http://abcnews.go.com/Health/SwineFluNews/story?id=8437630
A CDC report raises concern over Washington's potential response to H1N1.
What might life be like during the kind of major swine flu pandemic predicted by the White House to hit the U.S. this fall?
The worst-case scenarios percolate on the edges of thought: bans on public gatherings, restricting the movement of afflicted individuals, and compelled vaccinations. Conspiracy theorists go farther, suggesting that the World Health Organization is behind a secret plan to inoculate Americans at gunpoint with immune-system depleting vaccines to depopulate the globe.
The CDC's report, released Monday, may well create some level of hysteria. It said 1.8 million Americans could become seriously ill this fall and as many as 90,000 could die.
In truth, America's national pandemic response plan has been shaped by lessons from the 1918 Spanish flu epidemic, which killed millions globally and did include gun-point quarantines. If the circumstances are deemed dire enough, the government's "Pandemic Influenza Plan" allows for strong measures, such as banning public gatherings and calling in the military to help with law enforcement.
Yet the far greater concern for public-health officials right now is more mundane: trying to make sure that there is enough vaccine to meet demand – and that there are enough healthcare professionals on hand to handle a potential influx of patients.
The Department of Health and Human Services has fast-tracked production of a vaccine, but it will not have 120 million doses ready by the expected peak of the season, as it had hoped. Forty-five million doses will be available in mid-October, with 20 million more available each week afterward.
Massachusetts public-health officials, for instance, are urging nearly 90 percent of residents to get vaccinated.
In the event of a health crisis, the federal government has broad powers. New rules enacted by the Bush administration include swine flu among quarantinable communicable diseases. For its part, the Obama administration is also reportedly reviewing proposals to strengthen three-decade-old federal quarantine policies, including, according to some reports, presidential power to impose a six-day quarantine on those affected by swine flu. The Department of Health and Human Services has asked the Pentagon to assist local health officials in the event of a pandemic.
But these are clear attempts at preparing for the worst.
"There's not going to be compulsory vaccination," says Jennifer Nuzzo, an analyst at the Center for Biosecurity at the University of Pittsburgh Medical Center. "But what you may be picking up on is that the military does have a lot of healthcare professionals, so [the government] may be enlisting some of the extra hands that are out there."
Because the H1N1 flu has proven less deadly so far than initially feared, the Obama administration has actually ratcheted back immediate response plans.
For example: The administration is hinting that it will urge fewer school closings than took place during the spring outbreak. Colleges are being asked to formulate preparedness plans, but so far those include primarily voluntary dorm quarantines and suggestions for afflicted students to refrain from kissing – or at least to wear surgical masks when they do.
Compared with many other countries, "this administration has been pretty measured about wanting to balance the need to control a health threat with not wanting to interrupt society … [with] heavy-handed responses," says Ms. Nuzzo.
As to the fears about a WHO conspiracy, Nuzzo adds: "The WHO staff is smaller than the New York City Health Department, so its ability to impose worldwide martial law would be a miracle."
Yet some fears about the government potentially overstepping its bounds are justified, civil libertarians say.
Since 9/11, pandemic planning has taken a more authoritarian tone that harks back to the pre-vaccine days of forced quarantines during outbreaks, according to an American Civil Liberties Union report released in January 2008.
Pandemic flu plans adopted by the federal government and nearly every state and locality "rely heavily on a punitive approach and emphasize extreme measures such as quarantine and forced treatment," the report says. "People, rather than the disease, become the enemy."
Yet some pandemic experts predict that the police and military will more likely be used to protect clinics and hospitals against angry mobs demanding vaccination than to force Americans into quarantine against their will.
Monday, August 31, 2009
NY Hospital workers: Flu shot or get fired:
http://www.timesunion.com/AspStories/story.asp?storyID=836256
About 25,000 Capital Region hospital workers need the state-mandated shield, and the area's top sites say comply or quit
By LARRY RULISON, Business writer
First published in print: Saturday, August 29, 2009
ALBANY -- Workers at Capital Region hospitals are going to have to get a flu shot this year or face losing their jobs.
The requirement is part of a new emergency regulation adopted earlier this month by the State Hospital Review and Planning Council that requires that all hospital workers get the flu vaccine -- and that it be a requirement for employment.
Hospitals are quickly trying to assemble new workplace policies to comply with the regulation, and those that have been put in place threaten disciplinary action and even termination if workers, from janitors and food service workers to doctors and nurses, refuse to get the shots. The policy affects about 25,000 people in the region.
Albany Medical Center, the region's leading hospital, sent out announcements to workers earlier this week saying employees had to get flu shots by Oct. 16. Spokesman Gregory McGarry said the hospital may take "corrective action" against employees if they don't comply, although he declined to get into specifics about what type of penalties they would face.
The hospital, which will pay for the vaccine, is insisting that almost all of its 7,000 employees get the shots, even those who work at off-site buildings such as the finance center in Delmar. McGarry said that even those workers spend time at the main hospital buildings for meetings.
"It's anyone who has contact with patients or providers," McGarry said. "There may be rare exceptions."
St. Peter's Hospital in Albany is also developing a set of strict guidelines as it seeks to get all of its 4,500 employees shots by Dec. 1.
"There are very few exceptions," said spokesman Elmer Streeter. "We will be requiring it of all our employees as a condition of employment."
Workers will be suspended for five days initially if they do not get the shot. After that, they have another five days to comply before facing possible termination.
Public health officials across the world are gearing up for the flu season this year with special urgency, especially because of concerns over the H1N1 "swine" flu virus. The new state regulations do not cover the swine flu vaccine, only the seasonal flu vaccine.
The New York State Nurses Association, which represents 37,000 nurses in the state, has opposed mandatory policies, and still does, says spokesman Mark Genovese.
"We think it should not be mandatory," Genovese said. "But we of course urge them to protect themselves."
Northeast Health in Troy, the organization that owns Albany Memorial Hospital and Samaritan Hospital in Troy, is working toward new guidelines.
"We're still in the process of finalizing our policy on that," said spokeswoman Angela Yu. "Obviously, we are trying to comply with the health department rules."
Larry Rulison can be reached at 454-5504 or by e-mail at lrulison@timesunion.com.
About 25,000 Capital Region hospital workers need the state-mandated shield, and the area's top sites say comply or quit
By LARRY RULISON, Business writer
First published in print: Saturday, August 29, 2009
ALBANY -- Workers at Capital Region hospitals are going to have to get a flu shot this year or face losing their jobs.
The requirement is part of a new emergency regulation adopted earlier this month by the State Hospital Review and Planning Council that requires that all hospital workers get the flu vaccine -- and that it be a requirement for employment.
Hospitals are quickly trying to assemble new workplace policies to comply with the regulation, and those that have been put in place threaten disciplinary action and even termination if workers, from janitors and food service workers to doctors and nurses, refuse to get the shots. The policy affects about 25,000 people in the region.
Albany Medical Center, the region's leading hospital, sent out announcements to workers earlier this week saying employees had to get flu shots by Oct. 16. Spokesman Gregory McGarry said the hospital may take "corrective action" against employees if they don't comply, although he declined to get into specifics about what type of penalties they would face.
The hospital, which will pay for the vaccine, is insisting that almost all of its 7,000 employees get the shots, even those who work at off-site buildings such as the finance center in Delmar. McGarry said that even those workers spend time at the main hospital buildings for meetings.
"It's anyone who has contact with patients or providers," McGarry said. "There may be rare exceptions."
St. Peter's Hospital in Albany is also developing a set of strict guidelines as it seeks to get all of its 4,500 employees shots by Dec. 1.
"There are very few exceptions," said spokesman Elmer Streeter. "We will be requiring it of all our employees as a condition of employment."
Workers will be suspended for five days initially if they do not get the shot. After that, they have another five days to comply before facing possible termination.
Public health officials across the world are gearing up for the flu season this year with special urgency, especially because of concerns over the H1N1 "swine" flu virus. The new state regulations do not cover the swine flu vaccine, only the seasonal flu vaccine.
The New York State Nurses Association, which represents 37,000 nurses in the state, has opposed mandatory policies, and still does, says spokesman Mark Genovese.
"We think it should not be mandatory," Genovese said. "But we of course urge them to protect themselves."
Northeast Health in Troy, the organization that owns Albany Memorial Hospital and Samaritan Hospital in Troy, is working toward new guidelines.
"We're still in the process of finalizing our policy on that," said spokeswoman Angela Yu. "Obviously, we are trying to comply with the health department rules."
Larry Rulison can be reached at 454-5504 or by e-mail at lrulison@timesunion.com.
CAMC will require flu shots:
http://www.dailymail.com/News/200908250802
Wednesday August 26, 2009
by Michelle Saxton
Daily Mail Capitol Reporter
CHARLESTON, W.Va. -- Charleston Area Medical Center employees must get seasonal flu shots this year or risk losing their jobs.
All CAMC Health System workers must get vaccinated by Dec. 15 or their employment will be terminated, CAMC said in its August newsletter Vital Signs.
"The strongest recommendation that's out there is to take the vaccine every year," CAMC Director of Epidemiology Terrie Lee said Tuesday. "Our board of trustees and administrators had been discussing this for a couple years. We decided this year to make it a mandatory process for all of our employees."
Employees may submit a request for accommodation due to health reasons, such as allergies to a component of the flu vaccine. They have until Sept. 15 to do so, and if requests are confirmed, those employees would have to wear a mask over their nose and mouth while at work during flu season, the newsletter said.
"That's interesting," Dr. Rahul Gupta, health officer and executive director of the Kanawha-Charleston Health Department, said when asked about CAMC's new policy. "Health care employees are very essential to any flu response efforts."
From a public health standpoint it is a positive step, Gupta said, adding he was curious to see if other hospitals follow CAMC's lead.
"I'm not aware of any national guidelines recommending that all employees of any institutions, hospitals or not, be forced to have flu vaccines," Gupta said. "However ... I do understand they are private employers, and private employers do have a right to expect a healthy work force."
Flu shots will start Nov. 2 and will be offered at employee health offices and on nursing units, the newsletter said.
The requirement covers about 6,000 employees, including clinical staff, workers in off-site locations and office workers, CAMC said.
CAMC workers who submit requests for an accommodation regarding the flu shot because of health limitations must provide documentation from a physician or take a free allergy test, Lee said.
"Nobody would be given the vaccine if it would be a dangerous thing for them to do," Lee said.
CAMC always has offered free flu vaccinations to employees, Lee said, and it has raised its worker vaccination rate to 70 percent over the past few years from earlier rates of about 30 percent to 40 percent.
Past efforts to raise the flu shot rate have included training nursing staff representatives to educate and vaccinate their co-workers and requiring employees who work with patients to sign a declination statement if they choose not to take the vaccine, Lee said.
But CAMC officials want to raise the vaccination rate to 100 percent to help avoid spreading influenza or negatively affecting patient recovery, Lee said.
"It's just not good for anybody," Lee said. "People are infectious to other people with the flu before they become symptomatic.
"Many people are certainly misinformed about that," Lee added. "They'll say 'I would never want to make anybody sick. If I'm sick, I'll stay home.' That sounds like a real good idea and yet... it's too late."
Page 2 of 2
This is the first time CAMC has required mandatory vaccinations for the seasonal flu, Lee said. However, the hospital system requires several other vaccinations for workers upon hire. That includes measles, mumps, rubella, chickenpox, tetanus, pertussis and diphtheria.
Lee said she was unaware of any other hospitals in West Virginia requiring flu vaccinations for employment but colleagues seemed excited about the idea.
"Everybody who works in infection prevention as I do believes this is a critical element of their infection prevention program in their facility," Lee said.
Lee did not have a figure for how much the increased flu vaccines and allergy tests would cost but said it was not expected to be a huge additional cost and it also could help reduce absenteeism from illness.
Feedback has come from both employees who are glad for the policy and those who are unhappy about being told what to do, Lee said.
"Some of the people that have been so committed to increasing our participation feel that they're really gung ho about getting their co-workers to get the vaccine," Lee said.
With the unhappy workers, "we've had to gently remind them that there are other vaccines that they had to take to work here," Lee said.
"It's not an unusual concept," Lee added. "It's just one that has not been implemented regarding this vaccine up to this point."
Other vaccines usually are given to a person once or as a series, whereas the flu shot is given every year, Lee said.
"It's a safe vaccine," Lee said. "It's very good and effective, especially for young, healthy people."
The decision to make the seasonal flu shot mandatory comes as international concerns grow regarding swine flu, but Lee said the seasonal flu shot decision was unrelated.
"It's one of our top goals that's worked on for the infectious control plan," Lee said of the seasonal flu vaccine. "It's one of our top priorities. This was sort of a natural next step."
As for the swine flu, CAMC has no immediate plans to make that mandatory but expects to follow recommendations from the federal Centers for Disease Control and Prevention regarding targeted groups to receive that particular vaccination, Lee said.
Also, it still is unclear how much of the swine flu vaccine CAMC will receive, she said.
"It's not going to be something that is going to be readily available to all employees," Lee said.
"We would within our system then apply those categories to our own population and determine what the priorities are and develop a system for delivering them. It would probably not be mandatory, but we really have not made that kind of decision."
Contact writer Michelle Saxton at michelle.sax...@dailymail.com or 304-348-4843.
Wednesday August 26, 2009
by Michelle Saxton
Daily Mail Capitol Reporter
CHARLESTON, W.Va. -- Charleston Area Medical Center employees must get seasonal flu shots this year or risk losing their jobs.
All CAMC Health System workers must get vaccinated by Dec. 15 or their employment will be terminated, CAMC said in its August newsletter Vital Signs.
"The strongest recommendation that's out there is to take the vaccine every year," CAMC Director of Epidemiology Terrie Lee said Tuesday. "Our board of trustees and administrators had been discussing this for a couple years. We decided this year to make it a mandatory process for all of our employees."
Employees may submit a request for accommodation due to health reasons, such as allergies to a component of the flu vaccine. They have until Sept. 15 to do so, and if requests are confirmed, those employees would have to wear a mask over their nose and mouth while at work during flu season, the newsletter said.
"That's interesting," Dr. Rahul Gupta, health officer and executive director of the Kanawha-Charleston Health Department, said when asked about CAMC's new policy. "Health care employees are very essential to any flu response efforts."
From a public health standpoint it is a positive step, Gupta said, adding he was curious to see if other hospitals follow CAMC's lead.
"I'm not aware of any national guidelines recommending that all employees of any institutions, hospitals or not, be forced to have flu vaccines," Gupta said. "However ... I do understand they are private employers, and private employers do have a right to expect a healthy work force."
Flu shots will start Nov. 2 and will be offered at employee health offices and on nursing units, the newsletter said.
The requirement covers about 6,000 employees, including clinical staff, workers in off-site locations and office workers, CAMC said.
CAMC workers who submit requests for an accommodation regarding the flu shot because of health limitations must provide documentation from a physician or take a free allergy test, Lee said.
"Nobody would be given the vaccine if it would be a dangerous thing for them to do," Lee said.
CAMC always has offered free flu vaccinations to employees, Lee said, and it has raised its worker vaccination rate to 70 percent over the past few years from earlier rates of about 30 percent to 40 percent.
Past efforts to raise the flu shot rate have included training nursing staff representatives to educate and vaccinate their co-workers and requiring employees who work with patients to sign a declination statement if they choose not to take the vaccine, Lee said.
But CAMC officials want to raise the vaccination rate to 100 percent to help avoid spreading influenza or negatively affecting patient recovery, Lee said.
"It's just not good for anybody," Lee said. "People are infectious to other people with the flu before they become symptomatic.
"Many people are certainly misinformed about that," Lee added. "They'll say 'I would never want to make anybody sick. If I'm sick, I'll stay home.' That sounds like a real good idea and yet... it's too late."
Page 2 of 2
This is the first time CAMC has required mandatory vaccinations for the seasonal flu, Lee said. However, the hospital system requires several other vaccinations for workers upon hire. That includes measles, mumps, rubella, chickenpox, tetanus, pertussis and diphtheria.
Lee said she was unaware of any other hospitals in West Virginia requiring flu vaccinations for employment but colleagues seemed excited about the idea.
"Everybody who works in infection prevention as I do believes this is a critical element of their infection prevention program in their facility," Lee said.
Lee did not have a figure for how much the increased flu vaccines and allergy tests would cost but said it was not expected to be a huge additional cost and it also could help reduce absenteeism from illness.
Feedback has come from both employees who are glad for the policy and those who are unhappy about being told what to do, Lee said.
"Some of the people that have been so committed to increasing our participation feel that they're really gung ho about getting their co-workers to get the vaccine," Lee said.
With the unhappy workers, "we've had to gently remind them that there are other vaccines that they had to take to work here," Lee said.
"It's not an unusual concept," Lee added. "It's just one that has not been implemented regarding this vaccine up to this point."
Other vaccines usually are given to a person once or as a series, whereas the flu shot is given every year, Lee said.
"It's a safe vaccine," Lee said. "It's very good and effective, especially for young, healthy people."
The decision to make the seasonal flu shot mandatory comes as international concerns grow regarding swine flu, but Lee said the seasonal flu shot decision was unrelated.
"It's one of our top goals that's worked on for the infectious control plan," Lee said of the seasonal flu vaccine. "It's one of our top priorities. This was sort of a natural next step."
As for the swine flu, CAMC has no immediate plans to make that mandatory but expects to follow recommendations from the federal Centers for Disease Control and Prevention regarding targeted groups to receive that particular vaccination, Lee said.
Also, it still is unclear how much of the swine flu vaccine CAMC will receive, she said.
"It's not going to be something that is going to be readily available to all employees," Lee said.
"We would within our system then apply those categories to our own population and determine what the priorities are and develop a system for delivering them. It would probably not be mandatory, but we really have not made that kind of decision."
Contact writer Michelle Saxton at michelle.sax...@dailymail.com or 304-348-4843.
WVa hospital among few requiring flu vaccines:
http://www.seattlepi.com/local/6420ap_wv_mandatory_vaccines.html
By TOM BREEN
ASSOCIATED PRESS WRITER
CHARLESTON, W.Va. -- As flu season approaches, West Virginia's largest hospital has given its employees a choice: Get a flu vaccine or find another job.
Charleston Area Medical Center wants to get roughly 6,000 workers immunized against seasonal flu to protect patients from the ailment, just as health care workers there are currently required to get vaccinations against everything from measles to rubella.
A mandatory flu vaccine policy like CAMC's is rare for U.S. hospitals, but it may soon become more common. A New York state law takes effect this month requiring hospitals to provide records showing all their workers have seasonal flu vaccinations or face fines, and the impending arrival of a swine flu vaccine has policymakers looking for ways to get it to large numbers of people in a short amount of time.
CAMC decided to adopt the new policy this year after steadily increasing its vaccination rate among staff members to about 70 percent, according to Director of Epidemiology Terrie Lee.
The hospital had previously asked all employees to get vaccines or sign forms explaining why they refused, but even that presented problems.
"We have around 6,000 employees, and that's a lot of time to spend paper chasing," Lee said.
Now, employees with a reason for declining, such as allergies, can file by Sept. 15 for an exemption. Everyone else has to get a vaccination by Dec. 15.
"The number one reason for this is to protect our patients," Lee said. "There are plenty of studies showing hospitals with higher flu vaccination compliance rates have fewer patient deaths."
In 2007, the Infectious Diseases Society of America called for such mandatory policies, saying that on average, fewer than 40 percent of health care workers nationwide get flu vaccines every year.
Despite such calls, hospitals where employees must get flu vaccines as a condition of employment are so rare an American Hospital Association expert couldn't name another besides CAMC.
"As we listen to our hospitals and people in the state associations, vaccination for the flu has not been mandatory," said James Bentley, the association's senior vice president for strategic policy planning.
The American College of Occupational and Environmental Medicine has called for sustained and rigorous promotion of flu vaccines while stopping short of endorsing mandatory vaccines.
"If you're going to make anything mandatory, make education mandatory," said Dr. Mark Russi, director of occupational health at Yale-New Haven Hospital in Connecticut and a member of the American College's Council of Scientific Advisors.
"It's important to make sure you're reaching everyone in an appropriate way and explaining that this is not a hazardous vaccine and that it's generally 70 to 90 percent effective."
A mandate can seem faster to implement than an education effort, and states may follow the example of New York.
The New York regulation, which took effect Aug. 13, requires hospitals and other health care facilities to provide proof that their workers are vaccinated, or face fines of $2,000 for the first offense and up to $5,000 for subsequent offenses, said state health department spokeswoman Claire Pospisil.
The regulation was opposed by the New York State Nurses Association, which objected to the law's lack of provisions for health care workers who don't want the vaccine for religious or philosophical reasons.
The association says it supports health care workers being immunized, but opposes mandatory policies, a position that may complicate the spread of initiatives like the one at CAMC.
Virginia Mason Medical Center in Seattle is cited by many, including CAMC's Lee, as a national model in vaccination policies for its workers. In 2004, it decided to require seasonal flu vaccinations, but that policy was successfully challenged by the union representing nurses at the hospital.
The nurses objected not to the vaccinations, but to what they said was a change in the terms of employment covered under the collective bargaining agreement, and an arbitrator agreed.
Despite that, Virginia Mason has maintained a vaccination rate among workers of 99 percent or so for the last four seasons, said Dr. Joyce Lammert, chief of the Department of Medicine.
The hospital has also found a side benefit.
Vaccinating thousands of people in a short period of time is a good way to establish procedures that may be used in the event of a pandemic, Lammert said.
Fears of a pandemic, particularly tied to the swine flu virus, are spurring renewed discussion of mandatory vaccine polices around the country, Russi said.
A vaccine for swine flu won't be available until this fall, though, and making it mandatory would mean addressing the concerns of many that it could be unsafe.
Even hospitals encouraging the seasonal flu vaccine have to address fears that it will make recipients sick, or that it's not necessary for young, healthy people.
Those objections, along with religious or philosophical concerns, have made many health care facilities wary of instituting a mandatory policy, the AHA's Bentley said.
"Most institutions I have familiarity with say, 'We aren't going to require it because that gets into all kinds of other issues and we don't have time to take those on,'" he said.
By TOM BREEN
ASSOCIATED PRESS WRITER
CHARLESTON, W.Va. -- As flu season approaches, West Virginia's largest hospital has given its employees a choice: Get a flu vaccine or find another job.
Charleston Area Medical Center wants to get roughly 6,000 workers immunized against seasonal flu to protect patients from the ailment, just as health care workers there are currently required to get vaccinations against everything from measles to rubella.
A mandatory flu vaccine policy like CAMC's is rare for U.S. hospitals, but it may soon become more common. A New York state law takes effect this month requiring hospitals to provide records showing all their workers have seasonal flu vaccinations or face fines, and the impending arrival of a swine flu vaccine has policymakers looking for ways to get it to large numbers of people in a short amount of time.
CAMC decided to adopt the new policy this year after steadily increasing its vaccination rate among staff members to about 70 percent, according to Director of Epidemiology Terrie Lee.
The hospital had previously asked all employees to get vaccines or sign forms explaining why they refused, but even that presented problems.
"We have around 6,000 employees, and that's a lot of time to spend paper chasing," Lee said.
Now, employees with a reason for declining, such as allergies, can file by Sept. 15 for an exemption. Everyone else has to get a vaccination by Dec. 15.
"The number one reason for this is to protect our patients," Lee said. "There are plenty of studies showing hospitals with higher flu vaccination compliance rates have fewer patient deaths."
In 2007, the Infectious Diseases Society of America called for such mandatory policies, saying that on average, fewer than 40 percent of health care workers nationwide get flu vaccines every year.
Despite such calls, hospitals where employees must get flu vaccines as a condition of employment are so rare an American Hospital Association expert couldn't name another besides CAMC.
"As we listen to our hospitals and people in the state associations, vaccination for the flu has not been mandatory," said James Bentley, the association's senior vice president for strategic policy planning.
The American College of Occupational and Environmental Medicine has called for sustained and rigorous promotion of flu vaccines while stopping short of endorsing mandatory vaccines.
"If you're going to make anything mandatory, make education mandatory," said Dr. Mark Russi, director of occupational health at Yale-New Haven Hospital in Connecticut and a member of the American College's Council of Scientific Advisors.
"It's important to make sure you're reaching everyone in an appropriate way and explaining that this is not a hazardous vaccine and that it's generally 70 to 90 percent effective."
A mandate can seem faster to implement than an education effort, and states may follow the example of New York.
The New York regulation, which took effect Aug. 13, requires hospitals and other health care facilities to provide proof that their workers are vaccinated, or face fines of $2,000 for the first offense and up to $5,000 for subsequent offenses, said state health department spokeswoman Claire Pospisil.
The regulation was opposed by the New York State Nurses Association, which objected to the law's lack of provisions for health care workers who don't want the vaccine for religious or philosophical reasons.
The association says it supports health care workers being immunized, but opposes mandatory policies, a position that may complicate the spread of initiatives like the one at CAMC.
Virginia Mason Medical Center in Seattle is cited by many, including CAMC's Lee, as a national model in vaccination policies for its workers. In 2004, it decided to require seasonal flu vaccinations, but that policy was successfully challenged by the union representing nurses at the hospital.
The nurses objected not to the vaccinations, but to what they said was a change in the terms of employment covered under the collective bargaining agreement, and an arbitrator agreed.
Despite that, Virginia Mason has maintained a vaccination rate among workers of 99 percent or so for the last four seasons, said Dr. Joyce Lammert, chief of the Department of Medicine.
The hospital has also found a side benefit.
Vaccinating thousands of people in a short period of time is a good way to establish procedures that may be used in the event of a pandemic, Lammert said.
Fears of a pandemic, particularly tied to the swine flu virus, are spurring renewed discussion of mandatory vaccine polices around the country, Russi said.
A vaccine for swine flu won't be available until this fall, though, and making it mandatory would mean addressing the concerns of many that it could be unsafe.
Even hospitals encouraging the seasonal flu vaccine have to address fears that it will make recipients sick, or that it's not necessary for young, healthy people.
Those objections, along with religious or philosophical concerns, have made many health care facilities wary of instituting a mandatory policy, the AHA's Bentley said.
"Most institutions I have familiarity with say, 'We aren't going to require it because that gets into all kinds of other issues and we don't have time to take those on,'" he said.
Missouri veteran injured by vaccine ineligible for benefit:
http://www.kansascity.com/105/story/1415095.html
By DAVID GOLDSTEIN
The Star’s Washington correspondent
Missouri State University sophomore Josef Lopez has been unsuccessful in his attempts to collect a special GI benefit of up to $100,000 for injuries caused by a smallpox vaccine.
WASHINGTON | It wasn’t a bullet or roadside bomb that felled Lance Cpl. Josef Lopez three years ago, after just nine days in Iraq.
It was an injection into his arm before his Marine Corps unit left the United States.
It left Lopez in a coma, paralyzed and unable for a time to breathe on his own. He can walk now, but with a limp. He has to wear a urine bag, has short-term memory loss and must swallow 15 pills daily to control leg spasms and other ailments.
Yet the Springfield, Mo., man does not qualify for a special GI benefit of up to $100,000 for troops who suffer traumatic injuries.
Seemed “pretty traumatic to me,” Lopez said.
“I could have easily died or not been able to walk because of that. It destroyed my world.”
Lopez suffered a rare reaction to the smallpox vaccine. The vaccine is not mandatory, but the military strongly encourages troops to take it.
Even though his medical problems would not have occurred had he not been deployed, the benefit was denied.
Never mind that qualifying injuries don’t have be the result of combat, that a service member could be eligible because of a car accident on the way to the grocery store.
The hang-up? His injuries were caused by a vaccine.
Just following what is considered to be the intent of Congress, say officials at the Department of Veterans Affairs.
The benefit is “for traumatic injury, not disease, not illness, not preventive medicine,” said Stephen Wurtz, deputy assistant director for insurance. “It has nothing to do with not believing these people deserve some compensation for their losses.”
The VA was unable to say how many claims have been rejected because of vaccine-related injuries. Wurtz and others familiar with the program said it wasn’t many.
The Military Vaccine Agency, which oversees the troop vaccinations, did not respond to repeated requests for comment.
Sen. Claire McCaskill, a Missouri Democrat and a member of the Armed Services Committee, has drafted a bill named after Lopez to widen the program to include vaccine-related injuries.
She became aware of his case when he and his mother stopped by her Senate office last year. Lopez had come to Washington to compete in the wheelchair portion of the Marine Corps Marathon.
“The (benefit) program was created with a broad mandate to provide financial assistance to folks with serious injuries and given to VA to determine the outlines,” said Stephen Hedger, McCaskill’s legislative director and an Army veteran of Iraq. “It took a narrower approach and defined in greater detail what injuries and illnesses qualified for payment.
“Our view is it was way too narrow.”
The program is called Traumatic Servicemember Group Life Insurance; TSGLI for short. Congress created it in 2005 — retroactive to Oct. 1, 2001 — to provide short-term financial help to severely injured service members until their disability benefits kick in.
The money comes from a $1 fee each month on top of the regular military life insurance premium.
The compensation is intended to cover expenses such as the costs of having a family member temporarily relocate near a military hospital where a loved one is recovering. Another cost could be retrofitting a service member’s home to accommodate a wheelchair or other medical equipment.
As of July 1, the program had granted nearly 6,700 claims, a 63 percent approval rate, and paid $394 million in compensation, Wurtz said.
Lopez seemed to fit the profile. His injuries affected his normal daily activities, one of the hurdles to clear for coverage.
While Lopez’s health insurance through the military has covered all of his medical expenses and the VA has paid for his medical costs since he was discharged in June, his family has faced financial hardship.
His mother, Barbara Lopez, took a leave from her job as a high school secretary to move to Maryland to be with him during his six weeks at the National Naval Medical Center in Bethesda, Md. But she had to give up a part-time job as a cashier.
They also had to build a ramp and widen a door to accommodate his wheelchair at her home in Springfield, where he spent his recovery.
Barbara Lopez said she heard about TSGLI from families of other injured troops at Bethesda. Unlike theirs, her son’s application was turned down. She still can’t fathom it.
“In his spinal column, he has quite a bit of permanent scarring,” Barbara Lopez said. “He takes medication to help his legs. He can walk unassisted, but never far, and he can’t stand for very long. I kind of feel Joe was out there fighting the same fight they were. He should be just as eligible.”
The military began the smallpox vaccination program in 2003 because of post-Sept. 11, 2001, fears that terrorists might attack the U.S. with germ warfare. Plans for the invasion of Iraq were also under way. The military was concerned that Saddam Hussein might use biological weapons against American troops.
On rare occasions, as in Lopez’s case, the vaccine can be as dangerous as the disease. Side effects can range from a simple rash to swelling around the brain and heart, and even death.
Like the inoculation for anthrax, another pre-combat injection, troops are supposed to be informed of the side effects and told that taking the vaccine is optional. But many have said that it was made abundantly clear that refusing was not a good idea.
“No one said ‘no,’?” Lopez said. “I had no qualms. I had no reason not to.”
He enlisted in the Marines while still in high school. He said everyone ought to serve the country in some way. He was also looking for adventure and “knew I’d have lots of good stories.”
Lopez became a radio operator with a Marine Reserve unit out of Kansas City. He was sent to the Gulf of Mexico in 2005 to help after Hurricane Katrina. A year later, in September 2006, he was in Iraq.
Even in the short time he was there, he experienced some close calls. But one night, less than two weeks into his tour, he started feeling as if he had the flu. Then he couldn’t sleep. He had trouble with his balance and couldn’t walk. He had to crawl on his hands and knees to the latrine.
Within days, he was taken to hospitals in Iraq and Germany. Doctors placed him in a drug-induced coma. He didn’t wake up until Bethesda.
That was three years ago. Now Lopez has his own place and is a sophomore at Missouri State University in Springfield. He is thinking about graduate school, about teaching.
“Before, I just kind of coasted,” Lopez said. “Now I know I take some things a lot more seriously. I’m more driven to succeed.”
He has had to go back the hospital a few times.
He is angry about what happened.
“It’s like I’m being penalized because I got the vaccine,” Lopez said.
By DAVID GOLDSTEIN
The Star’s Washington correspondent
Missouri State University sophomore Josef Lopez has been unsuccessful in his attempts to collect a special GI benefit of up to $100,000 for injuries caused by a smallpox vaccine.
WASHINGTON | It wasn’t a bullet or roadside bomb that felled Lance Cpl. Josef Lopez three years ago, after just nine days in Iraq.
It was an injection into his arm before his Marine Corps unit left the United States.
It left Lopez in a coma, paralyzed and unable for a time to breathe on his own. He can walk now, but with a limp. He has to wear a urine bag, has short-term memory loss and must swallow 15 pills daily to control leg spasms and other ailments.
Yet the Springfield, Mo., man does not qualify for a special GI benefit of up to $100,000 for troops who suffer traumatic injuries.
Seemed “pretty traumatic to me,” Lopez said.
“I could have easily died or not been able to walk because of that. It destroyed my world.”
Lopez suffered a rare reaction to the smallpox vaccine. The vaccine is not mandatory, but the military strongly encourages troops to take it.
Even though his medical problems would not have occurred had he not been deployed, the benefit was denied.
Never mind that qualifying injuries don’t have be the result of combat, that a service member could be eligible because of a car accident on the way to the grocery store.
The hang-up? His injuries were caused by a vaccine.
Just following what is considered to be the intent of Congress, say officials at the Department of Veterans Affairs.
The benefit is “for traumatic injury, not disease, not illness, not preventive medicine,” said Stephen Wurtz, deputy assistant director for insurance. “It has nothing to do with not believing these people deserve some compensation for their losses.”
The VA was unable to say how many claims have been rejected because of vaccine-related injuries. Wurtz and others familiar with the program said it wasn’t many.
The Military Vaccine Agency, which oversees the troop vaccinations, did not respond to repeated requests for comment.
Sen. Claire McCaskill, a Missouri Democrat and a member of the Armed Services Committee, has drafted a bill named after Lopez to widen the program to include vaccine-related injuries.
She became aware of his case when he and his mother stopped by her Senate office last year. Lopez had come to Washington to compete in the wheelchair portion of the Marine Corps Marathon.
“The (benefit) program was created with a broad mandate to provide financial assistance to folks with serious injuries and given to VA to determine the outlines,” said Stephen Hedger, McCaskill’s legislative director and an Army veteran of Iraq. “It took a narrower approach and defined in greater detail what injuries and illnesses qualified for payment.
“Our view is it was way too narrow.”
The program is called Traumatic Servicemember Group Life Insurance; TSGLI for short. Congress created it in 2005 — retroactive to Oct. 1, 2001 — to provide short-term financial help to severely injured service members until their disability benefits kick in.
The money comes from a $1 fee each month on top of the regular military life insurance premium.
The compensation is intended to cover expenses such as the costs of having a family member temporarily relocate near a military hospital where a loved one is recovering. Another cost could be retrofitting a service member’s home to accommodate a wheelchair or other medical equipment.
As of July 1, the program had granted nearly 6,700 claims, a 63 percent approval rate, and paid $394 million in compensation, Wurtz said.
Lopez seemed to fit the profile. His injuries affected his normal daily activities, one of the hurdles to clear for coverage.
While Lopez’s health insurance through the military has covered all of his medical expenses and the VA has paid for his medical costs since he was discharged in June, his family has faced financial hardship.
His mother, Barbara Lopez, took a leave from her job as a high school secretary to move to Maryland to be with him during his six weeks at the National Naval Medical Center in Bethesda, Md. But she had to give up a part-time job as a cashier.
They also had to build a ramp and widen a door to accommodate his wheelchair at her home in Springfield, where he spent his recovery.
Barbara Lopez said she heard about TSGLI from families of other injured troops at Bethesda. Unlike theirs, her son’s application was turned down. She still can’t fathom it.
“In his spinal column, he has quite a bit of permanent scarring,” Barbara Lopez said. “He takes medication to help his legs. He can walk unassisted, but never far, and he can’t stand for very long. I kind of feel Joe was out there fighting the same fight they were. He should be just as eligible.”
The military began the smallpox vaccination program in 2003 because of post-Sept. 11, 2001, fears that terrorists might attack the U.S. with germ warfare. Plans for the invasion of Iraq were also under way. The military was concerned that Saddam Hussein might use biological weapons against American troops.
On rare occasions, as in Lopez’s case, the vaccine can be as dangerous as the disease. Side effects can range from a simple rash to swelling around the brain and heart, and even death.
Like the inoculation for anthrax, another pre-combat injection, troops are supposed to be informed of the side effects and told that taking the vaccine is optional. But many have said that it was made abundantly clear that refusing was not a good idea.
“No one said ‘no,’?” Lopez said. “I had no qualms. I had no reason not to.”
He enlisted in the Marines while still in high school. He said everyone ought to serve the country in some way. He was also looking for adventure and “knew I’d have lots of good stories.”
Lopez became a radio operator with a Marine Reserve unit out of Kansas City. He was sent to the Gulf of Mexico in 2005 to help after Hurricane Katrina. A year later, in September 2006, he was in Iraq.
Even in the short time he was there, he experienced some close calls. But one night, less than two weeks into his tour, he started feeling as if he had the flu. Then he couldn’t sleep. He had trouble with his balance and couldn’t walk. He had to crawl on his hands and knees to the latrine.
Within days, he was taken to hospitals in Iraq and Germany. Doctors placed him in a drug-induced coma. He didn’t wake up until Bethesda.
That was three years ago. Now Lopez has his own place and is a sophomore at Missouri State University in Springfield. He is thinking about graduate school, about teaching.
“Before, I just kind of coasted,” Lopez said. “Now I know I take some things a lot more seriously. I’m more driven to succeed.”
He has had to go back the hospital a few times.
He is angry about what happened.
“It’s like I’m being penalized because I got the vaccine,” Lopez said.
H1N1 Vaccine to Be Offered At Airport Kiosks:
http://liveshots.blogs.foxnews.com/2009/08/28/h1n1-vaccine-takes-off/
H1N1 Vaccine Takes Off
August 28, 2009 - 12:46 PM | by: David Lewkowict
Atlanta based AeroClinic announced it will start offering the H1N1 flu shot to travellers at a series of concourse based kiosks at Hartsfield Jackson International Airport.
AeroClinic will have seven location set-up to offer the vaccine as soon as it becomes available. Starting September 15 the privately held company will begin offering the seasonal flu vaccine.
Dr Martin Cetron, of the Centers for Disease Control and Prevention says airports are a natural place for H1N1 to spread with thousands of inbound and outbound passengers in close proximity.
The CDC's Dr. Anne Shuchat says they are on track to have 45 million to 52 million units of the H1N1 vaccine available mid-October. Most Americans will need at lease 2 doses between 21 and 28 days apart.
H1N1 Vaccine Takes Off
August 28, 2009 - 12:46 PM | by: David Lewkowict
Atlanta based AeroClinic announced it will start offering the H1N1 flu shot to travellers at a series of concourse based kiosks at Hartsfield Jackson International Airport.
AeroClinic will have seven location set-up to offer the vaccine as soon as it becomes available. Starting September 15 the privately held company will begin offering the seasonal flu vaccine.
Dr Martin Cetron, of the Centers for Disease Control and Prevention says airports are a natural place for H1N1 to spread with thousands of inbound and outbound passengers in close proximity.
The CDC's Dr. Anne Shuchat says they are on track to have 45 million to 52 million units of the H1N1 vaccine available mid-October. Most Americans will need at lease 2 doses between 21 and 28 days apart.
Friday, August 28, 2009
Early and Current Fears about Vaccine Dangers:
http://www.globalresearch.ca/index.php?context=va&aid=14937
by Stephen Lendman
Global Research, August 28, 2009
Given today's hysteria over a non-existent Swine Flu threat and possible mandating of experimental, untested, toxic, and likely bioengineered vaccines, it's appropriate to review early fears about their dangers - when evidence first surfaced and concerns were raised.
In 1920, Charles Michael Higgins' "Horrors of Vaccination Exposed and Illustrated: Petition to the President to Abolish Compulsory Vaccination in Army and Navy" (now available in a new 2008 edition) issued a "Public Challenge to Health Departments" in citing "Deaths from Vaccination Denied and Concealed - More Deaths from Vaccination than from Smallpox," then continued:
"In order that there shall be no misunderstanding about the serious charge which I bring against vaccination, as being now actually more dangerous to public health and human life than natural smallpox, and the equally serious charge which I make against vaccinating doctors - who now control our Departments of Health and Vital Statistics - of denying and concealing these facts from the people, I now issue this special challenge" to the New York city and state authorities that "I will....prove from their death certificates and vital records, now concealed and withheld from the public, that there have been more deaths from vaccination than from smallpox in every year for the past fifteen years in the City and State of New York."
Calling compulsory vaccinations "medical barbarism," Higgins petitioned President Woodrow Wilson to stop mandating them for army and navy personnel. He cited facts he called shocking, including death certificates of primary school aged children "all killed in one week in September, 1915, from vaccination resulting in lockjaw and septicemia" and numerous others dead from "vaccine infection." Yet throughout 1915, only three people died from smallpox.
Higgins bluntly stated that:
"Compulsory disease as a condition for public schooling or for service in army and navy is medically barbarous and legally unconstitutional, and should be abolished." They violate the "right to life, health, and education..."
He asked Wilson to pardon court-martialed soldiers who refused non-consensual vaccinations, then imprisoned at "hard labor for twenty-five years!....for asserting (their) right to the medical sanctity of (their) own bod(ies)...."
He said that in the 1904 - 05 Russo-Japanese War, typhoid vaccinations weren't used. Instead, for almost the first time, modern, effective sanitation and hygiene practices were employed, and few soldiers experienced typhoid fever. But in the WW I Gallipoli campaign, English soldiers got typhoid vaccinations. Unsanitary conditions prevailed, and many succumbed to typhoid and other infectious diseases. In 1918 under conditions of poor sanitation for US forces, vaccinations proved ineffective in preventing "a high death-rate among the well vaccinated men."
On March 28, 1919, an official report from the Chief Surgeon of the AEF in the US Public Health was titled, "Typhoid Vaccination no Substitute for Sanitary Precautions."
Higgins quoted medical authorities admitting vaccination dangers and condemning their mandatory use. The 1913 edition of Osler's "Modern Medicine," Volume I stated:
"With the greatest care, however, certain (vaccination) risks are present and so it is unwise for the physician to force the operation upon those who are unwilling, or to give assurance of absolute harmlessness."
In 1889, the English Commission on Vaccination exhaustively studied the issue, published its findings in 1896, concluded that vaccinations were dangerous, and said laws making them compulsory should be repealed or modified. An enacted "conscientious clause" subsequently let parents exempt their children. Yet, contrary to fears at the time, smallpox greatly declined because of improved sanitation and good hygiene practices.
As early as the mid-19th century, books about vaccine dangers included Dr. Charles Schieferdecker's "Dr. CGG Nittinger's evils of vaccination" (1856), William Tebb's "Sanitation, not Vaccination the True Protection against Small-Pox" (1881), William White's "The Story of a Great Delusion" (1885), Alfred Russel Wallace's "Vaccination Proved Useless & Dangerous" (1889), Dr. Tenison Deane's "The Crime of Vaccination" (1913), and many others.
In his book, Higgins referred to vaccinations as the cause of "great epidemics of deadly disease in animals and mankind...." and cited government reports he called "notorious public facts."
"In October, November, and December, 1901, (a tetanus epidemic occurred) after vaccination(s were administered) in Camden, Philadelphia, and to a certain extent in near-by towns." Higgins wrote the Secretary of War citing proof "that there was a distinct medical and logical relation between influenza and vaccination, and that many serious diseases, including smallpox and cowpox, commence like influenza...."
The "wholesale and repeated vaccinations in the military camps throughout the world (suggested) that this vaccine infection had escaped....and was running wild as a world-wide epidemic infection," and to check it required all vaccinations be halted. He stressed what he called "no mere hypothesis or theory, but rather a hard fact" borne out by "foot and mouth disease" epidemics in cattle and other animals, "some of which originated from two of the largest vaccine factories in this country," at the time in Philadelphia and Detroit.
He cited US Bureau of Animal Industry and US Department of Agriculture reports that clearly showed vaccine infection as the cause of the 1902 and 1908 epidemics, and the "strong suspicion" that later ones in 1914 and 1915 were as well.
He called for the abolition of "dangerous medical domination and monopoly which now controls our Departments," which had long abused public power, that denied "Medical Truth, Freedom and Progress (and) which should no longer be tolerated." He urged that compulsory army and navy personnel vaccinations be abolished, replaced solely by voluntary ones.
He said "the practice of inflicting on the human body a compulsory medical disease, which is dangerous to the health and life and causes many deaths every year, is obviously illegal and a medical crime on the people which must be suppressed." On September 17, 1919, he asked President Wilson to put a stop to "vaccination horrors and medical mendacities."
Vaccinations Given US Military Forces During Major Military Conflicts since 1775
From at least the 1770s to the present, inoculations were routinely used. From the American Revolution through the Spanish-American War, smallpox vaccinations were administered. In WW I, typhoid was added, and in WW II, shots were given for smallpox, typhoid, typhus, tetanus, cholera, diphtheria influenza, scarlet fever, plague, paratyphoid A and B, and yellow fever. The Korean War adopted the same regimen. Vietnam added immunizations for polio, tetanus-diphteria toxoids, measles and meningococcal.
For the Gulf War, still more were added for anthrax, botulinum, adenovirus types 4 and 7, hepatitis B, measles, mumps, and rubella (MMR), and rabies - a virtual toxic stew besides depleted uranium exposure that combined caused Gulf War syndrome, its devastating effects on many thousands of troops, yet the Pentagon denied it existed.
The Afghan and Iraq wars added varicella (chicken pox), hepatitis A, influenza, yellow fever, pneumococcal, plus the upcoming Swine Flu vaccine. In combination, US military forces now get a greater than ever toxic brew of up to 20 dangerous inoculations plus booster shots (including for diphtheria, tetanus, and pertussis DTaP) that assure damage to (or destruction of) their immune systems followed by serious health problems later on.
In 1919, Higgins called smallpox and typhoid inoculations "medical barbarism." Today it's at an intolerable level.
Confessions of a Medical Heretic
On April 16, 1988, a portion of a brief New York Times obituary read:
On April 5, "Dr. Robert S. Mendelsohn, a physician, author and critic of the medical establishment, died after a brief illness....He was 61 years old." Besides teaching at the University of Illinois and Northwestern University, he was best known as "The People's Doctor" and for his 1979 bestseller, "Confessions of a Medical Heretic," in which he cautioned against "the harmful impact upon your life of doctors, drugs and hospitals."
In a November 1984 East West Journal article, he called immunizations a "medical time bomb," and (as a paediatrician) said the "greatest threat to childhood diseases lies in the dangerous and ineffectual efforts made to prevent them." He referred to deceptive marketing practices and called paediatricians objecting to their "bread and butter" the equivalent of a priest denying the infallibility of the Pope.
He urged parents to reject all inoculations for their children, but explained that in many states they're mandatory. He administered them early in his practice, but later stopped "because of the myriad hazards they present." He summarized his concerns as follows:
-- no evidence confirms that vaccinations eliminate childhood diseases;
-- the Salk and Sabin polio vaccines don't work and cited Jonas Salk later admitting that mass inoculations caused an epidemic after 1961;
-- smallpox vaccinations are "the only source of smallpox-related deaths for three decades after the disease had disappeared;"
-- significant inoculation risks are real; parents should avoid them when possible;
-- doctors are derelict for not explaining their hazards and for "defend(ing) them to the death;"
-- a "myriad (of known) short-term hazards (exist but) no one knows the long-term consequences of injecting foreign (substances) into the bod(ies) of your child(ren);"
-- even more shocking is that "no one is making any structured effort to find out," yet
-- suspicions now confirm that mass-inoculations dramatically increase autoimmune and neurological diseases, including leukemia, rheumatoid arthritis, multiple sclerosis, heart disease, and numerous others ranging from annoying to lethal;
-- he asked: "Have we traded mumps and measles for cancer and leukemia," and blamed vaccinations for their destructive harm, including thousands of annual SIDS (sudden infant death syndrome) deaths; and
-- he said the best way to protect children is make sure they're not vaccinated.
Doctors Speak Out on Vaccine Dangers
The Merck Manual (first published in 1899, now available in a Home Edition) warns individuals with B and/or T cell immunodeficiencies to avoid live-virus vaccines (the main ingredient in ones produced by Novartis, GlaxoSmithKline, and perhaps others) due to the risk of severe or fatal infections. Immunodeficiencies include common food allergies, inhalant ones, eczema, dermatitis, neurological deterioration and heart disease. Vaccines may be lethal for people with these conditions because their immune systems can't produce a healthy reaction to the viral assault on them. Getting it may induce illnesses they're intended to prevent and many other potentially deadly ones.
It's no surprise that many doctors, earlier and now, share Mendelsohn's concerns and state them.
On April 2, 2002 in the London Telegraph, autism specialist Dr. Kenneth Aitken said: "When I was in training, one in 2,500 (children were autistic). Now it is one in 250. At the moment, the only logical explanation for this is MMR" immunizations.
On April 27, 1979, at the American Society of Microbiology meeting, a paper by Drs. Anthony Morris, John Chriss, and BG Young titled, "Occurrence of Measles in Previously Vaccinated Individuals" concluded that "By the (US) government's own admission, there has been a 41% failure rate in persons who were previously vaccinated against the (measles) virus."
A 1993 British Medical Journal article stated: "In 1993 a high court judge in the UK decided that it was impossible to know the exact contents of vaccines and that science had no idea what the cocktails of chemicals, contaminants and heavy metals contained in vaccines could do to the human body, or why they would work to prevent disease."
Dr. J. Anthony Morris, former FDA Vaccine Control head said: "There is a great deal of evidence to prove that immunization of children does more harm than good." He concluded that "There is no evidence that any influenza vaccine thus far developed is effective in preventing or mitigating any attack of influenza. The producers of these vaccines know that they are worthless, but they go on selling them anyway."
Professor LC Vincent, Bioelectronics founder, said "Vaccines DO predispose to cancer and leukemia."
In December 1985, Dr. Albert Sabin, discoverer of the oral polio vaccine, admitted that "Official data have shown that the large-scale vaccinations undertaken in the US have failed to obtain any significant improvement of the diseases against which they were supposed to provide protection."
The National Institute of Health's (NIH) Dr. James A. Shannon said that "The only wholly safe vaccine is a vaccine that is never used."
Professor Ari Zukerman of the World Health Organization (WHO) stated: "Immunization against smallpox is more hazardous than the disease itself."
Dr. Paul Frame in the Journal of Family Practice believes "There is insufficient evidence to support routine vaccination of healthy persons of any age."
Dr. John B. Classen stated that his "data proves that the studies used to support immunization are so flawed that it is impossible to say if immunization provides a net benefit to anyone or to society in general."
Dr. Gerhard Buchwald concluded from the results of 150 trials that "Vaccination is not necessary, not useful, (and) does not protect. There are twice as many casualties from vaccination as from AIDS."
The Association of American Physicians & Surgeons stated that "Public policy regarding vaccines is fundamentally flawed. It is permeated by conflicts of interest. It is based on poor scientific methodology (and it's) insulated from independent criticism."
In his book, "Health and Nutrition Secrets," Dr. Russell L. Blaylock wrote: "Multiple vaccinations, especially in newborns, are another major source of childhood mercury exposure because of the mercury-containing thimerosal preservative. Over twenty-two vaccinations are now recommended for children before the age of two! Effects of exposure can vary from subtle to major malformations but even minor degrees of maldevelopment can have unacceptable consequences."
Blaylock called flu vaccinations, especially for the elderly, "criminal" because of known substance dangers in them, including methylmercury, phenylmercury, ethylmercury, and aluminum that remain in the nervous system for decades and damage it.
According to the WHO, "The best vaccine against common infectious diseases (is) and adequate diet" along with good sanitation and hygiene practices.
Dr. Rebecca Carley calls vaccinations "The True Weapons of Mass Destruction Causing VIDS, Vaccine Induced Diseases."
Immunogeneticist Dr. Hugh Fudenberg concluded that individuals getting five consecutive flu shots between 1970 and 1980 (the time of his study) were 10 times more vulnerable to Alzheimer's disease than others receiving two or fewer shots. He cited dangerous mercury and aluminum ingredients that accumulate in the brain causing cognitive dysfunction.
Flu shots contain 25 micrograms of mercury. One microgram is considered toxic. By age two, most US children have received around 237 micrograms of mercury through vaccines alone.
Vaccines contain the following toxic and others substances:
-- thimerosal (mercury);
-- aluminum hydroxide and phosphate;
--ammonium sulfate;
-- amphotericin B,
-- animal tissues and fluids, including horse blood, rabbit brain, dog kidney, monkey kidney, chick embryo, chicken egg, duck egg, pig blood, and porcine (pig) protein/tissue;
-- calf serum and fetal bovine serum;
-- betapropiolactone;
-- macerated cancer cells;
-- formaldehyde;
-- formalin;
-- synthetic phenol;
-- gelatin and hydrolyzed gelatin;
-- glycerol;
-- human diploid cells (from aborted human fetal tissue);
-- MSG;
-- the anti-biotics neomycin and neomycin sulfate;
-- phenol red indicator disinfectant dye;
-- phenoxyethanol (antifreeze);
-- potassium monophosphate;
-- polymyxin B;
-- polysorbate 20 and 80;
-- residual MRC5 proteins;
-- sorbitol;
-- sucrose;
-- tri(n)butylphosphate;
-- VERO cells, a continuous line of monkey kidney cells linked to the SV-40 virus known to cause leukemia; and
-- washed sheep red blood cells.
One or a combinations of theses substances can play havoc with the human immune and neurological systems and cause deadly autoimmune and other diseases.
On August 15, a UK Mail Online article linked Swine Flu vaccines to a deadly nerve disorder called Guillan-Barre Syndrome (GBS). It cited a leaked letter from Britain's Health Protection Agency ahead of planned mass-vaccinations in the country. Sent to about 600 neurologists on July 29, it referred to America's 1976 killer virus Swine Flu scare, the urging then that everyone be vaccinated, and the millions who did with these results:
-- people died from the vaccine (from respiratory failure after severe paralysis), not Swine Flu;
-- 500 GBS cases were detected;
-- experts said the vaccine increased the GBS risk level eight-fold;
-- once the link was established, vaccinations were halted, but the damage was done after about 10 weeks of inoculations; and
-- the US government paid hundreds of millions of dollars to settle damage claims from thousands of victims.
UK press coverage currently describes concern over the government releasing a vaccine "of unknown safety," yet plans remain to proceed. According to Jackie Fletcher, founder of the vaccine support group Jabs: "The (UK) Government would not be anticipating (trouble) if they didn't think there was a (GBS) connection. What we've got is a massive guinea-pig trial."
In a July 26 rense.com article titled, "Startling New Evidence That The 'Swine Flu' Pandemic Is Man-Made," Dr. A. True Ott cited evidence showing that Novartis Pharmaceuticals "conspired with corrupt 'scientists' at the US Army Institute of Pathology, Ft. Detrick, Maryland, to create a 'novel' strain of weaponized 'influenza' virus by....'reverse engineering' the deadly 1918 killer strain (then) maliciously and surreptitiously releas(ing it globally) in March and April 2009 for the primary purpose of creating a panic-stricken world-wide demand for Novartis vaccine material."
Ott claims the vaccine will unleash "lethal waves of increasingly virulent and deadly disease, rather than to curtail and limit the existing outbreak" - for huge profits and "a massive and sudden (worldwide) depopulation" agenda.
He called the scheme much greater than Henry Kissinger's 1974 NSSM-200 diabolical plan for "the immediate reduction of world population" in the hundreds of millions.
In 1987, Dr. Maurice Hillerman, prominent vaccine expert and head of Merck's vaccine division admitted that mass inoculations in the 1950s and 1960s likely caused thousands of annual cancer deaths because the SV40 virus (from dead monkeys) contaminated the first polio vaccine. "According to Hillerman, MERCK KNEW THE VACCINES WERE INFECTED WITH SV40, but distributed them anyway."
Many other examples show that "live viruses in vaccines SPREAD....disease very effectively. When combined with SQUALENE ADJUVANT the virus becomes many times more potent and lethal."
Ott claims Novartis' patent application reveals "smoking gun" evidence. The company admitted that "their 'invented' vaccine will be effective because of ADVANCE KNOWLEDGE CONCERNING THE ORIGINS OF THE PANDEMIC FLU STRAIN THAT WAS 'REVERSE ENGINEERED'....Clearly the pandemic virus was not an act of nature. (It's) a conspiracy to commit mass murder" for profit.
Writing for Citizens for Legitimate Government (CLG), Dr. Andrew Bosworth sounded the alarm about "The Swine Flu Hoax," admitted its mysterious origins, expressed concern that it might be lethal, and suggested that it was either accidently or deliberately released by corporate or government sources to cause a global epidemic for profit and power.
He cited suspicions of doctors and scientists that Swine Flu was man-made because of its unique combination of viruses from different parts of the world. He mentioned spurious media and official reports of Swine Flu deaths, perhaps from conventional flu, another cause, or an unrelated medical condition. He called the US government's pandemic policy "ridiculous" and "repugnant," leaving people terrified and uninformed enough to react adversely to their own well-being.
Current News from Jane Burgermeister's theflucase.com
Burgermeister is the journalist who filed criminal charges against Baxter AG, Baxter International, and Avir Green Hills Biotechnology AG "for producing and distributing contaminated bird flu material this winter, alleging that this was a deliberate act to cause a pandemic, and also to profit" from it. In addition, she accused Austrian Health and other Ministry officials of knowledge and support of this practice, then later named Baxter, Novartis, Sanofi Aventis, world agencies (including the WHO, UN, and CDC), and high-level officials in Austria, other European countries, and America of conspiratorial involvement.
Her web site features the following recent reports:
-- on August 25, the UK Daily Mail said "Up to half of (British) family doctors do not want to be vaccinated against swine flu," and one-third of them said the vaccine was inadequately tested;
-- in Australia, "Leading infectious disease experts have called on the Federal Government to abandon its mass swine-flu vaccination plan because of fears the vaccine is a contamination risk that could spread blood-borne diseases;"
-- In Jacobson v. Commonwealth of Massachusetts (1905), the US Supreme Court ruled that the state could require people to be vaccinated for the common good; in April 2009, NECN.com reported that a possible new Massachusetts law (Bill 2028) will require compulsory vaccinations; those refusing face $1,000 a day fines or 30 days in prison; after the state senate unanimously passed it, Catherine Austin Fitts concluded that Boston's money men must be "very scared about something," given that the city is "the capital of equity investment;"
-- on August 25, Health Minister Ulla Schmidt admitted on German TV that the Swine Flu vaccination campaign was a hoax and the largest ever inoculation experiment in history; and
-- on August 22, Dr. Wolfgang Wogarg, chairman of the health committee in the German parliament and European Council, warned about potential Swine Flu vaccine safety. He said Novartis' vaccine contained cancerous animal cells, and emphasized peoples' fears over the disease from being inoculated. "It is a great business for the pharmaceutical industry," he told Neuen Presse. Swine flu is not very different from conventional flu, but the vaccine can have dangerous side effects.
Lessons from the 1976 Swine Flu Outbreak
Soldiers at Fort Dix, NJ were affected. About 240 became ill. One death was reported, but the illness never spread beyond the base, so it's curious why not. The US Centers for Disease Control and Prevention couldn't explain why the disease was contained or how it was introduced.
More curious is the current hype over person-to-person transmission when it didn't happen in 1976. Northwestern University's Immunology Professor Robert Lamb explains that isolated swine flu cases in humans aren't uncommon. "Every year, you will find some pig farmer somewhere who gets swine flu. But it usually doesn't transmit to his family," let alone to the surrounding area or beyond.
Several years ago, Texas A & M's head of microbial and molecular pathogenesis, John Quarles, isolated a swine flu virus in a student on campus. He took samples from him and about 100 others close to him. Not a single one of them was affected, and according to Quarles: "That's pretty classic for swine flu."
In research conducted by Dr. Pascal James Imperato, dean at SUNY's School of Public Health, he reported that "the 2009 H1N1 virus was less efficiently transmitted by droplet infection (inhalation of respiratory pathogens exhaled by someone infected) in ferrets compared to the seasonal human H1N1 virus. This is a significant finding as it indicates that the 2009 swine flu virus might not be as easily transmitted between humans as its seasonal counterpart" - unless it's bioengineered to make it contagious and deadly.
Conclusion
Swine Flu is a virus-induced respiratory illness in pigs. Few succumb and die, and humans are rarely infected, except occasionally among people having direct contact with infected animals. For most who do, symptoms are generally mild. Medications and other treatments aren't essential. The illness usually lasts from two to seven days, and most patients recover well on their own.
Currently, no global pandemic or public health emergency exists, nor does forensic evidence link H1N1 to reported deaths. Yet fear-mongering persists to convince people globally to submit voluntarily to dangerous, possibly deadly bioengineered, vaccines.
If large numbers of confirmed Swine Flu deaths occur, contrary to compelling scientific reasons why they should not, then serious investigation is called for to determine if inoculations, not H1N1, caused them, and whether corporate greed and government complicity are behind a sinister plot to distract world attention from a deepening global depression, enrich drug companies hugely, and depopulate nations in numbers too horrifying to imagine - or as some observers put it, "depopulation by inoculation."
Stephen Lendman is a Research Associate of the Centre for Research on Globalization. He lives in Chicago and can be reached at lendmanstephen@sbcglobal.net
Also visit his blog site at sjlendman.blogspot.com and listen to The Global Research News Hour on RepublicBroadcasting.org Monday - Friday at 10AM US Central time for cutting-edge discussions with distinguished guests on world and national issues. All programs are archived for easy listening.
by Stephen Lendman
Global Research, August 28, 2009
Given today's hysteria over a non-existent Swine Flu threat and possible mandating of experimental, untested, toxic, and likely bioengineered vaccines, it's appropriate to review early fears about their dangers - when evidence first surfaced and concerns were raised.
In 1920, Charles Michael Higgins' "Horrors of Vaccination Exposed and Illustrated: Petition to the President to Abolish Compulsory Vaccination in Army and Navy" (now available in a new 2008 edition) issued a "Public Challenge to Health Departments" in citing "Deaths from Vaccination Denied and Concealed - More Deaths from Vaccination than from Smallpox," then continued:
"In order that there shall be no misunderstanding about the serious charge which I bring against vaccination, as being now actually more dangerous to public health and human life than natural smallpox, and the equally serious charge which I make against vaccinating doctors - who now control our Departments of Health and Vital Statistics - of denying and concealing these facts from the people, I now issue this special challenge" to the New York city and state authorities that "I will....prove from their death certificates and vital records, now concealed and withheld from the public, that there have been more deaths from vaccination than from smallpox in every year for the past fifteen years in the City and State of New York."
Calling compulsory vaccinations "medical barbarism," Higgins petitioned President Woodrow Wilson to stop mandating them for army and navy personnel. He cited facts he called shocking, including death certificates of primary school aged children "all killed in one week in September, 1915, from vaccination resulting in lockjaw and septicemia" and numerous others dead from "vaccine infection." Yet throughout 1915, only three people died from smallpox.
Higgins bluntly stated that:
"Compulsory disease as a condition for public schooling or for service in army and navy is medically barbarous and legally unconstitutional, and should be abolished." They violate the "right to life, health, and education..."
He asked Wilson to pardon court-martialed soldiers who refused non-consensual vaccinations, then imprisoned at "hard labor for twenty-five years!....for asserting (their) right to the medical sanctity of (their) own bod(ies)...."
He said that in the 1904 - 05 Russo-Japanese War, typhoid vaccinations weren't used. Instead, for almost the first time, modern, effective sanitation and hygiene practices were employed, and few soldiers experienced typhoid fever. But in the WW I Gallipoli campaign, English soldiers got typhoid vaccinations. Unsanitary conditions prevailed, and many succumbed to typhoid and other infectious diseases. In 1918 under conditions of poor sanitation for US forces, vaccinations proved ineffective in preventing "a high death-rate among the well vaccinated men."
On March 28, 1919, an official report from the Chief Surgeon of the AEF in the US Public Health was titled, "Typhoid Vaccination no Substitute for Sanitary Precautions."
Higgins quoted medical authorities admitting vaccination dangers and condemning their mandatory use. The 1913 edition of Osler's "Modern Medicine," Volume I stated:
"With the greatest care, however, certain (vaccination) risks are present and so it is unwise for the physician to force the operation upon those who are unwilling, or to give assurance of absolute harmlessness."
In 1889, the English Commission on Vaccination exhaustively studied the issue, published its findings in 1896, concluded that vaccinations were dangerous, and said laws making them compulsory should be repealed or modified. An enacted "conscientious clause" subsequently let parents exempt their children. Yet, contrary to fears at the time, smallpox greatly declined because of improved sanitation and good hygiene practices.
As early as the mid-19th century, books about vaccine dangers included Dr. Charles Schieferdecker's "Dr. CGG Nittinger's evils of vaccination" (1856), William Tebb's "Sanitation, not Vaccination the True Protection against Small-Pox" (1881), William White's "The Story of a Great Delusion" (1885), Alfred Russel Wallace's "Vaccination Proved Useless & Dangerous" (1889), Dr. Tenison Deane's "The Crime of Vaccination" (1913), and many others.
In his book, Higgins referred to vaccinations as the cause of "great epidemics of deadly disease in animals and mankind...." and cited government reports he called "notorious public facts."
"In October, November, and December, 1901, (a tetanus epidemic occurred) after vaccination(s were administered) in Camden, Philadelphia, and to a certain extent in near-by towns." Higgins wrote the Secretary of War citing proof "that there was a distinct medical and logical relation between influenza and vaccination, and that many serious diseases, including smallpox and cowpox, commence like influenza...."
The "wholesale and repeated vaccinations in the military camps throughout the world (suggested) that this vaccine infection had escaped....and was running wild as a world-wide epidemic infection," and to check it required all vaccinations be halted. He stressed what he called "no mere hypothesis or theory, but rather a hard fact" borne out by "foot and mouth disease" epidemics in cattle and other animals, "some of which originated from two of the largest vaccine factories in this country," at the time in Philadelphia and Detroit.
He cited US Bureau of Animal Industry and US Department of Agriculture reports that clearly showed vaccine infection as the cause of the 1902 and 1908 epidemics, and the "strong suspicion" that later ones in 1914 and 1915 were as well.
He called for the abolition of "dangerous medical domination and monopoly which now controls our Departments," which had long abused public power, that denied "Medical Truth, Freedom and Progress (and) which should no longer be tolerated." He urged that compulsory army and navy personnel vaccinations be abolished, replaced solely by voluntary ones.
He said "the practice of inflicting on the human body a compulsory medical disease, which is dangerous to the health and life and causes many deaths every year, is obviously illegal and a medical crime on the people which must be suppressed." On September 17, 1919, he asked President Wilson to put a stop to "vaccination horrors and medical mendacities."
Vaccinations Given US Military Forces During Major Military Conflicts since 1775
From at least the 1770s to the present, inoculations were routinely used. From the American Revolution through the Spanish-American War, smallpox vaccinations were administered. In WW I, typhoid was added, and in WW II, shots were given for smallpox, typhoid, typhus, tetanus, cholera, diphtheria influenza, scarlet fever, plague, paratyphoid A and B, and yellow fever. The Korean War adopted the same regimen. Vietnam added immunizations for polio, tetanus-diphteria toxoids, measles and meningococcal.
For the Gulf War, still more were added for anthrax, botulinum, adenovirus types 4 and 7, hepatitis B, measles, mumps, and rubella (MMR), and rabies - a virtual toxic stew besides depleted uranium exposure that combined caused Gulf War syndrome, its devastating effects on many thousands of troops, yet the Pentagon denied it existed.
The Afghan and Iraq wars added varicella (chicken pox), hepatitis A, influenza, yellow fever, pneumococcal, plus the upcoming Swine Flu vaccine. In combination, US military forces now get a greater than ever toxic brew of up to 20 dangerous inoculations plus booster shots (including for diphtheria, tetanus, and pertussis DTaP) that assure damage to (or destruction of) their immune systems followed by serious health problems later on.
In 1919, Higgins called smallpox and typhoid inoculations "medical barbarism." Today it's at an intolerable level.
Confessions of a Medical Heretic
On April 16, 1988, a portion of a brief New York Times obituary read:
On April 5, "Dr. Robert S. Mendelsohn, a physician, author and critic of the medical establishment, died after a brief illness....He was 61 years old." Besides teaching at the University of Illinois and Northwestern University, he was best known as "The People's Doctor" and for his 1979 bestseller, "Confessions of a Medical Heretic," in which he cautioned against "the harmful impact upon your life of doctors, drugs and hospitals."
In a November 1984 East West Journal article, he called immunizations a "medical time bomb," and (as a paediatrician) said the "greatest threat to childhood diseases lies in the dangerous and ineffectual efforts made to prevent them." He referred to deceptive marketing practices and called paediatricians objecting to their "bread and butter" the equivalent of a priest denying the infallibility of the Pope.
He urged parents to reject all inoculations for their children, but explained that in many states they're mandatory. He administered them early in his practice, but later stopped "because of the myriad hazards they present." He summarized his concerns as follows:
-- no evidence confirms that vaccinations eliminate childhood diseases;
-- the Salk and Sabin polio vaccines don't work and cited Jonas Salk later admitting that mass inoculations caused an epidemic after 1961;
-- smallpox vaccinations are "the only source of smallpox-related deaths for three decades after the disease had disappeared;"
-- significant inoculation risks are real; parents should avoid them when possible;
-- doctors are derelict for not explaining their hazards and for "defend(ing) them to the death;"
-- a "myriad (of known) short-term hazards (exist but) no one knows the long-term consequences of injecting foreign (substances) into the bod(ies) of your child(ren);"
-- even more shocking is that "no one is making any structured effort to find out," yet
-- suspicions now confirm that mass-inoculations dramatically increase autoimmune and neurological diseases, including leukemia, rheumatoid arthritis, multiple sclerosis, heart disease, and numerous others ranging from annoying to lethal;
-- he asked: "Have we traded mumps and measles for cancer and leukemia," and blamed vaccinations for their destructive harm, including thousands of annual SIDS (sudden infant death syndrome) deaths; and
-- he said the best way to protect children is make sure they're not vaccinated.
Doctors Speak Out on Vaccine Dangers
The Merck Manual (first published in 1899, now available in a Home Edition) warns individuals with B and/or T cell immunodeficiencies to avoid live-virus vaccines (the main ingredient in ones produced by Novartis, GlaxoSmithKline, and perhaps others) due to the risk of severe or fatal infections. Immunodeficiencies include common food allergies, inhalant ones, eczema, dermatitis, neurological deterioration and heart disease. Vaccines may be lethal for people with these conditions because their immune systems can't produce a healthy reaction to the viral assault on them. Getting it may induce illnesses they're intended to prevent and many other potentially deadly ones.
It's no surprise that many doctors, earlier and now, share Mendelsohn's concerns and state them.
On April 2, 2002 in the London Telegraph, autism specialist Dr. Kenneth Aitken said: "When I was in training, one in 2,500 (children were autistic). Now it is one in 250. At the moment, the only logical explanation for this is MMR" immunizations.
On April 27, 1979, at the American Society of Microbiology meeting, a paper by Drs. Anthony Morris, John Chriss, and BG Young titled, "Occurrence of Measles in Previously Vaccinated Individuals" concluded that "By the (US) government's own admission, there has been a 41% failure rate in persons who were previously vaccinated against the (measles) virus."
A 1993 British Medical Journal article stated: "In 1993 a high court judge in the UK decided that it was impossible to know the exact contents of vaccines and that science had no idea what the cocktails of chemicals, contaminants and heavy metals contained in vaccines could do to the human body, or why they would work to prevent disease."
Dr. J. Anthony Morris, former FDA Vaccine Control head said: "There is a great deal of evidence to prove that immunization of children does more harm than good." He concluded that "There is no evidence that any influenza vaccine thus far developed is effective in preventing or mitigating any attack of influenza. The producers of these vaccines know that they are worthless, but they go on selling them anyway."
Professor LC Vincent, Bioelectronics founder, said "Vaccines DO predispose to cancer and leukemia."
In December 1985, Dr. Albert Sabin, discoverer of the oral polio vaccine, admitted that "Official data have shown that the large-scale vaccinations undertaken in the US have failed to obtain any significant improvement of the diseases against which they were supposed to provide protection."
The National Institute of Health's (NIH) Dr. James A. Shannon said that "The only wholly safe vaccine is a vaccine that is never used."
Professor Ari Zukerman of the World Health Organization (WHO) stated: "Immunization against smallpox is more hazardous than the disease itself."
Dr. Paul Frame in the Journal of Family Practice believes "There is insufficient evidence to support routine vaccination of healthy persons of any age."
Dr. John B. Classen stated that his "data proves that the studies used to support immunization are so flawed that it is impossible to say if immunization provides a net benefit to anyone or to society in general."
Dr. Gerhard Buchwald concluded from the results of 150 trials that "Vaccination is not necessary, not useful, (and) does not protect. There are twice as many casualties from vaccination as from AIDS."
The Association of American Physicians & Surgeons stated that "Public policy regarding vaccines is fundamentally flawed. It is permeated by conflicts of interest. It is based on poor scientific methodology (and it's) insulated from independent criticism."
In his book, "Health and Nutrition Secrets," Dr. Russell L. Blaylock wrote: "Multiple vaccinations, especially in newborns, are another major source of childhood mercury exposure because of the mercury-containing thimerosal preservative. Over twenty-two vaccinations are now recommended for children before the age of two! Effects of exposure can vary from subtle to major malformations but even minor degrees of maldevelopment can have unacceptable consequences."
Blaylock called flu vaccinations, especially for the elderly, "criminal" because of known substance dangers in them, including methylmercury, phenylmercury, ethylmercury, and aluminum that remain in the nervous system for decades and damage it.
According to the WHO, "The best vaccine against common infectious diseases (is) and adequate diet" along with good sanitation and hygiene practices.
Dr. Rebecca Carley calls vaccinations "The True Weapons of Mass Destruction Causing VIDS, Vaccine Induced Diseases."
Immunogeneticist Dr. Hugh Fudenberg concluded that individuals getting five consecutive flu shots between 1970 and 1980 (the time of his study) were 10 times more vulnerable to Alzheimer's disease than others receiving two or fewer shots. He cited dangerous mercury and aluminum ingredients that accumulate in the brain causing cognitive dysfunction.
Flu shots contain 25 micrograms of mercury. One microgram is considered toxic. By age two, most US children have received around 237 micrograms of mercury through vaccines alone.
Vaccines contain the following toxic and others substances:
-- thimerosal (mercury);
-- aluminum hydroxide and phosphate;
--ammonium sulfate;
-- amphotericin B,
-- animal tissues and fluids, including horse blood, rabbit brain, dog kidney, monkey kidney, chick embryo, chicken egg, duck egg, pig blood, and porcine (pig) protein/tissue;
-- calf serum and fetal bovine serum;
-- betapropiolactone;
-- macerated cancer cells;
-- formaldehyde;
-- formalin;
-- synthetic phenol;
-- gelatin and hydrolyzed gelatin;
-- glycerol;
-- human diploid cells (from aborted human fetal tissue);
-- MSG;
-- the anti-biotics neomycin and neomycin sulfate;
-- phenol red indicator disinfectant dye;
-- phenoxyethanol (antifreeze);
-- potassium monophosphate;
-- polymyxin B;
-- polysorbate 20 and 80;
-- residual MRC5 proteins;
-- sorbitol;
-- sucrose;
-- tri(n)butylphosphate;
-- VERO cells, a continuous line of monkey kidney cells linked to the SV-40 virus known to cause leukemia; and
-- washed sheep red blood cells.
One or a combinations of theses substances can play havoc with the human immune and neurological systems and cause deadly autoimmune and other diseases.
On August 15, a UK Mail Online article linked Swine Flu vaccines to a deadly nerve disorder called Guillan-Barre Syndrome (GBS). It cited a leaked letter from Britain's Health Protection Agency ahead of planned mass-vaccinations in the country. Sent to about 600 neurologists on July 29, it referred to America's 1976 killer virus Swine Flu scare, the urging then that everyone be vaccinated, and the millions who did with these results:
-- people died from the vaccine (from respiratory failure after severe paralysis), not Swine Flu;
-- 500 GBS cases were detected;
-- experts said the vaccine increased the GBS risk level eight-fold;
-- once the link was established, vaccinations were halted, but the damage was done after about 10 weeks of inoculations; and
-- the US government paid hundreds of millions of dollars to settle damage claims from thousands of victims.
UK press coverage currently describes concern over the government releasing a vaccine "of unknown safety," yet plans remain to proceed. According to Jackie Fletcher, founder of the vaccine support group Jabs: "The (UK) Government would not be anticipating (trouble) if they didn't think there was a (GBS) connection. What we've got is a massive guinea-pig trial."
In a July 26 rense.com article titled, "Startling New Evidence That The 'Swine Flu' Pandemic Is Man-Made," Dr. A. True Ott cited evidence showing that Novartis Pharmaceuticals "conspired with corrupt 'scientists' at the US Army Institute of Pathology, Ft. Detrick, Maryland, to create a 'novel' strain of weaponized 'influenza' virus by....'reverse engineering' the deadly 1918 killer strain (then) maliciously and surreptitiously releas(ing it globally) in March and April 2009 for the primary purpose of creating a panic-stricken world-wide demand for Novartis vaccine material."
Ott claims the vaccine will unleash "lethal waves of increasingly virulent and deadly disease, rather than to curtail and limit the existing outbreak" - for huge profits and "a massive and sudden (worldwide) depopulation" agenda.
He called the scheme much greater than Henry Kissinger's 1974 NSSM-200 diabolical plan for "the immediate reduction of world population" in the hundreds of millions.
In 1987, Dr. Maurice Hillerman, prominent vaccine expert and head of Merck's vaccine division admitted that mass inoculations in the 1950s and 1960s likely caused thousands of annual cancer deaths because the SV40 virus (from dead monkeys) contaminated the first polio vaccine. "According to Hillerman, MERCK KNEW THE VACCINES WERE INFECTED WITH SV40, but distributed them anyway."
Many other examples show that "live viruses in vaccines SPREAD....disease very effectively. When combined with SQUALENE ADJUVANT the virus becomes many times more potent and lethal."
Ott claims Novartis' patent application reveals "smoking gun" evidence. The company admitted that "their 'invented' vaccine will be effective because of ADVANCE KNOWLEDGE CONCERNING THE ORIGINS OF THE PANDEMIC FLU STRAIN THAT WAS 'REVERSE ENGINEERED'....Clearly the pandemic virus was not an act of nature. (It's) a conspiracy to commit mass murder" for profit.
Writing for Citizens for Legitimate Government (CLG), Dr. Andrew Bosworth sounded the alarm about "The Swine Flu Hoax," admitted its mysterious origins, expressed concern that it might be lethal, and suggested that it was either accidently or deliberately released by corporate or government sources to cause a global epidemic for profit and power.
He cited suspicions of doctors and scientists that Swine Flu was man-made because of its unique combination of viruses from different parts of the world. He mentioned spurious media and official reports of Swine Flu deaths, perhaps from conventional flu, another cause, or an unrelated medical condition. He called the US government's pandemic policy "ridiculous" and "repugnant," leaving people terrified and uninformed enough to react adversely to their own well-being.
Current News from Jane Burgermeister's theflucase.com
Burgermeister is the journalist who filed criminal charges against Baxter AG, Baxter International, and Avir Green Hills Biotechnology AG "for producing and distributing contaminated bird flu material this winter, alleging that this was a deliberate act to cause a pandemic, and also to profit" from it. In addition, she accused Austrian Health and other Ministry officials of knowledge and support of this practice, then later named Baxter, Novartis, Sanofi Aventis, world agencies (including the WHO, UN, and CDC), and high-level officials in Austria, other European countries, and America of conspiratorial involvement.
Her web site features the following recent reports:
-- on August 25, the UK Daily Mail said "Up to half of (British) family doctors do not want to be vaccinated against swine flu," and one-third of them said the vaccine was inadequately tested;
-- in Australia, "Leading infectious disease experts have called on the Federal Government to abandon its mass swine-flu vaccination plan because of fears the vaccine is a contamination risk that could spread blood-borne diseases;"
-- In Jacobson v. Commonwealth of Massachusetts (1905), the US Supreme Court ruled that the state could require people to be vaccinated for the common good; in April 2009, NECN.com reported that a possible new Massachusetts law (Bill 2028) will require compulsory vaccinations; those refusing face $1,000 a day fines or 30 days in prison; after the state senate unanimously passed it, Catherine Austin Fitts concluded that Boston's money men must be "very scared about something," given that the city is "the capital of equity investment;"
-- on August 25, Health Minister Ulla Schmidt admitted on German TV that the Swine Flu vaccination campaign was a hoax and the largest ever inoculation experiment in history; and
-- on August 22, Dr. Wolfgang Wogarg, chairman of the health committee in the German parliament and European Council, warned about potential Swine Flu vaccine safety. He said Novartis' vaccine contained cancerous animal cells, and emphasized peoples' fears over the disease from being inoculated. "It is a great business for the pharmaceutical industry," he told Neuen Presse. Swine flu is not very different from conventional flu, but the vaccine can have dangerous side effects.
Lessons from the 1976 Swine Flu Outbreak
Soldiers at Fort Dix, NJ were affected. About 240 became ill. One death was reported, but the illness never spread beyond the base, so it's curious why not. The US Centers for Disease Control and Prevention couldn't explain why the disease was contained or how it was introduced.
More curious is the current hype over person-to-person transmission when it didn't happen in 1976. Northwestern University's Immunology Professor Robert Lamb explains that isolated swine flu cases in humans aren't uncommon. "Every year, you will find some pig farmer somewhere who gets swine flu. But it usually doesn't transmit to his family," let alone to the surrounding area or beyond.
Several years ago, Texas A & M's head of microbial and molecular pathogenesis, John Quarles, isolated a swine flu virus in a student on campus. He took samples from him and about 100 others close to him. Not a single one of them was affected, and according to Quarles: "That's pretty classic for swine flu."
In research conducted by Dr. Pascal James Imperato, dean at SUNY's School of Public Health, he reported that "the 2009 H1N1 virus was less efficiently transmitted by droplet infection (inhalation of respiratory pathogens exhaled by someone infected) in ferrets compared to the seasonal human H1N1 virus. This is a significant finding as it indicates that the 2009 swine flu virus might not be as easily transmitted between humans as its seasonal counterpart" - unless it's bioengineered to make it contagious and deadly.
Conclusion
Swine Flu is a virus-induced respiratory illness in pigs. Few succumb and die, and humans are rarely infected, except occasionally among people having direct contact with infected animals. For most who do, symptoms are generally mild. Medications and other treatments aren't essential. The illness usually lasts from two to seven days, and most patients recover well on their own.
Currently, no global pandemic or public health emergency exists, nor does forensic evidence link H1N1 to reported deaths. Yet fear-mongering persists to convince people globally to submit voluntarily to dangerous, possibly deadly bioengineered, vaccines.
If large numbers of confirmed Swine Flu deaths occur, contrary to compelling scientific reasons why they should not, then serious investigation is called for to determine if inoculations, not H1N1, caused them, and whether corporate greed and government complicity are behind a sinister plot to distract world attention from a deepening global depression, enrich drug companies hugely, and depopulate nations in numbers too horrifying to imagine - or as some observers put it, "depopulation by inoculation."
Stephen Lendman is a Research Associate of the Centre for Research on Globalization. He lives in Chicago and can be reached at lendmanstephen@sbcglobal.net
Also visit his blog site at sjlendman.blogspot.com and listen to The Global Research News Hour on RepublicBroadcasting.org Monday - Friday at 10AM US Central time for cutting-edge discussions with distinguished guests on world and national issues. All programs are archived for easy listening.
British Medical Journal: Half Of Health Workers Reject H1N1 Vaccine:
http://www.bmj.com/cgi/content/abstract/339/aug25_2/b3391
Conclusions The willingness to accept pre-pandemic influenza vaccination was low, and no significant effect was observed with the change in WHO alert level. Further studies are required to elucidate the root cause of the low intention to accept pre-pandemic vaccination.
Conclusions The willingness to accept pre-pandemic influenza vaccination was low, and no significant effect was observed with the change in WHO alert level. Further studies are required to elucidate the root cause of the low intention to accept pre-pandemic vaccination.
Pandemic flu event staged:
http://www.pressargus.com/articles/2009/08/26/news/news02_082609.txt
by LAREIGN WARD, Press Argus-Courier Staff
Wednesday, August 26, 2009 10:10 AM CDT
Law enforcement joined with other emergency personnel, as well as local business and government leaders, for a Monday night exercise on how to react in case of a pandemic flu event.
The tabletop exercise was hosted by the Crawford County Local Emergency Planning Committee, the Crawford County Department of Emergency Management and the Crawford County Health Unit.
Jason Parks, chair of the planning committee, served as event facilitator. There were five modules, each of which offered up a hypothetical series of events for attendees to respond to and discuss.
Module A outlined the early stages of a new flu pandemic, dubbed H17N10, a combination of seasonal flu, the H1N1 virus and H5N1. While nationwide travel quarantines are issued by the Centers for Disease Control in late January, the new virus reaches the U.S. in March through a diplomat returning from the Phillippines. A vaccine is under development, with authorities hoping to have it available for distribution by October.
Parks told attendees that the new virus thrives in the summer and by September, all hospitals across the country are starting to fill up, including Summit Medical Center in Van Buren. Schools are shut down as the second wave of infection begins.
With an attack rate of 35 percent, 4,000 people are sickened in September, with thousands more expected to get sick over the coming months. The exercise expected 12 percent to be hospitalized, and two percent to die, with 60 percent of the sick 12 or under.
"What is the most important question you should be asking yourself in regards to your department or agency at this point?" Parks asked the attendees. He then gave each table a few minutes to talk among themselves and figure things out.
At one table, Donald Baltz with the Van Buren Fire Department referred to the tiered allocation for vaccines that's recommended in severe pandemics. The tier recommends protecting those who are "essential to the pandemic response and provide care for persons who are ill."
"We're on the critical list," Baltz said. "Hopefully we would have gotten our people inoculated."
Crawford County Sheriff's Office Cpl. Aaron Beshears mentioned mutual aid agreements with other agencies as a way to fill in the gap, but also said every agency will be understaffed because of the pandemic.
Also at the table was Van Buren Deputy Superintendent Lonnie Myers, who did some quick math to estimate just how many Van Buren students would be stricken.
"Worst-case scenario, we'd have about 3,000 kids sick," Myers said. "That's a lot of kids, isn't it? That's 60 percent of elementary and 40 percent of secondary (students) that we're talking about."
After a few minutes, Parks halted the discussion and went around each table to ask what each group had decided.
"Our concern initially, on our very first question, is how do we protect our responders," Sgt. George Cabaniss with the Van Buren Police Department said. "They're the first people, because folks, if we go down, there's no one else."
Later, attendees had to deal with how to get the vaccine out to as many people as possible without infecting others. A flu clinic is scheduled to be held at a single location, the old National Guard Armory building in Van Buren. When a limited supply of the vaccine arrives with little advance warning, word starts to spread and people begin camping out at the armory to get a shot.
Crawford County Sheriff's Department Sgt. Shawn Firestine suggested moving the vaccine clinic to another location, setting up quietly to avoid the mob.
Some in the room questioned having the clinic at one location, especially considering the size of the large and panicked crowd.
"Keep in mind that this is a worst-case scenario," Parks said. "I'm doing my best to tie your hands behind your back."
The recent emergence of the 2009-H1N1 virus — sometimes referred to as swine flu — has brought disaster plans to the forefront on a local and national level. According to the CDC's Web site, more cases are anticipated during the fall and winter, although the severity of the situation is hard to anticipate at this point. The U.S. government is working with manufacturers to develop a vaccine, which should become available in the fall.
by LAREIGN WARD, Press Argus-Courier Staff
Wednesday, August 26, 2009 10:10 AM CDT
Law enforcement joined with other emergency personnel, as well as local business and government leaders, for a Monday night exercise on how to react in case of a pandemic flu event.
The tabletop exercise was hosted by the Crawford County Local Emergency Planning Committee, the Crawford County Department of Emergency Management and the Crawford County Health Unit.
Jason Parks, chair of the planning committee, served as event facilitator. There were five modules, each of which offered up a hypothetical series of events for attendees to respond to and discuss.
Module A outlined the early stages of a new flu pandemic, dubbed H17N10, a combination of seasonal flu, the H1N1 virus and H5N1. While nationwide travel quarantines are issued by the Centers for Disease Control in late January, the new virus reaches the U.S. in March through a diplomat returning from the Phillippines. A vaccine is under development, with authorities hoping to have it available for distribution by October.
Parks told attendees that the new virus thrives in the summer and by September, all hospitals across the country are starting to fill up, including Summit Medical Center in Van Buren. Schools are shut down as the second wave of infection begins.
With an attack rate of 35 percent, 4,000 people are sickened in September, with thousands more expected to get sick over the coming months. The exercise expected 12 percent to be hospitalized, and two percent to die, with 60 percent of the sick 12 or under.
"What is the most important question you should be asking yourself in regards to your department or agency at this point?" Parks asked the attendees. He then gave each table a few minutes to talk among themselves and figure things out.
At one table, Donald Baltz with the Van Buren Fire Department referred to the tiered allocation for vaccines that's recommended in severe pandemics. The tier recommends protecting those who are "essential to the pandemic response and provide care for persons who are ill."
"We're on the critical list," Baltz said. "Hopefully we would have gotten our people inoculated."
Crawford County Sheriff's Office Cpl. Aaron Beshears mentioned mutual aid agreements with other agencies as a way to fill in the gap, but also said every agency will be understaffed because of the pandemic.
Also at the table was Van Buren Deputy Superintendent Lonnie Myers, who did some quick math to estimate just how many Van Buren students would be stricken.
"Worst-case scenario, we'd have about 3,000 kids sick," Myers said. "That's a lot of kids, isn't it? That's 60 percent of elementary and 40 percent of secondary (students) that we're talking about."
After a few minutes, Parks halted the discussion and went around each table to ask what each group had decided.
"Our concern initially, on our very first question, is how do we protect our responders," Sgt. George Cabaniss with the Van Buren Police Department said. "They're the first people, because folks, if we go down, there's no one else."
Later, attendees had to deal with how to get the vaccine out to as many people as possible without infecting others. A flu clinic is scheduled to be held at a single location, the old National Guard Armory building in Van Buren. When a limited supply of the vaccine arrives with little advance warning, word starts to spread and people begin camping out at the armory to get a shot.
Crawford County Sheriff's Department Sgt. Shawn Firestine suggested moving the vaccine clinic to another location, setting up quietly to avoid the mob.
Some in the room questioned having the clinic at one location, especially considering the size of the large and panicked crowd.
"Keep in mind that this is a worst-case scenario," Parks said. "I'm doing my best to tie your hands behind your back."
The recent emergence of the 2009-H1N1 virus — sometimes referred to as swine flu — has brought disaster plans to the forefront on a local and national level. According to the CDC's Web site, more cases are anticipated during the fall and winter, although the severity of the situation is hard to anticipate at this point. The U.S. government is working with manufacturers to develop a vaccine, which should become available in the fall.
Judge denies group's bid to block flu vaccine:
http://www.google.com/hostednews/ap/article/ALeqM5g6ps0HG8PFhCNM4b97MjLcDpqnbAD9AAOA104
By NEDRA PICKLER (AP) – 19 hours ago
WASHINGTON — A judge on Wednesday denied an advocacy group's bid to prevent the government from giving pregnant women flu vaccines with a preservative that contains mercury.
Leaders of the Coalition for Mercury-Free Drugs say their effort took on a new urgency when a government advisory committee recently recommended that pregnant women be among the first people to get swine flu vaccinations when the vaccine becomes available this fall.
A small amount of the mercury-containing preservative thimerosal is in most influenza shots, including swine flu vaccines, but some are produced thimerosal-free. The coalition argued that pregnant women should only get the thimerosal-free version because of a risk that the mercury in the shot could poison a fetus and cause medical problems, including autism.
But U.S. District Judge Reggie Walton ruled against the group's request for a preliminary injunction because he said the group couldn't prove that pregnant women they represent would get vaccines containing thimerosal.
Walton said he would consider further written arguments in the next month about whether the lawsuit can continue.
Thimerosal used to be used in a number of vaccines, but manufacturers began removing the preservative from all routine child vaccines in 2001 as a precaution. But numerous large studies have shown no link between thimerosal and autism, or other health problems.
On the Net:
• Coalition for Mercury-Free Drugs: http://mercury-freedrugs.org/
• Background from Centers for Disease Control and Prevention: http://tinyurl.com/konff8
By NEDRA PICKLER (AP) – 19 hours ago
WASHINGTON — A judge on Wednesday denied an advocacy group's bid to prevent the government from giving pregnant women flu vaccines with a preservative that contains mercury.
Leaders of the Coalition for Mercury-Free Drugs say their effort took on a new urgency when a government advisory committee recently recommended that pregnant women be among the first people to get swine flu vaccinations when the vaccine becomes available this fall.
A small amount of the mercury-containing preservative thimerosal is in most influenza shots, including swine flu vaccines, but some are produced thimerosal-free. The coalition argued that pregnant women should only get the thimerosal-free version because of a risk that the mercury in the shot could poison a fetus and cause medical problems, including autism.
But U.S. District Judge Reggie Walton ruled against the group's request for a preliminary injunction because he said the group couldn't prove that pregnant women they represent would get vaccines containing thimerosal.
Walton said he would consider further written arguments in the next month about whether the lawsuit can continue.
Thimerosal used to be used in a number of vaccines, but manufacturers began removing the preservative from all routine child vaccines in 2001 as a precaution. But numerous large studies have shown no link between thimerosal and autism, or other health problems.
On the Net:
• Coalition for Mercury-Free Drugs: http://mercury-freedrugs.org/
• Background from Centers for Disease Control and Prevention: http://tinyurl.com/konff8
WHO warns of severe form of swine flu:
http://www.alertnet.org/thenews/newsdesk/N28370720.htm
28 Aug 2009 16:51:05 GMT
Source: Reuters
* Flu in Japan, spreading in South Africa, Bolivia
* Countries need to prepare emergency rooms for patients
* Sick young adults may overwhelm healthcare systems (Recasts and updates throughout with second WHO report)
By Maggie Fox, Health and Science Editor
WASHINGTON, Aug 28 (Reuters) - Doctors are reporting a severe form of swine flu that goes straight to the lungs, causing severe illness in otherwise healthy young people and requiring expensive hospital treatment, the World Health Organization said on Friday.
Some countries are reporting that as many as 15 percent of patients infected with the new H1N1 pandemic virus need hospital care, further straining already overburdened healthcare systems, WHO said in an update on the pandemic.
"During the winter season in the southern hemisphere, several countries have viewed the need for intensive care as the greatest burden on health services," it said.
"Preparedness measures need to anticipate this increased demand on intensive care units, which could be overwhelmed by a sudden surge in the number of severe cases."
Earlier, WHO reported that H1N1 had reached epidemic levels in Japan, signaling an early start to what may be a long influenza season this year, and that it was also worsening in tropical regions.
"Perhaps most significantly, clinicians from around the world are reporting a very severe form of disease, also in young and otherwise healthy people, which is rarely seen during seasonal influenza infections," WHO said.
"In these patients, the virus directly infects the lung, causing severe respiratory failure. Saving these lives depends on highly specialized and demanding care in intensive care units, usually with long and costly stays."
MINORITIES AT RISK
Minority groups and indigenous populations may also have a higher risk of being severely ill with H1N1.
"In some studies, the risk in these groups is four to five times higher than in the general population," WHO said.
"Although the reasons are not fully understood, possible explanations include lower standards of living and poor overall health status, including a high prevalence of conditions such as asthma, diabetes and hypertension."
WHO said it was advising countries in the Northern Hemisphere to prepare for a second wave of pandemic spread. "Countries with tropical climates, where the pandemic virus arrived later than elsewhere, also need to prepare for an increasing number of cases," it said.
Every year, seasonal flu infects between 5 percent and 20 percent of a given population and kills between 250,000 and 500,000 people globally. Because hardly anyone has immunity to the new H1N1 virus, experts believe it will infect far more people than usual, as much as a third of the population.
It also disproportionately affects younger people, unlike seasonal flu which mainly burdens the elderly, and thus may cause more severe illness and deaths among young adults and children than seasonal flu does.
"Data continue to show that certain medical conditions increase the risk of severe and fatal illness. These include respiratory disease, notably asthma, cardiovascular disease, diabetes and immunosuppression," WHO said.
"When anticipating the impact of the pandemic as more people become infected, health officials need to be aware that many of these predisposing conditions have become much more widespread in recent decades, thus increasing the pool of vulnerable people."
WHO estimates that more than 230 million people globally have asthma, and more than 220 million have diabetes. Obesity may also worsen the risk of severe infection, WHO said.
The good news -- people infected with AIDS virus do not seem to be at special risk from H1N1, WHO said. (Editing by Mohammad Zargham)
28 Aug 2009 16:51:05 GMT
Source: Reuters
* Flu in Japan, spreading in South Africa, Bolivia
* Countries need to prepare emergency rooms for patients
* Sick young adults may overwhelm healthcare systems (Recasts and updates throughout with second WHO report)
By Maggie Fox, Health and Science Editor
WASHINGTON, Aug 28 (Reuters) - Doctors are reporting a severe form of swine flu that goes straight to the lungs, causing severe illness in otherwise healthy young people and requiring expensive hospital treatment, the World Health Organization said on Friday.
Some countries are reporting that as many as 15 percent of patients infected with the new H1N1 pandemic virus need hospital care, further straining already overburdened healthcare systems, WHO said in an update on the pandemic.
"During the winter season in the southern hemisphere, several countries have viewed the need for intensive care as the greatest burden on health services," it said.
"Preparedness measures need to anticipate this increased demand on intensive care units, which could be overwhelmed by a sudden surge in the number of severe cases."
Earlier, WHO reported that H1N1 had reached epidemic levels in Japan, signaling an early start to what may be a long influenza season this year, and that it was also worsening in tropical regions.
"Perhaps most significantly, clinicians from around the world are reporting a very severe form of disease, also in young and otherwise healthy people, which is rarely seen during seasonal influenza infections," WHO said.
"In these patients, the virus directly infects the lung, causing severe respiratory failure. Saving these lives depends on highly specialized and demanding care in intensive care units, usually with long and costly stays."
MINORITIES AT RISK
Minority groups and indigenous populations may also have a higher risk of being severely ill with H1N1.
"In some studies, the risk in these groups is four to five times higher than in the general population," WHO said.
"Although the reasons are not fully understood, possible explanations include lower standards of living and poor overall health status, including a high prevalence of conditions such as asthma, diabetes and hypertension."
WHO said it was advising countries in the Northern Hemisphere to prepare for a second wave of pandemic spread. "Countries with tropical climates, where the pandemic virus arrived later than elsewhere, also need to prepare for an increasing number of cases," it said.
Every year, seasonal flu infects between 5 percent and 20 percent of a given population and kills between 250,000 and 500,000 people globally. Because hardly anyone has immunity to the new H1N1 virus, experts believe it will infect far more people than usual, as much as a third of the population.
It also disproportionately affects younger people, unlike seasonal flu which mainly burdens the elderly, and thus may cause more severe illness and deaths among young adults and children than seasonal flu does.
"Data continue to show that certain medical conditions increase the risk of severe and fatal illness. These include respiratory disease, notably asthma, cardiovascular disease, diabetes and immunosuppression," WHO said.
"When anticipating the impact of the pandemic as more people become infected, health officials need to be aware that many of these predisposing conditions have become much more widespread in recent decades, thus increasing the pool of vulnerable people."
WHO estimates that more than 230 million people globally have asthma, and more than 220 million have diabetes. Obesity may also worsen the risk of severe infection, WHO said.
The good news -- people infected with AIDS virus do not seem to be at special risk from H1N1, WHO said. (Editing by Mohammad Zargham)
"Stop the Shot" Emergency Citizens Petition:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27791
Support the "Stop the Shot" Emergency Citizens Petition:
This form is for Individuals wishing to Support the Petition.
For Organizations wishing to Support the Petition, go to:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27793
Led by such health freedom luminaries as Gary Null, PhD, Human Nutrition & Public Health Science, Rima E. Laibow, MD, Medical Director of the Natural Solutions Foundation, www.HealthFreedomUSA.org, and Dr. Tedd Koren, DC of Citizens for Health Choice, we filed a formal Citizens Petition to the FDA today expressing our serious concerns about the approval of dangerous Swine Flu vaccines BEFORE ANY SAFETY TESTING IS COMPLETED.
A Citizens Petition, unlike an internet petition, is a formal statement of grievance which challenges the government’s actions, asks for specific protection and redress, as provided for by the Constitution of These United States:
“Pursuant to the Constitution of the United States of America, First Amendment, Right to Petition for Redress of Grievances the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., and the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), to amend the FDA’s rules respecting the safety, effectiveness and availability of vaccines said to be useful for swine flu (A-H1N1-09)… ”
The goal of this regulatory intervention is to stop FDA’s headlong, dangerous and unjustified rush to approve the so-called “swine flu” vaccination, even before safety testing has been completed. If FDA fails to act on our Petition in a timely fashion, a Temporary Restraining Order (TRO) can be sought from the Federal Courts to stop the alleged “emergency” approval process.
The Petition details, in ten pages of carefully structured and well supported reasoning, the legal and factual basis for a formal stay of the approval process, citing issues of transparency and science-based decision making, which the President claims to be the hallmarks of his Administration. The FDA has failed to follow statutory and case law requirements for the emergency approval of these un-insurable, untested and unproven vaccines which have been recently cited for their potential dangers to health and safety here and abroad.
This Action Item allows you to register your support for the Emergency Citizens Petition and join in our efforts. You can add your own comments below.
Read the Media Announcement here: http://www.healthfreedomusa.org/?p=3312
Here is the Petition: http://www.healthfreedomusa.org/?p=3314
Thank you,
Bert Stubblebine (Maj Gen US Army, Ret.) President
Natural Solutions Foundation
PS - And remember, you can make your tax-deductible donations to support this effort at:
http://www.healthfreedomusa.org/?page_id=189
Support the "Stop the Shot" Emergency Citizens Petition:
This form is for Individuals wishing to Support the Petition.
For Organizations wishing to Support the Petition, go to:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27793
Led by such health freedom luminaries as Gary Null, PhD, Human Nutrition & Public Health Science, Rima E. Laibow, MD, Medical Director of the Natural Solutions Foundation, www.HealthFreedomUSA.org, and Dr. Tedd Koren, DC of Citizens for Health Choice, we filed a formal Citizens Petition to the FDA today expressing our serious concerns about the approval of dangerous Swine Flu vaccines BEFORE ANY SAFETY TESTING IS COMPLETED.
A Citizens Petition, unlike an internet petition, is a formal statement of grievance which challenges the government’s actions, asks for specific protection and redress, as provided for by the Constitution of These United States:
“Pursuant to the Constitution of the United States of America, First Amendment, Right to Petition for Redress of Grievances the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., and the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), to amend the FDA’s rules respecting the safety, effectiveness and availability of vaccines said to be useful for swine flu (A-H1N1-09)… ”
The goal of this regulatory intervention is to stop FDA’s headlong, dangerous and unjustified rush to approve the so-called “swine flu” vaccination, even before safety testing has been completed. If FDA fails to act on our Petition in a timely fashion, a Temporary Restraining Order (TRO) can be sought from the Federal Courts to stop the alleged “emergency” approval process.
The Petition details, in ten pages of carefully structured and well supported reasoning, the legal and factual basis for a formal stay of the approval process, citing issues of transparency and science-based decision making, which the President claims to be the hallmarks of his Administration. The FDA has failed to follow statutory and case law requirements for the emergency approval of these un-insurable, untested and unproven vaccines which have been recently cited for their potential dangers to health and safety here and abroad.
This Action Item allows you to register your support for the Emergency Citizens Petition and join in our efforts. You can add your own comments below.
Read the Media Announcement here: http://www.healthfreedomusa.org/?p=3312
Here is the Petition: http://www.healthfreedomusa.org/?p=3314
Thank you,
Bert Stubblebine (Maj Gen US Army, Ret.) President
Natural Solutions Foundation
PS - And remember, you can make your tax-deductible donations to support this effort at:
http://www.healthfreedomusa.org/?page_id=189
CDC States H1N1 Vaccine May Maim and Kill 30,000 Americans, FDA Requires Minimal Efficacy:
http://www.yourspine.com/Chiropractic/Swine%20Flu%20Vaccine%20to%20Maim%20and%20Kill.aspx
By Herb Newborg
[PLEASE SEE THE LIVE LINK FOR SUB-LINKS]
CDC says to assume 1 in every 100,000 vaccine recipients will suffer serious side effects, FDA only requires vaccine be effective in 3 out of 10 recipients.
The Center for Disease Control and Prevention (CDC) has officially stated that there will be as many as 30,000 serious, potentially lethal adverse reactions to the novel H1N1 vaccine, while the FDA guidelines for the novel H1N1 vaccine only require that it work in 3 out of every 10 recipients.
Last Saturday, I attended one of 10 “public engagement” meetings the CDC is holding across the country, utilizing a new model of public engagement designed to provide a public viewpoint or societal perspective on the topic at hand (mass vaccination) to the sponsor (in this case, the CDC).
Part of the process entails the sponsor (CDC) providing the following: “Information on the many sides of an issue is provided to the participants in a fair and balanced manner so that all participants become well-informed, and the overall group process is convened and managed in a neutral, respectful fashion.”
This requirement is met by providing an oral presentation in easy to understand language, a booklet summarizing the key facts needed and a discussion guide summarizing the choices faced.
The assembled group of 80 participants was shown a video, given a brief oral presentation and a printed discussion guide. We were asked to accept several assumptions in considering the topic. We were asked to assume that the severity would be similar to what had already been observed in the spring of 2009; we were told to assume that the vaccination program would be voluntary, not mandatory; we were told to assume that initial vaccine supplies will be available in October but supply would be limited through February 2010.
The most disturbing assumption we were asked to accept dealt with the safety of the novel H1N1 vaccine. In the video, the CDC spokesperson explained that during the 1976 mass vaccination campaign, 1 in every 100,000 recipients of the vaccine developed Guillain Barré syndrome (GBS), a disorder in which the body's immune system attacks the peripheral nervous system often leading to paralysis and death. There is no known cure for GBS.
In 1976 roughly 40 million Americans received the vaccine and some 4,000 developed GBS.
The printed material that was distributed reiterated these horrific statistics and we were asked to accept the assumption that, “the estimated risk for more serious reactions (e.g. Guillain Barré syndrome) is between 1-10 per million persons vaccinated”.
This is a less direct way of stating that the risk is about the same as existed during the 1976 mass vaccination attempt and that as many as 1 in every 100,000 recipients will develop GBS or some other serious adverse reaction. The CDC is setting up a new intensive surveillance system with which to monitor and track GBS cases that result from the novel H1N1 vaccine.
Merriam-Webster defines assumption as a fact or statement taken for granted and assumed to be true. If we accept the documented assumption presented by the CDC, we are to consider it a fact that 1 in every 100,000 vaccine recipients will suffer a serious adverse effect such as GBS.
This means that if the entire U.S. population is vaccinated (a stated goal of the CDC), we are to assume as a fact that 30,000 Americans will suffer debilitating or lethal side effects. Apparently the CDC considers this an acceptable level of collateral damage.
As unthinkable as this is (destroying or ending the lives of as many as 30,000 Americans), that is only part of the story.
The novel H1N1 vaccine being developed must adhere to guidelines set forth by the U.S. Food and Drug Administration (FDA). The FDA has announced that a vaccine will be accepted if it creates antibodies in 4 out of 10 recipients (40%), with at least 70 percent of those 4 achieving an antibody level believed to provide benefit. This means that an acceptable vaccine candidate would provide “protection” for 28% of vaccine recipients (70% of the 40%), or less than 3 in 10 recipients. The requirement drops to 18% efficacy for those over 65 years of age (60% of 30%).
So here are the facts, as documented by the CDC and the FDA:
As many as 30,000 Americans will be harmed by the novel H1N1 vaccine.
The vaccine may be ineffective in more than 7 out of 10 recipients.
And in case you think I am alone in my concerns, here is what several vaccine experts associated with the CDC and the U.S. government say on the subject.
"I am very skeptical of finishing vaccine before we know the appropriate dose to be included in each inoculation, before immunogenicity studies are complete, or before safety assessments have been finished," William Schaffner, MD, Chairman of the Department of Preventive Medicine at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices (ACIP), wrote in an recent e-mail.
"We have assured both the profession and the public that the H1N1 vaccine will be evaluated with the same rigor that is applied to seasonal vaccine. We should NOT make vaccine available before the trials are complete and the results carefully assessed."
Others are worried about a repeat of the last swine flu "pandemic," now regarded as a public health and public relations debacle.
"I fear that a rush towards vaccinating the population without completing trials risks leading to the harmful outcome that we witnessed during the 1976 swine flu scare, where the government advocated rapid production and vaccination of the population without adequate safeguards, which led to an unexplained increase in cases of Guillain Barré syndrome (GBS), amongst other complications, and massive liability for the government," wrote Amir Afkhami, MD, PhD, of George Washington University, an international expert on the 1918 Influenza pandemic and an advisor to the U.S. State Department, the U.S. military, and the World Bank on issues pertaining to infectious diseases, public health and, mental health.
"I think in this regard, we must learn from lessons of the past and be mindful of not jumping from the proverbial frying pan into the fire by putting people's health at risk without adequate production and safety monitoring of the vaccines."
By Herb Newborg
[PLEASE SEE THE LIVE LINK FOR SUB-LINKS]
CDC says to assume 1 in every 100,000 vaccine recipients will suffer serious side effects, FDA only requires vaccine be effective in 3 out of 10 recipients.
The Center for Disease Control and Prevention (CDC) has officially stated that there will be as many as 30,000 serious, potentially lethal adverse reactions to the novel H1N1 vaccine, while the FDA guidelines for the novel H1N1 vaccine only require that it work in 3 out of every 10 recipients.
Last Saturday, I attended one of 10 “public engagement” meetings the CDC is holding across the country, utilizing a new model of public engagement designed to provide a public viewpoint or societal perspective on the topic at hand (mass vaccination) to the sponsor (in this case, the CDC).
Part of the process entails the sponsor (CDC) providing the following: “Information on the many sides of an issue is provided to the participants in a fair and balanced manner so that all participants become well-informed, and the overall group process is convened and managed in a neutral, respectful fashion.”
This requirement is met by providing an oral presentation in easy to understand language, a booklet summarizing the key facts needed and a discussion guide summarizing the choices faced.
The assembled group of 80 participants was shown a video, given a brief oral presentation and a printed discussion guide. We were asked to accept several assumptions in considering the topic. We were asked to assume that the severity would be similar to what had already been observed in the spring of 2009; we were told to assume that the vaccination program would be voluntary, not mandatory; we were told to assume that initial vaccine supplies will be available in October but supply would be limited through February 2010.
The most disturbing assumption we were asked to accept dealt with the safety of the novel H1N1 vaccine. In the video, the CDC spokesperson explained that during the 1976 mass vaccination campaign, 1 in every 100,000 recipients of the vaccine developed Guillain Barré syndrome (GBS), a disorder in which the body's immune system attacks the peripheral nervous system often leading to paralysis and death. There is no known cure for GBS.
In 1976 roughly 40 million Americans received the vaccine and some 4,000 developed GBS.
The printed material that was distributed reiterated these horrific statistics and we were asked to accept the assumption that, “the estimated risk for more serious reactions (e.g. Guillain Barré syndrome) is between 1-10 per million persons vaccinated”.
This is a less direct way of stating that the risk is about the same as existed during the 1976 mass vaccination attempt and that as many as 1 in every 100,000 recipients will develop GBS or some other serious adverse reaction. The CDC is setting up a new intensive surveillance system with which to monitor and track GBS cases that result from the novel H1N1 vaccine.
Merriam-Webster defines assumption as a fact or statement taken for granted and assumed to be true. If we accept the documented assumption presented by the CDC, we are to consider it a fact that 1 in every 100,000 vaccine recipients will suffer a serious adverse effect such as GBS.
This means that if the entire U.S. population is vaccinated (a stated goal of the CDC), we are to assume as a fact that 30,000 Americans will suffer debilitating or lethal side effects. Apparently the CDC considers this an acceptable level of collateral damage.
As unthinkable as this is (destroying or ending the lives of as many as 30,000 Americans), that is only part of the story.
The novel H1N1 vaccine being developed must adhere to guidelines set forth by the U.S. Food and Drug Administration (FDA). The FDA has announced that a vaccine will be accepted if it creates antibodies in 4 out of 10 recipients (40%), with at least 70 percent of those 4 achieving an antibody level believed to provide benefit. This means that an acceptable vaccine candidate would provide “protection” for 28% of vaccine recipients (70% of the 40%), or less than 3 in 10 recipients. The requirement drops to 18% efficacy for those over 65 years of age (60% of 30%).
So here are the facts, as documented by the CDC and the FDA:
As many as 30,000 Americans will be harmed by the novel H1N1 vaccine.
The vaccine may be ineffective in more than 7 out of 10 recipients.
And in case you think I am alone in my concerns, here is what several vaccine experts associated with the CDC and the U.S. government say on the subject.
"I am very skeptical of finishing vaccine before we know the appropriate dose to be included in each inoculation, before immunogenicity studies are complete, or before safety assessments have been finished," William Schaffner, MD, Chairman of the Department of Preventive Medicine at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices (ACIP), wrote in an recent e-mail.
"We have assured both the profession and the public that the H1N1 vaccine will be evaluated with the same rigor that is applied to seasonal vaccine. We should NOT make vaccine available before the trials are complete and the results carefully assessed."
Others are worried about a repeat of the last swine flu "pandemic," now regarded as a public health and public relations debacle.
"I fear that a rush towards vaccinating the population without completing trials risks leading to the harmful outcome that we witnessed during the 1976 swine flu scare, where the government advocated rapid production and vaccination of the population without adequate safeguards, which led to an unexplained increase in cases of Guillain Barré syndrome (GBS), amongst other complications, and massive liability for the government," wrote Amir Afkhami, MD, PhD, of George Washington University, an international expert on the 1918 Influenza pandemic and an advisor to the U.S. State Department, the U.S. military, and the World Bank on issues pertaining to infectious diseases, public health and, mental health.
"I think in this regard, we must learn from lessons of the past and be mindful of not jumping from the proverbial frying pan into the fire by putting people's health at risk without adequate production and safety monitoring of the vaccines."
Citizens Petition to Stay FDA “Swine Flu” Vaccine Approvals:
http://www.healthfreedomusa.org/?p=3314
[Note: this is also posted at: http://www.gnhealth.com/h1n1swineflupetition.html ]
Media Announcement at: http://www.healthfreedomusa.org/?p=3312
Before the
United States of America
Food and Drug Administration
In the Matter of the A-H1N1-09 “Swine Flu” Vaccines
} FDA Docket No. __________
} PETITION
} With Request for Emergency Relief:
} Temporary Stay of all Pending
} “Swine Flu” Vaccine Approvals
To: Dockets Management Branch
Food and Drug Administration
Room 1061 HFA-305
5630 Fishers Lane
Rockville, MD 20852
Dated: August 17, 2009 – rev.1.01 (08.23.09)
Pursuant to the Constitution of the United States of America, First Amendment, Right to Petition for Redress of Grievances, the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), 21 C.F.R. 10.20 and 10.30 (Citizens Petition) and, to the extent applicable, 21 C.F.R. 10.35, to amend the FDA’s rules respecting the safety, effectiveness and availability of vaccines said to be useful for swine flu (A-H1N1-09), the undersigned Petitioners PETITION the Unites States, to wit:
Introduction
1. This Petition is brought before the Executive Authority of the United States of America, mindful of the President’s call for transparency in government and science-based decision-making. This Revision 1.01 of the Petition has been modified in form to meet the terms of applicable portions of 21 C.F.R. 10.20 – 35. Petitioners, however, note that this Petition is grounded in the Constitutional Right to Petition which may not be “abridged” by Government and therefore any regulatory requirements are subordinate to that primary source of authority for this Petition. In so far as any of the Petitioners are protected under the RFRA, all rights are reserved under the Religious Freedom Restoration Act of 1993 (RFRA – P.L. 103-141).
The Petitioners therefore have included Addendum 1.1 in this Petition to address the formal requirements of Section 10.30: A. Action requested; B. Statement of Grounds; C. Environmental Impact/Exemption and D. Economic Impact. Furthermore, in so far as Sec. 10.35 (Stay of Actions) may apply, the Petitioners have included Addendum 1.2 to this Petition to address the formal requirements of Section 10.35: A. Decision Involved and B. Action Requested. Finally, Petitioners append to this Petition actual copies of non-governmental Citations referenced in Appendix B, which has been further amended to meet the “unfavorable representative data” requirement of the Sec. 10.30 Certification format.
2. Petitioners are several nongovernmental organizations involved in health care civil rights and several individuals who are adversely impacted by the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) actions referred to in this Petition, and all persons who join in this Petition hereafter.
3. This Petition is submitted to request specific action by the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) (the Federal Agencies) within the scope of the mandated duties thereof, in order to exhaust administrative remedies.
4. The primary purpose of the Petition is to seek emergency actions with regard to the imminent Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) granting of various drug-interest commercial applications or approval and widespread use of various so-called “H1N1” “A-H1N1-09” or “Swine Flu” vaccines (herein, the Vaccines).
5. The Vaccine Approvals are being treated as emergency drug approvals, but are being sought without even minimal science-based safety testing or testing for clinical efficacy in preventing disease, and with the inclusion of dangerous adjuvants, including Mercury, and squalene, which has never been heretofore approved as a vaccine adjuvant. Legal immunity has been granted a priori to the manufactures, the Federal Government and its agents in the event of harm or death from these vaccines.
6. a. As one example, within the past two weeks, the British Neurological Surveillance Unit (BNSU) warned of “the Government’s concern about releasing a vaccine of unknown safety.” and has alerted its members to be on the alert for an up to 8-fold increase in Guillain-Barre Syndrome (GBS) due to the Vaccines that are the subject of this Petition.
http://www.dailymail.co.uk/news/article-1206807/Swine-flu-jab-link-killer-nerve-disease-Leaked-letter-reveals-concern-neurologists-25-deaths-America.html#ixzz0OJSgKn4b
b. The United States government has paid nearly two billion dollars to the families of individuals who have been killed or maimed by vaccines as part the Vaccine Injury Compensation Program. A massive increase in the use of vaccines such as the swine flu vaccine that is the subject of this petition will be likely to significantly increase the number of individuals harmed by vaccines.
See: http://www.usdoj.gov/civil/torts/const/vicp/about.htm
Redress Sought
7. (a) The first action sought is an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in imminent peril of irreparable harm if the Temporary Stay is not granted immediately.
(b) Additionally, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, requiring strong warnings to the public, as mandated by the United States Supreme Court in another context, Thompson v. Western States Medical Center – 535 U.S. 357, 2002:
“If the First Amendment means anything, it means that regulating speech must be a last – not first – resort. … We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.”
“Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown.”
The warning should therefore read: “This Vaccine has not undergone FDA safety or efficacy testing and its risks are unknown in all age groups. This Vaccine contains ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.”
The warning should further advise that should the recipient experience an adverse event or death from the vaccine, the vaccine manufacturers, government and government agencies have no liability, and the National Vaccine Injury Compensation Program does not currently provide for possible compensation to victims of the Vaccines.
(c) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to engage in a vigorous public information campaign, interleaved with their promotion of the Vaccines, and given equal prominence in type face, media announcements, web presence and other methods of public information used to promote the Vaccines, stating that the Vaccines contain ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected. And, further that should the recipient experience an adverse event or death from the vaccine, the vaccine manufacturers, government and government agencies have no liability, and the National Vaccine Injury Compensation Program does not currently provide for possible compensation to victims of the Vaccines.
(d) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health, that these uninsurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.
(e) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.
Legal Basis for Relief
8. As an Executive Department Agency, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must “Take Care that the Laws be faithfully executed” (Article II, Section3, United States Constitution).
9. This Petition is grounded in fundamental principles of inalienable right, law and equity.
10. The primary legal basis for submitting this Petition to the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is the First Amendment to the Constitution of the United States: “Congress shall make no law…abridging… the right of the people… to petition the Government for a redress of grievances.” Additionally, the First Amendment Freedom of Speech, requiring transparency in government, as well as Fourth, Fifth, Ninth, Tenth and Fourteenth Amendments impact the arguments herein.
11. Petitioners also cite: the World Medical Association 1964 Declaration of Helsinki. See: http://www.wma.net/e/policy/b3.htm. This Declaration has the force of International Law, to which the United States is a party, and it clearly forbids experimental medication or medication without fully informed consent, as does United States law, for example, 42 U.S.C. 289(a).
12. The United Nations Universal Declaration of Human Rights – Article 12 – “No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honor and reputation. Everyone has the right to the protection of the law against such interference or attacks.” See: http://www.un.org/en/documents/udhr/ and the Geneva Conventions: Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of Non-International Armed Conflicts (Protocol II) – Article 17.-Prohibition of forced movement of civilians:
“1. The displacement of the civilian population shall not be ordered for reasons related to the conflict unless the security of the civilians involved or imperative military reasons so demand.
Should such displacements have to be carried out, all possible measures shall be taken in order that the civilian population may be received under satisfactory conditions of shelter, hygiene, health, safety and nutrition.
2. Civilians shall not be compelled to leave their own territory for reasons connected with the conflict.”
See: http://www2.ohchr.org/english/law/protocol2.htm
13. Current law and regulations provide for involuntary Provisional Quarantine, with removal, following refusal of persons to submit to vaccination with the untested, uninsurable, non-voluntary “informed consent” Vaccines. The Agency regulations should be amended to provide for voluntary Self-Shielding, Self-Quarantine and Self-Isolation as permitted alternatives.
14. Bivens v. Six Unknown-Named Agents of Fed. Bureau of Narcotics, 403 U.S. 388, 396-397, (1971); Carison v. Green, 466 U.S. 14, 18-19 (1980). – These cases construe “42 USC § 300aa-31” with its “more likely than not” evidentiary burden and its Daubert v. Merrell Dow Pharmaceuticals, Inc, 509 U.S. 579, 113 S.Ct 2786, 2797 (1993), prohibition against expert opinion reliance upon poor quality and flawed data, the surviving good quality data shows the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is statutorily required to reject the Vaccines approval since it “more likely than not” caused numerous neurological and immune system pandemics (e.g., autism, neurological disorders, autoimmune disorders, etc). Since the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) know of this linking data and intentionally exposed the public to these serous risks of harm, while attempting to hide/alter the data that showed the harm, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) also violated the 14th Amendment’s “Constitutional Safety Guarantees.” Under these egregious and horrifying circumstances, both Sec. 300aa-31 and a 28 USC § 1331 “Bivens Action” would authorize injunctive relief, and where warranted, damages.
15. Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), in which the Supreme Court of the United States, prior to the establishment of the Food, Drugs and Cosmetics Act revisions that established Federal pre-emption of drug approvals, gave deference to the Supreme Court of Massachusetts in an involuntary vaccination matter, also contains clear language authorizing Federal intervention in circumstances that are clearly present with regard to the Vaccines involved in this Petition.
“It is easy, for instance, to suppose the case of an adult who is embraced by the mere words of the act, but yet to subject whom to vaccination in a particular condition of his health or body, would be cruel and inhuman in the last degree. We are not to be understood as holding that the statute was intended to be applied to such a case, or, if it was so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned. “All laws,” this court has said, “should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression or absurd consequence. It will always, therefore, be presumed that the legislature intended exceptions to its language which would avoid results of that character. The reason of the law in such cases should prevail over its letter.” United States v. Kirby, 7 Wall. 482; Lau Ow Bew v. United States, 144 U.S. 47, 58. Until otherwise informed by the highest court of Massachusetts we are not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”
16. The Acts establishing the authority of the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) being herein petitioned are also a legal basis for the Petition. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) exist to protect the public, within the limits established by the Constitution of the United States of America. However, Article 16 of the original enabling legislation that created the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) indicates, in effect, that a primary purpose is to promote, protect and promulgate the pharmaceutical industry.
17. Petitioners note the statute in the derogation of the common law and Constitutional limitations, establishing certain exemptions from liability of Vaccine Injuries, 42 USC 300aa-16 (and the Vaccine Injury Compensation Program, there under). This law is further cited as a law that must be strictly construed in favor of patients, guardians, parents and children even if such construction is against the economic interests of the drug industry and other persons exempt there under.
18. Petitioners note that, given the exceptional exemption given to both manufactures of the Vaccines and employees of the Federal Agencies and their designees which purports to eliminate the possibility of redress through the Courts by the public in the event that individuals suffer irreversible harm or death, it is especially important that careful notification and protection be offered to the public in the face of instructions or compulsions to accept the use of the Vaccines which contain ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.
19. The total amount that the Vaccine Injury Compensation Program has paid in compensation since its 1989 founding is $1,884,145,255.29, however, this program does not currently list the Vaccines as being ones for which compensation under this program may be had.
See: http://www.hrsa.gov/Vaccinecompensation/statistics_report.htm
20. Basic common law principles prohibit forced acquiescence under duress and limited or intentionally distorted information, as exemplified by the United States Supreme Court decision in the case of Thompson v Western States Medical Centers – 535 U.S. 357 (2002). The Petitioners note with concern that FDA regulation permits a choice under duress upon limited and distorted information such that those refusing the Vaccines in a Pandemic Emergency situation face incarceration/quarantine under Provisional Quarantine regulations in violation of the prohibitions mentioned above against forced acquiescence under duress and limited or intentionally distorted information.
21. Additionally, the Statutes authorizing the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) contain general provisions that support the actions requested in this petition. Federal Law includes provisions that grant the responsible persons in the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) broad authority to promulgate rules and regulations “necessary to carry out the Act[s].”
22. The Food, Drug and Cosmetics Act (FD&C Act) Mission Statement requires that “…(B) human and veterinary drugs are safe and effective…” (21 USC §393(b)(2)). The Act had been amended repeatedly, to require that no drug be approved unless it is proven “safe and effective.”
This clear legal requirement is explained by the Agency on its web site:
“In October 1962, Congress passed the Kefauver-Harris Drug Amendments to the Federal FD&C Act. Before marketing a drug, firms now had to prove not only safety, but also provide substantial evidence of effectiveness for the product’s intended use. Temple says, “That evidence had to consist of adequate and well-controlled studies, a revolutionary requirement.”
“Also critically, the 1962 amendments required that the FDA specifically approve the marketing application before the drug could be marketed, another major change.” The Kefauver-Harris Drug Amendments also asked the Secretary to establish rules of investigation of new drugs, including a requirement for the informed consent of study subjects. The amendments also formalized good manufacturing practices, required that adverse events be reported, and transferred the regulation of prescription drug advertising from the Federal Trade Commission to the FDA.”
See: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm
23. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should issue the actions requested herein as an Interim Final Rule without first completing Notice and Comment, Risk Assessment, and Cost-Benefit Analysis. Additionally, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should not issue the drug-industry requested vaccine approvals as an emergency matter.
24. Under ordinary circumstances, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must comply with procedural requirements under the Administrative Procedures Act (APA) and the specific Acts authorizing the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC), including the use of notice-and-comment rulemaking and the completion of a risk assessment and cost-benefit analysis before issuance of a new rule. However, both Acts provide for exceptions to those requirements for circumstances such as those present here (with regard to the Petitioners herein, but not with regard to the drug-industry applications), where the continuation of current policy (the emergency approval of the Vaccines) would constitute an imminent threat to public safety and any delay in the policy-making the Petitioners herein would be contrary to the public interest.
25. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should only avail itself of those statutory exceptions with regard with Petitioner’s request herein and promulgate the requested policies while first providing the public with reasonable notice under these circumstances and an opportunity for comment and before completing a full risk assessment and cost-benefit analysis. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should first adopt the policy as an “interim-final rule,” which would become binding upon publication (or within a time certain; for example, a week after publication) and subsequently provide for public comment and complete its risk assessment and cost-benefit analysis. If such a time period is provided for public comment and the completion of risk assessment and cost-benefit analysis, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should make no declaration, take no action, approve no product or Vaccine related to this situation during such period.
26. The Requested Actions of Petitioners herein satisfy the “good cause” exception to the Administrative Procedure Act’s (APA) requirement for notice and comment, while the application of that exception should not apply to the Vaccine applications.
27. The Administrative Procedures Act (APA) provides that full notice-and-comment rulemaking is not required when an agency “for good cause finds (and incorporates the finding and a brief statement of the reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. Section 553(b)(B) The good cause exception “is an important safety valve to be used where delay would do real harm.” United States Steel v EPA, 595 F.2d207, 214 (5th Cir. 1979). According to the legislative history of the provision, “impracticable” means a situation in which the due and required execution of the agency functions would be unavoidably prevented by its undertaking public rule-making proceedings.” S. Rep. No. 752, 79thCong., 1st Sess., at 16 (1945). It has been held, determining “impracticality” requires analysis in practical terms of the particular statutory-agency setting and the reasons why agency action could not await notice and comment. American Transfer & Storage Company v. ICC, 719 F. 2d 1283, 1295 (5th Cir. 1983).
28. The same urgency which motivates the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with excessive rapidly and inappropriate zeal, in the light of an alleged pandemic threat (declared despite the mild nature of the supposed pandemic disease) should motivate the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with the measures proposed by Petitioners herein to protect both the public’s welfare and their right to fully informed consent and transparency.
29. Below are listed three of numerous instances in which courts have upheld an agency’s decision to invoke the “good cause” exception and issue a rule without providing notice and comment where a delay would threaten public safety or the environment. See: Hawaii Helicopter Operators Ass’n v. FAA, 51 F.3d 212, 24 (9th Cir. 1995) (good cause exception satisfied in view of “the threat to public safety reflected in an increasing number of helicopter accidents”); Northern Arapahoe Tribe v. Hodel, 808 F.2d741, 750-52 (10th Cir. 1987) (good cause exception satisfied in view of urgent need for hunting regulations where herds were threatened with extinction); Northwest Airlines v. Goldschmidt, 645 F2d 1309, 1321 (8th Cir. 1981) (good cause exception satisfied in view of urgent need to allocate landing slots at major airport).
30. The rationale underlying those decisions is that compliance with time-consuming procedural requirements would “do real harm” by delaying implementation of urgently needed policies to safeguard public health. Swine Flu causes a disease of low virulence and pathogenicity so that the need for current Agency displays of overwhelming haste in their approval is not present, but the Vaccines contain never-before-approved adjuvants and known toxins so that the need for caution in their approval is very much present. Clearly, the exigent circumstances necessary to satisfy the Administrative Procedures Act’s (APA’s) good cause exception are present with regard to Petitioner’s concerns as set forth in the Factual Basis for Relief. They are not present with regard to the Vaccine approval applications. On the contrary, such approval would harm the public health.
Factual Basis for Relief
31. Vaccinations cause well-known and foreseeable harm. Autism, neurological damage, Guillian Barré syndrome, post vaccination Encephalitis, asthma, coma, juvenile ALS, adult ALS, oil-in-water adjuvant-induced poly arthritis, dermatitis, fibromyalgia, fatigue, malaise, death and other known consequences of vaccine injury are not generally reversible and the present danger from the Vaccines to children and adults is so great that the “good cause” exception referenced above is well warranted in this case. Consumers are being defrauded while children and others are being irreversibly damaged. Once a child collapses into autism, for example, there is a virtually irreversible path which the child and family follow, often leading to eventual institutionalization. These are, in most cases, preventable tragedies. The probable harm is immediate and irreparable.
32. In order to redress the perceived harm, there are several procedural matters that should be addressed by Agency Rule or Court interpretation. These are the need for:
(1) Clear and prominent Warnings as specified elsewhere herein,
(2) Due-process compliant procedures for opting out of involuntary vaccinations,
(3) Sound information to support informed consent if the vaccination is truly voluntary, and
(4) Due-process compliant procedures required to involuntarily isolate or quarantine any person who refuses to take an involuntary vaccine, or for anyone who for voluntary reasons refuses to take a vaccine.
33. Medical ethics, United States law regarding medical experimentation and treatment, and international legal standards require nothing less. These international legal standards are among the international standards the Agency pledged to harmonize to in a notice published in the Federal Register of October 11, 1995 (60 FR 53078), “FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines…”
See: http://www.cfsan.fda.gov/~lrd/fr970707.html
34. Similarly, if the H1N1 “Swine Flu” vaccination results are similar to the 1976 “Swine Flu” vaccination panic, hundreds will die (more than are alleged to have died from the 2009 “Swine Flu”) and hundreds of thousands or more will be injured. If the Vaccines, with their squalene adjuvant, are as deadly as the experimental squalene Anthrax Vaccine mandated for United States soldiers during the First Gulf War, hundreds of thousands will be hospitalized due to vaccine adverse reactions with tragic consequences to them and enormous preventable financial burdens on the healthcare system.
35. The Petitioners append to this Petition further supporting materials as Appendix B – these address:
1. Epidemics Timeline – Andrew Maniotis, Ph.D
2. Voluntary vs Mandatory – Rima E. Laibow, MD
3. Legal Article: Basis for Injunction – Kent R. Holcome
4. Your Right to Self Shield – Ralph Fucetola, JD
5. Access to Representative Data Unfavorable to Petitioners
Actions Requested from Food and Drug Administration (FDA)
and/or the Centers for Disease Control (CDC)
36. Therefore the Petitioners request the following redress of grievances:
(a) The first action sought is an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in immanent peril of irreparable harm if the Temporary Stay is not granted immediately.
(b) Additionally, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, requiring strong warnings to the publics of each age groups, geographic location and any other relevant demographics, that a process be developed for individuals to opt out of any mandatory program and that clear instructions be given on the risk and benefits of the vaccine:
“This Vaccine has not undergone adequate FDA safety or efficacy testing and its risks are unknown in all age groups. This Vaccine contains ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.” Additionally, there is no legal mechanism, such as the VICP, which will provide compensation for those who may be foreseen to be injured by the Vaccines.
(c) Furthermore, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that the Vaccines not be subject to any legal mandate requiring their use by any class of persons in order for such persons to receive government services, or to work in particular employments, or to travel or to attend any public places or for any other purpose.
(d) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that these uninsurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.
(e) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.
Wherefore the undersigned certifies that to the best of his knowledge and belief the factual statements made herein are true, complete and not intentionally misleading.
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the Petitioner which are unfavorable to the petition.
August 17, 2009 (Rev.1.01 – 08.23.09)
Initial Petitioners Listed on Appendix A
By:
Ralph Fucetola JD
Natural Solutions Foundation Trustee, on behalf of all Petitioners
Express Mail: EO 964 064 326 US – 0144 4000 0332 0857
Revision by email to: [redacted]@fda.hhs.gov
Appendixes
Appendix A – Signatories
Gary Null, PhD – Human Nutrition & Public Health Science
New York, New York 10024
Dr. Tedd Koren, DC – Foundation for Health Choice
Hatfield, PA 19440
Albert N. Stubblebine III – (Maj Gen. US Army Ret.) President
Natural Solutions Foundation
Maryville, Missouri 64468
Rev. Dr. Robert H. Sorge – Pastor of Abunda Life Center
Asbury Park, New Jersey 07712
Rev. Kathy A. Greene, BARA – Chair of LifeSpirit Center
Newton, New Jersey 07860
Alan Phillips, J.D., VaccineRights.com
Chapel Hill, NC 27515-3473
Karen Horbatt – President – Institute for Health Research
Summit, NJ 07901-1826
Appendix B – Articles
1. Andrew Maniotis, Ph.D – How to Predict an Epidemic Timeline
http://www.healthfreedomusa.org/?p=3198
2. Rima E. Laibow, MD – Truth and the Ministry of Lies
http://www.healthfreedomusa.org/?p=3279
3. Kent R. Holcome – Basis for Injunction
http://www.medicalveritas.com/man1925_1936.pdf
4. Ralph Fucetola JD: Your Right to Self Shield
http://www.healthfreedomusa.org/?p=2752
5. Unfavorable Data:
21 C.F.R. 10.30 includes a form of Certification, as used in this Petition, which requires Petitioners to set forth “representative data and information known to the petitioner which are unfavorable to the petition” In fulfillment of this requirement, Petitioners cite the Government’s own web site on Vaccine Safety which includes a representative sample of opinions contrary to those of Petitioners:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm133806.htm
———————————–
Addendum 1.01
Requirements under 21 C.F.R. 10.30 (Citizens Petition)
A. Action requested
The Petitioners request the five specific actions set forth in Paragraph 36 of the Petition.
B. Statement of Grounds
The Legal and Factual Statement of Grounds is found in Paragraphs 8 through 35 of the Petition.
C. Environmental Impact/Exemption
The impact of the granting of the five specific relief actions requested herein will not have any measurable effect on the current environment. This Petition should therefore be exempt under 21 C.F.R. 25.31 (Human drugs and biologics).
D. Economic Impact
This decision will impact the economy as follows:
1. May limit upside profit potential of the vaccine makers and others who will profit from the sale of uninsured, un-tested-for-safety and unproven vaccines to the public.
2. Will reduce the cost to the economy of the lost productivity and other costs of persons who will suffer foreseeable harm from the vaccines.
3. Since the effectiveness of the vaccines are not proven, it cannot be determined what economic benefit may occur from any alleged immunization effect.
Addendum 1.02
Requirements under 21 C.F.R. 10.35 (Stay of Action)
A. Decision Involved
The Center for Biological Evaluation and Research (CBER) pending “Swine Flu”- A-H1N1-09 Vaccine Approvals under the Public Health Service Act, Biological Products:
Section 351(d) (Section 262 of Consolidated Title 21): “Licenses for the maintenance of establishments for the propagation or manufacture and preparation of products described in Subsection A of this Section may be issued only upon a showing that the establishment and the products licenses desired standards, designed to assure the continued safety, purity, and potency of such products, prescribed in regulations, and licenses for new products may be issued only upon a showing that they meet such standards.”
B. Action Requested.
Per Paragraph 36 (a) of the Petition: “an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in immanent peril of irreparable harm if the Temporary Stay is not granted immediately. ”
[Note: this is also posted at: http://www.gnhealth.com/h1n1swineflupetition.html ]
Media Announcement at: http://www.healthfreedomusa.org/?p=3312
Before the
United States of America
Food and Drug Administration
In the Matter of the A-H1N1-09 “Swine Flu” Vaccines
} FDA Docket No. __________
} PETITION
} With Request for Emergency Relief:
} Temporary Stay of all Pending
} “Swine Flu” Vaccine Approvals
To: Dockets Management Branch
Food and Drug Administration
Room 1061 HFA-305
5630 Fishers Lane
Rockville, MD 20852
Dated: August 17, 2009 – rev.1.01 (08.23.09)
Pursuant to the Constitution of the United States of America, First Amendment, Right to Petition for Redress of Grievances, the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), 21 C.F.R. 10.20 and 10.30 (Citizens Petition) and, to the extent applicable, 21 C.F.R. 10.35, to amend the FDA’s rules respecting the safety, effectiveness and availability of vaccines said to be useful for swine flu (A-H1N1-09), the undersigned Petitioners PETITION the Unites States, to wit:
Introduction
1. This Petition is brought before the Executive Authority of the United States of America, mindful of the President’s call for transparency in government and science-based decision-making. This Revision 1.01 of the Petition has been modified in form to meet the terms of applicable portions of 21 C.F.R. 10.20 – 35. Petitioners, however, note that this Petition is grounded in the Constitutional Right to Petition which may not be “abridged” by Government and therefore any regulatory requirements are subordinate to that primary source of authority for this Petition. In so far as any of the Petitioners are protected under the RFRA, all rights are reserved under the Religious Freedom Restoration Act of 1993 (RFRA – P.L. 103-141).
The Petitioners therefore have included Addendum 1.1 in this Petition to address the formal requirements of Section 10.30: A. Action requested; B. Statement of Grounds; C. Environmental Impact/Exemption and D. Economic Impact. Furthermore, in so far as Sec. 10.35 (Stay of Actions) may apply, the Petitioners have included Addendum 1.2 to this Petition to address the formal requirements of Section 10.35: A. Decision Involved and B. Action Requested. Finally, Petitioners append to this Petition actual copies of non-governmental Citations referenced in Appendix B, which has been further amended to meet the “unfavorable representative data” requirement of the Sec. 10.30 Certification format.
2. Petitioners are several nongovernmental organizations involved in health care civil rights and several individuals who are adversely impacted by the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) actions referred to in this Petition, and all persons who join in this Petition hereafter.
3. This Petition is submitted to request specific action by the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) (the Federal Agencies) within the scope of the mandated duties thereof, in order to exhaust administrative remedies.
4. The primary purpose of the Petition is to seek emergency actions with regard to the imminent Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) granting of various drug-interest commercial applications or approval and widespread use of various so-called “H1N1” “A-H1N1-09” or “Swine Flu” vaccines (herein, the Vaccines).
5. The Vaccine Approvals are being treated as emergency drug approvals, but are being sought without even minimal science-based safety testing or testing for clinical efficacy in preventing disease, and with the inclusion of dangerous adjuvants, including Mercury, and squalene, which has never been heretofore approved as a vaccine adjuvant. Legal immunity has been granted a priori to the manufactures, the Federal Government and its agents in the event of harm or death from these vaccines.
6. a. As one example, within the past two weeks, the British Neurological Surveillance Unit (BNSU) warned of “the Government’s concern about releasing a vaccine of unknown safety.” and has alerted its members to be on the alert for an up to 8-fold increase in Guillain-Barre Syndrome (GBS) due to the Vaccines that are the subject of this Petition.
http://www.dailymail.co.uk/news/article-1206807/Swine-flu-jab-link-killer-nerve-disease-Leaked-letter-reveals-concern-neurologists-25-deaths-America.html#ixzz0OJSgKn4b
b. The United States government has paid nearly two billion dollars to the families of individuals who have been killed or maimed by vaccines as part the Vaccine Injury Compensation Program. A massive increase in the use of vaccines such as the swine flu vaccine that is the subject of this petition will be likely to significantly increase the number of individuals harmed by vaccines.
See: http://www.usdoj.gov/civil/torts/const/vicp/about.htm
Redress Sought
7. (a) The first action sought is an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in imminent peril of irreparable harm if the Temporary Stay is not granted immediately.
(b) Additionally, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, requiring strong warnings to the public, as mandated by the United States Supreme Court in another context, Thompson v. Western States Medical Center – 535 U.S. 357, 2002:
“If the First Amendment means anything, it means that regulating speech must be a last – not first – resort. … We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.”
“Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown.”
The warning should therefore read: “This Vaccine has not undergone FDA safety or efficacy testing and its risks are unknown in all age groups. This Vaccine contains ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.”
The warning should further advise that should the recipient experience an adverse event or death from the vaccine, the vaccine manufacturers, government and government agencies have no liability, and the National Vaccine Injury Compensation Program does not currently provide for possible compensation to victims of the Vaccines.
(c) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to engage in a vigorous public information campaign, interleaved with their promotion of the Vaccines, and given equal prominence in type face, media announcements, web presence and other methods of public information used to promote the Vaccines, stating that the Vaccines contain ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected. And, further that should the recipient experience an adverse event or death from the vaccine, the vaccine manufacturers, government and government agencies have no liability, and the National Vaccine Injury Compensation Program does not currently provide for possible compensation to victims of the Vaccines.
(d) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health, that these uninsurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.
(e) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.
Legal Basis for Relief
8. As an Executive Department Agency, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must “Take Care that the Laws be faithfully executed” (Article II, Section3, United States Constitution).
9. This Petition is grounded in fundamental principles of inalienable right, law and equity.
10. The primary legal basis for submitting this Petition to the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is the First Amendment to the Constitution of the United States: “Congress shall make no law…abridging… the right of the people… to petition the Government for a redress of grievances.” Additionally, the First Amendment Freedom of Speech, requiring transparency in government, as well as Fourth, Fifth, Ninth, Tenth and Fourteenth Amendments impact the arguments herein.
11. Petitioners also cite: the World Medical Association 1964 Declaration of Helsinki. See: http://www.wma.net/e/policy/b3.htm. This Declaration has the force of International Law, to which the United States is a party, and it clearly forbids experimental medication or medication without fully informed consent, as does United States law, for example, 42 U.S.C. 289(a).
12. The United Nations Universal Declaration of Human Rights – Article 12 – “No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honor and reputation. Everyone has the right to the protection of the law against such interference or attacks.” See: http://www.un.org/en/documents/udhr/ and the Geneva Conventions: Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of Non-International Armed Conflicts (Protocol II) – Article 17.-Prohibition of forced movement of civilians:
“1. The displacement of the civilian population shall not be ordered for reasons related to the conflict unless the security of the civilians involved or imperative military reasons so demand.
Should such displacements have to be carried out, all possible measures shall be taken in order that the civilian population may be received under satisfactory conditions of shelter, hygiene, health, safety and nutrition.
2. Civilians shall not be compelled to leave their own territory for reasons connected with the conflict.”
See: http://www2.ohchr.org/english/law/protocol2.htm
13. Current law and regulations provide for involuntary Provisional Quarantine, with removal, following refusal of persons to submit to vaccination with the untested, uninsurable, non-voluntary “informed consent” Vaccines. The Agency regulations should be amended to provide for voluntary Self-Shielding, Self-Quarantine and Self-Isolation as permitted alternatives.
14. Bivens v. Six Unknown-Named Agents of Fed. Bureau of Narcotics, 403 U.S. 388, 396-397, (1971); Carison v. Green, 466 U.S. 14, 18-19 (1980). – These cases construe “42 USC § 300aa-31” with its “more likely than not” evidentiary burden and its Daubert v. Merrell Dow Pharmaceuticals, Inc, 509 U.S. 579, 113 S.Ct 2786, 2797 (1993), prohibition against expert opinion reliance upon poor quality and flawed data, the surviving good quality data shows the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is statutorily required to reject the Vaccines approval since it “more likely than not” caused numerous neurological and immune system pandemics (e.g., autism, neurological disorders, autoimmune disorders, etc). Since the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) know of this linking data and intentionally exposed the public to these serous risks of harm, while attempting to hide/alter the data that showed the harm, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) also violated the 14th Amendment’s “Constitutional Safety Guarantees.” Under these egregious and horrifying circumstances, both Sec. 300aa-31 and a 28 USC § 1331 “Bivens Action” would authorize injunctive relief, and where warranted, damages.
15. Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), in which the Supreme Court of the United States, prior to the establishment of the Food, Drugs and Cosmetics Act revisions that established Federal pre-emption of drug approvals, gave deference to the Supreme Court of Massachusetts in an involuntary vaccination matter, also contains clear language authorizing Federal intervention in circumstances that are clearly present with regard to the Vaccines involved in this Petition.
“It is easy, for instance, to suppose the case of an adult who is embraced by the mere words of the act, but yet to subject whom to vaccination in a particular condition of his health or body, would be cruel and inhuman in the last degree. We are not to be understood as holding that the statute was intended to be applied to such a case, or, if it was so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned. “All laws,” this court has said, “should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression or absurd consequence. It will always, therefore, be presumed that the legislature intended exceptions to its language which would avoid results of that character. The reason of the law in such cases should prevail over its letter.” United States v. Kirby, 7 Wall. 482; Lau Ow Bew v. United States, 144 U.S. 47, 58. Until otherwise informed by the highest court of Massachusetts we are not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”
16. The Acts establishing the authority of the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) being herein petitioned are also a legal basis for the Petition. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) exist to protect the public, within the limits established by the Constitution of the United States of America. However, Article 16 of the original enabling legislation that created the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) indicates, in effect, that a primary purpose is to promote, protect and promulgate the pharmaceutical industry.
17. Petitioners note the statute in the derogation of the common law and Constitutional limitations, establishing certain exemptions from liability of Vaccine Injuries, 42 USC 300aa-16 (and the Vaccine Injury Compensation Program, there under). This law is further cited as a law that must be strictly construed in favor of patients, guardians, parents and children even if such construction is against the economic interests of the drug industry and other persons exempt there under.
18. Petitioners note that, given the exceptional exemption given to both manufactures of the Vaccines and employees of the Federal Agencies and their designees which purports to eliminate the possibility of redress through the Courts by the public in the event that individuals suffer irreversible harm or death, it is especially important that careful notification and protection be offered to the public in the face of instructions or compulsions to accept the use of the Vaccines which contain ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.
19. The total amount that the Vaccine Injury Compensation Program has paid in compensation since its 1989 founding is $1,884,145,255.29, however, this program does not currently list the Vaccines as being ones for which compensation under this program may be had.
See: http://www.hrsa.gov/Vaccinecompensation/statistics_report.htm
20. Basic common law principles prohibit forced acquiescence under duress and limited or intentionally distorted information, as exemplified by the United States Supreme Court decision in the case of Thompson v Western States Medical Centers – 535 U.S. 357 (2002). The Petitioners note with concern that FDA regulation permits a choice under duress upon limited and distorted information such that those refusing the Vaccines in a Pandemic Emergency situation face incarceration/quarantine under Provisional Quarantine regulations in violation of the prohibitions mentioned above against forced acquiescence under duress and limited or intentionally distorted information.
21. Additionally, the Statutes authorizing the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) contain general provisions that support the actions requested in this petition. Federal Law includes provisions that grant the responsible persons in the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) broad authority to promulgate rules and regulations “necessary to carry out the Act[s].”
22. The Food, Drug and Cosmetics Act (FD&C Act) Mission Statement requires that “…(B) human and veterinary drugs are safe and effective…” (21 USC §393(b)(2)). The Act had been amended repeatedly, to require that no drug be approved unless it is proven “safe and effective.”
This clear legal requirement is explained by the Agency on its web site:
“In October 1962, Congress passed the Kefauver-Harris Drug Amendments to the Federal FD&C Act. Before marketing a drug, firms now had to prove not only safety, but also provide substantial evidence of effectiveness for the product’s intended use. Temple says, “That evidence had to consist of adequate and well-controlled studies, a revolutionary requirement.”
“Also critically, the 1962 amendments required that the FDA specifically approve the marketing application before the drug could be marketed, another major change.” The Kefauver-Harris Drug Amendments also asked the Secretary to establish rules of investigation of new drugs, including a requirement for the informed consent of study subjects. The amendments also formalized good manufacturing practices, required that adverse events be reported, and transferred the regulation of prescription drug advertising from the Federal Trade Commission to the FDA.”
See: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm
23. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should issue the actions requested herein as an Interim Final Rule without first completing Notice and Comment, Risk Assessment, and Cost-Benefit Analysis. Additionally, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should not issue the drug-industry requested vaccine approvals as an emergency matter.
24. Under ordinary circumstances, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must comply with procedural requirements under the Administrative Procedures Act (APA) and the specific Acts authorizing the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC), including the use of notice-and-comment rulemaking and the completion of a risk assessment and cost-benefit analysis before issuance of a new rule. However, both Acts provide for exceptions to those requirements for circumstances such as those present here (with regard to the Petitioners herein, but not with regard to the drug-industry applications), where the continuation of current policy (the emergency approval of the Vaccines) would constitute an imminent threat to public safety and any delay in the policy-making the Petitioners herein would be contrary to the public interest.
25. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should only avail itself of those statutory exceptions with regard with Petitioner’s request herein and promulgate the requested policies while first providing the public with reasonable notice under these circumstances and an opportunity for comment and before completing a full risk assessment and cost-benefit analysis. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should first adopt the policy as an “interim-final rule,” which would become binding upon publication (or within a time certain; for example, a week after publication) and subsequently provide for public comment and complete its risk assessment and cost-benefit analysis. If such a time period is provided for public comment and the completion of risk assessment and cost-benefit analysis, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should make no declaration, take no action, approve no product or Vaccine related to this situation during such period.
26. The Requested Actions of Petitioners herein satisfy the “good cause” exception to the Administrative Procedure Act’s (APA) requirement for notice and comment, while the application of that exception should not apply to the Vaccine applications.
27. The Administrative Procedures Act (APA) provides that full notice-and-comment rulemaking is not required when an agency “for good cause finds (and incorporates the finding and a brief statement of the reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. Section 553(b)(B) The good cause exception “is an important safety valve to be used where delay would do real harm.” United States Steel v EPA, 595 F.2d207, 214 (5th Cir. 1979). According to the legislative history of the provision, “impracticable” means a situation in which the due and required execution of the agency functions would be unavoidably prevented by its undertaking public rule-making proceedings.” S. Rep. No. 752, 79thCong., 1st Sess., at 16 (1945). It has been held, determining “impracticality” requires analysis in practical terms of the particular statutory-agency setting and the reasons why agency action could not await notice and comment. American Transfer & Storage Company v. ICC, 719 F. 2d 1283, 1295 (5th Cir. 1983).
28. The same urgency which motivates the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with excessive rapidly and inappropriate zeal, in the light of an alleged pandemic threat (declared despite the mild nature of the supposed pandemic disease) should motivate the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with the measures proposed by Petitioners herein to protect both the public’s welfare and their right to fully informed consent and transparency.
29. Below are listed three of numerous instances in which courts have upheld an agency’s decision to invoke the “good cause” exception and issue a rule without providing notice and comment where a delay would threaten public safety or the environment. See: Hawaii Helicopter Operators Ass’n v. FAA, 51 F.3d 212, 24 (9th Cir. 1995) (good cause exception satisfied in view of “the threat to public safety reflected in an increasing number of helicopter accidents”); Northern Arapahoe Tribe v. Hodel, 808 F.2d741, 750-52 (10th Cir. 1987) (good cause exception satisfied in view of urgent need for hunting regulations where herds were threatened with extinction); Northwest Airlines v. Goldschmidt, 645 F2d 1309, 1321 (8th Cir. 1981) (good cause exception satisfied in view of urgent need to allocate landing slots at major airport).
30. The rationale underlying those decisions is that compliance with time-consuming procedural requirements would “do real harm” by delaying implementation of urgently needed policies to safeguard public health. Swine Flu causes a disease of low virulence and pathogenicity so that the need for current Agency displays of overwhelming haste in their approval is not present, but the Vaccines contain never-before-approved adjuvants and known toxins so that the need for caution in their approval is very much present. Clearly, the exigent circumstances necessary to satisfy the Administrative Procedures Act’s (APA’s) good cause exception are present with regard to Petitioner’s concerns as set forth in the Factual Basis for Relief. They are not present with regard to the Vaccine approval applications. On the contrary, such approval would harm the public health.
Factual Basis for Relief
31. Vaccinations cause well-known and foreseeable harm. Autism, neurological damage, Guillian Barré syndrome, post vaccination Encephalitis, asthma, coma, juvenile ALS, adult ALS, oil-in-water adjuvant-induced poly arthritis, dermatitis, fibromyalgia, fatigue, malaise, death and other known consequences of vaccine injury are not generally reversible and the present danger from the Vaccines to children and adults is so great that the “good cause” exception referenced above is well warranted in this case. Consumers are being defrauded while children and others are being irreversibly damaged. Once a child collapses into autism, for example, there is a virtually irreversible path which the child and family follow, often leading to eventual institutionalization. These are, in most cases, preventable tragedies. The probable harm is immediate and irreparable.
32. In order to redress the perceived harm, there are several procedural matters that should be addressed by Agency Rule or Court interpretation. These are the need for:
(1) Clear and prominent Warnings as specified elsewhere herein,
(2) Due-process compliant procedures for opting out of involuntary vaccinations,
(3) Sound information to support informed consent if the vaccination is truly voluntary, and
(4) Due-process compliant procedures required to involuntarily isolate or quarantine any person who refuses to take an involuntary vaccine, or for anyone who for voluntary reasons refuses to take a vaccine.
33. Medical ethics, United States law regarding medical experimentation and treatment, and international legal standards require nothing less. These international legal standards are among the international standards the Agency pledged to harmonize to in a notice published in the Federal Register of October 11, 1995 (60 FR 53078), “FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines…”
See: http://www.cfsan.fda.gov/~lrd/fr970707.html
34. Similarly, if the H1N1 “Swine Flu” vaccination results are similar to the 1976 “Swine Flu” vaccination panic, hundreds will die (more than are alleged to have died from the 2009 “Swine Flu”) and hundreds of thousands or more will be injured. If the Vaccines, with their squalene adjuvant, are as deadly as the experimental squalene Anthrax Vaccine mandated for United States soldiers during the First Gulf War, hundreds of thousands will be hospitalized due to vaccine adverse reactions with tragic consequences to them and enormous preventable financial burdens on the healthcare system.
35. The Petitioners append to this Petition further supporting materials as Appendix B – these address:
1. Epidemics Timeline – Andrew Maniotis, Ph.D
2. Voluntary vs Mandatory – Rima E. Laibow, MD
3. Legal Article: Basis for Injunction – Kent R. Holcome
4. Your Right to Self Shield – Ralph Fucetola, JD
5. Access to Representative Data Unfavorable to Petitioners
Actions Requested from Food and Drug Administration (FDA)
and/or the Centers for Disease Control (CDC)
36. Therefore the Petitioners request the following redress of grievances:
(a) The first action sought is an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in immanent peril of irreparable harm if the Temporary Stay is not granted immediately.
(b) Additionally, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, requiring strong warnings to the publics of each age groups, geographic location and any other relevant demographics, that a process be developed for individuals to opt out of any mandatory program and that clear instructions be given on the risk and benefits of the vaccine:
“This Vaccine has not undergone adequate FDA safety or efficacy testing and its risks are unknown in all age groups. This Vaccine contains ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.” Additionally, there is no legal mechanism, such as the VICP, which will provide compensation for those who may be foreseen to be injured by the Vaccines.
(c) Furthermore, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that the Vaccines not be subject to any legal mandate requiring their use by any class of persons in order for such persons to receive government services, or to work in particular employments, or to travel or to attend any public places or for any other purpose.
(d) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that these uninsurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.
(e) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.
Wherefore the undersigned certifies that to the best of his knowledge and belief the factual statements made herein are true, complete and not intentionally misleading.
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the Petitioner which are unfavorable to the petition.
August 17, 2009 (Rev.1.01 – 08.23.09)
Initial Petitioners Listed on Appendix A
By:
Ralph Fucetola JD
Natural Solutions Foundation Trustee, on behalf of all Petitioners
Express Mail: EO 964 064 326 US – 0144 4000 0332 0857
Revision by email to: [redacted]@fda.hhs.gov
Appendixes
Appendix A – Signatories
Gary Null, PhD – Human Nutrition & Public Health Science
New York, New York 10024
Dr. Tedd Koren, DC – Foundation for Health Choice
Hatfield, PA 19440
Albert N. Stubblebine III – (Maj Gen. US Army Ret.) President
Natural Solutions Foundation
Maryville, Missouri 64468
Rev. Dr. Robert H. Sorge – Pastor of Abunda Life Center
Asbury Park, New Jersey 07712
Rev. Kathy A. Greene, BARA – Chair of LifeSpirit Center
Newton, New Jersey 07860
Alan Phillips, J.D., VaccineRights.com
Chapel Hill, NC 27515-3473
Karen Horbatt – President – Institute for Health Research
Summit, NJ 07901-1826
Appendix B – Articles
1. Andrew Maniotis, Ph.D – How to Predict an Epidemic Timeline
http://www.healthfreedomusa.org/?p=3198
2. Rima E. Laibow, MD – Truth and the Ministry of Lies
http://www.healthfreedomusa.org/?p=3279
3. Kent R. Holcome – Basis for Injunction
http://www.medicalveritas.com/man1925_1936.pdf
4. Ralph Fucetola JD: Your Right to Self Shield
http://www.healthfreedomusa.org/?p=2752
5. Unfavorable Data:
21 C.F.R. 10.30 includes a form of Certification, as used in this Petition, which requires Petitioners to set forth “representative data and information known to the petitioner which are unfavorable to the petition” In fulfillment of this requirement, Petitioners cite the Government’s own web site on Vaccine Safety which includes a representative sample of opinions contrary to those of Petitioners:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm133806.htm
———————————–
Addendum 1.01
Requirements under 21 C.F.R. 10.30 (Citizens Petition)
A. Action requested
The Petitioners request the five specific actions set forth in Paragraph 36 of the Petition.
B. Statement of Grounds
The Legal and Factual Statement of Grounds is found in Paragraphs 8 through 35 of the Petition.
C. Environmental Impact/Exemption
The impact of the granting of the five specific relief actions requested herein will not have any measurable effect on the current environment. This Petition should therefore be exempt under 21 C.F.R. 25.31 (Human drugs and biologics).
D. Economic Impact
This decision will impact the economy as follows:
1. May limit upside profit potential of the vaccine makers and others who will profit from the sale of uninsured, un-tested-for-safety and unproven vaccines to the public.
2. Will reduce the cost to the economy of the lost productivity and other costs of persons who will suffer foreseeable harm from the vaccines.
3. Since the effectiveness of the vaccines are not proven, it cannot be determined what economic benefit may occur from any alleged immunization effect.
Addendum 1.02
Requirements under 21 C.F.R. 10.35 (Stay of Action)
A. Decision Involved
The Center for Biological Evaluation and Research (CBER) pending “Swine Flu”- A-H1N1-09 Vaccine Approvals under the Public Health Service Act, Biological Products:
Section 351(d) (Section 262 of Consolidated Title 21): “Licenses for the maintenance of establishments for the propagation or manufacture and preparation of products described in Subsection A of this Section may be issued only upon a showing that the establishment and the products licenses desired standards, designed to assure the continued safety, purity, and potency of such products, prescribed in regulations, and licenses for new products may be issued only upon a showing that they meet such standards.”
B. Action Requested.
Per Paragraph 36 (a) of the Petition: “an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in immanent peril of irreparable harm if the Temporary Stay is not granted immediately. ”
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