Friday, December 19, 2014
"38 The Oxford criteria (published in the Journal of the Royal 39 Society of Medicine in February 1991) are flawed and include people with other conditions, 40 confounding the ability to interpret the science." "378 Specifically, continuing to use the Oxford definition may impair progress and cause 379 harm. Thus, for needed progress to occur we recommend (1) that the Oxford definition be 380 retired" SOURCE: https://prevention.nih.gov/docs/programs/mecfs/ODP-MECFS-DraftReport.pdf
Tuesday, December 16, 2014
- See more at: http://globenewswire.com/news-release/2014/12/09/689822/10111624/en/Hemispherx-Announces-Data-Showing-Inhibition-of-Ebola-by-Ampligen-R-Enlarged-by-Howard-University-Research.html#sthash.cbim3z1y.dpuf
PHILADELPHIA, Dec. 9, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced today that it has received a new research report (dated December 5, 2014) from researchers at Howard University, Washington DC. The report describes a study in which Ampligen® (Poly I : Poly C12U) strongly inhibited the Ebola minigenome in the human embryonic kidney cell system. The Ebola minigenome replication system was recently described by the researchers in the Journal of Biological Chemistry (2014) (Role of Protein Phosphatase 1 in Dephosphorylation of Ebola Virus VP30 Protein and Its Targeting for the Inhibition of Viral Transcription; Ilinykh et al. 289(33):22723-22738). In the minigenome replication system, certain genetic information for viral proteins has been deleted from the genomic array to permit safer and more efficient laboratory manipulations.
Most importantly, the current Howard University results taken in conjunction with previous data on anti-Ebola actions of Ampligen® reported by other US and European collaborators, indicate that the antiviral molecular actions of Ampligen® may be triggered at levels reached by the common human treatment regimens of Ampligen which have historically been used in clinical studies in a variety of other human diseases. These regimens of Ampligen®, an experimental therapeutic, have been deployed to date over 100,000 times in over 1,000 patients. Today's report also extends the histologic range of human cell types in which Ampligen® has demonstrated strong bioactivity against Ebola at low drug concentrations. Ebola is known to multiply in many different parts of the body destroying multiple types of cells, leading to high morbidity and mortality rates.
Recent articles in New England Journal of Medicine (November 27, 2014) emphasize that in subsets of severely ill EVD patients, parenteral therapy, rather than oral based treatments, will be necessary. Ampligen®, an experimental therapeutic, may be able to meet this requirement.
Previously, the Department of Life and Environmental Sciences, University of Cagliari, Italy reported that Ampligen® can successfully bind to the lethal EVD viral protein designated VP35. VP35 protein normally inactivates a patient's immune/antiviral system by binding to viral dsRNA thereby sequestering a critical antiviral/immune activator of the body which leads to high morbidity and death rates. The experimental outcome achieved by the Cagliari University is consistent with recent predictions published in the Nature group Emerging Microbes and Infections (3, e77; doi:10.1038/emi.2014.77; published online 29 October 2014) by affiliates of Hemispherx.
Another recent US government research report observed that the inhibiting concentration (EC50) of Ampligen® for Ebola was very low relative to the Ampligen® serum levels achievable in humans (See November 3, 2014 press release entitled Hemispherx Biopharma and United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Collaborate on Alferon® and Ampligen® Against the Ebola Virus… Initial Ebola Studies of Alferon® and Ampligen® at USAMRIID Show Protective Activity of Both Compounds at Low Concentrationshttp://www.hemispherx.net/content/investor/default.asp?goto=805 ). Together, the three recent reports by Howard University, University of Cagliari, and USAMRIID scientists set the stage for accelerated clinical development of Ampligen® for prevention and treatment of EVD.
Our overall objectives include plans to continue seeking approval for commercialization of Ampligen® in the United States and abroad as well as to widen existing commercial therapeutic indications of Alferon® N Injection® presently approved in the United States and Argentina. In addition, we have formed collaborations with multiple research laboratories around the world to examine Ampligen®, an experimental therapeutic, and Alferon® N, an FDA-approved commercial product as potential preventatives for, and treatments of, Ebola Virus Disease.
About Alferon® N
Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age, or older. Positive results against Ebola in vitro have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Clinical trial data will be necessary to establish human efficacy of Alferon® N for Ebola virus.
Ampligen®, an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation. Ebola virus specifically inhibits the dsRNA within cells via a sequestration process. Such RNA would otherwise cause a robust antiviral response to be mounted: Ampligen may be able to overcome this deficiency in host response. Positive results against Ebola in vitro have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and other research/academic institutions. Clinical trial data will be necessary to establish human efficacy of Ampligen® for Ebola viruses.
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 especially life-threatening viruses. Hemispherx's flagship products include Alferon® N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases including cancers. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon® N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon® N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon") for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. Most newer regimens for creating apparent "cures" in chronic active hepatitis C disease require interferon as a vital component of a successful treatment regimen. 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.
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The production of new Alferon® API inventory will not commence until validation phases are complete. While the facility is approved by FDA under the Biological License Application ("BLA") for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries.
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, changes 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. The final results of these efforts could vary materially from Hemispherx's expectations.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "plans," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that Alferon® N, Alferon® LDO and/or Ampligen will ever be commercially approved for the new potential treatment indications mentioned in this release.
Company/Investor Contact Charles Jones CJones & Associates Public Relations Office: 888-557-6480 Cell: 305-987-7418 Email:
Saturday, December 13, 2014
Tuesday, December 9, 2014
Friday, December 5, 2014
By Jenny Hope, Medical Correspondent for the Daily Mail:
PUBLISHED: 18:23 GMT, 10 November 2014 | UPDATED: 18:25 GMT, 10 November 2014
People with mental health problems are victims of a ‘scam’ therapy that is wasting vast sums of money, a leading psychologist has warned.
They are being misled because the short-term fix offered by Cognitive Behavioural Therapy (CBT) does not have a lasting benefit, says Oliver James.
The most popular of the ‘talking therapies’ CBT aims to help people manage their problems by changing the way they think and behave to become more positive.
It is frequently recommended for people with problems ranging from anxiety and depression to eating disorders.
In the short-term, 40 per cent of those who complete a course of CBT, typically five to 20 sessions of up to an hour, are said to have recovered.
But ‘extensive evidence’ shows that two years on, depressed or anxious people who had CBT were no more likely to have recovered than those who had no treatment, said Mr James.
He said: ‘As a treatment, rafts of studies have shown it to be ineffective in delivering long-term therapeutic benefits to patients with anxiety and depression.
‘While studies show that in the short-term - six to 12 months - patients who have received CBT are more likely to report themselves as ‘recovered’ compared to those who have received no treatment, these results are not sustained in the long-term.
‘CBT is largely ineffective for the majority of patients. It is in essence a form of mental hygiene.
‘However filthy the kitchen floor of your mind, CBT soon covers it with a thin veneer of ‘positive polish’.
Unfortunately, shiny services tend not to last. CBT fails to address the root cause of many people’s problems, which often stem from traumatic experiences during their childhood.
The UK Government has pledged up to £400 million on treatment programmes which mostly use CBT and it is recommended as frontline NHS treatment for many mental health issues.
Mr James, a chartered psychologist, author and broadcaster, delivered his argument to the CBT industry at the Limbus Critical Psychotherapy Conference in Devon this weekend.
WHAT IS CBT?
He and other psychotherapists are calling on the Government and policymakers to refocus funding into alternative talking treatments, such as psychodynamic therapy, which focus on addressing the root cause of people’s cognitive problems.
The NHS has been advised that CBT may be offered to patients with a range of conditions by the National Institute for Health and Clinical Excellence (NICE), the guideline body.
It is free on the NHS after referral by a GP but not available in all areas and there can be long waiting lists.
The cost of private therapy sessions varies, but it is usually £40 - £100 a session.
Many mental health groups welcome the shift in emphasis in recent years away from medication towards personalised therapy.
But Mr James says research shows CBT is no more effective than placebo in treating anxiety or depression
He says proponents have ‘mis-sold’ the treatment to policymakers and the public, who are wasting their time.
Friday, November 28, 2014
Thursday, November 27, 2014
Wednesday, November 26, 2014
Tuesday, November 25, 2014
"Also, please note that we have no further information to share on Karina's current condition, as no one from the family has seen her for over a year." Justice for Karina Hansen, October 8 at 5:55pm 2014. @ https://www.facebook.com/story.php?story_fbid=885102518176124&id=100000291531400&comment_id=887044924648550&offset=0&total_comments=24¬if_t=share_comment&ref=m_notif&refid=48#!/story.php?story_fbid=774252402636219&id=521548841239911 no one from the family has been ALLOWED to see Karina for over a year in a western european country, ABSOLUTELY DISGRACEGUL !!!
Monday, November 24, 2014
sounds like more psycho crap. Those drs need to be tried at the Hague for crimes against humanity. doing jail time with the lifers!!! where is amnesty ???
Friday, November 21, 2014
Wednesday, November 19, 2014
What gets me down about having severe M.E... Its not the poverty or the loneliness or the total sleep disruption -all or nothing- 0r even the loss of my previous life as a qualified dental nurse that gets me down, nor the fact I was a talented painter attnding uni for my "B.A. Hons.fine art history and practice" with a view to teaching, (but now due to loss of spatial judgement I can't even draw, and can't read books now due to cognitive dysfunction). And its not that I miss my weekly horse riding hacks or the regular long walks I loved (beach, forest, mountain) or being unable to communicate verbally, nor my severely restricted diet (without which I am faecally incontinent,) it is not being house and bedbound for many years now, Nor that I can't use my wheelchair any more to "walk" my own dog, Nor the constant muscle and joint pain, Its not even the severe cognitive dysfunction and endless headaches, it isn't the total isolation of being confined to one darkened room. IT IS the total loss of my credibility and complete lack of support directly resulting from the ubiquitous disbelief that has been deliberately generated by political machinations of rich healthy Psychiatrists blithely working outside their field for financial gain (i.e. M.E. is Neurological thus totally not their Dept) . Excuse my spelling, I have M.E. x by Sally Katch1na.
Sunday, November 16, 2014
Many of us were pushed into severe disability by graded exercise. The last thing we need is yet more psychobabble.See also: GET (graded exercise therapy) is torture for ME patients and directly contravenes the do NO Harm principle of the GMC