正文
CVM potential is the sky limit. current vaccine is not safe and cvm seems the only back up currently in addition to its only treatment available for the Swine flu patient.. and not even mention its cancer drug.. I believe the price will increase before 10/7.
September 29, 2009 10:58:27 AM EDT
Government scrambling to search for answers to swine flu pandemic
Pablo Y Romanus, M.D.September 28, 2009
The fact that schools, universities and other places where large groups gather are starting to report a record numbers of absence rates tells us that the H1N1 pandemic has officially arrived here, early.
This would be comparable to what we would see in a moderate flu season in January or February, says Mark Springer, the Spokane Regional Health District\'s epidemiologist. This is just a snapshot in time. We would anticipate increases.
According to a special report in Friday\'s Time Magazine, across the country, the pattern is much the same. This year\'s novel flu virus is hitting much sooner than normal, long before cold weather forces people inside, where viruses like to fester, and weeks before the official start of flu season on Oct. 4. The virus has been gobbling geographic terrain in recent weeks, with 26 states reporting widespread flu illness on Sept. 19, up from 21 states a week earlier and just four states at the beginning of August. On the CDC\'s website, one can find a flu situation update that provides several research indicators that point out the same thing in alarming fashion.
As Director for the Health Research Group my job is to bring critical information about health issues to constituents, an the public in general, with to keep them up-to-date with information so they can make better health care decisions.
I\'m here to tell you that the planning and hard work of a few of the government entities whose activities I track and with whom I have directly worked under in the past are starting to pay off. The people who were in charge and ill-planned responses to natural catastrophes like Katrina are no longer running the show.
Still, it doesn\'t mean that a very real threat to the nation\'s health and economy do not exist.
According to a report in Time Magazine on Friday, the Centers for Disease Control and Prevention, visits to doctors for influenza-like illness (ILI) are increasing nationally and have increased for six consecutive weeks now.
Flu season is definitely here, says Dr. Anne Schuchat, a CDC assistant surgeon general who is helping to coordinate the response. We don\'t know when it is going to peak or how many waves there will be.
But the magazine says Schuchat and other government officials are getting closer to putting a better solution in place.
I would like to confirm this to our readers.
Officials from the Food And Drug Administration, under the guidance of the Obama administration and the department of Health and Human Services have been actively reaching out to the medical research community in an effort to keep tabs on various development efforts that may help the country deal with the H1N1 pandemic. As some of you may know, the legal ability for the FDA to approve unlicensed vaccines and drugs whenever a national public health emergency has been declared was given to the FDA by Congress under an Emergency Use Authorization, or EUA, provision included in 2004 Project Bioshield.
The outreach has been impressive and the planning among government groups at the federal, state and local levels has been increasing well ahead of schedule. Still, it remains to be seen whether this will be enough.
Under one program, FDA officials were recently presented with several treatments which might be made available to those who have already been infected with the virulent strain of the Swine Flu that is causing emergency rooms to overflow long before flu season has hit it\'s stride here in the U.S.
FDA staff were presented with a number of novel drugs and medical devices that might make a difference the battle against H1N1 and which might be considered for Emergency Use Authorization.
So far only one proposed treatment has met the stringent safety and efficacy requirements to be fast tracked into human studies. That treatment was being developed by Virginia based, Cel-Sci Corporation and is based on their Ligand Epitope Antigen Presentation System. Animal study results and technology data were compelling enough to make the FDA grant the company overnight approval to move directly into human trials of the treatment. The novel T-cell modulation platform enables Cel-Sci to design and synthesize proprietary immunogens and provides the ability to preferentially direct the immune system. The technology was considered a major breakthrough it was presented to a prestigious group of scientists from academia, bio-tech, large pharmaceutical companies and the FDA in 1995, but it has taken years of patient research to develop the approach to this point. Last week, the company hired a full-service Clinical Research Organization (CRO) with an office in the Washington, D.C./Baltimore area to support its research and report findings as quickly as possible to the FDA.
Other treatments which were presented, but did not yet make it to the next round included:
DAS181 or Fludase developed by NanoViricides, Inc. is headed back to for more testing, this time with Southern Research, a company registered with the CDC that stores several dangerous pathogens, including the current novel Influenza A/California/4/2009 H1N1 isolate (swine flu) from the Centers for Disease Control (CDC).
We maximize the likelihood of having a successful drug by advancing several candidates through the pipeline for each of our programs, said Eugene Seymour, MD, MPH, CEO of the Company.
The danger of aiming for the host could be increased side effects. Molecules in the body are not there just to serve as doorways for viruses. They usually have some function, which could be disrupted by a drug. The sugar to which the flu virus attaches, called sialic acid, has various functions in the immune system and in metabolism.
BioCryst Pharmaceuticals of Birmingham, Ala., which is developing Peramivir with federal financing, is still planning a clinical trial of hospitalized patients to seek regulatory approval. Peramivir is a drug that works the same way as Tamiflu and Relenza but is given intravenously.
Dr. Frederick G. Hayden, a virologist at the University of Virginia, said intravenous administration gives a high concentration in the plasma rapidly and makes a lot of sense. But he said peramivir did not appear to work that well against infections resistant to Tamiflu.
Most antiviral drugs aim at the virus — trying, for instance, to disable an enzyme produced by the pathogen. NexBio, a small San Diego company, has developed a drug that breaks down the sugar on human respiratory cells that acts as the flu virus′s landing pad. This makes it harder for the virus to attach to and infect the cells. The advantage of blocking a human molecule is that it does not usually mutate. The danger of aiming for the host could be increased side effects. Molecules in the body are not there just to serve as doorways for viruses. They usually have some function, which could be disrupted by a drug. The sugar to which the flu virus attaches, called sialic acid, has various functions in the immune system and in metabolism.
Energex Systems Inc. notified the FDA of its interest in applying for an Emergency Use Approval to offer its HemoModulation therapy for the treatment of type A, H1N1. According to the company, HemoModulation therapy has been shown to inactivate the virus in mice. HemoModulation is a process using UVC energy to inactivate the particular strain of virus that the patient is infected with, and returning it to the body. The hypothesis is that UV inactivated virus will serve as an autologous vaccine and boost the immune system of the patient against their particular strain of virus. The process could be administered in any healthcare facility. This same therapy had been under review by the FDA and is in human clinical trials for Hepatitis C and HIV.
Just last month, the Food and Drug Administration issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas. Tamiflu and Relenza are two well known drugs that were also expedited through the medical trials process and granted Emergency Use Authorization by the government.
In a situation like this one where a known medical need can not be met any other way, the agency is looking to expedite a medical product through their regulatory process. There are not time lines or schedules when a process like this one is underway. Safety and efficacy are the measuring sticks and it looks like the government is acting very responsibly to respond to the situation as quickly, yet responsibly as possible.
Dr. Pablo Romanus, M.D. contracts as an analyst for the Health Research Group at Public Citizen, a government watchdog group in Washington, D.C.
September 29, 2009 10:58:27 AM EDT
Government scrambling to search for answers to swine flu pandemic
Pablo Y Romanus, M.D.September 28, 2009
The fact that schools, universities and other places where large groups gather are starting to report a record numbers of absence rates tells us that the H1N1 pandemic has officially arrived here, early.
This would be comparable to what we would see in a moderate flu season in January or February, says Mark Springer, the Spokane Regional Health District\'s epidemiologist. This is just a snapshot in time. We would anticipate increases.
According to a special report in Friday\'s Time Magazine, across the country, the pattern is much the same. This year\'s novel flu virus is hitting much sooner than normal, long before cold weather forces people inside, where viruses like to fester, and weeks before the official start of flu season on Oct. 4. The virus has been gobbling geographic terrain in recent weeks, with 26 states reporting widespread flu illness on Sept. 19, up from 21 states a week earlier and just four states at the beginning of August. On the CDC\'s website, one can find a flu situation update that provides several research indicators that point out the same thing in alarming fashion.
As Director for the Health Research Group my job is to bring critical information about health issues to constituents, an the public in general, with to keep them up-to-date with information so they can make better health care decisions.
I\'m here to tell you that the planning and hard work of a few of the government entities whose activities I track and with whom I have directly worked under in the past are starting to pay off. The people who were in charge and ill-planned responses to natural catastrophes like Katrina are no longer running the show.
Still, it doesn\'t mean that a very real threat to the nation\'s health and economy do not exist.
According to a report in Time Magazine on Friday, the Centers for Disease Control and Prevention, visits to doctors for influenza-like illness (ILI) are increasing nationally and have increased for six consecutive weeks now.
Flu season is definitely here, says Dr. Anne Schuchat, a CDC assistant surgeon general who is helping to coordinate the response. We don\'t know when it is going to peak or how many waves there will be.
But the magazine says Schuchat and other government officials are getting closer to putting a better solution in place.
I would like to confirm this to our readers.
Officials from the Food And Drug Administration, under the guidance of the Obama administration and the department of Health and Human Services have been actively reaching out to the medical research community in an effort to keep tabs on various development efforts that may help the country deal with the H1N1 pandemic. As some of you may know, the legal ability for the FDA to approve unlicensed vaccines and drugs whenever a national public health emergency has been declared was given to the FDA by Congress under an Emergency Use Authorization, or EUA, provision included in 2004 Project Bioshield.
The outreach has been impressive and the planning among government groups at the federal, state and local levels has been increasing well ahead of schedule. Still, it remains to be seen whether this will be enough.
Under one program, FDA officials were recently presented with several treatments which might be made available to those who have already been infected with the virulent strain of the Swine Flu that is causing emergency rooms to overflow long before flu season has hit it\'s stride here in the U.S.
FDA staff were presented with a number of novel drugs and medical devices that might make a difference the battle against H1N1 and which might be considered for Emergency Use Authorization.
So far only one proposed treatment has met the stringent safety and efficacy requirements to be fast tracked into human studies. That treatment was being developed by Virginia based, Cel-Sci Corporation and is based on their Ligand Epitope Antigen Presentation System. Animal study results and technology data were compelling enough to make the FDA grant the company overnight approval to move directly into human trials of the treatment. The novel T-cell modulation platform enables Cel-Sci to design and synthesize proprietary immunogens and provides the ability to preferentially direct the immune system. The technology was considered a major breakthrough it was presented to a prestigious group of scientists from academia, bio-tech, large pharmaceutical companies and the FDA in 1995, but it has taken years of patient research to develop the approach to this point. Last week, the company hired a full-service Clinical Research Organization (CRO) with an office in the Washington, D.C./Baltimore area to support its research and report findings as quickly as possible to the FDA.
Other treatments which were presented, but did not yet make it to the next round included:
DAS181 or Fludase developed by NanoViricides, Inc. is headed back to for more testing, this time with Southern Research, a company registered with the CDC that stores several dangerous pathogens, including the current novel Influenza A/California/4/2009 H1N1 isolate (swine flu) from the Centers for Disease Control (CDC).
We maximize the likelihood of having a successful drug by advancing several candidates through the pipeline for each of our programs, said Eugene Seymour, MD, MPH, CEO of the Company.
The danger of aiming for the host could be increased side effects. Molecules in the body are not there just to serve as doorways for viruses. They usually have some function, which could be disrupted by a drug. The sugar to which the flu virus attaches, called sialic acid, has various functions in the immune system and in metabolism.
BioCryst Pharmaceuticals of Birmingham, Ala., which is developing Peramivir with federal financing, is still planning a clinical trial of hospitalized patients to seek regulatory approval. Peramivir is a drug that works the same way as Tamiflu and Relenza but is given intravenously.
Dr. Frederick G. Hayden, a virologist at the University of Virginia, said intravenous administration gives a high concentration in the plasma rapidly and makes a lot of sense. But he said peramivir did not appear to work that well against infections resistant to Tamiflu.
Most antiviral drugs aim at the virus — trying, for instance, to disable an enzyme produced by the pathogen. NexBio, a small San Diego company, has developed a drug that breaks down the sugar on human respiratory cells that acts as the flu virus′s landing pad. This makes it harder for the virus to attach to and infect the cells. The advantage of blocking a human molecule is that it does not usually mutate. The danger of aiming for the host could be increased side effects. Molecules in the body are not there just to serve as doorways for viruses. They usually have some function, which could be disrupted by a drug. The sugar to which the flu virus attaches, called sialic acid, has various functions in the immune system and in metabolism.
Energex Systems Inc. notified the FDA of its interest in applying for an Emergency Use Approval to offer its HemoModulation therapy for the treatment of type A, H1N1. According to the company, HemoModulation therapy has been shown to inactivate the virus in mice. HemoModulation is a process using UVC energy to inactivate the particular strain of virus that the patient is infected with, and returning it to the body. The hypothesis is that UV inactivated virus will serve as an autologous vaccine and boost the immune system of the patient against their particular strain of virus. The process could be administered in any healthcare facility. This same therapy had been under review by the FDA and is in human clinical trials for Hepatitis C and HIV.
Just last month, the Food and Drug Administration issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas. Tamiflu and Relenza are two well known drugs that were also expedited through the medical trials process and granted Emergency Use Authorization by the government.
In a situation like this one where a known medical need can not be met any other way, the agency is looking to expedite a medical product through their regulatory process. There are not time lines or schedules when a process like this one is underway. Safety and efficacy are the measuring sticks and it looks like the government is acting very responsibly to respond to the situation as quickly, yet responsibly as possible.
Dr. Pablo Romanus, M.D. contracts as an analyst for the Health Research Group at Public Citizen, a government watchdog group in Washington, D.C.
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