Thursday, November 12, 2009
Chronic Fatigue Syndrome — Could a "Stealth Virus" Be Lurking?
By John F. Joseph, MD, FACP, FIDSA, FSHEA, Associate Chief of Staff for Education, Ralph H. Johnson Veterans Administration Medical Center; Professor of Medicine, Medical University of South Carolina, Charleston, is Associate Editor for Infectious Disease Alert.
"It has been known for years that patients with chronic fatigue syndrome (CFS) have a defect in a major antiviral pathway, the 2-5A/RNase L pathway. The RNaseL produces non-specific viral cleavage and, thus, protects us from many viral infections (innate immunity).
Defects in this pathway not only lead to susceptibility to viral infections but may also increase our susceptibility to tumor development. The RNaseL gene, called Human Prostate Cancer 1 (HPC1), has a variant R462Q related to a potential etiologic agent of prostate cancer, a novel human retrovirus, xenotropic murine leukemia virus (MuLV), named XMRV.
So, it was by a bit of serendipity that a group of workers headed by several from the Whittemore Peterson Institute in Reno, Nevada, asked if XMRV could be associated with CFS. What led to any rationale connection between prostate cancer and CFS is not clear, but the question led to a series of experiments that culminated in a very recent publication showing an association between the presence of this retrovirus in the peripheral blood mononuclear cells (PBMCs) of patients with CFS.
We are dealing here with intricate science that surely ...
"It has been known for years that patients with chronic fatigue syndrome (CFS) have a defect in a major antiviral pathway, the 2-5A/RNase L pathway. The RNaseL produces non-specific viral cleavage and, thus, protects us from many viral infections (innate immunity).
Defects in this pathway not only lead to susceptibility to viral infections but may also increase our susceptibility to tumor development. The RNaseL gene, called Human Prostate Cancer 1 (HPC1), has a variant R462Q related to a potential etiologic agent of prostate cancer, a novel human retrovirus, xenotropic murine leukemia virus (MuLV), named XMRV.
So, it was by a bit of serendipity that a group of workers headed by several from the Whittemore Peterson Institute in Reno, Nevada, asked if XMRV could be associated with CFS. What led to any rationale connection between prostate cancer and CFS is not clear, but the question led to a series of experiments that culminated in a very recent publication showing an association between the presence of this retrovirus in the peripheral blood mononuclear cells (PBMCs) of patients with CFS.
We are dealing here with intricate science that surely ...
Wednesday, November 11, 2009
Two Irish hunters ...
Two Irish hunters got a pilot to fly them to Canada to hunt moose. They managed to bag 6.
As they were loading the plane to return, the pilot said the plane could take only 4 moose.
The two lads objected strongly. "Last year we shot six. The pilot let us take them all and he had the same plane as yours."
Reluctantly, the pilot gave in and all six were loaded.
However, even on full power, the little plane couldn't handle the load and went down crashing in the woods.
Somehow, surrounded by the moose bodies, Paddy and Mick survived the crash.
After climbing out of the wreckage, Paddy asked Mick, "Any idea where we are?"
Mick replied, "I think we're pretty close to where we crashed last year."
As they were loading the plane to return, the pilot said the plane could take only 4 moose.
The two lads objected strongly. "Last year we shot six. The pilot let us take them all and he had the same plane as yours."
Reluctantly, the pilot gave in and all six were loaded.
However, even on full power, the little plane couldn't handle the load and went down crashing in the woods.
Somehow, surrounded by the moose bodies, Paddy and Mick survived the crash.
After climbing out of the wreckage, Paddy asked Mick, "Any idea where we are?"
Mick replied, "I think we're pretty close to where we crashed last year."
Tuesday, November 10, 2009
Forgotten supercars: VW W12
Speed records were broken and the car was developed further with a 6.0-litre engine, giving 600bhp and a 217mph top speed. As recently as the 2002 Geneva motor show, VW was still showing a revised W12 on its stand, but within months the project was canned, thanks to a glut of supercars under development within the VW Group.
Record breaking daredevil wingsuit base jumper Heather Swan
Six years after her first skydive Heather Swan began base jumping in 2005. Here she can be seen jumping off Tombstone, Utah
Monday, November 9, 2009
South Australian whooping cough outbreakArticle
TORY SHEPHERD:
SOUTH Australia is experiencing its worst whooping cough outbreak on record - and babies are the main victims of the potentially fatal and highly infectious disease.
Babies are most vulnerable as they are too young to be immunised, and rely upon 'herd immunity' - the high immunisation of those around them .
SA Health has received almost 3500 notifications this year, compared with 859 at the same time last year and 318 in 2007.
National statistics show the rate in South Australia is twice as high as the national average.
A four-week-old NSW baby who died in March was the first fatality from the disease in a decade. Since then it is understood two other children have died.
SA Health Communicable Disease Control branch director Dr Ann Koehler said nationally there had been a "big wave" of infections. She said SA had the highest rate, although it was not clear why. Dr Koehler said more cases were being diagnosed as people were tested for swine flu
THE PACE TRIAL AND THE MEDICAL RESEARCH COUNCIL
Anonymous: 'Will the charity Action for ME (whose only members in law are the executive, everyone else is merely a subscriber to their magazine)now stop funding only psychological research into ME that uses the discredited Oxford criteria to select patients?
The PACE trial (part funded by AfME) - why it is one of the worst scandals in medical history: ....'
The PACE trial (part funded by AfME) - why it is one of the worst scandals in medical history: ....'
Sunday, November 8, 2009
XMRV Research - A Landmark for ME
Some years ago those suffering from diabetes and Multiple Sclerosis (MS) were denigrated and trivialised by the same type of establishment corruption which has been directed toward ME sufferers. Both diabetes and MS were illnesses which were regarded as psychiatric until insulin and MRI were discovered. The ability of an MRI scan to show the pathology of MS destroyed the psychiatrists who wished to portray that illness as "women's hysteria".
The discovery by the Whittemore-Peterson, the National Cancer Institute and the Cleveland Clinic researchers of xenotropic murine leukemia virus-related virus (XMRV) in ME patients may well be the equivalent defining moment for ME.
As our letter to the CMO in 2006 stated - "although there is much to learn about the details of these illnesses our present understanding and treatments have emerged from careful research studies that have exposed the inadequacies of the psychiatric models".
The WPI has tested more samples since submitting the first paper and our EMEA colleagues report of the interest around Europe in studying this. One Swedish clinical virologist has described this research as important as the discovery of HIV and already there are plans for studying this in Swedish ME patients.
The news of the XMRV research is really encouraging in bringing ME into the main stream media coverage and getting new researchers interested in the field, and wanting to reproduce the results. This is exactly what ME needs - to be perceived and treated as a mainstream organic illness needing funding to provide correct treatments.
Although the discovery is quite serious, as it is a retrovirus and therefore has its own consequences, we feel it is better in the long term for patients to know what is wrong with them rather than continually being left in limbo due to ignorance and outdated information.
Researchers will now have to study the XMRV virus, how it behaves etc. and it is necessary for governments and healthcare organisations to treat ME with the urgency it requires. We now have another biomarker which, of course, needs to be verified by other researchers first before we can be absolutely certain of its importance. There are bound to be people in support groups who have different reasons for their illness and we need biomarkers to make sure a diagnosis given is a correct one.
The WPI website states:
"We have detected the retroviral infection XMRV is greater than 95% of the more than 200 ME/CFS, Fibromylagia, Atypical MS patients tested. The current working hypothesis is that XMRV infection of B, T, NK and other cells of the innate immune response causes the chronic inflammation and immune deficiency resulting in an inability to mount an effective immune response to opportunistic infections."
Interestingly, in a discussion after this year’s IiME Pre-Conference Dinner presentation by Hillary Johnson, Professor Harald Nyland mentioned how some diseases need two viruses for a disease to develop. He also mentioned Burkitt’s lymphoma as an example where the presence of two viruses, EBV and malaria is needed.
The elapsed time taken by Science magazine in publishing the research findings may be seen as proof of the excellence of the work being performed by the team of researchers at the WPI, the NCI and the Cleveland Clinic.
There have been comments about Lombardi et al. not giving demographic details of the patients and controls used in the recently published XMRV study. Scientific journals have all their own rules governing the format in which they want research articles written. This XMRV study has been written according to the rules given by the Science magazine and all other interested researchers can request more detailed information on methodology etc. if they wish.
For Science to publish an article on ME is a landmark itself and has a huge positive effect on all biomedical ME research. Having the National Cancer Institute and the Cleveland Clinic working with the WPI and publishing these results, in a journal of the calibre of Science, is as good as it gets. This work should open up more funding opportunities for other existing biomedical ME researchers.
If the WPI and subsequent research does not conclusively prove that XMRV is the cause of ME it will at least have interested more researchers to participate in biomedical research in this area. And will have broken the mould.
We should all take this opportunity to make a real push for funding for more biomedical studies based on homogenous well defined patient groups. IiME will continue to campaign for biomedical research, and apply for grants for biomedical research, in the sure knowledge that good science eventually will win through.
Our view on the XMRV research is echoed by the words of Professor Martin Pall, a speaker at our 2007 conference -
"There have been comments in the media to the effect that this finally shows that CFS/ME is physiological, not psychological. This is true, but this should have been obviously true anyway, at least six or seven years ago. Nevertheless the media coverage of CFS/ME obtained by Mikovits and her colleagues must be viewed as a true gift to those interested in extending public knowledge of this disease."
The discovery of XMRV in ME patients has changed the ME/CFS landscape for good.
We have more detail on the XMRV research - click here .
Our statement on the research was published here .
Saturday, November 7, 2009
Friday, November 6, 2009
Thursday, November 5, 2009
Wednesday, November 4, 2009
Top Gear lap record smashed
With a new series due in weeks and Top Gear Live shortly to hit London and Birmingham expect to see a flurry of activity from the team.
Having said that, news that the Top Gear test track lap record has just been smashed surprisingly has nothing to do with the TV show.
Frustrated at being denied the opportunity to prove itself on the programme, British sports car builder Ultima took things into its own hands and hired the track out. The result? A lap time to humble a Ferrari FXX.
A Ferrari FXX with Michael Schumacher at the wheel, no less, the seven-time world champion famously posting a 1min 10.7sec time in the track-only Enzo-derived mega Ferrari. So, what about the Ultima GTR720?
LATEST NEWS: XMRV TESTING
Dr. Vincent Lombardi, the primary investigator and first author on a paper that appeared in the 8 October 2009 issue of “Science”, is the Director of Operations for the licensing and development of the XAND test assays used by VIP Dx for the detection of XMRV.
To read this landmark publication, "Detection of an Infectious Retrovirus, XMRV, in Blood Cells of Patients with Chronic Fatigue Syndrome", please go to (www.sciencemag.org).
We are pleased to announce that VIP Dx has licensed this technology allowing us to offer the most accurate and sensitive testing available for XAND (XMRV associated neuro-immune disease).
TO ORDER XAND TEST KITS, CONTACT VIP Dx.
To learn more about our XMRV tests,
CLICK HERE.
To read this landmark publication, "Detection of an Infectious Retrovirus, XMRV, in Blood Cells of Patients with Chronic Fatigue Syndrome", please go to (www.sciencemag.org).
We are pleased to announce that VIP Dx has licensed this technology allowing us to offer the most accurate and sensitive testing available for XAND (XMRV associated neuro-immune disease).
TO ORDER XAND TEST KITS, CONTACT VIP Dx.
To learn more about our XMRV tests,
CLICK HERE.
Retrovirus may shed light on mystery of chronic fatigue
BY: Dr Garrett FitzGerald was once sent many patients who suffered from chronic fatigue. He listened with sympathy but believed the condition was psychological.
Back in the news big-time is Chronic Fatigue Syndrome. A recent paper in Science reports infection with a gammaretrovirus (XMRV) in 67 per cent of cases. The virus has been detected from blood and saliva in long-term sufferers.
Is it time to apologise to all the patients who were diagnosed as being somewhat cracked? I recall one colleague referring to the condition as the Muirisheen Durkan syndrome:
So, goodbye Muirisheen Durkan
I’m sick and tired of workin’!
For some unknown reason, I was sent many patients with the syndrome from all over the country. I was almost always impressed by the genuine nature of the symptoms, having no doubt that there just had to be something other than psychological reasons underneath.
I could do nothing for them
I listened (often the consultation lasted more than an hour) and in most instances after investigation told the patients that they were probably suffering from CFS/ME. I told them I could do nothing for them in terms of cure or alleviation.
The only contribution I made was to warn them about the quacks which they (understandably) were attending or ...
Tuesday, November 3, 2009
Virus Tied To Chronic Fatigue Syndrome
National Public Radio:
IRA FLATOW, host:
You're listening to SCIENCE FRIDAY from NPR News. I am Ira Flatow.
Up next, the latest on a mysterious illness called chronic fatigue syndrome. Researchers have been studying people who have been diagnosed with it, trying to figure out what might be causing their symptoms, which range from joint pain, debilitating fatigue and inflammation.
A team of researches reports that - the team report that they hit - they've hit on something. Out of 101 people diagnosed with chronic fatigue, 67 percent of them had a specific virus in their blood: a virus called XMRV. And just four percent, or so, of healthy volunteers had the virus in their blood. Scientists have known about the virus for a while. It's been implicated in other diseases.
Joining me now to talk more about this work, published in the journal Science, is John Coffin, professor of molecular biology and microbiology at Tufts University in Boston.
Welcome to SCIENCE FRIDAY, Dr. Coffin.
Dr. JOHN COFFIN (Professor of molecular biology and microbiology, Tufts University, Boston): Good afternoon, Ira. Thank you.
FLATOW: So, this is a pretty good indication, a pretty good connection?
Dr. COFFIN: For a first report, it's very good, in fact. There's still a lot of work to be done, to firmly establish a causal relationship between the virus and the disease. But it's a very, very interesting first step.
FLATOW: Well, this would also vindicate a lot of people who have chronic fatigue syndrome who have, you know, been abused by people who think it's all in your head, you've got something else, it's just a syndrome, there's no real cause to it. Things like that.
Dr. COFFIN: I would imagine that's the case, yes.
FLATOW: Mm-hmm. And so how did you go about - what was your motivation for looking for this viral connection?
Dr. COFFIN: I have to make one thing very clear right here. The work we're discussing was not mine. It was done by other groups. I'm a very interested observer and chronicler of their work. And I had worked on this virus many years ago when we thought it was just a mouse virus.
The people that did work on it, ...
World Pneumonia Day, November 2, 2009
CDC.gov: Announcement: World Pneumonia Day --- November 2, 2009
In the United States, seven-valent pneumococcal conjugate and Hib vaccines are recommended for infants and children aged <2, the first World Pneumonia Day, November 2, 2009, is being promoted by a coalition of 40 major health, humanitarian relief, advocacy, faith-based, government, and other organizations; CDC and UNICEF are providing technical assistance. Events are scheduled at CDC and
elsewhere in the United States, and in other countries. Additional information is available at http://worldpneumoniaday.org.
In the United States, seven-valent pneumococcal conjugate and Hib vaccines are recommended for infants and children aged <2, the first World Pneumonia Day, November 2, 2009, is being promoted by a coalition of 40 major health, humanitarian relief, advocacy, faith-based, government, and other organizations; CDC and UNICEF are providing technical assistance. Events are scheduled at CDC and
elsewhere in the United States, and in other countries. Additional information is available at http://worldpneumoniaday.org.
Hemispherx Biopharma Updates Chronic Fatigue Syndrome (CFS) Treatment and Commercial...
Reuters Mon Nov 2, 2009 8:46am EST
PHILADELPHIA, Nov. 2, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE
Amex:HEB) (the "Company"), announced a two-prong CFS clinical mission for November and December 2009.
The Company plans to widen its ongoing clinical programs in CFS by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome (please see October 8, 2009, online issue of Science). A clinically validated test to detect retrovirus antibodies in patients plasma is also currently under development
(please see US National Institutes of Health at:
http://www.cancer.gov/newscenter/pressreleases/CFSxmrv). With the consortium of
researchers at the Whittemore Peterson Institute, the Company is also now evaluating the defect in immunosurveillance in specific subsets of CFS patients in a clinical study entitled "Therapeutic Activation of NK lymphocytes to Alleviate Chronic Fatigue Syndrome." These immune defects may be due to the previously undetected retrovirus.
The Company also plans to complete all outstanding queries from the FDA regarding its New Drug Application (NDA) for Ampligen(R), an experimental therapeutic, during November and December, 2009. On May 26, 2009, the Company announced a delay on the Ampligen NDA which, at the time, had a PDUFA date of May 25, 2009. As noted in the 10-Q and 10-K filings at the time, the FDA did not request additional information from the Company at that time.
However, several outstanding NDA items, requiring Hemispherx responses, existed at the time of the FDA delay as noted in the August 8, 2009, 10Q filing. Between March 9, 2009
and September 15, 2009, the Company issued six (6) new reports to the Agency spanning various subjects including a) clinical safety assessments, b) specialized pre-clinical toxicology reports, and c) abbreviated chemistry and manufacturing control reports. The Company believes that these reports may fully retire all Agency queries in these particular areas.
The Company also plans to submit four (4) additional reports on interrelated topics in November and December, 2009, which will include pharmacokinetic analyses in multiple lower animal species (primates, rodents, etc.) ("the Lovelace Laboratory Studies") and final validation reports of certain manufacturing procedures conducted at an independent facility, Hollister-Stier
Laboratories in Spokane, WA. Some of these reports were recently cited in
BioMedReports.com and the Science Business Exchange (October 15, 2009).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders
of the immune system. Hemispherx's platform technology includes large and small
agent components for potential treatment of various severely debilitating and
life threatening diseases. Hemispherx has in excess of 50 patents comprising its
core intellectual property estate and a fully commercialized product (Alferon N
Injection(R)). The Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial products. For more
information please visit www.hemispherx.net.
About Whittemore Peterson Institute
The Whittemore Peterson Institute for Neuro Immune Disease exists to bring
discovery, knowledge, and effective treatments to patients with illnesses that
are caused by acquired dysregulation of both the immune system and the nervous
system, often resulting in lifelong disease and disability. www.wpinstitute.org.
Information contained in this news release other than historical information,
should be considered forward-looking and is subject to various risk factors and
uncertainties. For instance, the strategies and operations of Hemispherx involve
risk of competition, changing market conditions, change in laws and regulations
affecting these industries and numerous other factors discussed in this release
and in the Company's filings with the Securities and Exchange Commission.
Any specifically referenced investigational drugs and associated technologies of the
Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental
in nature and as such are not designated safe and effective by a regulatory
authority for general use and are legally available only through clinical trials
with the referenced disorders. The forward-looking statements represent the
Company's judgment as of the date of this release. The Company disclaims,
however, any intent or obligation to update these forward-looking statements.
Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
-0-
CONTACT: Hemispherx Biopharma, Inc.
Dianne Will
518-398-6222
ir@hemispherx.net
PHILADELPHIA, Nov. 2, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE
Amex:HEB) (the "Company"), announced a two-prong CFS clinical mission for November and December 2009.
The Company plans to widen its ongoing clinical programs in CFS by accelerating collaborations with a consortium of researchers who have just discovered a retroviral link to Chronic Fatigue Syndrome (please see October 8, 2009, online issue of Science). A clinically validated test to detect retrovirus antibodies in patients plasma is also currently under development
(please see US National Institutes of Health at:
http://www.cancer.gov/newscenter/pressreleases/CFSxmrv). With the consortium of
researchers at the Whittemore Peterson Institute, the Company is also now evaluating the defect in immunosurveillance in specific subsets of CFS patients in a clinical study entitled "Therapeutic Activation of NK lymphocytes to Alleviate Chronic Fatigue Syndrome." These immune defects may be due to the previously undetected retrovirus.
The Company also plans to complete all outstanding queries from the FDA regarding its New Drug Application (NDA) for Ampligen(R), an experimental therapeutic, during November and December, 2009. On May 26, 2009, the Company announced a delay on the Ampligen NDA which, at the time, had a PDUFA date of May 25, 2009. As noted in the 10-Q and 10-K filings at the time, the FDA did not request additional information from the Company at that time.
However, several outstanding NDA items, requiring Hemispherx responses, existed at the time of the FDA delay as noted in the August 8, 2009, 10Q filing. Between March 9, 2009
and September 15, 2009, the Company issued six (6) new reports to the Agency spanning various subjects including a) clinical safety assessments, b) specialized pre-clinical toxicology reports, and c) abbreviated chemistry and manufacturing control reports. The Company believes that these reports may fully retire all Agency queries in these particular areas.
The Company also plans to submit four (4) additional reports on interrelated topics in November and December, 2009, which will include pharmacokinetic analyses in multiple lower animal species (primates, rodents, etc.) ("the Lovelace Laboratory Studies") and final validation reports of certain manufacturing procedures conducted at an independent facility, Hollister-Stier
Laboratories in Spokane, WA. Some of these reports were recently cited in
BioMedReports.com and the Science Business Exchange (October 15, 2009).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders
of the immune system. Hemispherx's platform technology includes large and small
agent components for potential treatment of various severely debilitating and
life threatening diseases. Hemispherx has in excess of 50 patents comprising its
core intellectual property estate and a fully commercialized product (Alferon N
Injection(R)). The Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial products. For more
information please visit www.hemispherx.net.
About Whittemore Peterson Institute
The Whittemore Peterson Institute for Neuro Immune Disease exists to bring
discovery, knowledge, and effective treatments to patients with illnesses that
are caused by acquired dysregulation of both the immune system and the nervous
system, often resulting in lifelong disease and disability. www.wpinstitute.org.
Information contained in this news release other than historical information,
should be considered forward-looking and is subject to various risk factors and
uncertainties. For instance, the strategies and operations of Hemispherx involve
risk of competition, changing market conditions, change in laws and regulations
affecting these industries and numerous other factors discussed in this release
and in the Company's filings with the Securities and Exchange Commission.
Any specifically referenced investigational drugs and associated technologies of the
Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental
in nature and as such are not designated safe and effective by a regulatory
authority for general use and are legally available only through clinical trials
with the referenced disorders. The forward-looking statements represent the
Company's judgment as of the date of this release. The Company disclaims,
however, any intent or obligation to update these forward-looking statements.
Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
-0-
CONTACT: Hemispherx Biopharma, Inc.
Dianne Will
518-398-6222
ir@hemispherx.net
Monday, November 2, 2009
Sunday, November 1, 2009
Medical breakthrough puts Reno in spotlight
By Lenita Powers • lpowers@rgj.com • November 1, 2009
Judy Mikovits remembers that "eureka" moment when she realized that she and her team of researchers at the Whittemore-Peterson Institute in Reno had discovered a new retrovirus that could lead to a possible treatment, even a vaccine, to combat Chronic Fatigue Syndrome.
"It was January 22, and we were in a San Diego restaurant called the Yard House," said Mikovits, who had gone there with fellow scientist Vincent Lombardi to present the results of their research to Frank Ruscetti and Robert Silverman, two of the world's leading virologists.
"We kept waiting for them to say something," Mikovits said. "I was nauseous. Bob (Silverman) waited a long a time, and then he looked up and said, 'Well, this is going to change their world.'"
The institute's finding also ...
Judy Mikovits remembers that "eureka" moment when she realized that she and her team of researchers at the Whittemore-Peterson Institute in Reno had discovered a new retrovirus that could lead to a possible treatment, even a vaccine, to combat Chronic Fatigue Syndrome.
"It was January 22, and we were in a San Diego restaurant called the Yard House," said Mikovits, who had gone there with fellow scientist Vincent Lombardi to present the results of their research to Frank Ruscetti and Robert Silverman, two of the world's leading virologists.
"We kept waiting for them to say something," Mikovits said. "I was nauseous. Bob (Silverman) waited a long a time, and then he looked up and said, 'Well, this is going to change their world.'"
And it has.
The research resulted in a paper that was published last month in a prestigious scientific journal, which set off a flurry of media coverage that put the Whittemore-Peterson Institute and Reno's name in reports from the New York Times, the Wall Street Journal and the BBC.The institute's finding also ...
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