Saturday, March 22, 2008

The Truth, Making money on line, and the LIES

Junk mail is at its all time high, delete, delete, and delete, make money while sitting on your computer working at home financial freedom is just a click away, you have seen them, but for a price, or maybe a one time start up fee, and this is how many folks are making money on line,they will show you all the secretes of making money on the Internet from eBay to real estate ,then ask you for a one time Start up fee for that information and they got your money then they ask you to sign up people under you asking others for the " start up fee" and you make money even if your product is useless the money is in the " Start Up Fee" ,its called a pyramid scheme, that has been twisted and sharpened over the years to trick you into sending the advertiser money and THEY make money, and so on ,and so on,my advice to this would be NEVER SEND ANYONE MONEY FOR INFORMATION REGARDING A HOME BASED INTERNET BUSINESS,NEVER GIVE OUT YOUR BANK ACCOUNT INFORMATION OR PASSWORDS , if they ask you for money like Investment fees,one time start up fees, or download this information for a fee, or even want to call you and tell you about their making money strategies its a scam, also take care who you give your email address to this will only fill your email server with junk mail BEGGING you to click here and click there promising to make you 3000 dollars a week thats just bullshit and untrue clams like that are just stupid remember that if it sounds to good to be true its a scam so use your judgment and try not to be despite when looking for home based businesses.The truth is that all that information can be found on line for FOR FREE,its not going to make you 8000 dollars an hour but you can find descent, work all you need to do is look for it,( to send money thinking you can get rich in a week is to error, to GOOGLE search is Divine)
There are only a few legit "home based business" that are on line, the trick is to swim though tons and tons of gravy to get to the meat,these days you need to be a real good swimmer or you drown before you get to that information even then you need a life jacket,its frustration 101, give yourself at least 6 months to find a real business that will met your needs and give you the results you want BEFORE YOU TELL YOUR BOSS TO TAKE THIS JOB AND SHOVE IT, this concept has not caught on fully, for you to retire on or make a living off your computer, just yet anyway.
I have done a some research, and have fond some real business that you can make money from, but still,results may vary the rest is up to you.
Sign up for "Audio Adds" it can be found at cyberadvise.blogspot.com if you have a website this is a must to ad, they play audio ads on your website, no click , no in your face ads, you just add the link to your web page and you make money how, much is yet to be determined right now they are still in their beginning stages , but they offer a better then nothing chance to make money using your computer and they are legit so give them a try.
Check out affiliate programs, these are programs that pay you if someone clicks and buys their products, IE Mcfee,Norton's or companies that offer a part of the profit you bring to them, computer programmer's and private sales people EXAMPLE " Joe's used computer store" if there is enough traffic on your website for others to see these ads, it will generate money for them by clicking their links and you, it takes some work but can return some profit in time.
Lastly there is a women on the Internet that seems to be everywhere and legit
she owns a website called cyberadvise.blogspot.com there are tons for things on that website to look at and take in , good luck and don't quit your day job just yet....

Friday, March 21, 2008

Fight the good fight.

Most of us work hard at what we do, we build roads, we cook , we clean, we take care of our children and we try to make it in this world the best way we can, some of us go to school, some of us take our kids to school and some even vote, we make up the United States , we cry , we sweat and some of us shed our blood to live the way we do without fear of what we say and how we say it, we form our own opinions we have our own sense of Logic but at the end of the day we all try to meet on one common ground, life.
It bothers me that some of the events that are taking place today are out of control, I am bothered that someone I have never met wants me dead, I am bewildered by the way this Government handles our foreign affairs,and here at home I elect them to make my life better and they give away my hard earned money on other countries then deny me food stamps and medical cause I am poor, but not poor enough to give this county most of my money in the form of taxes, and I am grief stricken at the rich business man who would rather buy a 4th home in China, adopt a child from Russia and then turn a blind eye to the community with charitable offers of kindness, time in and time again I hear him say " I gave enough" my hope and prayer is that in my life I see this turn around I hope there is a day when we can work and run the companies that feed us and not the other way around, I hope that in my life time there is no one who is forced to go homeless and the same hope would never having to see a child go hungry , god its SO hard to be a child, there world is so wrapped up in play and Imagination thinking they can fly, climb a huge building from the outside, and have fun time with mom and dad, sadly I don't see life getting better for some people, the same people who work so hard that they don't have time to play with their children or even have time to enjoy life...its sad.
I have to end my blogs for a while I am one of them folks that have been hit hard by this killing field of the rich buying up land here in south Florida and kicking people out of their homes mostly trailers and trailer parks so until I am able to get a home and meet you all back here I must say goodbye to you all its been a pleasure take care and fight the good fight...

Wednesday, March 19, 2008

Its Time Americans take care of Americans

Crazy thought, I do believe it is time for Americans to take care of each other no more policing the world looking for people to force our narrow minded beliefs on, no more taking over small countries and telling the rest of world that we are just restoring democracy,most of these people have never heard of democracy to them its called being Occupied, no more telling people that we are the seekers of good and freedom and allow evil soulless greedy politicians, to run our country so they can take away our freedoms by killing the 4th amendment and let people go homeless and starve to death by putting limits on food stamps and welfare calling it " tough love", NO MORE!!!! the time has come to stop.
It is time for the US to stop killing its own people, ignore the sick and the dieing, by allowing pharmaceutical companies to own people making them decide this week " should I eat or get medicines?" ,how about building more shelters for the homeless and stop hate crimes before we become a nation of empty headed dumb asses in need of protection from ourselves, (this maybe too late), our nation talks a bunch of crap,and never does what it says its going to do, its time to take care of our own problems and fix what is wrong here before we tell others that we have all the right solutions, stop acting so arrogant!!!, I guess people do not realize that the rest of the world wants to destroy us,its not our way of life they hate its our thinking that our way of life is better?? and you wonder why??, when will the people of this country speck out thats its not the people "citizens" who live in this country you have to fear, its the government that some of us have elected to represent SOME of us, that has fallen from grace and has grown so fat and out of control trying to take total control over this nation and the way good honest hard working people think and feel, we all know that absolute power corrupts, absolutely.
I for one am not afraid to stand up and say I am sorry for the crap this country has put you all through in their quest of greed and power greedy bastards most of them....I remember when,An American dream was to own a home and land in this country, not own the land in other countries, an American dream was to live by what was right by his family,and community it was taught in schools and small churches to be right by morals and values,at one time standards in clear and honest thinking ,meant something.
an American dream was to live free and not watched by a government willing to take things from you, an American dream was just that a dream , a dream that today has become a nightmare for most..
I don't remember the American dream as forcing a person to think the way I do or else kill them and force their family and friends to think like I do or suffer the same fate, take away their religion and shove a Christian bible in their hand and at gun point force them to pray to my god with the thought that there is only one god and he is American?? BULL!!!!,and then we all sit at the dinner table and wonder why people around the world hate us....god stopped blessing America when we decided to stop believing in the messages and the meaning of his teachings they DO Include, morals and respecting ALL LIFE, something Americans forgot about a long time ago. pick up your bible and read it, and stop this way of thinking before its too late.

Tuesday, March 18, 2008

Immunizations more harm then good? You Decide.

Think about this before you hold your son or daughter down and let a doctor stick a needle full of shit in their bodies...

Can Vaccines Actually Cause More Harm Than Good?

Franklin E. Payne, MD

For a half-century, "officials"* have promoted the mass vaccination of the world's population, primarily children. In the United States, recommendations by non-legislative bodies, such as the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP), have been mandated into state laws by willing legislators who are always ready to promote any action that is for the "good of the children." (Wouldn't you like some laws for the "good of the parents?")

As with any medication, vaccines have side effects, allergies, and unintended effects. These range from slight redness at the site of injection to low-grade fevers, paralysis, and death. The milder reactions are more common, and the more severe reactions are rare. Indeed, the latter are so rare statistically they cannot be distinguished from rare diseases in children that cause the same effects. And, complicating the situation is the fact there is usually no definitive test to determine the cause.

For the most part, the American people have gladly accepted these vaccinations. After all, as parents, they remembered the epidemics of smallpox, diphtheria, polio, and other diseases that crippled and killed by the thousands. They worried a little that their little Johnny or Susie might have one of the rare and severe complications, but that risk was far better than the risk of some epidemic disease.

A few Americans were more concerned. First, all the hoopla about the success of vaccines had to do more with timing than anything else. "Whooping cough, measles, and diphtheria were mostly under control by the end of World War II, when vaccines began to appear."(1) Thus, most of the success attributed to vaccines was their implementation at the time those diseases had already declined dramatically. This decline, however, has been conveniently forgotten (or covered up) to bolster the notion that vaccines dramatically reduce and prevent disease.

Second, evidence began to accumulate that some vaccines might have greater risks than those of the disease against which the vaccine was supposed to protect. Indeed, for one vaccine the evidence was clear in this regard. For the last two decades, the live polio vaccine has been the only cause of polio in children in the United States!

Supporting this belief was that the duration of immunity for vaccines was unknown. Would the person be protected for a few years only to contract a more severe form of the disease later? Because vaccines were introduced shortly after they were researched, all vaccines were mandated without long term evidence of their efficacy or continued immunity.

Third, statistics are based upon populations of people (children). What about an individual? If he is paralyzed or dies from an immunization, that is 100 percent for that individual. The individual must be considered, as well as populations.

In spite of these concerns, the drive toward vaccination programs in American society became a juggernaut. Any critical voice just did not have a chance of being heard in this maelstrom of support. But, cracks began to appear.

In the late 1970s, the swine flu immunization debacle occurred. The swine flu was predicted to sweep around the world, killing and maiming like the black plagues of the Middle Ages. An unprecedented massive and immediate inoculation of Americans was carried out. The swine flu never appeared, but hundreds had crippling diseases from the immunization itself. The question arose, perhaps for the first time, "Is it possible that the good of immunization could be outweighed by its unintended effects?"

But, while some thought immunizations ought to be examined more closely, "officials' " stance on immunizations was unfazed. They had even more immunizations for "the good of the children": mumps, Haemophilus, and hepatitis B. And, so the little darlings did not have to be punctured too often, more and more combinations of vaccines at once were devised. One count has some 33 vaccinations by the time children enter the first grade.

Parents and a few researchers were becoming more concerned. Some childhood diseases (allergies and asthma, for example) were becoming more common in children. Was there a link between these immunizations and the increase of these diseases? A principle of medicine learned early by medical students is that a lot of a good thing (some treatment or drug) often causes more harm than good. Perhaps, immunizations were becoming too much of a good thing.

Not to worry said the "official" establishment. The effects of every disease were more to be feared than the unintended effects of the vaccines. We are promoting what is best for the health of your child.



A Change in Culture and Motivations



But society was evolving, and these changes could not help but find their way into medical practice and preventive medicine. Abortion, the elimination of unwanted, unborn children, became national law and common practice. Every state in the union allowed by law the treatment of minor children for abortion, contraception, and sexually transmitted diseases without parental notification or permission. AIDS became the first politically protected disease because time proven principles of epidemic control for sexually transmitted diseases were not employed.

Relative to immunizations, at least two recommendations came from this cultural milieu. Hepatitis B was epidemic. Something had to be done. Prevention by vaccine was considered the best answer. So, several plans were implemented to vaccinate adults and teenagers. But, the result was that only a small percentage was immunized. Most did not care to be vaccinated and were getting around the nets designed to catch them.

So, where are people, specifically children, almost always predictably present? In the hospital when they are delivered! And, there was a precedent: dousing the eyes with silver nitrate, and later, erythromycin ointment to prevent gonococcal conjunctivitis. Thus, laws were enacted to inoculate newborn babies in the delivery room itself! The few babies who are delivered at home can easily be tracked and immunized also.

(I know an instance in which a lawyer, whose expertise was constitutional law, was unable to prevent his own child from being vaccinated in the delivery room!)

But, there is a powerful cultural agenda in the hepatitis vaccine that has not been present in any previous vaccine: not random exposure to epidemic disease, but the assumption that every child will become sexually promiscuous, an IV-drug user, or a health care worker!

The second recommendation was Hib, vaccination against Haemophilus influenzae B. Hib is a common bacteria of upper respiratory infections in children. Sometimes, it spreads and becomes a more serious life-threatening infection, as epiglotitis, mastoiditis, or meningitis. Usually, a simple course of antibiotics will cure the infections. However, in these more severe infections, hospitalization and intensive care is needed. Thus, the reason for the vaccine.

However, these severe infections are rare, except in those children who attend day care centers. So, vaccination is mostly an attempt to prevent a complication of children being placed where they ought not to be. Admittedly, making a cultural case against Hib is more tentative than with hepatitis B, but it has plausibility.



Even "Officials" Finally Break the Wall of Unity



Complications with three vaccines have caused them to be suspended. 1) Hepatitis B has been found to have a mercury content that is considered unsafe for infants.(2) 2) Live polio vaccine has been stopped because it has become the sole cause of polio, rather than the natural disease itself. 3) Rotavirus vaccine has been linked to intestinal obstruction in infants. This effect is likely from an incomplete testing of the vaccine. This vaccine provides protection against only one cause of diarrhea in children.

Also, in 1998, the Vaccine Adverse Event Reporting System (VAERS) received 11,000 reports of severe complications. This system was implemented some years ago, as evidence mounted that vaccines did have major complications, including death, and to relieve manufacturers of liability from these effects.

So, immunizations are under scrutiny as they have never been before. This close examination is good and past due. Many questions need to be answered and better research on vaccines needs to be carried out.

Christians should remember that the state does have a Biblical role in public health (Leviticus 13-15). However, that authority can be corrupted, as can the state's other forms of authority. The best that can be hoped for is more freedom for parents to decide what immunizations their children receive. While I doubt that "officials" will ever go that far (they "know" better what your child needs than you do), the opportunity to break down the juggernaut of automatic acceptance and implementation of vaccines is present like it has never been before. When the establishment admits its own errors, their citadel is ripe for storming. Let us hope and work towards greater freedom for parents to choose.



Footnotes

* I often place "officials" in quotes because they are either grossly ignorant or they have hidden agendas --- power, money, self-aggrandizement, etc. All these cancel any moral authority they have. Unfortunately, many have legal authority to enforce their tainted opinions.

References

1. Sagan LA. Health of Nations: True Causes of Sickness and Well-being. New York, Basic Books, 1987, p. 68.
2. Terrell HP. Mercurial Logic. Medical Sentinel 2000;5(2):66.

Dr. Payne is editor of Biblical Reflections, P.O. Box 14488, Augusta, GA 30919-0488. E-mail: edpayne@pol.net.

Originally published in the Medical Sentinel 2000;5(2):53-54. Copyright ©2000 Association of American Physicians and Surgeons.

Understanding Vaccine Safety: Immunization Remains Our Best Defense Against Deadly Disease

by Michelle Meadows

Smallpox and polio have been wiped out in the United States. Cases of measles, mumps, tetanus, whooping cough (pertussis) and other life-threatening illnesses have been reduced by more that 95 percent. Immunization against influenza and pneumonia prevent tens of thousands of deaths annually among elderly persons and those who are chronically ill. As a result, millions of lives have been saved. But don't let the success of vaccines fool you into thinking we no longer need them. Most vaccine-preventable diseases aren't gone.

Steve Berman, M.D., president of the American Academy of Pediatrics and a pediatrician in Denver, says he and his colleagues were devastated to recently see an infant die of whooping cough. "This was a case where the family thought the risks of vaccination outweighed the benefits," Dr. Berman says. The baby was exposed to the disease by two older brothers who hadn't been vaccinated.

Vaccines contain a weakened (attenuated) or killed (inactivated) form of disease-causing bacteria or viruses, or components of these microorganisms, that trigger a response by our body's immune system. For example, vaccines stimulate our bodies to make antibodies--proteins that specifically recognize and target the bacteria and viruses against which the vaccines are designed, and that help eliminate them from the body when we encounter them.

Without vaccine protection, we can easily contract and transmit infectious diseases. It may only take one person, whether it's a family member, a neighbor, or a visitor from another country, to start the spread of a disease. And even immunized individuals can be at risk because no vaccine is ever 100 percent effective for everyone. (See "Recommended Childhood Immunization Schedule, United States, January-December 2001.)

Most parents believe in the benefits of vaccination, as evidenced by record high childhood vaccination rates, and more and more adults are getting vaccinated against influenza, pneumococcal disease, and tetanus. But some people who need vaccines don't get them for a variety of reasons, including fear of side effects. Lately, a surge of negative publicity focusing on the risks of vaccines--some of which are unproven or inaccurate--has some wondering whether they do more harm than good. But vaccine experts and the overwhelming majority of health-care providers caution consumers against skipping important vaccinations because of an evening news report or a posting on the Internet.

Sometimes such reports contain unsubstantiated or inaccurate information and don't reflect a balanced view of the risks and benefits of a particular vaccine.

The Food and Drug Administration recommends that consumers arm themselves with the facts about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against certain diseases. According to a Washington state-based organization called Parents of Kids with Infectious Diseases (PKIDS), some parents are shocked to learn that children can die of chickenpox and other vaccine-preventable diseases they hadn't considered a threat.

The FDA's Center for Biologics Evaluation and Research (CBER) regulates vaccines in the United States, and works with several other agencies, including the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), to study and monitor vaccine safety and effectiveness. New vaccines are licensed only after the FDA thoroughly reviews the results of extensive laboratory studies and clinical trials performed by scientists, physicians, and manufacturers.

For vaccines intended for wide use in healthy populations such as children, clinical testing with careful safety monitoring typically involves thousands of patients before a vaccine is ever licensed. And after a vaccine hits the market, the safety monitoring continues, as does FDA oversight to assure the highest levels of quality control in the vaccine production process.

"We are always monitoring for evidence that might suggest possible problems with vaccines," says Karen Midthun, M.D., director of CBER's office of vaccine research and review. CBER scientists also conduct research to better ensure vaccine safety and to better understand vaccine-related side effects.
A Commitment to Safety

On the surface, it may seem that approaching vaccine safety as a continuous process--always looking into problems and potential problems--implies that vaccines are unsafe. "But it's actually a reflection of our ongoing commitment to safety, and to assuring the prevention of potentially lethal infectious diseases," says Jesse Goodman, M.D., M.P.H., deputy director for medicine at CBER. "It's also the nature of science to seek and implement improvements which make for safer and more effective medical products."

Since 1996, for example, CBER has licensed several acellular pertussis vaccines. Acellular pertussis vaccines use only parts of the disease-causing bacteria and are associated with fewer side effects than the whole cell pertussis vaccines that had been in use. In 1997, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended a switch from using the whole cell pertussis component of the diphtheria, tetanus, pertussis (DTP) vaccine to using acellular pertussis vaccines for all five doses in the childhood schedule (see "Recommended Childhood Immunization Schedule").

The National Institute of Allergy and Infectious Diseases (NIAID) sponsored clinical trials for some of the experimental acellular vaccines. "We set out to develop an improved vaccine that would be as effective as the standard whole cell vaccine but cause less extended crying, fevers, and other side effects," says Carole Heilman, Ph.D., director of NIAID's division of microbiology and infectious diseases. CBER scientists also played a critical role by developing methods to evaluate the acellular vaccines, which helped them get to clinical trials faster.

There have been other recent policy changes to improve vaccine safety, including ACIP's 1999 recommendation to change from the use of oral polio vaccine (OPV) to the inactivated polio virus (IPV). OPV had been highly effective in controlling naturally occurring polio outbreaks, preventing thousands of cases of paralysis a year. But as a live virus, it mutated in extremely rare cases to cause polio itself. Continued use of OPV resulted in about 10 cases of paralytic polio each year among millions vaccinated and their contacts, according to William Egan, Ph.D., deputy director of CBER's office of vaccine research and review. Switching to the use of IPV eliminated this risk and was appropriate once epidemic polio was controlled.

"There are times when we also take action even when there is just the theoretical potential for harm," Goodman says. Thimerosal, a mercury-containing compound, had been the most widely used preservative in vaccines. Its use in minute amounts helped to prevent bacteria from contaminating multi-dose vials of vaccines and other medicines, protecting against potentially serious infections. But thimerosal has been nearly eliminated from vaccines because of legitimate and growing scientific concerns about the possible effects of mercury on the nervous system, Goodman says.

"In addition, as the numbers of vaccines used in children have increased, small infants who received every recommended vaccine could be exposed to cumulative doses of mercury that exceeded some, but not all, federal guidelines," Goodman explains.

Even though there are no convincing data that show harm because of thimerosal in vaccines, the U.S. Public Health Service recommended moving rapidly to vaccines that are thimerosal-free. The FDA encouraged manufacturers to comply and set the highest priority for its reviews of such products, Goodman says. As a result, all recommended pediatric vaccines available are now thimerosal free or have greatly reduced thimerosal contents. In March 2001, the FDA approved a newly formulated version of Tripedia, a diphtheria and tetanus toxoids and acellular pertussis (DTAP) vaccine with only a trace amount of thimerosal.
A Thorough Process

The most common components of vaccines are weakened microbes (disease-causing microorganisms), killed microbes, and inactivated toxins. In addition, subunit vaccines, which only use a part of the bacterium or virus, are increasingly being used.

Manufacturers conduct stringent tests to make sure that cell lines used for producing viral vaccines do not contain adventitious agents (unwanted viruses) such as simian virus 40 (SV40), which was found in some early polio vaccines. These vaccines had been manufactured in kidney cells from simians (monkeys) that harbored SV40. Following its discovery, SV40 was removed from vaccines, and vaccines have been free of the virus since the early 1960s. CBER scientists are developing potentially better methods to detect such infectious agents.

Developing vaccines is a thorough and rigorous process, Egan says. Vaccines are tested for safety on animals first, and then in humans during several phases of clinical trials. The most important clinical trial for the recently licensed vaccine Prevnar involved nearly 40,000 people, equally divided between those who received the vaccine and those who did not. Prevnar was approved to prevent invasive pneumococcal diseases such as meningitis.

A group of FDA scientists reviews data and the proposed labeling of the vaccine, which includes directions for use and information about potential side effects. The committee also reviews manufacturing protocols, conducts its own tests, and inspects the manufacturing facility. The FDA's Vaccines and Related Biological Products Advisory Committee, which includes scientific experts and consumer representatives, can be consulted at any time to review data and recommend action to the agency.

After a vaccine is licensed, the FDA generally requires that manufacturers use validated methods to test samples from each vaccine lot for safety, potency, and purity prior to its release for public use. The FDA also tests selected lots and products to help assure the accuracy of tests conducted by the manufacturers.
Common Concerns

"Most vaccines cause some side effects, but they are usually minor and short-lived like low-grade fever and soreness at the injection site," Midthun says. Serious vaccine reactions--causing disability, hospitalization, or death--are extremely rare but they can happen.

Like any medicine, vaccines carry a small risk of serious harm such as severe allergic reaction. But experts point out that the risk of being harmed by a vaccine is much lower than the risk that comes with infectious diseases.

For example, in 1976, the swine influenza (flu) vaccine was associated with a severe paralytic illness called Guillain-Barré Syndrome (GBS). According to the CDC's vaccine information sheet on the influenza vaccine, "if there is a risk of GBS from current influenza vaccines, it is estimated at 1 or 2 cases per million persons vaccinated, much less than the risk of severe influenza, which can be prevented by vaccination." Each year, flu causes tens of thousands of deaths, mostly among older people. Most people who get the influenza vaccine have no serious problem from it.

And though some people worry about it, you can't get the flu from the flu vaccine, Midthun says. "Just as there are no vaccines that are 100 percent safe, there are also none that are 100 percent effective," she says. "So you may get the flu soon after you received the vaccine, before it could be expected to protect you. It does not mean the shot gave you the flu," she says.

Some live virus vaccines, such as the chickenpox vaccine, can cause mild versions of the disease they protect against, says Goodman. "But this is usually only a serious problem if the patient has a severely compromised immune system." And vaccines are generally not advised for such people. It's important to talk with your doctor about the benefits and risks of vaccines, and any concerns you may have, specifically as it relates to you and your family (see "Steps to Take When You Vaccinate"). If you or your child has previously had a significant reaction to a vaccine, that may affect the risk/benefit ratio for the individual and whether that vaccine should be recommended again.
How Reactions Are Evaluated

Before a vaccine is put into standard medical practice, it must be studied in clinical trials of thousands of people, which allows for evaluation of relatively common side effects. For example, a common side effect might occur in one or more of several hundred vaccine recipients. But rare events (fewer than one case in several thousand recipients) aren't usually evident in clinical trials. "Unless you've studied something in a million or more people, you might never see the very rare event or be able to know whether it occurred due to vaccination or simply by chance," Goodman says.

Through the Vaccine Adverse Event Reporting System (VAERS), jointly operated by the FDA and the CDC to monitor the safety of licensed vaccines, experts look for patterns and any unusual trends that may raise questions about a vaccine's safety once it is used more widely in the population. The FDA continuously reviews and evaluates individual reports, in addition to monitoring overall reporting patterns. The FDA also monitors reporting trends for individual vaccine lots. Most reports come from health-care providers, but anyone can report an unexpected event after vaccination to VAERS. (See "Steps to Take When You Vaccinate" for the VAERS toll-free number.)

VAERS receives 800 to 1,000 reports each month. Because it often can't be determined whether an adverse event occurring after vaccination was actually caused by the vaccination, health-care providers and consumers are encouraged to report any event that might be attributable to a vaccine.

"You don't have to be sure," says Susan Ellenberg, Ph.D., director of CBER's office of biostatistics and epidemiology. "Reporting possible reactions will help identify adverse events that might be truly associated with vaccinations and need further study." But this approach to reporting means that one can't assume that all VAERS reports describe true vaccination reactions.

VAERS is a passive, voluntary reporting system, which means not all adverse events get reported. It also means that many reports are incomplete or even contain inaccurate information because the forms are not filled out by trained personnel. Another problem with interpreting VAERS data is the lack of information on the total number of individuals who received a particular vaccine, making it impossible to estimate the incidence of reported adverse events. It's also often the case that multiple vaccines are given at the same time, further complicating the interpretation of what might have caused the event, Ellenberg says.

Despite these problems, VAERS does contribute in important ways to understanding vaccine safety. VAERS data may suggest the need for more research on certain vaccines. "In this sense, VAERS is a signal generator," Egan says. Recently, VAERS data were instrumental in evaluating RotaShield, a vaccine licensed to protect against rotavirus infection. Rotavirus is the most common cause of gastroenteritis in children younger than five and can result in severe diarrhea, dehydration, and death. This virus is an especially serious problem in developing nations, where it kills hundreds of thousands of children every year.

Following the vaccine's licensure, VAERS started to receive reports of bowel obstruction in a number of infants who had received RotaShield. Careful review of these reports revealed that the bowel obstruction occurred most often in the first two weeks after RotaShield was administered. As a result, the CDC recommended postponing any further distribution or administration of RotaShield until more data could be collected and evaluated.

The FDA discussed the concerns with the manufacturer, which decided to voluntarily withdraw the product from use. In November 1999, ACIP withdrew its previous recommendation for universal use of the vaccine. At this time, the FDA, NIH, and CDC are still studying the bowel obstruction and RotaShield-associated cases, Egan says. "We continue to look into mechanisms for any serious adverse events. We want to understand why they happen so that we can prevent them from occurring in the future."

The CDC's Vaccine Safety DataLink, which links computerized histories of vaccination to hospitalization records and other medical information for members of eight large managed care organizations, supplements the information in VAERS and permits more rigorous evaluation of possible safety concerns. For example, the system allows researchers to compare how often an adverse event occurs in people recently vaccinated with those not recently vaccinated, to evaluate the likelihood that the vaccine caused the adverse event.
Alleged Associations

Some have looked to vaccines to explain a host of serious conditions that we don't fully understand, including sudden infant death syndrome (SIDS), multiple sclerosis, diabetes, and autism. There have been a number of epidemiological studies of these possible associations, and experts say there is no good scientific evidence at this time showing that vaccines cause these diseases or conditions.

"Physicians give vaccines to children at multiple time points during their development and a lot can happen during that time," says Midthun. She stresses that both the FDA and the CDC take concerns of parents seriously. After careful review of all available information, neither agency has found that existing data support any link between the measles, mumps, and rubella (MMR) vaccines and autism, a hypothesis that has received considerable publicity over the last year.

The CDC and the NIH recently contracted with the Institute of Medicine, part of the National Academy of Sciences, to establish the Immunization Safety Review Committee. The independent committee is charged with evaluating nine vaccine safety topics over a three-year span. The possible association of the MMR vaccine and autism was the first topic.

On April 23, 2001, the Immunization Safety Review Committee reported its finding that the current evidence does not favor the hypothesis that there is a link between MMR and autism, and that no changes should be made in the current policy of administering the MMR vaccine. The committee could not rule out the possibility that the MMR vaccine might be linked to autism in some sub-population, and recommended that targeted research in this area be conducted. To date, there is no indication as to whether there is any such subpopulation, or what the genetic makeup or other characteristics of such a subpopulation would be, Egan says.

"It's important that policy decisions about vaccine safety be based on science," says Martin G. Myers, M.D., director of the U.S. Department of Health and Human Service's National Vaccine Program Office. As vaccine safety research continues, Myers says, we can't afford to lose sight of what life was like before immunization. Vaccination is the reason we don't see the suffering, disability, and death from whooping cough, measles, polio and other infectious diseases like we used to.

"Vaccines are very safe," Myers adds, "but nothing is without risk." Not vaccinating against certain diseases means choosing another type of risk, he says. Myers recalls treating an infant with seizures from tetanus so strong they shook the baby's whole body. These types of seizures and many deaths are preventable by vaccination. And Myers still has an audiotape from the early eighties of a child hacking and gasping for air because of whooping cough. "The child's mother asked me to play it for parents who might be undecided about getting vaccinated." He's also played the tape for medical students and residents. "It doesn't take long before somebody in the room asks me to please turn it off."
National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program became effective in 1988. The program is a federal "no-fault" system designed to compensate those individuals, or families of individuals, who have been injured by childhood vaccines. A claim may be made for any injury or death thought to be the result of a vaccine covered under the program. The program is administered jointly by the U.S. Department of Health and Human Services, the U.S. Court of Federal Claims, and the U.S. Department of Justice. For more information, call 1-800-338-2382, or visit www.bhpr.hrsa.gov/vicp.

--M.M.
Steps to Take When You Vaccinate

1. Review the vaccine information sheets that explain the potential risks of each vaccine. Health practitioners are required by law to provide them.
2. Talk to your doctor about whether certain reactions to vaccines can be controlled. For example, fever may be prevented or reduced by taking acetaminophen before or after vaccination.
3. Tell your doctor if you, your child, or a sibling has ever had a bad reaction to a vaccine.
4. Ask your doctor about conditions under which you or your child should not be vaccinated. This might include being sick or having a history of certain allergic or other adverse reactions to previous vaccinations or their components, such as allergies to eggs, which are used to grow influenza vaccines.
5. Report unexpected events after vaccinations to your doctor and to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967.

--M.M.