Friday, August 21, 2009
collegeotr.com THE NEW WORLD ORDER DECIEVERS ARE WOLVES IN SHEEPS CLOTHING.SAYING PEACE,LOVE,UTOPIA WHILE SECRETLY 5.5 BILLION HAS TO BE CLEANSED FROM FEEDING(DEATH)
THEIR NEEDLING US TO DEATH.restoretherepublic.com
phoenixsourcedistributors.com THE FANGS OF DEATH INTO OUR BODIES AS THE VACCINES ARE KILLING LOTS OF PEOPLE AND THE NEW WORLD ORDER EUGENICIST NUTCASES ARE LOVING EVERY SECOND OF IT.
7 And when he had opened the fourth seal, I heard the voice of the fourth beast say, Come and see.
8 And I looked, and behold a pale horse:(CHLORES GREEN) and his name that sat on him was Death, and Hell followed with him. And power was given unto them over the fourth part of the earth, to kill with sword,(WEAPONS) and with hunger,(FAMINE) and with death,(INCURABLE DISEASES) and with the beasts of the earth.(ANIMAL TO HUMAN DISEASE).
DRUG PUSHERS AND ADDICTS
23 And the light of a candle shall shine no more at all in thee; and the voice of the bridegroom and of the bride shall be heard no more at all in thee: for thy merchants were the great men of the earth; for by thy sorceries (DRUGS) were all nations deceived.
21 Neither repented they of their murders, nor of their sorceries (DRUGS), nor of their fornication, nor of their thefts.
MILITARY TO WORK WITH FEMA WHEN PANDEMIC HITS
SAY NO TO THE VACCINES
LAB MADE FLU
EUGENICS THEY WANT US DEAD
THIS MAY BE THE REAL THING BY THE NEW WORLD ORDER TO TRY TO KILL US OFF.THE REPORTED CASES MAY BE DOUBLE WORLDWIDE BY THE WAY THE C.D.C,W.H.O JUDGE IF YOU GOT THE FLU OR NOT.IN ORDER TO BE COUNTED IN THE W.H.O STATS YOU MUST HAVE A FEVER TO LEGALLY BE COUNTED AS A SWINE FLU OR H1N1 CASE.SO PEOPLE WHO MIGHT HAVE THE SWINE FLU BUT DO NOT HAVE A FEVER WILL NOT BE COUNTED IN THE WORLD STATS AS A SWINE FLU CASE.SO NOW WE KNOW WHY ON JULY 11,09 THE U.N AND W.H.O AND C.D.C ROSE THE PANDEMIC LEVEL TO 6AND HIGHEST.THESE CORRUPT 3 PLUS PHARMACIES WOULD GET A CERTAIN AMOUNT OF CASES WORLDWIDE BY THEIR WAY OF JUDGING CASES WITH THE FEVER.THEN THEY WOULD JUST DOUBLE THE CASES.SO IF YOU DON'T HAVE A FEVER WITH THE FLU YOU DON'T HAVE SWINE FLU BY THEIR RULES.
BY COUNTING STATS LIKE THIS ALL KINDS OF SCHOOL CHILDREN COULD HAVE SWINE FLU BUT IF THEY DON'T HAVE A FEVER ITS NOT CONSIDERED SWINE FLU.THIS IS THE FIRST WAY THE NEW WORLD ORDER EUGENICISTS COULD SPREAD IT WORLDWIDE FAST BECAUSE AT LEAST HALF OF THE CHILDREN AND FAMILY MEMBERS WOULD THINK THEY ONLY GOT A NORMAL FLU AND NOT SWINE FLU AND WOULD GO ABOUT THEIR BUSINESSES AS USUAL GOING PLACES AND TRAVELING ETC.
RIGHT NOW THERES SCHOOL GOING ON IN GEORGIA AND LOTS OF CHILDREN ARE OUT SICK BUT THE U.N,CDC,WHO, ARE ONLY COUNTING THE CHILDREN WITH FEVERS AS SWINE FLU,SO WE CAN SEE WHEN IN SEPTEMBER WHEN ALL THE SCHOOLS IN NORTH AMERICA ARE IN FULL GEAR AND THE CHILDREN START GETTING SICK,THE ONLY ONES COUNTED AS SWINE FLU WILL BE THE ONES WITH THE FEVER.SO THE REST OF THE CHILDREN AND THEIR FAMILIES WILL THINK THEY ONLY GOT A NORMAL FLU AND WILL ASSOCIATE WITH OTHER PEOPLE AND TRAVEL.I CAN SEE THE NEW WORLD ORDER NUTCASES JUST LAUGHING AMOUNG THEMSELVES SAYING WE HAVE THESE FOOLS UNDER OUR CONTROL AND WE CAN OFF THEM NOW BY THE MILLIONS AND ALL WE HAVE TO SAY IS WE NEVER KNEW THE SWINE FLU WOULD BE SPREAD WITHOUT THE FEVER.
NOW THE VACCINE
IN SEPTEMBER OR OCTOBER AROUND THE WORLD ALL THE COUNTRIES WANT THEIR POPULATIONS VACCINATED UP TO 4 SHOTS PER PERSON.LETS JUST SAY THIS FLU IS LABRATORY MADE AND THE NEW WORLD ORDER NUTCASES MADE THIS FLU TO BLOSSOM WHEN A WARM VACCINE (TAMIFLU) IS INJECTED INTO THE SKIN THAT ACTIVATES THE SWINE FLU.AFTER ABOUT 4 OR 5 DAYS WHEN THE PERSON THINKS THAT THEY ARE PROTECTED FROM THE SWINE FLU SUDDENLY THEY COME DOWN WITH A FEVER.LITTLE DO THEY KNOW THE VACCINE WAS MADE TO MAKE THE PERSON INJECTED WITH THE TAMIFLU TO CREATE A FEVER WHICH WILL SET OFF THE SWINE FLU INCERTED IN THE VACCINE TO COME TO LIFE AFTER 4 OR 5 DAYS.JUST THINK IF 1/3 OF THE POPULATION OR 2 BILLION PEOPLE TOOK THE VACCINE HOW MANY OF US THE NEW WORLD ORDER NUTCASES COULD OFF QUICK.
FOR SOME REASON THE CDC,WHO,UN ARE ONLY COUNTING THE FEVER CASES AS SWINE FLU.THIS COULD BE A REASON WHY THEY WANT EVERY ONE INJECTED WITH THE VACCINE BEFORE THE FLU SEASON IS IN HIGH GEAR BECAUSE THEN THEY COULD GET THE SWINE FLU AROUND THE WORLD REAL QUICK AND MILLIONS DEAD FAST.
ANOTHER THING IN 1976 WHEN THE FLU BROKE OUT THEY MADE 200 MILLION DOSES IN STOCK AND VACCINATED 40 MILLION PEOPLE.BUT BECAUSE THE VACCINE KILLED LOTS OF PEOPLE AND GAVE THEM INCURABLE DISEASES THE VACCINATING WAS STOPPED.NOW HOWS THIS FOR INFORMATION CAN YOU GUESS HOW MANY MILLION VACCINES WERE ORDERED FOR THIS SEPTEMBER OR OCTOBERS FIRST INJECTIONS.YYYYESSSSS YOU GOT IT 2009 THERE IS 160 MILLION VACCINES ORDERED BY THE GOVERNMENT FOR THE FIRST INJECTIONS.COULD AS I BELIEVE OBAMA AND COMPANY BE USING UP THIS 33 YEAR OLD CONTAMINATED FLU VACCINE WITH THIS ADDED FEATURE TO IT THAT IT HAS TO GO IN THE BODY WARM TO ACTIVATE THE SWINE FLU IN THE VACCINE AFTER 4 OR 5 DAYS THAT CREATES A FEVER AND THE BEGINNING OF THE SWINE FLU IN THE BODY.WELL WE WILL FIND OUT IF MY SPECULATION IS CORRECT OR NOT WHEN THE FIRST SHOTS ARE INJECTED AND SWINE FLU GOES WORLDWIDE QUICK,KILLING MILLIONS AND GIVING MILLIONS MORE INCURABLE DISEASES.
OH AND ONE LAST THING THE EUGENICIST PRESIDENT OF THE USA OBAMA AND LUGAR WERE INVOLVED IN WRITING A STORY IN 2005.IT SEEMS OBAMA IS ACQUAINTED WITH FLU PANDEMICS.
Grounding a Pandemic-Barack Obama and Richard Lugar, New York Times, June 6, 2005 (2)
WHAT A BETTER WAY TO BRING THE WORLDS PEOPLE TO THEIR KNEES FROM FRIGHT AND DEATH TO BRING ABOUT A QUICK CHANGE TO WORLD GOVERNMENT CONTROLLED BY THE EUROPEAN UNION AND THE G-20 AND THE VATICAN.THE NEW WORLD ORDERERS COULD QUICKLY SAY WE NEED TO PUT THE WORLD IN 10 REGIONAL BLOCS TO TRY TO GET THIS PANDEMIC UNDER CONTROL.THE G-20 AND THE EUROPEAN UNION WOULD BRING ABOUT A QUICK MICROCHIP IMPLANT SYSTEM AND SAY EVERYONE MUST GET A CHIP IMPLANT IN THEM SO WE CAN KEEP TRACK OF ALL THE WORLD CITIZENS,IF THEY GET THE SWINE FLU WE CAN TRACK BACK TO WHOEVER THEY CAME IN CONTACT WITH AND WERE EVER THEY WHERE.AND THE VATICAN AND MANY CHURCHES WOULD BE THE SUPPORT GROUP FOR ALL THE FAMILIES OF THE DEAD LOOKING FOR COMFORT.I BELIEVE OBAMA WILL GO BY THIS STORY WHICH I HAVE ON HERE TO DO HIS DIABOLICAL DEEDS-History-Reflections on the 1976 Swine Flu Vaccination Program.
Op-Ed Contributors Grounding a Pandemic By BARACK OBAMA and RICHARD LUGAR
Published: June 6, 2005
Washington — When we think of the major threats to our national security, the first to come to mind are nuclear proliferation, rogue states and global terrorism. But another kind of threat lurks beyond our shores, one from nature, not humans - an avian flu pandemic. An outbreak could cause millions of deaths, destabilize Southeast Asia (its likely place of origin), and threaten the security of governments around the world.
Forum: Op-Ed Contributors
Earlier this year, Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention, called the possibility of avian flu spreading from Southeast Asia a very ominous situation for the globe.A killer flu could spread around the world in days, crippling economies in Southeast Asia and elsewhere.From a public health standpoint, Dr. Gerberding said, an avian flu outbreak is the most important threat that we are facing right now.
International health experts say that two of the three conditions for an avian flu pandemic in Southeast Asia have already been met. First, a new strain of the virus, called A(H5N1), has emerged, and humans have little or no immunity to it. Second, this strain can jump between species. The only remaining obstacle is that A(H5N1) has not yet mutated into a form that is easily transmitted from human to human. However, there have been some alarming developments. In recent months, the virus has been detected in mammals that have never previously been infected, including tigers, leopards and domestic cats. This spread suggests that the virus is mutating and could eventually emerge in a form that is readily transmittable among humans, leading to a full-blown pandemic. In fact, according to government officials, a few cases of human-to-human spread of A(H5N1) have already occurred.The precedent that experts fear is the 1918 flu pandemic, which began in the American Midwest and swept the planet in the era before air travel, killing 20 million to 40 million people.As John M. Barry, author of The Great Influenza, has observed,Influenza killed more people in a year than the Black Death of the Middle Ages killed in a century; it killed more people in 24 weeks than AIDS has killed in 24 years.At the moment, effective responses to an avian flu pandemic are limited and will come far too late for many people in Southeast Asia. Indeed, so far more than 60 percent of those diagnosed with the avian flu have died. There is no proven vaccine for the A(H5N1) strain and it could take months to produce a fully effective one. Moreover, while some antiviral treatments may help flu sufferers, they are not widely available and must be administered to patients within 24 hours after the onset of symptoms.
It is essential for the international community, led by the United States, to take decisive action to prevent a pandemic.So what should we do? Recently, the World Health Organization called for more money and attention to be devoted to effective preventive action, appealing for $100 million. Congress responded promptly. A bipartisan group of senators obtained $25 million for prevention efforts (a quarter of the request, the traditional contribution of the United States), allowing the C.D.C., the Agency for International Development, the Health and Human Services Department and other agencies to improve their ability to act. In addition, the Senate Foreign Relations Committee unanimously approved legislation directing President Bush to form a senior-level task force to put in place an international strategy to deal with the avian flu and coordinate policy among our government agencies. We urge the Bush administration to form this task force immediately without waiting for legislation to be passed. But these are only modest first steps. International health experts believe that Southeast Asia will be an epicenter of influenza for decades. We recommend that this administration work with Congress, public health officials, the pharmaceutical industry, foreign governments and international organizations to create a permanent framework for curtailing the spread of future infectious diseases.
Among the parts of that framework could be these: Increasing international disease surveillance, response capacity and public education and coordination, especially in Southeast Asia.Stockpiling enough antiviral doses to cover high-risk populations and essential workers.Ensuring that, here at home, Health and Human Services and state governments put in place plans that address issues of surveillance, medical care, drug and vaccine distribution, communication, protection of the work force and maintenance of core public functions in case of a pandemic. Accelerating research into avian flu vaccines and antiviral drugs.
Establishing incentives to encourage nations to report flu outbreaks quickly and fully.So far, A(H5N1) has not been found in the United States. But in an age when you can board planes in Bangkok or Hong Kong and arrive in Chicago, Indianapolis or New York in hours, we must face the reality that these exotic killer diseases are not isolated health problems half a world away, but direct and immediate threats to security and prosperity here at home.Barack Obama, Democrat of Illinois, is a member of the Senate Foreign Relations Committee and Richard Lugar, Republican of Indiana, is its chairman.
Preventing an Outbreak: McCain and Obama on Pandemics As fear of another massive influenza breakout grows, we parse the candidates' records on bioterrorism and more By Stuart Fox Posted 10.12.2008 at 3:01 pm
Question Six: Pandemic Flu
Yesterday we looked at Senator Obama's and Senator McCain’s opinions on using science to protect Americans from other countries. Today, we look at the candidates’ plans to protect Americans from other organisms. In particular, influenza, which has killed more Americans than all the wars of the 20th Century, combined. Do the candidates have a record of bird flu awareness and bioterrorism prevention? Let’s take a look.
Pandemic flu didn’t pop up on any politicians’ radar until 2004, when a major breakout of highly deadly H5N1 avian bird flu began killing birds and people in Asia. With the threat of a deadly pandemic arising for the first time in decades, President Bush asked Congress to appropriate money to help prepare for a possible outbreak. The result has been a flurry of bills like S 2968, the Emergency Flu Response Act of 2004, and S 2038 the Flu Protection Act of 2004. Additionally, money to combat a flu pandemic has been added to Defense Department appropriation bills and hurricane relief bills.With the majority of funds to combat bird flu coming in those appropriation bills that usually pass the Senate unanimously, both candidates have voted for funds to prevent or manage an outbreak of pandemic flu. Oddly, only Senator McCain’s Science Debate answer specifically mentions a flu pandemic. That is odd because Senator Obama has been far more active on this issue than McCain.
Obama was on of the co-sponsors of S 375, the Flu Prevention Act of 2005. That bill sought to appropriate $150 million a year for vaccine development and production, awareness campaigns and other preparations for a pandemic. Additionally, Obama supported HR 4939, the Emergency Supplemental Appropriations Act for Defense, the Global War on Terror, and Hurricane Recovery of 2006 that provided $2.3 billion for avian and pandemic flu efforts. McCain, on the other hand, voted against HR 4939 and has never sponsored any bills that provide money to prevent a pandemic flu outbreak.
On the bioterrorism front, the reverse effect occurs. While Obama’s Science Debate answer talked about bioterrorism, though his record involved more work on pandemic flu, McCain’s answer highlighted flu but his record indicates a greater focus on bioterrorism. McCain voted for HR 3448, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, but so did everyone else in the Senate. Interestingly, however, was McCain’s absence as a sponsor of S 1765, the Bioterrorism Preparedness Act of 2001. S 1765 was the Senator version of HR 3448, and the bill had 80 cosponsors. Despite being introduced by a Republican and cosponsored by nearly everyone in the Senate, McCain did not become a cosponsor of the bill.
In the end, McCain’s record does not support his Science Debate answer. He has not cosponsored, and even voted against, legislation to fund anti-pandemic flu programs. On the other hand, Obama has a clear history of engagement with this issue and even cosponsored bills specifically designed to deal with a pandemic flu outbreak.Next we look at Obama and McCain’s opinions genetics research. Little known fact, McCain gained superpowers after being bitten by a radioactive spider and Obama has a mutant healing ability.
Cold vs. Flu Tool-Know the Difference Between Cold and Flu.
Symptoms-Can you tell the difference between symptoms of flu and the common cold? To learn more about your symptoms, if they are associated with the flu, and how TAMIFLU may help check out the Symptoms at a Glance chart below.
Symptom(1) - Cold(2) - Flu(3)
Fever(1)- Fever is rare with a cold.(2)Fever is usually present with the flu in up to 80% of all flu cases.A temperature of 100°F or higher for 3 to 4 days is associated with the flu.(3)
Coughing(1)- A hacking, productive (mucus- producing) cough is often present with a cold.(2) A non-productive (non-mucus producing) cough is usually present with the flu (sometimes referred to as dry cough).(3)
Aches(1)- Slight body aches and pains can be part of a cold.(2)Severe aches and pains are common with the flu.(3)
Stuffy Nose(1)- Stuffy nose is commonly present with a cold and typically resolves spontaneously within a week.(2) Stuffy nose is not commonly present with the flu.(3)
Chills(1)- Chills are uncommon with a cold.(2)60% of people who have the flu experience chills.(3)
Tiredness(1)- Tiredness is fairly mild with a cold.(2)Tiredness is moderate to severe with the flu.(3)
Sneezing(1)- Sneezing is commonly present with a cold.(2)Sneezing is not common with the flu.(3)
Sudden Symptoms(1)- Cold symptoms tend to develop over a few days.(2)The flu has a rapid onset within 3-6 hours. The flu hits hard and includes sudden symptoms like high fever, aches and pains.(3)
Headache(1)- A headache is fairly uncommon with a cold.(2)A headache is very common with the flu, present in 80% of flu cases.(3)
Sore Throat(1)- Sore throat is commonly present with a cold.(2)Sore throat is not commonly present with the flu.(3)
Chest Discomfort(1)- Chest discomfort is mild to moderate with a cold.(2) Chest discomfort is often severe with the flu.(3)
This is not a substitute for a professional, on-site medical diagnosis. However, you can use the printable symptoms results for discussion with your doctor or other healthcare professional during your visit to aid in a professional diagnosis.
Side Effects and Safety of TAMIFLU
Rare but serious skin reactions and allergic reactions have been reported. Stop taking TAMIFLU and call your doctor if you experience any of these reactions, as they could be very serious.People with the flu, particularly children and adolescents, may be at an increased risk of self injury and confusion shortly after taking TAMIFLU and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking TAMIFLU shows any signs of unusual behavior.The most common side effects of TAMIFLU are mild to moderate nausea and vomiting. TAMIFLU is generally well tolerated.
In addition, take the following precautions when using TAMIFLU:
You should not take TAMIFLU if you are allergic to oseltamivir phosphate or any other ingredients of TAMIFLU.TAMIFLU is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. If you are pregnant, planning to become pregnant or breastfeeding while taking TAMIFLU, talk to your doctor before taking TAMIFLU. If you have any type of kidney disease, talk to your doctor before starting TAMIFLU therapy.The use of TAMIFLU along with an intranasal flu vaccine like (flumist)has not been evaluated. However, due to the possibility for interference between these products, an intranasal flu vaccine should not be given within 2 weeks before or 48 hours after taking TAMIFLU, unless it is deemed appropriate by your doctor. The type of flu vaccine administered as a shot through the skin can be given at any time relative to use of TAMIFLU.As with any medication, be sure to discuss with your doctor any over–the–counter or prescription medicines you are currently taking before beginning TAMIFLU therapy.
History-Reflections on the 1976 Swine Flu Vaccination Program
David J. Sencer* and J. Donald Millar†
*Atlanta, Georgia, USA; and †Murraysville, Georgia, USA
In 1976, 2 recruits at Fort Dix, New Jersey, had an influenzalike illness.Isolates of virus taken from them included A/New Jersey/76 (Hsw1n1), a strain similar to the virus believed at the time to be the cause of the 1918 pandemic, commonly known as swine flu.Serologic studies at Fort Dix suggested that 200 soldiers had been infected and that person-to-person transmission had occurred.We review the process by which these events led to the public health decision to mass-vaccinate the American public against the virus and the subsequent events that led to the program's cancellation. Observations of policy and implementation success and failures are presented that could help guide decisions regarding avian influenza.
Flu to the Starboard! Man the Harpoons! Fill with Vaccine! Get the Captain! Hurry!
Edwin D. Kilbourne, New York Times, February 13, 1976 (1)
Grounding a Pandemic-Barack Obama and Richard Lugar, New York Times, June 6, 2005 (2)
It has been 37 years since the last influenza pandemic, or widespread global epidemic, so by historic patterns we may be due for another.New York Times, July 17, 2005 (3)
Kilbourne in 1976 (1) noted that pandemics of influenza occur every 11 years. Since the latest prediction in the New York Times (3) suggests that after 39 years we may be overdue for a pandemic, and since 2 US senators have recently headlined the possibility (2), that observation may become a political fact. Whether it becomes a scientific fact and a policy fact is yet to be seen. Some reflections on 1976 from 2 insiders' viewpoints may identify some of the pitfalls that public health policymakers will face in addressing potential influenza pandemics.
Swine Flu at Fort Dix
On February 3, 1976, the New Jersey State Health Department sent the Center for Disease Control (CDC) in Atlanta isolates of virus from recruits at Fort Dix, New Jersey, who had influenzalike illnesses. Most of the isolates were identified as A/Victoria/75 (H3N2), the contemporary epidemic strain.Two of the isolates, however, were not typeable in that laboratory.On February 10, additional isolates were sent and identified in CDC laboratories as A/New Jersey/76 (Hsw1N1), similar to the virus of the 1918 pandemic and better known as swine flu.A meeting of representatives of the military, the National Institute of Health, the Food and Drug Administration (FDA), and the State of New Jersey Department of Health was quickly convened on Saturday, February 14, 1976. Plans of action included heightened surveillance in and around Fort Dix, investigation of the ill recruits to determine if contact with pigs had occurred, and serologic testing of recruits to determine if spread had occurred at Fort Dix.Surveillance activities at Fort Dix gave no indication that recruits had contact with pigs. Surveillance in the surrounding communities found influenza caused by the current strain of influenza, A/Victoria, but no additional cases of swine flu. Serologic testing at Fort Dix indicated that person-to-person transmission had occurred in 200 recruits (4).In 1974 and 1975, 2 instances of humans infected with swine influenza viruses had been documented in the United States. Both persons involved had close contact with pigs, and no evidence for spread of the virus beyond family members with pig contact could be found (5).
The National Influenza Immunization Program
On March 10, 1976, the Advisory Committee on Immunization Practices of the United States Public Health Service (ACIP) reviewed the findings. The committee concluded that with a new strain (the H1N1 New Jersey strain) that could be transmitted from person to person, a pandemic was a possibility. Specifically, the following facts were of concern: 1) persons 50 years of age had no antibodies to this new strain; 2) a current interpandemic strain (A/Victoria) of influenza was widely circulating; 3) this early detection of an outbreak caused by A/New Jersey/76/Hsw1N1 (H1N1) provided an opportunity to produce a vaccine since there was sufficient time between the initial isolates and the advent of an expected influenza season to produce vaccine. In the past when a new pandemic strain had been identified, there had not been enough time to manufacture vaccine on any large scale; 4) influenza vaccines had been used for years with demonstrated safety and efficacy when the currently circulating vaccine strain was incorporated; 5) the military vaccine formulation for years had included H1N1, an indication that production was possible, and no documented adverse effects had been described.ACIP recommended that an immunization program be launched to prevent the effects of a possible pandemic.One ACIP member summarized the consensus by stating If we believe in prevention,we have no alternative but to offer and urge the immunization of the population.One ACIP member expressed the view that the vaccine should be stockpiled, not given.Making this decision carried an unusual urgency. The pharmaceutical industry had just finished manufacture of the vaccine to be used in the 1976–1977 influenza season.At that time, influenza vaccine was produced in fertilized hen's eggs from special flocks of hens.Roosters used for fertilizing the hens were still available; if they were slaughtered, as was customary, the industry could not resume production for several months.
On March 13, an action memo was presented to the Secretary of the Department of Health Education and Welfare (DHEW).It outlined the problem and presented 4 alternative courses of action.First was business as usual,with the marketplace prevailing and the assumption that a pandemic might not occur.The second was a recommendation that the federal government embark on a major program to immunize a highly susceptible population.As a reason to adopt this plan of action, the memo stated that the Administration can tolerate unnecessary health expenditures better than unnecessary death and illness if a pandemic should occur.The third proposed course of action was a minimal response, in which the federal government would contract for sufficient vaccine to provide for traditional federal beneficiaries—military personnel, Native Americans, and Medicare-eligible persons.The fourth alternative was a program that would represent an exclusively federal response without involvement of the states.The proposal recommended by the director of CDC was the second course, namely, for the federal government to contract with private pharmaceutical companies to produce sufficient vaccine to permit the entire population to be immunized against H1N1.The federal government would make grants to state health departments to organize and conduct immunization programs.The federal government would provide vaccine to state health departments and private medical practices.Since influenza caused by A/Victoria was active worldwide, industry was asked to incorporate the swine flu into an A/Victoria product to be used for populations at high risk.Before the discussions with the secretary of DHEW had been completed, a member of his staff sent a memo to a health policy advisor in the White House, raising the specter of the 1918 pandemic, which had been specifically underemphasized in the CDC presentation. CDC's presentation highlighted the pandemic potential, comparing it with the 1968–69 Hong Kong and 1957–58 Asian pandemics. President Gerald Ford's staff recommended that the president convene a large group of well-known and respected scientists (Albert Sabin and Jonas Salk had to be included) and public representatives to hear the government's proposal and make recommendations to the president about it. After the meeting, the president had a press conference, highlighted by the unique simultaneous appearance of Salk and Sabin. President Ford announced that he accepted the recommendations that CDC had originally made to the secretary of DHEW. The National Influenza Immunization Program (NIIP) was initiated.
The proposal was presented to 4 committees of the Congress, House and Senate authorization committees and House and Senate appropriation committees.All 4 committees reported out favorable legislation, and an appropriation bill was passed and signed.The estimated budgeted cost of the program was $137 million. When Congress passed the appropriation, newspapers mischaracterized the cost as $1.9 billion because the $137 million was included as part of a $1.9 billion supplemental appropriation for the Department of Labor. In the minds of the public, this misconception prevailed.Immediately after the congressional hearing, a meeting of all directors of state health departments and medical societies was held at CDC.The program was presented by CDC, and attendees were asked for comments. A representative from the New Jersey state health department opposed the plan; the Wisconsin state medical society opposed any federal involvement.Otherwise, state and local health departments approved the plan.Within CDC, a unit charged with implementing the program,which reported to the director, was established. This unit, NIIP, had complete authority to draw upon any resources at CDC needed. NIIP was responsible for relations with state and local health departments (including administration of the grant program for state operations,technical advice to the procurement staff for vaccine, and warehousing and distribution of the vaccine to state health departments) and established a proactive system of surveillance for possible adverse effects of the influenza vaccines,the NIIP Surveillance Assessment Center (NIIP-SAC). (This innovative surveillance system would prove to be NIIP's Trojan horse.) In spite of the obstacles discussed below, NIIP administered a program that immunized 45 million in 10 weeks, which resulted in doubling the level of immunization for persons deemed to be at high risk, rapidly identifying adverse effects, and developing and administering an informed consent form for use in a community-based program.
Obstacles to the Vaccination Plan
The principal obstacle was the lack of vaccines.As test batches were prepared, the largest ever field trials of influenza vaccines ensued.The vaccines appeared efficacious and safe (although in the initial trials, children did not respond immunologically to a single dose of vaccine,and a second trial with a revised schedule was needed) (6).Hopes were heightened for a late summer/early fall kickoff of mass immunization operations.In January 1976, before the New Jersey outbreak, CDC had proposed legislation that would have compensated persons damaged as a result of immunization when it was licensed by FDA and administered in the manner recommended by ACIP. The rationale given was that immunization protects the community as well as the individual (a societal benefit) and that when a person participating in that societal benefit is damaged, society had a responsibility to that person. The proposal was sent back from a staff member in the Surgeon General's office with a handwritten note,This is not a problem.Soon, however, NIIP received the first of 2 crippling blows to hopes to immunize every man, woman, and child.The first was later in 1976, when instead of boxes of bottled vaccine,the vaccine manufacturers delivered an ultimatum—that the federal government indemnify them against claims of adverse reactions as a requirement for release of the vaccines.The government quickly capitulated to industry's demand for indemnification.While the manufacturers' ultimatum reflected the trend of increased litigiousness in American society, its unintended, unmistakable subliminal message blared There's something wrong with this vaccine.This public misperception, warranted or not, ensured that every coincidental health event that occurred in the wake of the swine flu shot would be scrutinized and attributed to the vaccine.
On August 2, 1976, deaths apparently due to an influenzalike illness were reported from Pennsylvania in older men who had attended the convention of the American Legion in Philadelphia.A combined team of CDC and state and local health workers immediately investigated.By the next day,epidemiologic evidence indicated that the disease was not influenza (no secondary cases occurred in the households of the patients).By August 4, laboratory evidence conclusively ruled out influenza.However,this series of events was interpreted by the media and others as an attempt by the government to stimulate NIIP.Shortly after the national campaign began,3 elderly persons died after receiving the vaccine in the same clinic.Although investigations found no evidence that the vaccine and deaths were causally related,press frenzy was so intense it drew a televised rebuke from Walter Cronkite for sensationalizing coincidental happenings.
What NIIP did not and could not survive,however,was the second blow, finding cases of Guillain-Barré syndrome (GBS) among persons receiving swine flu immunizations.As of 1976, 50 antecedent events had been identified in temporal relationship to GBS, events that were considered as possible factors in its cause.The list included viral infections,injections,and being struck by lightning.Whether or not any of the antecedents had a causal relationship to GBS was, and remains,unclear.When cases of GBS were identified among recipients of the swine flu vaccines,they were, of course, well covered by the press. Because GBS cases are always present in the population, the necessary public health questions concerning the cases among vaccine recipients were Is the number of cases of GBS among vaccine recipients higher than would be expected? And if so, are the increased cases the result of increased surveillance or a true increase?Leading epidemiologists debated these points, but the consensus, based on the intensified surveillance for GBS (and other conditions) in recipients of the vaccines, was that the number of cases of GBS appeared to be an excess.Had H1N1 influenza been transmitted at that time, the small apparent risk of GBS from immunization would have been eclipsed by the obvious immediate benefit of vaccine-induced protection against swine flu. However, in December 1976, with 40 million persons immunized and no evidence of H1N1 transmission, federal health officials decided that the possibility of an association of GBS with the vaccine, however small, necessitated stopping immunization, at least until the issue could be explored. A moratorium on the use of the influenza vaccines was announced on December 16; it effectively ended NIIP of 1976.Four days later the New York Times published an op-ed article that began by asserting, Misunderstandings and misconceptions..have marked Government ... during the last eight years,attributing NIIP and its consequences to political expediency and the self interest of government health bureaucracy(7).These simple and sinister innuendos had traction, as did 2 epithets used in the article to describe the program, debacle in the text and Swine Flu Fiasco in the title.On February 7, the new secretary of DHEW, Joseph A. Califano, announced the resumption of immunization of high-risk populations with monovalent A/Victoria vaccine that had been prepared as part of the federal contracts, and he dismissed the director of CDC.
Figure. Lessons learned from the 1976 National Influenza Immunization Program (NIIP).NIIP may offer lessons for today's policymakers, who are faced with a potential pandemic of avian influenza and struggling with decisions about preventing it (Figure).Two of these lessons bear further scrutiny here.
Media and Presidential Attention
While all decisions related to NIIP had been reached in public sessions (publishing of the initial virus findings in CDC's weekly newsletter, the Morbidity and Mortality Weekly Report (MMWR); New York Times reporter Harold Schmeck's coverage of the ACIP sessions, the president's press conference, and 4 congressional hearings), effective communication from scientifically qualified persons was lacking, and the perception prevailed that the program was motivated by politics rather than science. In retrospect (and to some observers at the time), the president's highly visible convened meeting and subsequent press conference, which included pictures of his being immunized, were mistakes.These instances seemed to underline the suspicion that the program was politically motivated, rather than a public health response to a possible catastrophe.Annex 11 of the draft DHEW pandemic preparedness plan states, For policy decisions and in communication, making clear what is not known is as important as stating what is known. When assumptions are made, the basis for the assumptions and the uncertainties surrounding them should be communicated (11).This goal is much better accomplished if the explanations are communicated by those closest to the problem, who can give authoritative scientific information.Scientific information coming from a nonscientific political figure is likely to encourage skepticism, not enthusiasm.Neither CDC nor the health agencies of the federal government had been in the habit of holding regular press conferences.CDC considered that its appropriate main line of communication was to states and local health departments, believing that they were best placed to communicate with the public. MMWR served both a professional and public audience and accounted for much of CDC's press coverage.In 1976, no all-news stations existed, only the nightly news. The decision to stop the NIIP on December 16, 1976, was announced by a press release from the office of the assistant secretary for health. The decision to reinstitute the immunization of those at high risk was announced by a press release from the office of the secretary, DHEW. In retrospect, periodic press briefings would have served better than responding to press queries. The public must understand that decisions are based on public health, not politics. To this end, health communication should be by health personnel through a regular schedule of media briefings.
Decision To Begin Immunization
This decision is worthy of serious question and debate. As Walter Dowdle (12) points out in this issue of Emerging Infectious Diseases, the prevailing wisdom was that a pandemic could be expected at any time. Public health officials were concerned that if immunization was delayed until H1N1 was documented to have spread to other groups, the disease would spread faster than any ability to mobilize preventive vaccination efforts. Three cases of swine influenza had recently occurred in persons who had contact with pigs. In 1918, after the initial outbreak of influenza at Fort Riley in April,widespread outbreaks of influenza did not occur until late summer(13).
The Delphi exercise of Schoenbaum in early fall of 1976 (13) was the most serious scientific undertaking to poll scientists to decide whether or not to continue the program. Its main finding was that the cost benefit would be best if immunization were limited to those 25 years of age (and now young children are believed to be a potent source of spread of influenza virus).Unfortunately, no biblical Joseph was there to rise from prison and interpret the future.As Dowdle further states (12), risk assessment and risk management are separate functions.But they must come together with policymakers, who must understand both. These discussions should not take place in large groups in the president's cabinet room but in an environment that can establish an educated understanding of the situation.Once the policy decisions are made,implementation should be left to a single designated agency.Advisory groups should be small but representative.CDC had the lead responsibility for operation of the program. Implementation by committee does not work. Within CDC, a unit was established for program execution,including surveillance,outbreak investigation, vaccine procurement and distribution, assignment of personnel to states, and awarding and monitoring grants to the states.Communications up the chain of command to the policymakers and laterally to other directly involved federal agencies were the responsibility of the CDC director, not the director of NIIP, who was responsible for communications to the states and local health departments, those ultimately implementing operations of the program. This organizational mode functioned well, a tribute to the lack of interagency jealousies.
When lives are at stake, it is better to err on the side of overreaction than underreaction. Because of the unpredictability of influenza, responsible public health leaders must be willing to take risks on behalf of the public.This requires personal courage and a reasonable level of understanding by the politicians to whom these public health leaders are accountable.All policy decisions entail risks and benefits: risks or benefits to the decision maker; risks or benefits to those affected by the decision.In 1976, the federal government wisely opted to put protection of the public first.Dr Sencer was director of CDC from 1966 to 1977.Dr Millar was director of NIIP in 1976.
1-Kilbourne ED. Flu to the starboard! Man the harpoons! Fill with vaccine! Get the captain! Hurry! New York Times. 1976 Feb 13. p. 32, col. 4.
2-Obama B, Lugar R. Grounding a pandemic.Op-ed section. New York Times. 2005 Jun 6. [cited 1 Nov 2005]. Available from http://www.nytimes.com/2005/06/06/opinion/06obama.html?ex=1130994000&en=1b199f715505a19c&ei=5070
3-Unprepared for a flu pandemic [editorial]. New York Times. 2005 Jul 17; Sect. 4:11 (col. 1).
4-Hodder RA, Gaydos JC, Allen RG, Top FH Jr, Nowosiwsky T, Russell PK. Swine influenza A at Fort Dix, New Jersey (January–February 1976). III. Extent of spread and duration of the outbreak. J Infect Dis. 1977;136:S369–75.
5-Dowdle WR, Hattwick MAW. Swine influenza virus infections in humans. J Infect Dis. 1977;136:S386–9.
6-Denny FW, Glezen WP, Karzon DT, Katz SL, Krugman S, McIntosh K, Parrott RH. Swine-like influenza vaccine: a commentary. J Pediatr. 1976;88:1057.
7-Schwartz H. Swine flu fiasco. New York Times. 1976 Dec. 21. p. 33, col. 1–2.
8-Schmeck HM Jr. More deaths reported after shots but no link to flu vaccine is found. New York Times. 1976 Oct 14; Sect. A:1+.
9-Fraser DW, Tsai TR, Orenstein W, Parkin WE, Beecham HJ, Sharrar RG, et al. Legionnaires' disease: description of an epidemic of pneumonia. N Engl J Med. 1977;297:1189–97.
10-Schonberger LB, Hurwitz ES, Katona P, Holman RC, Bregman DJ. Guillain-Barré syndrome: its epidemiology and associations with influenza vaccination. Ann Neurol. 1981;9(Suppl):31–8.
11-Department of Health and Human services. Annex 11: Pandemic influenza response and preparedness plan. Washington: The Department; 2003 Aug 26.
12-Dowdle WR. Influenza pandemic periodicity, virus recycling, and the art of risk assessment. Emerg Infect Dis. 2006;12. This issue.
13-Schoenbaum SC, McNeil BJ, Kavat J. The swine-influenza decision. N Engl J Med. 1976;295:759–65.
1976 Swine Flu Pandemic Scare
On 27 January 1976, an outbreak of respiratory disease was identified at Ft. Dix, New Jersey. On 04 February 1976, after leaving his sick bed and making a forced, five-mile, night march, Private David Lewis, Fort Dix recruit, collapsed and died. The virus caused disease with radiologic evidence of pneumonia in at least 4 soldiers and 1 death; all of these patients had previously been healthy. On 12 February 1976 the CDC influenza laboratory notified the CDC Director that a swine influenza virus strain (H1N1) had been isolated from patients that possessed hemagglutinin and neuraminidase subtypes that had not circulated for more than 50 years - the H1(swine) N1r virus that was the putative virus of the 1918 Spanish Flu [that turned out not to be the case - the virus implicated in 1918 was probably derived from an avian species of the flu virus]. Experience had led scientists to conclude at that time that introduction of a new strain inevitably resulted in a pandemic. This new flu strain might conceivably become as big a killer as the flu of 1918, the worst ever.One death, thirteen sick men [other accounts say that as many as 240 people fell ill, but it seems these were due to the Victoria seasonal flu virus] and up to 500 recruits who evidently had caught and resisted the disease, all in one Army camp, were the only established instances of human-to-human swine flu found around the world as February turned into March, the last month of flu season in the Northern Hemisphere. Nothing quite like Fort Dix and the lack of spread beyond it had been seen before. But an epidemic spreading into a pandemic had to be anticipated as a possibility. There was also for the first time the possibility to better the quite dismal record of 1957 and of 1968 in getting vaccine to Americans ahead of a pandemic.On 24 March 1976 President Gerald R. Ford met with CDC, FDA, and NIH representatives and other experts. There was a unanimous recommendation to initiate mass immunization. An appropriation in precisely the amount requested was tacked onto a pending supplemental bill by an accommodating Senate Appropriations Committee. It was voted by the Senate April 9, by the House April 12, and signed into law (Public Law 94-266) on April 15, 1976, providing over $135 million for the swine flu program.
This program was an unprecedented venture in preventive medicine. It was the Government's first attempt at immunization of the entire US population. Faced with the possibility of an epidemic that could cost many lives and billions of dollars and offered a chance to prevent it, the Department of Health, Education, and Welfare (EW) planned, and the Congress approved, the $135 million swine flu program.By June 1976 no swine flu had shown up anywhere, not even in the southern hemisphere where flu season would shortly reach its peak. All around the world there had not been a single case of swine flu for six months. The lack of cases had changed the feelings of most specialists, who sensed that odds of a pandemic were dropping week by week. Top advisers met with President Ford on 19 July 1976. Since a pandemic remained possible, with probabilities unknown, the vaccination program continued.In June 1976 the lack of available liability coverage for several program participants including vaccine manufacturers and some States became threatened the successful implementation of the program. Thus ended hopes of immunizing anybody in July or even August. Nothing like that had ever occurred with immunization programs. Polio immunization had entailed far fewer numbers with sponsorship free from political taint, in a relatively unlitigious era. To resolve the liability problem, the Congress, in August 1976, enacted Public Law 94-380. Under this act, the Federal Government assumed liability for personal injuries or death resulting from the swine flu vaccine. The act provided that claims and lawsuits for injury or death resulting from the swine flu program must be filed against the Federal Government and decided through procedures of the Federal Tort Claims Act (28 U.S.C. 2671 et seq.). The new legislation became effective with the start of the new fiscal year on 01 October. Until then, manufacturers and their insurers were determined that nobody would use swine vaccine on anybody.The first vaccine dose was given 7.5 months after the virus was identified. By 9.5 months, 200 million doses of vaccine had been produced under a federal contract. All vaccine which was released for use in the swine flu program ultimately met Food and Drug Administration potency and safety standards. Almost 30 percent of the vaccine was considered subpotent, and the agency did not permit its release to the public until the minimum potency requirement was met. Tests showed that some of the trial vaccine did not meet specified potency levels, and trial participants were not given the same protection as the general publi:. The potency test does not accurately indicate the protection provided by the vaccine.
The first vaccine was shipped to State Health Departments on 22 September 1976 and the first injections were given on 01 October 1976. HEW estimated in late March 1976 that manufacturers could produce and deliver 200 million doses of vaccine by the end of November. Primarily because of the unresolved liability questions, the first delivery was delayed -- from July to October. Vaccine available then could immunize only about 12 percent of the population. Although three of the four manufacturers said they continued to produce at full capacity during the delay and the fourth had met its original estimate, vaccine production fell short of the original estimates by about 43 million doses and required over 2 months longer to produce.On October 11, at Pittsburgh, Pennsylvania, three persons over 70, all with cardiac conditions, dropped dead shortly after receiving swine flu shots at the same clinic. President Ford and his family got televised flu shots. On October 14, the hullabaloo subsided. HEW officials estimated, based on past experience and trials, that the swine flu vaccine would adequately protect 70 to 90 percent of those vaccinated. Vaccination programs proceeded based on state plans and capacities, with some aggressively implementing mass vaccination and others implementing more limited programs. Overall, between October 1 and December 16, more than 40 million civilians were vaccinated. In November 1976, several cases of Guillain-Barré syndrome (GBS) - a severe neurological condition associated with paralysis that may include the respiratory muscles and may be fatal - were reported from Minnesota. On 16 December 1976, based on CDC's recommendation and after consultation with the President, the Assistant Secretary for Health announced the suspension of the swine influenza vaccination program. The risk of developing Guillain-Barré syndrome seemed to be eleven times greater with vaccination than without. But the risk was still remote, about 1 in 105,000, and the risk of death but 1 in 2 million.Before the swine flu program there were comparatively few vaccine-related claims made against the Government. Since 1963, Public Health Service records showed that only 27 non-swine flu claims were filed. However, as of December 31, 1979, a total of 3,839 claims and 988 lawsuits had been filed against the Government alleging injury, death, or other damage resulting from the 45 million swine flu immunizations given under the program. been filed. As of October 2, 1980, 3,965 claims and 1,384 lawsuits had been filed. Of the 3,965 claims filed, 316 claims had been settled for about $12.3 million, 2,666 claims had been denied, 151 claims had been closed, 694 claims had become lawsuits before an administrative decision was made on the claims, and 138 claims were pending action by the Justice Department. As of October 2, 1980, Federal payments for swine flu claims ($12.3 million) and lawsuits ($0.9 million) amounted to about $13.2 million. The killer never came. The fact that it was feared is one of many things to show how little experts understand the flu, and thus how shaky are the health initiatives launched in its name. It is still not clear why the 1976 swine flu didn't spread beyond the Fort Dix base. The factors limiting its spread and duration are unknown. Nor is it known exactly how the virus was introduced. The Fort Dix outbreak may have been a zoonotic anomaly caused by introduction of an animal virus into a stressed population in close contact in crowded facilities during a cold winter. However, the impact of A/New Jersey virus on this healthy young population was severe in terms of estimated infections, hospitalizations, and duration of the outbreak.
The Sky is Falling: An Analysis of the Swine Flu Affair of 1976
by Joel Warner
In 1976, due to an outbreak of influenza at Fort Dix, New Jersey, the United States set a precedent in immunology by attempting to vaccinate the entire population of the country against the possibility of a swine-type Influenza A epidemic. While a great many people were successfully immunized in a very short period of time, the National Influenza Immunization Program (NIIP) quickly became recognized as a failure, one reason being that the feared epidemic never surfaced at all. But this massive undertaking deserves more analysis than just a simple repudiation. For example, all evidence linked to the pathology, microbiology, and historical cycle of influenza and the outbreak at Fort Dix suggests that the reactions of the scientists and other personnel involved in the NIIP were correct. However, one must also acknowledge the many complications and misjudgments that plagued the program after its initiation, from biological difficulties, logistical problems, to tensions with the media. The swine flu is a historical event that needs to be evaluated, regarding both its successes and its failures, so that lessons can be learned for future immunization programs.While influenza, or the flu, is not commonly recognized as an extremely lethal disease, the pathology of influenza, and especially of the kind found at Fort Dix, does suggest that an immunization program was a reasonable course to take in 1976.In the public's mind, influenza is often not seen as a specific disease, using interchangeable names for it like flu, gripe, and virus. (Silverstein: 1) However, influenza is very different from an everyday low fever or stomach flu. It is a respiratory infection, connected with a fever,coughing, and muscle aches, which often lasts a few days in duration.
While the disease itself is usually harmless, it can lead to exposure of the lungs to viral or bacterial pneumonia, which can prove fatal, especially for the very young, elderly, or infirm. (Silverstein: 13) There are three types of influenza, depending on their activity: type A, which is usually the cause of outbreaks; type B, which is linked to sporadic cases, and type C, which rarely causes disease reactions. (Silverstein: 54) The virus which causes influenza enters the host through the respiratory tract, and binds itself to epithelial cells. The virus causes the cell to engulf it by endocytosis, and then fuses to the wall of the endocytic vesicle, injecting the contents of the virus into the cytosol of the cell. The RNA of the virus enter the nucleus of the cell, and spur the creation of new copies of the genes. These genes, as well as new viral proteins that are created in the cell, leave the cell as fresh viruses, budding off the plasma membrane of the cell.While Scientists still do not know a great deal about the communicability of influenza, they do know that it can be spread by human-to-human contact, and has some airborne stability. (Silverstein: 59) Specifically, the characteristics of the influenza at Fort Dix was extremely discouraging. First of all, it was very similar to the 1918 swine influenza A pandemic, which turned out to be one of the most lethal outbreaks of disease in recorded history, and one victim had already died. Also, while usually this disease is caused by exposure to pigs, it was obvious that this was the first time since the earlier pandemic that it was being spread by people. (Silverstein: 23) While influenza is usually not deadly in itself, the scientists in 1976 were right to assume that the virus was a serious threat.The biological similarity between the influenza at Fort Dix and the swine flu of 1918 was one of the biggest factors in determining the course of action to be taken at that point.The influenza virus is globular in shape, and is approximately 100 nanometers in diameter. The sheath of the virus is made up of a lipid bilayer, taken from the plasma membrane of the original host. Within the central core of this bilayer are located about 3000 matrix proteins (which differ depending on the type of the influenza), and 8 RNA genes. The surface membrane is spiked with protein molecules of two kinds: about 500 hemagglutinin (H) and 100 neuraminidase (N) molecules. Hemagglutinin molecules appear as pointed spikes, which are used to bind the virus to a cell and inject contents into it. Neuraminidase appear as blunt spikes, and possesses specialized enzymes which cause the infected cell to release the new viruses. (Silverstein: 50-52 and Flu).
The influenza virus is relatively unique in its ability to change its H and N molecules, called antigenic shift. For example, the swine flu of 1918 was named H1N1, while a later strain of influenza which was found to have changed its hemagglutinin molecules was named H2N1, and an even later influenza was found to have changed both its surface molecules (double antigenic shift), and was named H2N2. Scientists believe that these changes are due to the recombination of influenza viruses from different sources, such as if an influenza from a swine was mixed with an influenza from a person, which could create an new strain that has swine-type hemagglutinin and human-type neuraminidase. (Silverstein: 55-56) Spot mutations on the viral RNA, or missence mutations, also occur and are thought to cause slight changes in the make-up of the influenza virus, or antigenic drift. (Flu) It has been observed that an antigenic shift usually occurs after a number of years, after the population has built up immunities to the old strain. It is common for a major outbreak to occur after a shift, and even more likely after a double shift, because the antibodies in the population are useless against these new forms of disease. Missence mutations usually cause smaller epidemics, since the change in the virus is not so great. It has also been found that older strains of influenza are likely to return to a population once the antibodies against them have mostly died out. (Silverstein: 55, 62and Flu) What was particularly alarming about the influenza at Fort Dix was that not only was it a double antigenic shift, but it was a shift back to H1N1, the cause of the 1918 pandemic. (Silverstein: 55) The biological make-up of the swine flu was evidence enough to take precautions against a major outbreak.The influenza virus' shifts created a cycle of virility of the disease, one that also pointed to the possibilities of a major outbreak in 1976. Owing to its constant adaptation and re-emergence, there is much reason why influenza is called The last great plague, since it is basically impossible to come up with a lasting solution to it. (Silverstein: 9) While influenza has been recorded since the 15th century, the number of years between major world outbreaks (or pandemics) has decreased in the last century, due to increased and faster intercontinental travel, which accelerates the build-up of immunity to a given influenza strain.(Silverstein: 11) It has been hypothesized that the cycle has now stratified into 11-year periods between major antigenic shift pandemics.Within these periods occur smaller epidemics (centralized outbreaks), linked to an antigenic drift. (Silverstein: 18-19) It is also suggested that the strains recycle themselves in about 50 years, long enough so that most of the original immunities have died out in a population. (Silverstein: 55) This model appears to function well, since there were exactly 11 years between the pandemics of 1946, 1957, and 1968, as well as the fact that the 1957 disease was similar to the 1889 disease, and the 1968 disease was similar to that of 1900. (Silverstein: 57) Using this model, the next year for a major pandemic would be fairly close to 1976, and the next strain up for recycling would likely be the swine flu of 1918.
Looking at the pathological, microbiological, as well as historical evidence surrounding the Fort Dix outbreak, it is not difficult to see why those in charge in 1976 decided that action had to be taken. It is also important to note, however, how they decided what action this was going to be. There are a few possibilities of drugs that can be taken to fight influenza. Examples of these are Amantadine, which blocks the shift of pH in the infected cell which triggers the release of the RNA into the cytosol; Zanamivir, which blocks the neuraminidase and inhibits the release of the viruses (though this drug was not even around in 1976); and antibiotics, which do not affect the flu, but can help against secondary bacterial infections. There are very few drugs that can be taken, however, because it is difficult to find a drug which affects the processes of the virus which does not also hurt the cell (Flu) Vaccines, which trigger the body's production of antibodies without actually causing the disease, are usually more productive then drugs. While antibodies created against the core proteins of the influenza virus do not create an ineffective immunity, the antibodies created against hemagglutinin are extremely potent, and block the penetration of cells by the virus. Also, neuraminidase antibodies help to lessen the release of viruses from cells and the disease's spread. (Silverstein: 52-54) Because of these reasons, the scientists in 1976 chose to create a vaccine against the swine flu. Another question surrounding the action to be taken involved whether to stockpile the vaccine after manufacturing it for the country, or immediately moving to immunization. It was decided to go ahead with immunization, because they had a good amount of time until the next flu season to organize the project, the threat of swine flu seemed real, and if they waited until influenza hit they would not have time to start the vaccinations before the disease set in. (Silverstein: 29-31) Another, though more personal reason for the decision to immunize was that it gave the scientists, like those at the Center for Disease Control (CDC) who were heading up the project, an opportunity to demonstrate to the public the value of immunizations. (Silverstein: 38)To truly understand the National Influenza Immunization program, it is necessary to look at the operation itself. The preparation of the vaccine was similar to previous vaccine productions, except it was to a much larger scale - about 200 million doses. (Silverstein: 105) To create the vaccine, the scientists inject the appropriate strain of influenza (and possibly another strain to increase growth) into embryonated eggs, which create a culture for the viruses. The multiplied viruses are separated from the yolk and rendered noninfectious by formaldehyde. The potency of this vaccine is measured in the amount which the vaccine,using its hemagglutinin, clumps together blood cells (agglutination),and is recorded in terms of chick cell agglutination (CCA).Since the vaccine can be somewhat toxic, causing sore arms and fevers,it is important to find the right balance of efficacy (immune response) and safety for the vaccine, by either reducing the virus amount or using split-virus vaccine,which is made up of further purified viruses. (Silverstein: 61) After massive field tests, it was decided that 200 CCA units was very effective for most of the population (85% had at least 40 units of hemagglutinin antibody, the accepted amount), and caused few side effects. (Silverstein: 82) Once the appropriate vaccine was determined, four manufacturers went into production of the substance, and the vaccination procedures were organized. The high-risk groups for the disease (elderly and infirm) would be vaccinated first, in nursing homes and health departments. Then the rest of the population would be reached through the schools, factories, medical centers, and shopping centers. (Silverstein: 108) To speed up the process, jet guns would be used for the injections instead of syringes. (Silverstein: 80) Not only this, but an informed consent authorization would be required for all participants, so that the vaccination of every person, as well as track outbreaks of the flu, could be monitored. (Silverstein: 78) Despite all the planning, NIIP began three months late, and only vaccinated 24% of the population before the program was terminated. (Silverstein: 113) And while the feared swine flu pandemic failed to surface, this was just one example of the many complications which surrounded the program.
One major difficulty in the immunization program involved the fact that the biological results of the vaccine did not always go as planned. For example, while the organizers expected two doses of vaccine from each egg that was used for incubation, the eggs only yielded one dose, drastically setting back the timetable for production. (Silverstein: 79) Also, while the vaccine produced the desired hemagglutinin antibody, the neuraminidase antibody was not created. This was probably due to the inactivation of this protein in the virus in treatment or production. While this antibody was not as necessary as that of hemagglutinin, it was still important in stopping the spread of the disease. (Silverstein: 84) Not only this, but the field trials demonstrated that, while the vaccine worked well for adults, it did not work well in these doses for young adults and children. (Silverstein: 83) This problem was not fully resolved until the vaccinations had already begun, when it was decided that children ages 3-18 should get two doses of split virus vaccine, four weeks apart. Unfortunately, there were only 4 million doses of split-virus left for 57 million children.(Silverstein: 112) To make matters worse, while the swine flu influenza never surfaced, the original influenza of the time, Victoria, did appear this season. This disease could not be confronted, however, since all the vaccine for this strain had been mixed with the new vaccine, and by this point the president had called a moratorium of all influenza vaccinations. It was only after the moratorium was lifted for the mixed swine and Victoria vaccine that the original influenza could be combated. (Silverstein: 126) It was obvious that one can not always count on Nature to be as effective apartner as one would hope.A major biological complication to the immunization campaign was its connection to Guillain-Barréacute; Syndrome (GBS). For the most part, the vaccination went more smoothly than even expected, with less than the predicted side effects and deaths.(Silverstein: 116) However, it was discovered that the vaccinations could be a factor in an increased number of cases of GBS. GBS is a rare paralytic disease, similar to polio, which causes an onset of polyneuritis, or tingling and weakness of the extremities and then some extent of paralysis.While most recover in the following months, there is a 5% fatality rate (mostly due to secondary respiratory disease or pneumonia), and 10% remain paralyzed to some extent. GBS is thought to result from an immunopathological reaction to an foreign agent in the body. (Silverstein: 117 and Laitin) While it was difficult to know for certain if the vaccines were causing GBS, since there were few prior statistics of GBS incidences to compare it with, there was enough evidence to suggest that this was the case. Preliminary calculations estimated that while there were 0.7 cases of GBS per million of non-vaccines at this time, there were 8.3 cases per million in vaccines. Not only this, but those non-vaccines which developed GBS were much more likely to have been sick prior to the syndrome than those who were vaccines, suggesting that the vaccine contained the trigger effect that usually would not have been present in healthy individuals. (Laitin ) While the vaccination program did not create an epidemic of GBS, this was enough to shut down the already flailing NIIP, which ended on December 16, 1976. (Silverstein: 119) This date was not the end of the troubles between the NIIP and the GBS, however, since the 500 cases of the syndrome and 25 deaths cost the government (who had agreed to take liability of the program) millions of dollars, not to mention a serious blow to its image. (Silverstein: 127 and Laitlin).
If the scientific complications of the NIIP were not enough, the media only helped to make the situation worse. First of all, while the program received broad support at its inception, the press was quick to criticize the program once no new incidents of swine flu appeared in the months after the Fort Dix affair, and emphasized the criticisms of people such as Albert Sabin, known for his polio vaccinations, who originally supported the project, but later pushed for a stockpiling of the vaccination. (Silverstein: 85-6) The press did more than just discourage the immunization plan, for they also helped to push the program forward. In August, when the NIIP appeared likely to never get off the ground, an outbreak of a particularly lethal strain of pneumonia occurred at the Pennsylvania State Convention of the American Legion, killing 29 of 182 cases. While it was later discovered that the disease, called Legionnaire's Disease, was caused by a relatively unknown bacteria, and was in no way connected to swine flu, the press had already played its part. Immediately, despite no evidence to support the claim, the connection was made in the media between the Legionnaires' Disease and swine flu. This was enough public agitation to push necessary legislation through congress, allowing the NIIP to go forward. While the press had helped to save the immunization program, it had done so using extravagant claims, and it might have proved useful if the NIIP had not survived at all. (Silverstein: 98-99, 106) Another example of sensationalism in the media occurred when a few days after the beginning of the immunization program three elderly people died at a vaccination station. Once again, while there was no evidence that the deaths were related to the vaccine, the press quickly exaggerated the story, creating an imagined body-count of vaccine victims. The hysteria that followed caused nine states to close down their immunization programs until the CDC announced decisively that the deaths were in no way connected to the vaccination. (Silverstein: 110-111) Judging from these incidents, it is not surprising that the press acted little differently when the actual connection between GBS and the vaccine was discovered. While the press can be slighted for its sensationalist portrayals of the immunization program, the leaders of the program should also be held responsible, for not creating a better relationship with the media, and not using this source as a way to educate the public about the program and influenza.
What made all of these difficulties more troublesome at the time was the inability of the program to adapt to new situations and obstacles. When the outbreak was announced, the responsibility of facing the threat quickly moved up the political hierarchy, until President Gerald Ford himself announced the instigation of the NIIP. By this time, however, the threat of the pandemic had been exaggerated, in part to serve political purposes. (Silverstein: 42-43) While the prestige of the presidency helped gather momentum for the project, it also complicated matters, since because the President had taken control of the undertaking, no one beneath him could take initiative and re-organize the plans to face unexpected obstacles. (Silverstein: 47) Another problem with the logistics of the NIIP was that its planning was so overwhelmingly optimistic about the success of all the different facets of this immense endeavor that only in the best-case scenario would all go as planned. If the organizers had instead planned for the worst, they very well might have been able to deal with the many difficulties that occurred in a more suitable manner. (Silverstein: 138) Not only this, there was no re-evaluation of the program at different stages of its progress. For example, once the decision had been made to go ahead with both the manufacturing of the vaccine and the immunization, there was no reconsideration of stockpiling the vaccine, even when the disease failed to appear in the months after the manufacturing. (Silverstein: 142) Because of these organizational difficulties, the NIIP was unable to adapt to challenges the occurred, and there were many such challenges. Aside from those already listed, the NIIP and the government also had to face the refusal of the of the American Insurance Association to insure the manufacturers of the influenza vaccine, since it was afraid of mass quantities of invalid lawsuits regarding the immunization. This dilemma threatened to kill the NIIP, and it took many months for Congress to accept liability for the vaccinations, having to pass special legislation to allow individuals to fail claims against the government. (Silverstein: 96-7, 106) Other predicaments which plagued the immunization program included the discovery that one of the manufacturers had made millions of the wrong kind of influenza vaccine, legal complications which stalled the organization of advertising for the campaign, and arguments over the form and content of the consent forms for the vaccination. (Silverstein: 79, 108-109) Because of the inadequacies of the logistics of the NIIP, these complications often set the entire program back weeks or months, and threatened the integrity of the undertaking altogether.
This is not to say that the immunization program did not have its positive points. First of all, it would be ridiculous to renounce the NIIP because the swine flu never occurred. The program was a preventative action, in order to protect the population if the disease did occur, and things would have been a lot worse if swine flu had erupted and the government had done nothing to prepare for it.(Silverstein: 134) Also, despite the mistakes of those in charge of the project, and the negative publicity it received from the press, the NIIP was successful in vaccinating a large amount of the population in a very short time. This is proof that the people had made their own decisions about the benefits and risks of the program, and that the local health officials had adequately taken control of the program in their areas. (Silverstein: 115) And because of this vast undertaking, there is no question that the people had become more knowledgeable of immunization, for as one Senator explained, We have raised the public's awareness of the need to prevent disease from happening.(Silverstein: 124) Also, for the most part, the surveillance system of the vaccinations was largely successful, in that it competently kept track of every individual vaccinated, carefully watched for outbreaks of the swine flu, and was able to monitor adverse side effects to the immunization. (Laitlin) In fact, because the syndrome's increase was so slight, the connection between GBS and the influenza vaccinations probably would never have been noticed if not for the scrutiny of the surveillance system. (Silverstein: 121) Because of the information that this system gathered, as well as the increased scientific and public interest in influenza at the time, the NIIP has undoubtedly helped to further knowledge of the influenza disease, as well as contribute to the fields of microbiology and epidemiology in general. (Laitlin)With such a massive undertaking as the National Influenza Immunization Campaign of 1976, it is normal to try to identify heroes and villains among those who were involved in the endeavor. However, it is not possible to do so. The immunization campaign had its strong points and its weak points, and the people who organized the project made both good decisions and mistakes. The scientists and the politicians who evaluated the Fort Dix were right to take the most cautious reaction they could, because all of the pathological, microbiological, and historical evidence they had at the time strongly suggested that a dangerous pandemic could occur. But while many of the unforeseen difficulties which arose to complicate the NIIP can not be blamed on the organizers of the immunization campaign, they should be held responsible for not creating a more adaptable program that could deal with these occurrences. The NIIP must be evaluated for its drawbacks and its successes, so that people will not just see this as an unfortunate historical event, but can use it to help further immunization and disease-fighting programs in the future.
2002 CDC Sterilization Rules For Reusing Bifurcated Needles
From Patricia Doyle, PhD email@example.com 12-17-2
At the very end,It is stated that a bifurcated needle should not be reprocessed and reused more than 50 times.Patricia Doyle
8. 2002 CDC Recommendations for Handling, Cleaning, and Sterilizing Bifurcated
Immunization Needles in Healthcare Settings
Sterile, bifurcated needles are used to administer smallpox immunization. The needles are designed to hold the designated dose of vaccine (2.5l) between the needle prongs to allow delivery to the skin surface. Once on the skin, the needle is used to make 15-16 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.Trace amounts of blood at the vaccination site are evidence of successful vaccine delivery.Bifurcated needles may arrive from the manufacturer sterilized and individually wrapped, or in bulk, requiring subsequent sterilization prior to use. These needles are intended for single-patient use followed by disposal in a puncture-resistant sharps container. Because of limited supplies, especially during mass vaccination programs, it may be necessary to reprocess and reuse these needles.The strategies and procedures described here are restricted to the cleaning and reprocessing of bifurcated needles ONLY.
Protocols for reprocessing bifurcated needles must address: 1) the prevention of blood exposures and patient-to-patient transmission of bloodborne viruses (i.e., hepatitis B and C viruses [HBV, HCV], and human immunodeficiency virus [HIV]); and 2) prevention of sharps injury and occupational transmission of bloodborne viruses to healthcare personnel. The following procedures are designed to protect both patients and healthcare personnel involved in smallpox vaccination programs.
1.Initial Sterilization of Unsterile Bifurcated Needles Received From the Manufacturer in Bulk Supply. Needles received in bulk from the manufacturer should be assumed to be clean and ready for packaging and sterilization. If there is any concern regarding the cleanliness of these items, they should be cleaned then sterilized as described below.
2.Identify Resources. Identify equipment and personnel to carry out reprocessing. The reprocessing area should either have an ultrasonic bath, commercial dishwasher, and an autoclave or dry heat sterilizer. The area should be of sufficient size to have clearly demarcated dirty and clean areas. The flow of traffic should always be from dirty to clean.
3.Methods for Reprocessing Bifurcated Needle. Moist heat sterilization (i.e., autoclaving) or dry heat sterilization are the preferred methods for sterilizing cleaned bifurcated needles. However, boiling or flaming, as described below, may be used if an autoclave or a forced air dry heat oven is not available. These alternative methods have some historical precedence, especially in developing nations, but have not been validated. A. Care in handling. To prevent worker injury, used needles should be handled as little as possible during reprocessing. The use of fine mesh containers with secure tops that facilitate containment and transfer during reprocessing is preferred. Tongs, forceps, hemostats, or other devices that eliminate the need for hands-on contact with needles should be used to transfer them from their container.
Used needles MUST BE CLEANED prior to sterilization. Place needles in a soaking solution immediately after use and prior to any physical cleaning. Soaking will facilitate cleaning by preventing blood and organic soil from drying on the needle. Commercial products used by healthcare facilities for soaking contaminated instruments (e.g., any detergent, detergent-disinfectant, enzyme formulation/cleaner) are appropriate for this purpose. Do not use alcohol, glutaraldehyde, or formaldehyde as a soaking solution for the needles (these will fix protein to the needle surfaces). Also avoid use of strong oxidizing solutions (hypochlorites, peroxides, peracetic acid) because these may damage the needle tip,. Transport used needles in the soaking solution (cover or cap the container) and send to designated area for cleaning and reprocessing. Automated cleaning with an ultrasonic cleaning device or commercial dish/glassware washer is preferred to manual cleaning as there is less opportunity for worker injury. The manufacturer's instructions for use of the device should be followed.The needles should then be rinsed with potable water, and allowed to air dry on a clean surface .Personnel should wear gloves during the cleaning process and use transfer devices (e.g., tongs, forceps, or hemostats) as needed to avoid direct handling of needles. C. Autoclaving. Bifurcated needles that have been cleaned and dried are ready to be packaged and autoclaved. Needles may be individually wrapped or placed in groups of 10 to 15 in plastic/paper peel-down packages or pouches, or clean screw-top glass container, and autoclaved. The bifurcated end of the needle should point toward the bottom of the tube/ pouch away from the opening to allow easy aseptic retrieval. The manufacturer's instructions for use of the autoclave should be followed.Sterilization times will vary depending on temperature and load (i.e., 121ºC for 30 minutes or 133ºC for 4 minutes).
The tubes/packs should be placed in a rack or carrier that holds the tubes in a horizontal or slightly slanted position to ensure that the steam will penetrate fully to the bottom. During autoclaving, tops of glass tubes should be loose enough to allow penetration of steam and prevent breakage of the container. After autoclaving and cooling, caps should be tightly screwed. D. Dry Heat Sterilization. Screw capped glass test tubes are the best choice for dry heat sterilization. Clean and package bifurcated needles as above for glass tubes (i.e., cap tubes but leave loose enough to allow for air). The needles can be placed in a dry heat oven and baked as follows: (i) 170°C for 60 minutes; (ii) 160°C for 120 minutes; (iii) 150°C for 150 minutes; (iv) 140°C for 180 minutes; or (v) 121°C overnight.
B-184. Other Sterilization Alternatives
Boiling and flaming are alternative methods for sterilizing bifurcated needles, but should be used only when other options are not available.
A. Boiling. After cleaning, needles that will be reused may be placed in boiling water for 20 minutes, allowed to air dry, and then stored in a sterile receptacle. To minimize handling before and after sterilization heat-resistant fine mesh containers should be used where possible. If such containers are not available, a transfer device (e.g., tongs, forceps, hemostat) should be used to insert and remove needles from the water bath. The transfer device should be boiled along with the needles to facilitate aseptic removal. Although the handle of the transfer device need not be immersed in the boiling water, it will become very hot during needle reprocessing. Care should be taken to prevent burn injury during handling. Needles must be thoroughly dried to ensure that no residual water enters the vaccine vial. This is best accomplished by placing the needles on one half of an absorbent, plastic-backed, sterile barrier and folding the other have over the needles, providing a protective cover. When dry, the needles should be transferred aseptically into a dry sterile container (e.g., glass tube) with the bifurcated ends pointed away from the opening to permit aseptic retrieval. The top of the receptacle should be secured tightly to prevent contamination.
B. Flaming. In the past, flaming has been used to reprocess bifurcated needles, but no data exists on sterilization efficacy. Flaming should be used only when the needle must be reused immediately (i.e., a mass vaccination campaign is underway, vaccine recipients are present, and a supply of new or reprocessed sterile needles is not available) and only when none of the other sterilization methods described above are available. Pass the bifurcated end of the needle through the flame of an alcohol lamp or Bunsen burner. If an alcohol burner is used, the concentration of the alcohol must be 95% for adequate burn. The optimal duration of exposure to the flame is not known. The needle must become sufficiently hot to allow sterilization. However, to maintain needle integrity, the needle should not remain in the flame for more than 3 seconds. Measures should be taken to prevent burn injury to the fingers by handling the blunt end of the needle with a non-conductive device (i.e., forceps or tweezers with rubber or hard plastic handles). Allow the needle to cool completely before inserting into the vaccine. Flaming is not considered a terminal reprocessing procedure as it does not provide an environment for maintaining sterile conditions. If needles that have been flamed for immediate reuse will be used again in the future, they should be cleaned and sterilized (autoclaving, baking, or boiling), as described above.
Frequency Of Reuse
A bifurcated needle should not be reprocessed and reused more than 50 times. Reports have shown that vaccination effectiveness was reduced to 80.8% with needles used 86 to 172 times.
Procedures should be established to monitor the frequency of needle reuse. Prevention of cross-contamination.Patient-to-patient transmission of bloodborne viruses has been associated with contamination of multi-dose vials. To prevent opportunity for such transmission, a contaminated needle should never be allowed to reenter a vaccine vial. Furthermore, surfaces where vaccine is being handled should be free of visible blood, body fluids or other organic soil. Preparation of vaccine and needle reprocessing should be physically separate. If a contaminated needle is inadvertently redipped into a vaccine vial, that vial should be removed and not used for further vaccination.
Patricia A. Doyle, PhD.
Barack Obama's answers to the top 14 science questions facing America
August 30, 2008
6.Pandemics and Biosecurity. Some estimates suggest that if H5N1 Avian Flu becomes a pandemic it could kill more than 300 million people. In an era of constant and rapid international travel, what steps should the United States take to protect our population from global pandemics or deliberate biological attacks?
It’s time for a comprehensive effort to tackle bio-terror. We know that the successful deployment of a biological weapon—whether it is sprayed into our cities or spread through our food supply—could kill tens of thousands of Americans and deal a crushing blow to our economy.Overseas, I will launch a Shared Security Partnership that invests $5 billion over 3 years to forge an international intelligence and law enforcement infrastructure to take down terrorist networks. I will also strengthen U.S. intelligence collection overseas to identify and interdict would-be bioterrorists before they strike and expand the U.S. government’s bioforensics program for tracking the source of any biological weapon. I will work with the international community to make any use of disease as a weapon declared a crime against humanity.And to ensure our country is prepared should such an event occur, we must provide our public health system across the country with the surge capacity to confront a crisis and improve our ability to cope with infectious diseases. I will invest in new vaccines and technology to detect attacks and to trace them to their origin, so that we can react in a timely fashion. I have pledged to invest $10 billion per year over the next 5 years in electronic health information systems to not only improve routine health care, but also ensure that these systems will give health officials the crucial information they need to deploy resources and save lives in an emergency. I will help hospitals form collaborative networks to deal with sudden surges in patients and will ensure that the U.S. has adequate supplies of medicines, vaccines, and diagnostic tests and can get these vital products into the hands of those who need them.
We also have to expand local and state programs to ensure that they have the resources to respond to these disasters. I will work to strengthen the federal government’s partnership with local and state governments on these issues by improving the mechanisms for clear communication, eliminating redundant programs, and building on the key strengths possessed by each level of government. I introduced legislation which would have provided funding for programs in order to enhance emergency care systems throughout the country.I will build on America’s unparalleled talent and advantage in STEM fields and the powerful insights into biological systems that are emerging to create new drugs, vaccines, and diagnostic tests and to manufacture these vital products much more quickly and efficiently than is now possible. Unfortunately, the Bush administration has failed to take full advantage of the Bioshield initiative. Because of the unpredictability of the mode of biological attack, I will stress the need for broad-gauged vaccines and drugs and for more agile and responsive drug development and production systems. This effort will strengthen the U.S. biotech and pharmaceutical industry and create high-wage jobs.
7. Genetics research.The field of genetics has the potential to improve human health and nutrition, but many people are concerned about the effects of genetic modification both in humans and in agriculture. What is the right policy balance between the benefits of genetic advances and their potential risks?
The progress that has occurred in genetics over the past half century has been remarkable—from the discovery of DNA’s double helix structure in 1953 to the recent deciphering of all three billion letters of the human genome. New knowledge about genes is already transforming medicine and agriculture and has the potential to change other fields, including energy and environmental sciences and information technology.I also recognize that the power of modern genetics has raised important ethical, legal, and social issues that require careful study. For example, new developments in human genetics allow individuals to be informed about their risks of various diseases; such information can be useful for diagnosing and treating disease, but it can also be misused by employers or insurers to discriminate. For this reason, I have been a long-time supporter of the recently passed Genetic Information Non-Discrimination Act. In addition, concerned about the premature introduction of genetic testing into the public domain without appropriate oversight, I introduced the Genomics and Personalized Medicine Act of 2007 aimed at ensuring the safety and accuracy of such testing.Advances in the genetic engineering of plants have provided enormous benefits to American farmers. I believe that we can continue to modify plants safely with new genetic methods, abetted by stringent tests for environmental and health effects and by stronger regulatory oversight guided by the best available scientific advice.
Disease treatment and identification is likewise being transformed by modern genetics. Recombinant DNA (rDNA) technology has produced a number of products such as human growth hormone or insulin or other complicated proteins that are known to be involved in bone metabolism, immune response, and tissue repair. The promise of rDNA is its ability to sidestep potentially harmful intermediaries that could have a pathogenic effect. Some forms of gene therapy-replacing faulty genes with functional copies-in comparison have encountered safety issues that arise from how the functional gene is delivered. As a result, the NIH established the Recombinant DNA Advisory Committee, which now provides advice and guidance on human gene therapy as well as other ethical concerns or potential abuse of rDNA technology. Until we are equipped to ascertain the safety of such methods, I will continue to support the activities and recommendations of the Recombinant DNA Advisory Committee.
11. Space.The study of Earth from space can yield important information about climate change; focus on the cosmos can advance our understanding of the universe; and manned space travel can help us inspire new generations of youth to go into science. Can we afford all of them? How would you prioritize space in your administration?
As president, I will establish a robust and balanced civilian space program. Under my administration, NASA not only will inspire the world with both human and robotic space exploration, but also will again lead in confronting the challenges we face here on Earth, including global climate change, energy independence, and aeronautics research. In achieving this vision, I will reach out to include international partners and to engage the private sector to amplify NASA’s reach. I believe that a revitalized NASA can help America maintain its innovation edge and contribute to American economic growth.There is currently no organizational authority in the federal government with a sufficiently broad mandate to oversee a comprehensive and integrated strategy and policy dealing with all aspects of the government’s space-related programs, including those being managed by NASA, the Department of Defense, the National Reconnaissance Office, the Department of Commerce, the Department of Transportation, and other federal agencies. This wasn’t always the case. Between 1958 and 1973, the National Aeronautics and Space Council oversaw the entire space arena for four presidents; the Council was briefly revived from 1989 to 1992. I will re-establish this Council reporting to the president. It will oversee and coordinate civilian, military, commercial, and national security space activities. It will solicit public participation, engage the international community, and work toward a 21st century vision of space that constantly pushes the envelope on new technologies as it pursues a balanced national portfolio that expands our reach into the heavens and improves life here on Earth.
14. Health.Americans are increasingly concerned with the cost, quality and availability of health care.How do you see science, research and technology contributing to improved health and quality of life?
Americans have good reasons to be proud of the extraordinary role that medical science has had in combating disease, here and throughout the world, over the past century. Work sponsored by the National Institutes of Health (NIH), other government agencies, and our pharmaceutical and biotechnology industries has produced many vaccines, drugs, and hormones that have improved the quality of life, extended life expectancy, and reduced the dire consequences of many serious illnesses and disabilities. These advances include methods for preventing and treating coronary artery disease and stroke, which have reduced mortality rates by two-thirds; new drugs and antibodies that allow us to effectively treat certain cancers; anti-viral agents that allow most patients with AIDS to control their disease; drugs that often help make severe psychiatric illnesses manageable; and new vaccines that are reducing the incidence of virus-related cancers; and minimally invasive surgery techniques that reduce hospitalizations, complications, and costs. We can expect much more from the exciting biomedical research now underway. For example, we can foresee medical care that will allow physicians to tailor care to individual patients, matching therapies to those most likely to benefit.However, today our citizens have understandable concerns about their ability to afford the care they need, especially when our underlying system of paying for health care is broken. We spend more on health care per capita than people of other countries, yet lower income groups continue to suffer significant disparities in both access to care and health outcomes. Without major changes, costs will continue to increase. Our population is aging, many cancers and chronic disorders remain difficult to treat, and there are continuing threats of new and re-emerging infectious diseases.
It's wrong that America's health care system works better for insurance and drug companies than it does for average Americans, who face skyrocketing health care costs. My plan makes health care more secure and affordable by strengthening employer-based coverage, protecting patients' ability to choose their own doctors, and saving families $2,500 dollars by requiring insurance companies to cover prevention and limiting excessive insurance company charges. My plan covers everybody by requiring insurance companies to cover pre-existing conditions, providing tax credits to small businesses and working families, and covering all uninsured children.These are difficult problems, and science and technology can solve only some of them. The effectiveness of medical care can be improved, and its costs can be reduced, by greater emphasis on best practices, electronic medical records, hospital safety, preventive strategies, and improved public health surveillance. The increased investments I support for medical research at the NIH may yield discoveries that reduce the cost of drug development, and we may produce new methods to prevent diseases that are costly to treat. But efforts to control costs also should make greater use of the tools for prevention and clinical management that already exist; enlist more effective participation of the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), as well as the NIH; and encourage investments in healthcare and health research by the private and not-for-profit sectors. Overall, I am committed to three major tasks that will be necessary to confront widespread concerns about the nation’s health: provision of healthcare plans to all of our citizens; comprehensive efforts to make our health care system more cost-efficient; and continued biomedical research to understand diseases more thoroughly and find better ways to prevent and treat them.
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