Guest guest Posted October 10, 2009 Report Share Posted October 10, 2009 Jane, The clinical trials leading up to FDA approval is almost always done by the developing pharmaceutical companies. They're the ones that have the millions of dollars necessary to do the studies. My wife has conducted numerous such trials in-house, the latest one being the lactoferrin study done in Peru. There are ethical review committees in every study, and they generally have advisors who are prominent scientists and researchers in academia who review and make recommendations. The data are reviewed by independent committees, and the process of getting approval is rigorous. As far as mandating immunizations, for years every child had to show a smallpox vaccination scar in order to be admitted to school in the first grade. That's how we wiped out smallpox. My understanding of the H1N1 vaccine is that the carrier is the same as has been used for years in other flu vaccines. Most of the objections have arisen over what's in the carrier. The 1976 " scare " has not been borne out since then. The figures I have been able to turn up show an increase in GBS of approximately 1 in 1 million persons since this vaccine came out. There is a risk/benefit to every medicine and vaccine. I am in favor of maximum personal freedom, but that also includes freedom from epidemics caused by people who spread disease. Government also has the power to quarantine those who develop certain communicable diseases. If you have MDR TB, you can be locked up, as was the guy who flew home from Europe with it. Here's what the CDC says about the flu vaccine and GBS: " In 1976, there was a small risk of GBS following influenza (swine flu) vaccination (approximately 1 additional case per 100,000 people who received the swine flu vaccine). That number of GBS cases was slightly higher than what is normally seen in the population, whether or not people were vaccinated. Since then, numerous studies have been done to evaluate if other flu vaccines were associated with GBS. In most studies, no association was found, but two studies suggested that approximately 1 additional person out of 1 million vaccinated people may be at risk for GBS associated with the seasonal influenza vaccine. FDA and CDC will be closely monitoring reports of serious problems following the 2009 H1N1 influenza vaccines, including GBS. " One study found 41,600 deaths per year from flu from 1979 to 2001. http://aje.oxfordjournals.org/cgi/content/full/163/2/181 The Wrong Diagnosis cite lists the number of annual deaths from influenza at 63,729, or 1 in 7 deaths. GBS affects about 1 in 100,000 people, and the death rate is 1-2% of that number in the U.S. and about 3-4% in the world according to numerous sources I read in Google. Given the world's estimated population, there would be 6,706 cases of GBS worldwide. If the mortality rate is 4%, there would be 268 deaths per year from GBS worldwide vs. 41,600 or 63,729 from flu, depending upon whose figures one accepts. At any rate, the morbidity from GBS is a fraction of that of flu, and since GBS is known to be caused by a number of things, the number of cases that might be attributable to H1N1 vaccine is minute. Everybody should make his own decision about taking the vaccine or not, but it should be based on all the facts available. Much has been made about the fact that the circular that goes with the vaccine lists GBS as a possible side effect. What the hysteria-mongers do not say is that it's just one thing in a very long list of possible side effects. Read the aspirin circular and compare. Nuff said. A few minutes with Google will give one plenty of information on which to make a decision. GG > > The sad part about this is that from what I have gathered so far, flu > vaccine research is usually done by the pharmaceutical companies who design the > vaccines to begin with, including the H1N1 vaccine.... Unless someone can > produce some solid info on here (Dr. Bledsoe ?) about solid, verifiable > and reproducable research on this subject by bipartisan companies OTHER than > the manufacturing company, who knows how valid ANY of that research really > is........ Kind of like having the wolf guarding the henhouse. > > > > Jane Dinsmore > > > > To: texasems-l > From: summedic@... > Date: Sat, 10 Oct 2009 09:14:35 -0500 > Subject: RE: NEW YORK STATE – DEPARTMENT OF HEALTH - > INTEROFFICE MEMORANDUM > >  > > > > Can anyone tell me if there is a research study involving Guillian Barre > syndrome as it pertains to vaccinations such as these for the flu? > > Health Care Personnel Influenza Vaccination Requirements > > DATE: October 7, 2009 > > There remains some confusion and concern among EMS Providers and Agencies > regarding the applicability of the recent changes to Part 66 regulations > regarding Health Care Personnel Influenza Vaccination Requirements and how > they apply to EMS. The Bureau of EMS requested a clarification of this > health care regulation as it applies to EMS agencies. The following is a > summary > of the response provided by the Department of Health’s Division of Legal > Affairs which we hope will clarify some of these questions. > > 1. Are EMS personnel mandated to receive flu vaccination under the > recently enacted healthcare facility regulations? > > EMS personnel who are employed by a hospital-owned ambulance service or > ALS first response service must be vaccinated for the flu. > > EMS agencies that have a contract with a healthcare facility to provide > transport of patients are mandated to have their employees who provide > these > transports vaccinated. (Contracted EMS Agencies are encouraged to review > their staffing practices as it relates to the conditions of these > contracts > and requirements of this regulation). > > EMS services that respond in the 9-1-1 system and do not have a > contractual relationship with a healthcare facility as described above are > not > required to be vaccinated. They are strongly encouraged to be vaccinated. > > 2. Will the mandate include H1N1 Vaccine? > > Yes. As soon as H1N1 vaccine is made available, EMS personnel and agencies > that fit the criteria in Question One will be mandated to have H1N1 > vaccination. They are also required to have the regular seasonal flu > vaccination. > > 3. Do all EMS students who have clinical rotations at a Healthcare > institution covered under Part 66 have to be vaccinated? > > Yes. Any EMS student, who is doing clinical or internship rotations at a > Healthcare institution, even if they do not work for an EMS service, must > be > vaccinated with a seasonal flu shot and H1N1 when it is available. This > includes BLS or ALS clinical and internship rotations. (EMS Course > Sponsors > are encouraged to review their clinical agreements as it relates to the > requirements of this regulation) > > 4. Should all other EMS personnel who have patient contact be vaccinated? > Yes they should - While not mandated beyond the circumstances stated above > , EMS personnel have been identified by the Department of Health and Human > Services (HHS) as a high priority group to be vaccinated. It is highly > recommended by the NYS Department of Health that all healthcare workers > who > work with patients, including EMS, be vaccinated with seasonal flu vaccine > and > H1N1 vaccine. > > The New York State Department of Health Call Center Line for Novel H1N1 > Flu questions and concerns is: 1-. > *EMS Program Agencies > Regional DOH Offices > Regional Emergency Medical Service Council > State Emergency Medical Services Advisory Committee > State Emergency Medical Services Council > State Trauma Advisory Committee > > Louis N. Molino, Sr., CET > FF/NREMT-B/FSI/EMSI > Freelance Consultant/Trainer/Author/Journalist/Fire Protection Consultant > > LNMolino@... > > (Cell Phone) > > " A Texan with a Jersey Attitude " > > " Great minds discuss ideas; Average minds discuss events; Small minds > discuss people " Eleanor Roosevelt - US diplomat & reformer (1884 - 1962) > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 10, 2009 Report Share Posted October 10, 2009 Jane, The clinical trials leading up to FDA approval is almost always done by the developing pharmaceutical companies. They're the ones that have the millions of dollars necessary to do the studies. My wife has conducted numerous such trials in-house, the latest one being the lactoferrin study done in Peru. There are ethical review committees in every study, and they generally have advisors who are prominent scientists and researchers in academia who review and make recommendations. The data are reviewed by independent committees, and the process of getting approval is rigorous. As far as mandating immunizations, for years every child had to show a smallpox vaccination scar in order to be admitted to school in the first grade. That's how we wiped out smallpox. My understanding of the H1N1 vaccine is that the carrier is the same as has been used for years in other flu vaccines. Most of the objections have arisen over what's in the carrier. The 1976 " scare " has not been borne out since then. The figures I have been able to turn up show an increase in GBS of approximately 1 in 1 million persons since this vaccine came out. There is a risk/benefit to every medicine and vaccine. I am in favor of maximum personal freedom, but that also includes freedom from epidemics caused by people who spread disease. Government also has the power to quarantine those who develop certain communicable diseases. If you have MDR TB, you can be locked up, as was the guy who flew home from Europe with it. Here's what the CDC says about the flu vaccine and GBS: " In 1976, there was a small risk of GBS following influenza (swine flu) vaccination (approximately 1 additional case per 100,000 people who received the swine flu vaccine). That number of GBS cases was slightly higher than what is normally seen in the population, whether or not people were vaccinated. Since then, numerous studies have been done to evaluate if other flu vaccines were associated with GBS. In most studies, no association was found, but two studies suggested that approximately 1 additional person out of 1 million vaccinated people may be at risk for GBS associated with the seasonal influenza vaccine. FDA and CDC will be closely monitoring reports of serious problems following the 2009 H1N1 influenza vaccines, including GBS. " One study found 41,600 deaths per year from flu from 1979 to 2001. http://aje.oxfordjournals.org/cgi/content/full/163/2/181 The Wrong Diagnosis cite lists the number of annual deaths from influenza at 63,729, or 1 in 7 deaths. GBS affects about 1 in 100,000 people, and the death rate is 1-2% of that number in the U.S. and about 3-4% in the world according to numerous sources I read in Google. Given the world's estimated population, there would be 6,706 cases of GBS worldwide. If the mortality rate is 4%, there would be 268 deaths per year from GBS worldwide vs. 41,600 or 63,729 from flu, depending upon whose figures one accepts. At any rate, the morbidity from GBS is a fraction of that of flu, and since GBS is known to be caused by a number of things, the number of cases that might be attributable to H1N1 vaccine is minute. Everybody should make his own decision about taking the vaccine or not, but it should be based on all the facts available. Much has been made about the fact that the circular that goes with the vaccine lists GBS as a possible side effect. What the hysteria-mongers do not say is that it's just one thing in a very long list of possible side effects. Read the aspirin circular and compare. Nuff said. A few minutes with Google will give one plenty of information on which to make a decision. GG > > The sad part about this is that from what I have gathered so far, flu > vaccine research is usually done by the pharmaceutical companies who design the > vaccines to begin with, including the H1N1 vaccine.... Unless someone can > produce some solid info on here (Dr. Bledsoe ?) about solid, verifiable > and reproducable research on this subject by bipartisan companies OTHER than > the manufacturing company, who knows how valid ANY of that research really > is........ Kind of like having the wolf guarding the henhouse. > > > > Jane Dinsmore > > > > To: texasems-l > From: summedic@... > Date: Sat, 10 Oct 2009 09:14:35 -0500 > Subject: RE: NEW YORK STATE – DEPARTMENT OF HEALTH - > INTEROFFICE MEMORANDUM > >  > > > > Can anyone tell me if there is a research study involving Guillian Barre > syndrome as it pertains to vaccinations such as these for the flu? > > Health Care Personnel Influenza Vaccination Requirements > > DATE: October 7, 2009 > > There remains some confusion and concern among EMS Providers and Agencies > regarding the applicability of the recent changes to Part 66 regulations > regarding Health Care Personnel Influenza Vaccination Requirements and how > they apply to EMS. The Bureau of EMS requested a clarification of this > health care regulation as it applies to EMS agencies. The following is a > summary > of the response provided by the Department of Health’s Division of Legal > Affairs which we hope will clarify some of these questions. > > 1. Are EMS personnel mandated to receive flu vaccination under the > recently enacted healthcare facility regulations? > > EMS personnel who are employed by a hospital-owned ambulance service or > ALS first response service must be vaccinated for the flu. > > EMS agencies that have a contract with a healthcare facility to provide > transport of patients are mandated to have their employees who provide > these > transports vaccinated. (Contracted EMS Agencies are encouraged to review > their staffing practices as it relates to the conditions of these > contracts > and requirements of this regulation). > > EMS services that respond in the 9-1-1 system and do not have a > contractual relationship with a healthcare facility as described above are > not > required to be vaccinated. They are strongly encouraged to be vaccinated. > > 2. Will the mandate include H1N1 Vaccine? > > Yes. As soon as H1N1 vaccine is made available, EMS personnel and agencies > that fit the criteria in Question One will be mandated to have H1N1 > vaccination. They are also required to have the regular seasonal flu > vaccination. > > 3. Do all EMS students who have clinical rotations at a Healthcare > institution covered under Part 66 have to be vaccinated? > > Yes. Any EMS student, who is doing clinical or internship rotations at a > Healthcare institution, even if they do not work for an EMS service, must > be > vaccinated with a seasonal flu shot and H1N1 when it is available. This > includes BLS or ALS clinical and internship rotations. (EMS Course > Sponsors > are encouraged to review their clinical agreements as it relates to the > requirements of this regulation) > > 4. Should all other EMS personnel who have patient contact be vaccinated? > Yes they should - While not mandated beyond the circumstances stated above > , EMS personnel have been identified by the Department of Health and Human > Services (HHS) as a high priority group to be vaccinated. It is highly > recommended by the NYS Department of Health that all healthcare workers > who > work with patients, including EMS, be vaccinated with seasonal flu vaccine > and > H1N1 vaccine. > > The New York State Department of Health Call Center Line for Novel H1N1 > Flu questions and concerns is: 1-. > *EMS Program Agencies > Regional DOH Offices > Regional Emergency Medical Service Council > State Emergency Medical Services Advisory Committee > State Emergency Medical Services Council > State Trauma Advisory Committee > > Louis N. Molino, Sr., CET > FF/NREMT-B/FSI/EMSI > Freelance Consultant/Trainer/Author/Journalist/Fire Protection Consultant > > LNMolino@... > > (Cell Phone) > > " A Texan with a Jersey Attitude " > > " Great minds discuss ideas; Average minds discuss events; Small minds > discuss people " Eleanor Roosevelt - US diplomat & reformer (1884 - 1962) > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 11, 2009 Report Share Posted October 11, 2009 Thanks, Gene. I understand what you are saying about expense and such. But on the other hand with THIS vaccine, there has only been one or two SMALL studies which have not been reproduced or done on a large enough scale to really get a feel for the vaccine from what I have read. Correct? And yes, every child is required to have certain vaccinations for potential life-threatening or extremely debilitating diseases of which H1N1 is low on the spectrum. Children and their parents don't have a choice on those vaccinations because of the potential for widespread death and desctruction. H1N1 doesn't appear to rank in the same category so far. So what is the current death rate ratio so far for H1N1? Jane Dinsmore To: texasems-l From: wegandy1938@... Date: Sun, 11 Oct 2009 00:05:07 -0400 Subject: Re: RE: NEW YORK STATE – DEPARTMENT OF HEALTH - INTEROFFICE MEMORANDUM Jane, The clinical trials leading up to FDA approval is almost always done by the developing pharmaceutical companies. They're the ones that have the millions of dollars necessary to do the studies. My wife has conducted numerous such trials in-house, the latest one being the lactoferrin study done in Peru. There are ethical review committees in every study, and they generally have advisors who are prominent scientists and researchers in academia who review and make recommendations. The data are reviewed by independent committees, and the process of getting approval is rigorous. As far as mandating immunizations, for years every child had to show a smallpox vaccination scar in order to be admitted to school in the first grade. That's how we wiped out smallpox. My understanding of the H1N1 vaccine is that the carrier is the same as has been used for years in other flu vaccines. Most of the objections have arisen over what's in the carrier. The 1976 " scare " has not been borne out since then. The figures I have been able to turn up show an increase in GBS of approximately 1 in 1 million persons since this vaccine came out. There is a risk/benefit to every medicine and vaccine. I am in favor of maximum personal freedom, but that also includes freedom from epidemics caused by people who spread disease. Government also has the power to quarantine those who develop certain communicable diseases. If you have MDR TB, you can be locked up, as was the guy who flew home from Europe with it. Here's what the CDC says about the flu vaccine and GBS: " In 1976, there was a small risk of GBS following influenza (swine flu) vaccination (approximately 1 additional case per 100,000 people who received the swine flu vaccine). That number of GBS cases was slightly higher than what is normally seen in the population, whether or not people were vaccinated. Since then, numerous studies have been done to evaluate if other flu vaccines were associated with GBS. In most studies, no association was found, but two studies suggested that approximately 1 additional person out of 1 million vaccinated people may be at risk for GBS associated with the seasonal influenza vaccine. FDA and CDC will be closely monitoring reports of serious problems following the 2009 H1N1 influenza vaccines, including GBS. " One study found 41,600 deaths per year from flu from 1979 to 2001. http://aje.oxfordjournals.org/cgi/content/full/163/2/181 The Wrong Diagnosis cite lists the number of annual deaths from influenza at 63,729, or 1 in 7 deaths. GBS affects about 1 in 100,000 people, and the death rate is 1-2% of that number in the U.S. and about 3-4% in the world according to numerous sources I read in Google. Given the world's estimated population, there would be 6,706 cases of GBS worldwide. If the mortality rate is 4%, there would be 268 deaths per year from GBS worldwide vs. 41,600 or 63,729 from flu, depending upon whose figures one accepts. At any rate, the morbidity from GBS is a fraction of that of flu, and since GBS is known to be caused by a number of things, the number of cases that might be attributable to H1N1 vaccine is minute. Everybody should make his own decision about taking the vaccine or not, but it should be based on all the facts available. Much has been made about the fact that the circular that goes with the vaccine lists GBS as a possible side effect. What the hysteria-mongers do not say is that it's just one thing in a very long list of possible side effects. Read the aspirin circular and compare. Nuff said. A few minutes with Google will give one plenty of information on which to make a decision. GG > > The sad part about this is that from what I have gathered so far, flu > vaccine research is usually done by the pharmaceutical companies who design the > vaccines to begin with, including the H1N1 vaccine.... Unless someone can > produce some solid info on here (Dr. Bledsoe ?) about solid, verifiable > and reproducable research on this subject by bipartisan companies OTHER than > the manufacturing company, who knows how valid ANY of that research really > is........ Kind of like having the wolf guarding the henhouse. > > > > Jane Dinsmore > > > > To: texasems-l > From: summedic@... > Date: Sat, 10 Oct 2009 09:14:35 -0500 > Subject: RE: NEW YORK STATE – DEPARTMENT OF HEALTH - > INTEROFFICE MEMORANDUM > > > > > > Can anyone tell me if there is a research study involving Guillian Barre > syndrome as it pertains to vaccinations such as these for the flu? > > Health Care Personnel Influenza Vaccination Requirements > > DATE: October 7, 2009 > > There remains some confusion and concern among EMS Providers and Agencies > regarding the applicability of the recent changes to Part 66 regulations > regarding Health Care Personnel Influenza Vaccination Requirements and how > they apply to EMS. The Bureau of EMS requested a clarification of this > health care regulation as it applies to EMS agencies. The following is a > summary > of the response provided by the Department of Health’s Division of Legal > Affairs which we hope will clarify some of these questions. > > 1. Are EMS personnel mandated to receive flu vaccination under the > recently enacted healthcare facility regulations? > > EMS personnel who are employed by a hospital-owned ambulance service or > ALS first response service must be vaccinated for the flu. > > EMS agencies that have a contract with a healthcare facility to provide > transport of patients are mandated to have their employees who provide > these > transports vaccinated. (Contracted EMS Agencies are encouraged to review > their staffing practices as it relates to the conditions of these > contracts > and requirements of this regulation). > > EMS services that respond in the 9-1-1 system and do not have a > contractual relationship with a healthcare facility as described above are > not > required to be vaccinated. They are strongly encouraged to be vaccinated. > > 2. Will the mandate include H1N1 Vaccine? > > Yes. As soon as H1N1 vaccine is made available, EMS personnel and agencies > that fit the criteria in Question One will be mandated to have H1N1 > vaccination. They are also required to have the regular seasonal flu > vaccination. > > 3. Do all EMS students who have clinical rotations at a Healthcare > institution covered under Part 66 have to be vaccinated? > > Yes. Any EMS student, who is doing clinical or internship rotations at a > Healthcare institution, even if they do not work for an EMS service, must > be > vaccinated with a seasonal flu shot and H1N1 when it is available. This > includes BLS or ALS clinical and internship rotations. (EMS Course > Sponsors > are encouraged to review their clinical agreements as it relates to the > requirements of this regulation) > > 4. Should all other EMS personnel who have patient contact be vaccinated? > Yes they should - While not mandated beyond the circumstances stated above > , EMS personnel have been identified by the Department of Health and Human > Services (HHS) as a high priority group to be vaccinated. It is highly > recommended by the NYS Department of Health that all healthcare workers > who > work with patients, including EMS, be vaccinated with seasonal flu vaccine > and > H1N1 vaccine. > > The New York State Department of Health Call Center Line for Novel H1N1 > Flu questions and concerns is: 1-. > *EMS Program Agencies > Regional DOH Offices > Regional Emergency Medical Service Council > State Emergency Medical Services Advisory Committee > State Emergency Medical Services Council > State Trauma Advisory Committee > > Louis N. Molino, Sr., CET > FF/NREMT-B/FSI/EMSI > Freelance Consultant/Trainer/Author/Journalist/Fire Protection Consultant > > LNMolino@... > > (Cell Phone) > > " A Texan with a Jersey Attitude " > > " Great minds discuss ideas; Average minds discuss events; Small minds > discuss people " Eleanor Roosevelt - US diplomat & reformer (1884 - 1962) > > Quote Link to comment Share on other sites More sharing options...
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