Showing posts with label Flu Vaccine. Show all posts
Showing posts with label Flu Vaccine. Show all posts

Vaccine Studies: Under the Influence of Pharma

by Barbara Loe Fisher

If you take more than a casual look at the way the mass vaccination system in the U.S. works, you see that pharmaceutical companies marketing vaccines have a lot of clout. It was the pharmaceutical industry that told Congress in 1982 that they were going to leave the nation without vaccines if they didn't get liability protection but have opposed making it less difficult for vaccine victims to obtain federal compensation in the U.S. Court of Claims under a 1986 law that gave them liability protection. It is Pharma lobbyists, who bully the FDA into fast tracking vaccines like Gardasil and who sit at the CDC's policymaking tables urging that new vaccines be recommended for use by all children so they can persuade state legislators to mandate vaccines like influenza vaccine.

Today, a study published in the British Medical Journal reveals the clout that Big Pharma has in the world of medicine journal publishing, specifically the publishing of scientific articles about vaccines. In a Cochrane Collaboration review and analysis of published influenza vaccine studies conducted by Tom Jefferson, M.D., Ph.D. and his colleagues, they found that influenza vaccine studies sponsored by industry are treated more favorably by medical journals even when the studies are of poor quality.

Click here to view the BMJ study:

Jefferson's analysis confirms that drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety. The preferential treatment of Pharma-funded studies also explains why the risks of an inappropriately fast-tracked vaccine like Gardasil are underplayed in the medical literature and why a physician like Andrew Wakefield, M.D., who dared to publish a study in 1998 in a medical journal (The Lancet) calling for more scientific investigation into the possible link between MMR vaccine and regressive autism, has been mercilessly persecuted for more than a decade by both Pharma-funded special interest groups as well as public health officials maintaining close relationships with vaccine manufacturers.

Jefferson and his colleagues identified and assessed 274 published studies on influenza vaccines for their methodological quality and found no relationship between study quality, publication in prestige journals or their subsequent citation in other articles. They also found that most influenza vaccine studies are of poor quality but those with conclusions favorable to influenza vaccinations are of significantly lower methodological quality. The single most important factor determining where the studies were published or how much they were cited was sponsorship, with those partially or wholly funded by the pharmaceutical industry having higher visibility.

Dr. Jefferson commented, "The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharma sponsors order many reprints of studies supporting their products, often with in house translations into many languages. They also purchase advertising space in the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding.

Earlier this week the National Vaccine Information Center (www.NVIC.org) called on the Obama Administration and Congress to investigate Gardasil vaccine risks. NVIC has long questioned the inappropriate influence of vaccine manufacturers in federal vaccine licensing and policymaking and state vaccine mandates. In 2006, Merck's Gardasil vaccine was fast tracked by the FDA at Merck's request and in 2007 Merck lobbyists mounted an aggressive lobbying campaign to get Gardasil mandated by state legislators for all sixth grade girls, which would have assured the big drug company a predictable market.

The Pharma lobbying effort in 2007 to get all states to mandate Gardasil failed but every other vaccine produced by drug companies and licensed by the FDA in the past quarter century has been mandated. Those new mandates were added to state vaccine laws by legislators and public health officials at the urging of vaccine manufacturer lobbyists and Pharma funded organizations touting vaccine studies published in the medical literature.

In the past three decades, the numbers of doses of government recommended vaccines for children and medical organizations like the American Academy of Pediatrics has tripled to 69 doses of 16 vaccines, with 48 doses of 14 vaccines targeted to children under age six. Pharma lobbyists have persuaded most states to pass laws requiring two to three dozen doses of most of the 16 government recommended vaccines. Last year New Jersey became the first state to mandate influenza vaccine for children attending daycare and school.

In the past few years, Dr. Jefferson has authored several independent reviews of influenza studies published in the medical literature for the Cochrane Collaboration, which have been published in the British Medical Journal, questioning the quality of published scientific evidence for influenza vaccine effectiveness and safety for the elderly as well as children.

Clearly, if the makers and marketers of vaccines can influence the quality and quantity of the scientific evidence published in the medical literature proving that vaccines are safe and effective - evidence that is used by states to mandate vaccines and by the U.S. Court of Claims to deny compensation to vaccine injured children - then Congress was wrong in 1986 to protect the makers and marketers of vaccines from liability for injuries and deaths caused by those vaccines.

Government vaccine recommendations, U.S. Court of Claims vaccine injury compensation awards and state vaccine mandates are justified on the strength of scientific published in medical journals. It is time for medical journals to disclose all financial ties to the pharmaceutical industry. It is time for studies questioning the safety and effectiveness of vaccines to receive a fair hearing in scientific journals rather than editors confining themselves to primarily publishing studies funded by the pharmaceutical industry maintaining that every vaccine is totally safe, effective and necessary.

Kudos to the British Medical Journal for having the integrity to publish Jefferson's comprehensive analysis of pharmaceutical money influence on vaccine studies published in the medical literature. Hopefully, this will be a wake-up call for the scientific community, Congress and the public to put an end to the undue influence the pharmaceutical industry has on the science and policy of mass vaccination in the U.S..


BMJ

Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review


T Jefferson, coordinator, C Di Pietrantonj, statistician, M G Debalini, researcher, A Rivetti, researcher , V Demicheli, director of health, Piemonte region

Cochrane Vaccines Field, ASL(Azienda Sanitaria Locale) AL 20,15100 Alessandria, Italy
Correspondence to: T Jefferson jefferson.tom@gmail.com
Cite this as: BMJ 2009;338:b354 doi:10.1136/bmj.b354


ABSTRACT

Objective To explore the relation between study concordance, take home message, funding, and dissemination of comparative studies assessing the effects of influenza vaccines.

Design Systematic review without meta-analysis.

Data extraction Search of the Cochrane Library, PubMed, Embase, and the web, without language restriction, for any studies comparing the effects of influenza vaccines against placebo or no intervention. Abstraction and assessment of quality of methods were carried out.

Data synthesis We identified 259 primary studies (274 datasets). Higher quality studies were significantly more likely to show concordance between data presented and conclusions (odds ratio 16.35, 95% confidence interval 4.24 to 63.04) and less likely to favour effectiveness of vaccines (0.04, 0.02 to 0.09). Government funded studies were less likely to have conclusions favouring the vaccines (0.45, 0.26 to 0.90). A higher mean journal impact factor was associated with complete or partial industry funding compared with government or private funding and no funding (differences betweenmeans5.04). Study sizewas not associated with concordance, content of take home message, funding, and study quality. Higher citation index factor was associated with partial or complete industry funding. This was sensitive to the exclusion from the analysis of studies with undeclared funding.

Conclusion Publication in prestigious journals is associated with partial or total industry funding, and this association is not explained by study quality or size.

Flu & You: Know Your Options

by Barbara Loe Fisher

These days you can't turn around without being reminded that the "flu" season is just around the corner and it is time for every American - but especially infants, kindergarteners through high school graduates and anyone over 50 - to get a shot of influenza vaccine. But there are lots of new questions about whether the influenza vaccine is ineffective in children and whether it is also ineffective in the elderly at the same time there are growing doubts about whether many doctors and health officials have told the public the truth and nothing but the truth about the risks associated with infectious disease and the risks associated with vaccination.

Christian Broadcasting Network (CBN) has produced several investigative reports on vaccination during the past several years and a recent CBN report on influenza vaccine examined the validity of the annual influenza mortality figure that the CDC routinely uses (36,000 deaths per year in the U.S. from influenza). The report also presented several perspectives about getting a flu shot versus using a more natural approach to staying well in the flu season. (See VIDEO of report as well as VIDEO outtakes not included in the broadast story featuring Vitamin D Council Executive Director John Cannell, M.D. on pandemic influenza, Heather Maurer on how she made an educated flu shot decision for her child; Virginia Health Commissioner Karen Remley, M.D. on why public health officials like flu shots; and my comments on "cradle-to-grave" vaccine policies and development of a "supervaccine.")

Joseph Mercola, M.D., a champion of the holistic health and wellness lifestyle and strong advocate for the informed consent ethic in medicine, frequently offers alternative perspectives about infectious disease and vaccination. See Dr. Mercola's past newsletters discussing flu vaccination and other vaccination topics at www.mercola.com and view a speech I gave at the Natural Living Conference sponsored by Holistic Moms Network on his website.



In the coming months, the push for Americans to get flu shots will increase but how many will understand the government-acknowledged risks and precautions for inactivated, injected influenza vaccine or the live virus nasal influenza vaccine which are more fully outlined in the manufacturer's product inserts available on the web and at pharmacies and in doctor's offices?

How many Americans know there are practical steps to take during the flu season that will not only help protect against all infections, including actual influenza as well as other "flu-like illnesses" that can often be mistaken for influenza? (Only about 20 percent of all "flu-like" illness is actually influenza and only three strains of the many strains of type A and type B influenza that may be circulating during the year are actually included in the influenza vaccine).

To prevent and treat influenza or flu-like respiratory illness that does not involve fever over 103 F., pneumonia or serious complications which may require medical intervention, the National Vaccine Information Center offers the following non- toxic suggestions:

1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamin D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.


Whatever you do this flu season - whether or not you choose to vaccinate - become vaccine educated and know your options.

Knowledge is power and an informed, empowered consumer is one who can stand up for the right to freely exercise informed preventive health options.


See www.NVIC.org and www.StandUpBeCounted.org for more information. Please email PaulNVIC@gmail.com if you would like to volunteer to work in your state to help NVIC educate Americans about vaccination or have special expertise you would like to share. NVIC is also looking for volunteers in the Northern Virginia and greater Washington, D.C. area to assist our staff with many exciting and challenging projects.




"The federal government finds of that 36,000, about 1,000 people die directly from the flu virus. Blame for the remaining 35,000 deaths goes to diseases like pneumonia that may follow the flu. However there's no clear scientific connection between the flu and these more serious afflictions. That means most of the time the shot would have little impact in actually preventing death. Barbara Loe Fisher heads of the non-governmental National Vaccine Information Center. She says the repeated references to 36,000 seems to be an attempt to scare people into getting the shot. Fisher suggests the public is smart enough to decide independently. A free market would be better, she believes. "If we allow vaccines to be subject to the test of the marketplace, then the public will use those vaccines they consider to be safe, effective, and necessary," Fisher says......Dr. John Cannell, Executive Director of the Vitamin D Council, suggests the reason we even have a flu season is because our vitamin D levels drop. That takes place naturally as we get less and less sun with the approach of winter. Cannell explains that less sun means we produce less vitamin D in our skin. "Pretty much any disease, any infectious disease, that is more common in winter is a target of vitamin D," Cannell says. He says that's true even of some serious non-seasonal, prolonged diseases such as tuberculosis. Early in the 19th century, TB sanitariums where people would get sun were one of the few ways to recover from "consumption," as it was known. So Cannell suggests babies get a 1,000 units a day and those two and older get 2,000 units. Many adults and some children need to take more than that. For kids, that can come as a single daily drop of liquid D. Cannell says a recent discovery explains vitamin D's role in the flu season. The vitamin triggers your body to produce its own antibiotics against flu as well as colds." - Gailon Totheroh, CBN News Service (November 4, 2008) VIDEOS at http://www.cbn.com/CBNnews/475564.aspx and http: //www.cbn.com/cbnnews/479085.aspx


"Led by Dr. Peter Szilagyi, researchers at University of Rochester studied 414 children aged 5 and younger, who came down with the flu during the 2003-2004 or 2004-2005 flu seasons. These children were compared with over 5,000 controls who did not have influenza during the same seasons. Turns out that flu shots seemed not to make much difference: Kids who got immunized did not get the flu at lower rates than unvaccinated kids. In fact, the immunized youngsters were just as likely to be hospitalized or to visit the doctor as kids who never received the vaccine.......Targeting the correct strain is a always a bit of a guessing game, however; researchers make their best scientifically based prediction as to which flu virus will be making the rounds in a coming season, but they often have to make these predictions up to nine months ahead of time, in order to keep up with the lengthy vaccine manufacturing process. "In some circumstances, it is like forecasting the weather," says Dr. Geoffrey Weinberg, professor of pediatrics at University of Rochester. "Sometimes we are right on, and sometimes we are off." - Alice Park, Time Magazine (October 6 2008) http://www.time.com/time/health/artic le/0,8599,1847794,00.html

"The influenza vaccine, which has been strongly recommended for people over 65 for more than four decades, is losing its reputation as an effective way to ward off the virus in the elderly. A growing number of immunologists and epidemiologists say the vaccine probably does not work very well for people over 70, the group that accounts for three-fourths of all flu deaths. The latest blow was a study in The Lancet last month that called into question much of the statistical evidence for the vaccine's effectiveness. The authors said previous studies had measured the wrong thing: not any actual protection against the flu virus but a fundamental difference between the kinds of people who get vaccines and those who do not. This contention is far from universally accepted. And even skeptics say that until more effective measures are found, older people should continue to be vaccinated, because some protection against the flu is better than none. Still, the Lancet article has reignited a longstanding debate over claims that the vaccine prevents thousands of hospitalizations and deaths in older people. "The whole notion of who needs the vaccine and why is changing before our eyes," said Peter Doshi, a doctoral candidate at M.I.T. who published a paper on the historical impact of influenza in May in The American Journal of Public Health ." - Brenda Goodman, New York Times (September 2, 2008) http://www.nytimes.com/2008/09/02/health/02flu. html





Forced Flu Vaccination and Freedom

by Barbara Loe Fisher

www.vaccineawakening.blogspot.com
www.NVIC.org
www.StandUpBeCounted.org

It is no wonder parents in New Jersey are protesting in the streets in opposition to a mandate by the state health department that all children entering daycare and school have to get an annual flu shot. The mandating of the notoriously ineffective and risky influenza vaccine is turning out to be one vaccine too many for parents. Rightfully, they are calling for scientific evidence that obeying CDC officials and giving children 69 doses of 16 vaccines from birth to age 18 will keep them healthy while demanding the right to make informed, voluntary choices about vaccination.

October 2008 has been a busy month for those who want to force all Americans - especially children - to get a flu shot every year. It doesn't matter if scientific studies have failed to prove that influenza vaccine is effective in children or many adults. It doesn't matter that flu vaccines during the past few years have been essentially worthless because they have not matched circulating strains of Type A and B influenza viruses. And apparently it also doesn't matter if the mortality statistic the flu police cling to - "36,000 annual deaths from influenza" - is scientifically correct or just hype, especially in light of the fact that only about 20 percent of all flu-like illness is actually caused by "influenza."

Bottom line: the flu you thought you caught last year might not actually be "influenza" and, even if it was, the chances that you got a strain of influenza actually contained in the flu vaccine out on the market was slim to none.

But that isn't stopping the pro-forced vaccinators from pushing mandatory flu vaccination on all health care workers, who have an historically low uptake (about 40 percent) when it comes to getting an annual flu shot. So if you are a nurse, doctor, social worker, minister or any other professional who interfaces with "patients" in a medical setting, you are going to be rolling up your sleeve every year and getting that flu shot or you could be forced to divulge your vaccination status to patients, wear a mask or be denied contact with patients.

And what about influenza vaccine injury victims? A quick look at the federal Vaccine Adverse Events Reporting System (VAERS) influenza vaccine reaction reports that now number between 24,000 and 34,000 (depending upon if the flu vaccine was given alone or not), illustrate the disturbing similarity of the report descriptions: inflammation of the brain; Guillain-Barre syndrome; chronic joint and limb pain and numbness, chronic fatigue, and permanent neurological damage.

On NVIC's Memorial for Vaccine Victims, there is a report of two children in the same family who regressed after influenza vaccination. Born in 2003, their mother reports that her baby son got a flu shot at seven months and her baby daughter at one year old. They both had behavior changes and regressed developmentally. Their mother said:"Both stopped sleeping, lost the few words they had at seven months and our daughter developed night terrors. Our son lost eye contact after each vax round, finally truly regressing at three after milk was added to their diet. He was diagnosed with autism; our daughter was diagnosed with "benign" language delay." Although their Mom reports that diet changes (gluten/casein/soy free diets) helped them partially recover, she said they still show "all the immune suppression and inflammation of efflux disorder and will have to be treated."At the end of her report she includes the following quote by Rabelais: "Science without conscience is but the ruin of the soul."

Yes, indeed.
__________________________________________

"New Jersey is the first state in the nation to require a flu shot for all children before they enroll in preschools and daycare centers.....But the mandate has infuriated many parents, hundreds of whom gathered in protest Thursday outside the statehouse in Trenton. Parents have formed advocacy groups and enlisted support online for fellow residents to sign their petition against the law. They've banned together to demand what they see as their right to choose what is injected in the bodies of their children. "I have a really big problem with mandatory flu shots in this country," said Louis Kuo-Habukus, a mother of three from New Jersey. "We need to have a choice." Parents flooded the statehouse, carrying signs with slogans like "Parent Power" and "My Child, My Choice," and chanting "No American should be forced to play vaccine roulette with their child." They rallied for support of a "conscientious objectors" clause, which they want added to the bill. It would grant exemptions for children and parents who have a moral objection to the vaccination." - Sharyn Alfonsi, ABC News and ABC World News Tonight (October 16, 2008)

"Parental informed consent is "a civil right, a human right to be free to make intelligent, rational decisions about using pharmaceutical products that risk their children's lives," Fisher told the Holistic Moms Network fifth annual Natural Living Conference. "What the entire debate comes down to is freedom" of choice, said Fisher, a mother, and president of the National Vaccine Information Center. Fisher co-founded the non-profit grass-roots group in Washington in 1982. Health officials and physicians in the past three decades have tripled the number of shots that children are required to have, without adequately studying the possible long-term effects, Fisher charged....From birth to age 18, children currently receive 69 doses of 16 vaccines, including annual flu shots, she said. In 1982, 23 doses of seven vaccines were required, she said. "Today, twice as many children are chronically ill and disabled than in the 1970s and 1980s, when half as many vaccines were given," Fisher said." - Bob Groves, Bergen County Record (NJ), (October 19, 2008) http://www.northjersey.com/news/health/312 44264.html

"In the face of chronic low influenza vaccination rates among healthcare workers, the leading US society of infection control professionals says it's time to require medically eligible workers to either get the immunization or sign a form saying they understand the risks to patients if they skip it. "As part of a comprehensive strategy, we recommend that influenza vaccine be required annually for all healthcare personnel with direct patient care," the Associat ion for Professionals in Infection Control and Epidemiology (APIC) said in a policy statement released yesterday. "Organizations should adopt a system in which an informed declination is obtained from employees that decline for other than medical reasons," the statement continues. "This information should be utilized by the facility to develop improvement strategies for the following vaccine season." - Robert Roos, CIDRAP News (October 10, 2008)

"Over the past two flu seasons, vaccinating children five and younger did not reduce the number of child hospitalizations or doctor's visits linked to influenza, according to results of a new study....In the study, a team led by Dr. Peter G. Szilagyi, from the University of Rochester School of Medicine and Dentistry and Strong Memorial Hospital in Rochester, N.Y., looked at 414 children aged five and younger who developed flu in the 2003-2004 or 2004-2005 flu seasons......after they adjusted for flu risk factors -- such as a child's location, sex, insurance status, chronic health conditions or timing of the vaccine -- the effectiveness of the vaccine could no longer be shown. The effectiveness of the flu shot ranged from 7 percent to 52 percent for 6- to 59-month-old children who had been fully vaccinated, the researchers found. The less- than-perfect match between the strain of flu in the vaccine during the two seasons studied and the flu that was actually circulating may have contributed substantially to the poor effectiveness of the vaccine, Szilagyi's team speculated. In 2003 to 2004, 99 percent of circulating flu was influenza A, but only 11 percent of the influenza A strain in the United States was similar to the strains included in the vaccine." - Health Day News (October 6, 2008) http://www.nlm.nih.gov/medlineplus/ne ws/fullstory_70107.html

CDC Committee Vote on Flu Vaccine Endangers Chlidren to Age 18

by Barbara Loe Fisher

Without scientific evidence that it is both safe and effective to repeatedly administer influenza vaccine to children, the members of the CDC's Advisory Committee on Immunization Practices(ACIP) voted Feb. 28, 2008 to vaccinate all infants and children up to age 18 with influenza vaccine every year. http://www.nytimes.com/2008/02/28/health/28flu.ht ml? em&ex=1204261200&en=a727f3655a7f32cc&ei=5087 %0A The vote came in the middle of a flu season that has seen widespread outbreaks of type A and type B strains of influenza that were not included in this year's influenza vaccine. http://www.reuters.com/article/domesticNews/idUSN0 850501820080208? feedType=RSS&feedName=domesticNews&sp=true A report out of Canada last fall indicated that influenza vaccine strains contained in last year's vaccines appeared to be mutating. http://www.ctv.ca/servlet/ArticleNews/story/CTVNe ws/20071024/flu_shot_071024/20071024hub=TopSto ries

The questionable safey and efficacy of influenza vaccine has been a subject of controversy for decades, despite the insistence by the drug industry and doctors selling the vaccine and government health officials promoting its use that most Americans should get a flu shot every year. Often public health officials at the World Health Organization (WHO) and in the U.S. fail to choose the right influenza strains for the vaccine. http://www.nvic.org/History/News letters/%203770Reaction.pdf

In the past few years, comprehensive reviews of influenza vaccine studies published in the medical literature revealed a stunning lack of scientific support for the safety and effectiveness of giving influenza vaccine to not only children but also to the elderly http://www.bmj.com/cgi/content/full/333/7574/912. The truth is that (1) only 20 percent of all respiratory flu-like illness in a normal flu season is, in fact influenza, and misdiagnosis often occurs; (2) the CDC has never provided published documentation that 36,000 Americans die from actual influenza every year versus respiratory illness that looks like influenza but is not; (3) there is little scientific evidence that influenza vaccine works or is safe for anyone; (4) government policies targeting all infants and children for annual flu vaccination may well endanger the long term health of this and future generations of children by atypically manipulating the immune system with repeated vaccination in an attempt to prevent all natural experience with type A or type B influzenza; and (5) these misguided flu vaccine policies could not only weaken the ability of future generations to experience and successfully heal from a bout with the flu without severe complications or death but also could put pressure on influenza viruses to mutate into more virulent, vaccine resistent forms that will cause future virulent epidemics in populations.

The majority of the American public, including doctors and nurses, refuse to get a flu shot every year despite the millions of dollars spent by the pharmaceutical industry and taxpayer money spent by the CDC to vigorously promote its use. http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/jul0207 acip.html

Recently, there have been calls by doctors advocating a cradle to the grave approach to vaccination that would require all 300 million Americans to get an annual flu shot. http://www.abcnews.go.com/Health/Flu/s tory?id=3781181

The drug companies selling flu vaccine have one goal: making profit on the millions of doses of vaccine produced every year rather than throwing it away because of poor uptake. CDC officials, eager to help the drug companies out, keep issuing ever widening recommendations to qualify more Americans for getting a flu shot. What began as an effort decades ago to protect those over 65 from complications of influenza that can be deadly for the elderly, has become a boondoggle for drug companies selling and doctors making profit on administering influenza vaccine to everyone, including babies, children and adults.

For the past four decades, every time the CDC has recommended a vaccine for "universal use" by children, those "recommendations" are translated into vaccine laws at the state level. Last year, New Jersey became the first state to mandate influenza vaccine for children as a requirement for attending school. Most states now require nearly three dozen doses vaccines that the CDC has "recommended."

The majority of Americans may not want to get a flu shot every year but the time is soon approaching when they will have no choice. Strident calls by vaccine makers, administrators and policymakers for more vaccine mandates and societal punishments for refusing to comply (" No shots - no education, no health insurance, no job) are paving the way for the day when rolling up your sleeve for a flu shot will become as mandatory and punishable as drinking and driving.

Increasingly, the CDC is guilty of endangering the public health, not protecting it. There is no excuse for issuing vaccine policies not supported by scientific data. The only recourse the public has is to change vaccine laws in the states to allow exemptions for conscientious and religious beliefs, as well as widen the medical exemption to allow enlightened doctors to exempt those with health conditions that are not acknowledged by the CDC as a reason for deferring vaccination. If vaccine laws cannot be made more flexible by allowing wider exemptions, then the day will come when the public will have no choice but to work for the repeal of all vaccine laws.

The National Vaccine Information Center remains committed to working to insert vaccine safety and informed consent protections in vaccine laws in America.

NO FORCED VACCINATION. NOT IN AMERICA.

Flu Vaccine Misses Flu Strains.....Again

by Barbara Loe Fisher

Every year, officials at the World Health Organization (WHO) and the U.S. Department of Health and Human Services (DHHS) look into a crystal ball and try to figure out which strains of Type A and Type B influenza will be prevalent in the U.S.. Sometimes they guess right and sometimes they guess wrong. This year, they guessed wrong as more than half of the influenza virus strains circulating in the U.S. right now are Type A and B strains that are not covered in this year's influenza vaccine.
http://www.reuters.com/article/domesticNews/idUSN0850501820080208?feedType=RSS&feedName=domesticNews&sp=true

In a typical flu season, only 20 percent of all flu-like illness is actually influenza. In 2003-2004 a mini-epidemic of a more severe type of influzenza caused by the A/Fujian strain occurred around the world, including the U.S. In spring of 2003, federal health agencies and the pharmaceutical industry knew the genetically mutated type A flu was emerging out of Asia and causing significant complications, including death, but chose not to include it in the 2003/2004 flu vaccine formula after the WHO voted to stay with strains that had been included in the previous year's formulation (A/Panama, A/Caledonia and B/Hong Kong). Without informing the public that the flu vaccine did not contain the strain of flu causing severe flu that season, the CDC heavily publicized child flu deaths in the fall of 2003 and Americans stood in long lines that fall and winter to get flu vaccine, which caused a vaccine shortage and subsequent CDC-recommended rationing of flu vaccine supplies. (http://www.nvic.org/History/Newsletters/%203770Reaction.pdf). The FDA stated that "between October 2003 and early January 2004, the deaths of 93 children younger than 18 had been reported to the CDC, according to preliminary data" and eventually the CDC would state that 152 flu related deaths occurred in children younger than 18 that year.

This year, the CDC is wisely admitting that this year's influenza vaccine does not match the circulating strains and is advising common sense strategies for prevention and management of flu, such as hand-washing.
http://www.webmd.com/cold-and-flu/news/20080208/flu-vaccine-most-flu-bugs-dont-match?src=RSS_PUBLIC
Those who are suffering with an especially nasty bout with the flu this year can take comfort in the fact that natural experience with type A or type B influenza will produce immunological memory that will help minimize the risk of a severe case of that same strain of influenza when it circulates in the future. In fact, pandemic flu planners are counting on the superior, longer lasting cell mediated immunity of those Americans, who have actually recovered from influenza infection in the past, because drug companies won't be able to produce pandemic flu vaccine fast enough to provide doses for everyone for up to a year after the pandemic begins.

Many Americans are taking steps to deal with influenza or flu-like illnesses by enhancing the functioning of the immune system through diet, exercise and other positive lifestyle and health care changes. And if they do get the flu, they are taking a common sense approach. To prevent and treat influenza or flu-like illness that does not involve a fever over 103 F, pneumonia or serious complications which may require special medical intervention, here are a few non-toxic suggestions:

1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamins A and D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.

FLU SHOT MANDATE LOOMS; FLU SHOT FAILS TO PROTECT

FLU SHOT MANDATE LOOMS; FLU SHOT FAILS TO PROTECT

by Barbara Loe Fisher

In 2006, Mayo Clinic's Greg Poland, M.D., who has been a CDC vaccine policymaker and promotes worldwide use of multiple vaccines throughout life, called for mandatory vaccination of all health care workers with flu vaccine.
http://www.sptimes.com/2006/06/13/Tampabay/Expert_calls_for_heal.shtml.

This year, the CDC issued a formal recommendation for all health care workers to do just that
http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/jul0207acip.html Dr. Poland has also been instrumental in defending the "safety" of the highly reactive anthrax vaccine the U.S. Department of Defense has required all soldiers to get.
http://www.vaccines.mil/documents/library/MilitaryImztn2005fulc.pdf. Last week, he called for all 300 million Americans to get a flu shot every year.
http://www.abcnews.go.com/Health/Flu/story?id=3781181

Dr. Poland, like so many doctors in public health and pediatrics today, considers himself a "warrior" in the crusade to kill all infectious microbes that cause human disease. He says, "Vaccines are the singularly most important medical technology ever devised. We administer a series of vaccines over a lifetime to every single human being on earth."
http://mayoresearch.mayo.edu/mayo/research/vaccine_research_group/

When ideology blinds a doctor, scientific truth is often the first casualty.

A report out of Canada last week reveals that two of the three strains (Soloman Islands A, Wisconsin A, Malaysia B) selected by doctors at the World Health Organization and the CDC for North America "appear to be drifting and mutating, raising questions about how much protection this year's flu vaccine will offer."
http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20071024/flu_shot_071024/20071024hub=TopStories The Public Health Agency of Canada reports that the Wisconsin strain has already mutated into a different form than is contained in the vaccine and the Malaysia strain is also showing signs of mutating. This is similar to what happened in the 2003-2004 flu season when there was a mismatch of circulating flu strains with the ones selected for the flu vaccine. http://www.nvic.org/History/Newsletters/%203770Reaction.pdf

So just how effective will the flu shot be at preventing death and illness from the flu this year, especially for children, the chronically ill and the elderly?

Probably not any more effective than it has ever been, which is not very effective according to yet another study in the medical literature ( Lancet Infect Dis. 2007;7:658-666). The Lancet reported this month that the elderly over age 70, who have always been targeted for flu vaccination because they account for 90 percent of all flu related deaths, may not be protected at all from dying from complications of the flu. Flu vaccine use by the elderly and those with chronic diseases has increased from 15% to 65% in the US and other high-income countries since 1980 but there has been no decrease in influenza-related mortality among these groups. The few clinical trials that have included elderly people have indicated there is a decrease in antibody responses and clinical benefits of flu vaccination as people age beyond 70 years.
http://www.medscape.com/viewarticle/563393?src=mp This new report reinforces an analysis of flu vaccine clinical trials published last year in the British Medical Journal by Cochrane Collaboration researchers
http://www.bmj.com/cgi/content/full/333/7574/912
The 2006 Cochrane Collaboration analysis found that the majority of published influenza vaccine studies were methodologically flawed with selection biases, cofounders and heavy reliance on non-randomized studies. Authors pointed out that potential confusion between respiratory infections caused by flu viruses and those caused by non-flu viruses can result in a misdiagnosis and gross overestimation of the true impact of influenza on death and illness in a given flu season (CDC officials have never produced documented evidence for the 36,000 deaths they attribute to the flu every year).

The 2006 study concluded that too few clinical trials have been conducted to prove flu vaccine safety and current evidence indicates that use of inactivated influenza vaccine has only a modest or no effect on preventing flu in children or the elderly. Co-author Tom Jefferson, an Italian epidemiologist said "There is a big gap between policies promoting annual influenza vaccinations for most children and adults and supporting scientific evidence."

NVIC has taken the position that the CDC should stop recommending annual influenza vaccination for all young children when there is insufficient scientific justification for it.
http://www.nvic.org/PressReleases/pr1031flu.htm

Unfortunately, when the CDC makes a recommendation for universal use of vaccines, state mandates soon follow. Greg Poland's call for 300 million Americans to get an annual flu shot is a pretty good indicator the CDC will eventually follow suit and drug company lobbyists seeking higher profits will pressure state legislatures to institute flu vaccine mandates. Once every American has been softened up to accept an annual flu shot, more shots and mandates will follow.

Only this time, the vaccine mandates will not just mean being barred from getting an education. Today, parental refusal to get a child vaccinated with all state mandated vaccines means the child can be barred from going to school or getting health insurance. Tomorrow vaccine mandates may mean being barred from getting a job or a driver's license unless you show proof you've saluted smartly and rolled up your sleeve for scores of new vaccines now being developed in more than 200 clinical trials worldwide. And that is a future that drug companies selling vaccines are convincing stockholders they can take all the way to the bank.

http://www.abcnews.go.com/Health/Flu/story?id=3781181

Moldy FluMist Holds Up Final FDA Approval

Moldy FluMist Holds Up Final FDA Approval

by Barbara Loe Fisher

Until June 2003, when the FDA approved the first live virus flu vaccine, FluMist, the only flu vaccine that was used in the US was the killed or inactivated flu vaccine injected into the arm. FluMist manufactured by MedImmune was the first vaccine designed to be squirted up the nose and given to healthy children and adults.

Generally, Americans have not been enthusiastic about squirting live virus flu vaccine up their noses. Call it irrational. Call it the "yuck" factor. Call it instinct. FluMist has largely remained a non-starter.

The fact that the FDA had to recently slap MedImmune on the hands after inspectors reportedly found excessive amounts of mold and bacteria during early stages of the production process of FluMist doesn't help. A September 10, 2007 Washington Post article said the company was cited for "significant deviations for current good manufacturing practice."
http://www.washingtonpost.com/wp-dyn/content/article/2007/09/09/AR2007090901612.html?nav=rss_business

In pre-licensure clinical trials of FluMist, there was an increased risk of asthma, upper respiratory infections, musculoskeletal pain, otitis media and croup for some children and an increased risk for upper respiratory symptoms in adults after inhaling the live vaccine. FluMist contains attenuated live flu viruses and poses a risk of transmission of live flu virus from the recently vaccinated to close contacts. When I was sitting on the FDA Vaccines and Related Biological Products Advisory Committee in 2002, I voted "no" when asked if safety had been proven. http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3912t1-03.pdf

Among other things, I said "The fact that live vaccine flu virus is shed in 80 percent of recipients poses an additional risk for our population at large, particularly for immune compromised individuals across all age groups. The outstanding questions about the true rate of transmission of vaccine strain viruses among children needs to be clarified as does the retention of the attenuation of shed viruses and the high frequency of nucleotide changes. Because this live virus nasal vaccine is not indicated for high risk health groups, which have historically been the targeted populations to receive flu vaccine, it's a very serious step to move to the use of a live virus vaccine for the majority of healthy individuals, and a standard for proof of safety must be very high. I don't think that standard has yet been met by the data which have been presented so far."

Initially, the FDA approved the vaccine for healthy children over 5 and adults under 49. Both MedImmune and vaccine distributor, Wyeth, thought they had a blockbuster on their hands. In the summer and fall of 2003, the companies launched a $100 million ad campaign that featured Wal Marts offering to squirt the vaccine up the noses of shoppers.(MedImmune, Inc. [Investors] News Releases. September 10, 2003 "FluMist Available in Pharmacies This Fall."). At a cost of between $46 and $150 a dose, the companies were projecting between $120 million and $140 million in sales.

But by late October 2003, it became apparent that few of the four million doses of FluMist that MedImmune had produced were being purchased. By January 2004, the company was trying to give it away. MedImmune has been trying to capture market share for FluMist ever since the disastrous FluMist debut in the 2003-2004 flu season.

Now, the FDA has given MedImmune (recently acquired by British drug firm Astra Zeneca) another chance by approving FluMist for healthy children over two years. But still, the warning remains about not giving FluMist to anyone with asthma or children under five with a history of wheezing. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01705.html

What healthy adults and parents of healthy children need to ask themselves is: why do healthy people need to deliberately inhale live flu viruses when the majority of healthy people don't get that sick from the flu and recover without any complications?

Keep reading NVIC's E-News for further reports on the Flu and You as the flu season approaches and the Flu Patrol gears up to scare the living daylights out of you so you inhale deeply or roll up your sleeve without giving it a second thought.

In the News:

"The FDA sent the Gaithersburg firm a lengthy warning letter in May, citing "significant deviations from current good manufacturing practice." Agency officials were concerned that MedImmune had not properly followed up after excessive levels of mold and bacteria were found during early stages of the production process. The FDA said the vaccine had not been contaminated. The FDA's warning letter has held up shipments of FluMist. It also put on hold MedImmune's efforts to win regulatory approval for use of the vaccine by children under 5. Expanding the vaccine's use in that important market has been a cornerstone of the firm's efforts to boost the prospects for FluMist, which has not been a hit in the marketplace. It is now approved only for people ages 5 to 49. FDA and MedImmune officials said the process to win approval for use by younger children could now continue. Less than two weeks before the warning letter was issued, an FDA advisory panel unanimously agreed that FluMist worked in children under 5. The panel was mixed on whether FluMist was safe enough for children younger than 2." - Michael Rosenwald, Washington Post (September 10, 2007)
http://www.washingtonpost.com/wp-dyn/content/article/2007/09/09/AR2007090901612.html?nav=rss_business

"The U.S. Food and Drug Administration today approved expanding the population for use of the nasal influenza vaccine FluMist to include children between the ages of 2 and 5. Approval for the vaccine, which contains a weakened form of the live virus and is sprayed in the nose, was previously limited to healthy children 5 years of age and older and to adults up to age 49.......Children under the age of 2 should not receive FluMist because there was an increased risk of hospitalization and wheezing for this age group during the clinical trials. Commonly observed adverse events from the vaccine were generally mild and most often included runny nose and/or nasal congestion, as well as a slight fever in children 2 to 6 years of age. FluMist should not be administered to anyone with asthma or to children under the age of 5 years with recurrent wheezing because of the potential for increased wheezing after receiving the vaccine. People who are allergic to any of FluMist's components, including eggs or egg products, should also not receive the vaccine....." - FDA Press Release (September 19, 2007) http://www.fda.gov/bbs/topics/NEWS/2007/NEW01705.html MedImmune Says FluMist Problems




Flu Vaccine Glut - Nobody Wants It

“I sent out a blast fax to 700 physicians in the Youngstown area offering to give it away if they just come pick it up,” said Mr. Stefanak, the health commissioner of Mahoning County, Ohio, which includes Youngstown. So far, he said, there have been few takers..........While experts say an excess is better than a shortage, too large a surplus could hamper the government’s goal of steadily increasing the production and use of flu vaccines. Because makers, distributors, doctors and health departments lose money from vaccine they cannot sell to patients, they may be discouraged from making or ordering as much in coming years — potentially leading to future shortages." - Andrew Pollack, The Ledger, December 16, 2006
After Shortage, Flu Vaccine in Unused

Barbara Loe Fisher Commentary:

What part of "no thanks" do CDC officials and drug company execs not understand when it comes to most Americans refusing to get a flu shot every year? Despite all the hype about how 36,000 Americans die every year from influenza and 200,000 more are hospitalized, it is hard to find somebody who knows anybody who was hospitalized or died from infection with one of the three influenza viruses contained in the flu vaccine. Yet, those figures keep getting bandied about by public health officials, who steadfastly refuse to produce the hard scientific evidence to back up their numbers.

In light of the fact that only 20 percent of all flu-like illness in any given flu season is actually influenza, inquiring minds want to know the truth and are asking for proof that backs up the rhetoric. So far, the flu vaccine studies published in the medical literature fail to give credence to any of the inflated influenza mortality figures the CDC is using to try to scare the people.

Guaranteeing Drug Company Profits - Unable to frighten Americans into getting an annual flu shot, public health officials have taken to playing the sympathy card. On behalf of drug companies, they are pleading for the people to roll up their sleeves, dig deep into their pockets and shell out some bucks for the flu shot to guarantee the drug companies big profits. It doesn't look good on drug company stockholder proft/loss statements when unused surplus vaccine has to be dumped after the flu season is over. No, wait! Now public health officials are saying that there is no such thing as the beginning and ending of a flu season: the flu is actually a killer all year round so everybody should get vaccinated all year round!

Exercising the Immune System - It wasn't so very long ago when the flu vaccine was only recommended for those at very high risk for suffering serious complications from influenza infection, such as the elderly or those already seriously ill. The majority of healthy young Americans accepted getting the flu every couple of years as a part of life. It was a great excuse to take a few days off from school or work and stay in bed with plenty of kleenex, Vicks vapor rub, OJ, chicken noodle soup and a good book. Then, after experiencing the sore throat, chills, fever and other symptoms of acute inflammation that are part of a robust immune system exercise, often recovery from influenza was followed by an extended period of good health. And when that same strain of influenza came around again, there was either no re-infection (immunity) or fewer and milder symptoms of illness.

Superior Natural Immunity - Experience with type A and type B influenza infection has another bonus: immunological memory that could help resist the ravages of a nastier version of type A or type B influenza that comes around someday. Flu vaccine only provides temporary immunity. So pandemic flu planners are counting on the superior, longer lasting immunity of those Americans, who have actually recovered from influenza infection, because drug companies won't be able to produce pandemic flu vaccine fast enough to provide doses for everyone for up to a year after the pandemic begins.

If public health officials are depending upon Americans with qualitatively superior cell mediated immunity to influenza, which can only be obtained from recovering from the flu the old fashioned way, to limit morbidity and mortality from a future pandemic flu - then why are they insisting that every American get annual flu vaccinations from birth?

Dealing with the Flu - These days, many Americans are taking steps to deal with influenza or flu-like illnesses by enhancing the functioning of the immune system through diet, exercise and other positive lifestyle and health care changes. And if they do get the flu, they are taking a common sense approach. To prevent and treat influenza or flu-like illness that does not involve a fever over 103 F, pneumonia or serious complications which may require special medical intervention, here are a few non-toxic suggestions:


1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamins A and D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.

There is little indication that CDC officials are going to stop asking Americans to roll up their sleeves and guarantee drug companies flu vaccine profits. There is also little indication that Americans are paying much attention to that request. In the wings: most likely a CDC and drug industry plan to try to get politicians to mandate the stuff.

"No forced vaccination. Not in America."


Flu Drug and Vaccine Risks Revealed

"Officials at the U.S. Food and Drug Administration don't know if the more than 100 new cases of strange behavior, including three deaths from falls, are tied to the drug, to the flu itself, or a combination of both, the Associated Press reported. The FDA is mulling changes to the Tamiflu label that may recommend that all patients, especially children, be closely monitored while on the drug.........In related news, a study in the Nov. 13 issue of the Archives of Internal Medicine finds that the flu vaccine slightly increases the risk of Guillain-Barre syndrome, which occurs when the body's immune system attacks part of the nervous system, resulting in tingling or weakness and possible paralysis." - Steven Reinberg, HealthDay

"I'd like the flu shot to actually work and be safe. This is where things start to fall apart. Surprisingly, even though the flu vaccine is one of the few immunizations recommended for most of the population, we're still not certain about its efficacy, and only a few large-scale studies have been done on its safety in small children. Scientists have even raised questions about whether U.S. death figures from the flu are accurate because of the confusion between flu and flulike illnesses." - Julie Deardorf, Baltimore Sun


Barbara Loe Fisher Commentary:
Tamiflu and flu vaccine apparently have one thing in common: they both can cause brain dysfunction and consumers should become fully informed before taking the risk. Influenza and flu-like illnesses have been part of the human condition for centuries. Only 20 percent of all flu-like illness is actually caused by influenza viruses.

Exposure to and recovery from type A and type B influenza results in immunity which is qualitatively superior to vaccine-induced temporary immunity. Most published studies examining influenza vaccine effectiveness are methodologically flawed and very few have demonstrated that influenza vaccine is effective in preventing influenza in children and adults.

To prevent and treat influenza or flu-like respiratory illness that does not involve fever over 103 F., pneumonia or serious complications which may require medical intervention, the National Vaccine Information Center offers the following non- toxic suggestions:

1. Wash your hands frequently.
2. Avoid close contact with those who are sick.
3. If you are sick, avoid close contact with those who are well.
4. Cover your mouth if you cough or sneeze.
5. Drink plenty of fluids, especially water.
6. Get adequate sleep.
7. Eat a healthy diet rich in vitamins and minerals, especially foods containing vitamin C (such as citrus fruits) and vitamin D (such as cod liver oil) and spend a few minutes a day in sunlight to help your body make and store vitamin D.
8. Exercise regularly when you are well.
9. Lower stress.
10. Consider including holistic alternatives in your wellness or healing plan, such as chiropractic adjustments, homeopathic and naturopathic remedies, acupuncture and other health care options.

For more information about studies which fail to prove that influenza vaccine is safe or effective, see NVIC's Oct. 31 press release on flu vaccine at www.nvic.org

Flu Vaccine Survey Finds America Clueless

"A survey of 9,024 people conducted by Zogby International, a public opinion group, between Oct. 27-30 of this year, found that many people are uninformed about vaccinations, but have strong opinions when provided with information. According to the survey, when asked what they knew about flu shots, 74 percent of respondents were unaware that most flu shots contained mercury." - Manny Alvarez, Fox News, November 13, 2006, Anti-Vaccine Group Challenges CDC's Flu Shot Guidelines for Infants

"We are concerned that we're going to have more doses of flu (vaccine) than we might use," said Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention. More than 110 million doses — a record amount — are being made for the 2006-07 flu season. The previous record was 95 million in 2002-03. That year 12 million doses went unused and one manufacturer quit making shots. CDC officials said they want to prevent a repeat of that experience and are promoting Nov. 27-Dec. 3 as "National Influenza Vaccination Week." - Mike Stobbe, Associated Press,
November 13, 2006, CDC Urges More People To Get Flu Shots


Barbara Loe Fisher Commentary:

While the CDC pleads with Americans to roll up their sleeves and get a flu shot and parent groups concerned about the mercury preservative, thimerosal, call for it to be removed from flu vaccine, the National Vaccine Information Center stands by its position that whether flu vaccine contains mercury or not, the right to informed consent to medical risk taking is a human right and vaccination is no exception. It will be many years before the idealogues at the CDC or the executives making stock decisions at the big pharmaceutical companies or the researchers in academia taking both CDC and drug company money ever come clean with the American people about the real risks of mercury-containing or mercury-free vaccines.

Vaccination involves atypical manipulation of the immune system with lab altered viruses and bacteria as well as many potentially harmful components from aluminum and formaldehyde to endotoxin and residual DNA from animal and human cell substrates. The biological mechanisms for brain and immune system dysfunction caused by live virus or killed bacterial vaccines are varied. Removing mercury from vaccines will lessen the toxic load from vaccination but will not eliminate vaccine injury and death, including vaccine induced autism and other developmental delays.

It is sad that health officials at the CDC cannot embrace the "first do no harm" principle and remove a known neurotoxin from the flu vaccine. Their refusal to take this logical step should be a warning to the public that becoming an informed consumer when it comes to vaccination can mean the difference between long term good health or a lifetime of chronic illness and disability.

Flu Vaccine Studies Flawed - NVIC Calls For Policy Change

October 31, 2006 - Press Release
Studies Fail to Demonstrate Safety or Effectiveness
of Influenza Vaccine in Children and Adults
National Vaccine Information Center Calls for Influenza Vaccine Policy Change

WASHINGTON, Oct. 31 /PRNewswire/ -- An independent analysis by the internationally renowned Cochrane Collaboration of worldwide influenza vaccine studies, published in the British Medical Journal on Oct. 28, concluded there is little scientific proof that inactivated influenza vaccine is safe and effective for children and adults. Citing the Cochrane Collaboration finding as well as methodological flaws in a child influenza vaccine study published Oct. 25 in the Journal of the American Medical Association (JAMA), the National Vaccine Information Center is calling on the Centers for Disease Control (CDC) to stop recommending annual flu shots for all infants and children until methodologically sound studies are conducted.

"There is a big gap between policies promoting annual influenza vaccinations for most children and adults and supporting scientific evidence," said epidemiologist Tom Jefferson, Cochrane Vaccines Field, Rome, Italy, who coordinated the comprehensive analysis for the prestigious Cochrane Collaboration. "Given the significant resources involved in annual mass influenza campaigns, there is urgent need for re- evaluation of these strategies."

The Cochrane Collaboration analysis found that the majority of published influenza vaccine studies were methodologically flawed with selection biases, confounders and heavy reliance on non-randomized studies. The report points out that potential confusion between respiratory infections caused by influenza viruses and those caused by non-influenza viruses can result in misdiagnosis and gross overestimation of the true impact of influenza on death and illness in a given influenza season. The report concluded that too few clinical trials have been conducted to prove vaccine safety and current evidence indicates that use of inactivated influenza vaccine has only a modest or no effect on preventing influenza in the children and the elderly.

"The CDC has pushed mass use of influenza vaccine in all children without scientific evidence the policy is either necessary or safe," said NVIC President Barbara Loe Fisher. "Where is the good science to back up the policy? If the recently published CDC-funded influenza vaccine study in JAMA is the kind of flawed science public health officials are using to convince the public the vaccine is safe, it is no wonder that many parents don't trust what public health officials say about vaccination. The CDC should stop recommending annual influenza vaccination of all young children when there is insufficient scientific justification for it."

The JAMA study, which was conducted by Kaiser Permanente doctors with CDC funding, was a non-randomized retrospective analysis of the medical records of children 6 to 23 months old who were given influenza vaccine as well as other vaccines between 1991 and 2003. Vaccines were not randomly administered and unvaccinated controls were not used. Children's case histories were included in the study only if an HMO doctor had seen them within 14 days of influenza vaccination. Dozens of convulsions and other adverse events, including brain injury experienced by children after vaccination, were excluded from the study if the children had not been seen by a doctor within 14 days of the adverse event or were sick in the weeks before and after vaccination.

Because of arbitrarily chosen cut-off periods, adverse events which occurred before and after different observation times cancelled each other out and were not classified as vaccine-related. In some cases, convulsions and cases of Guillain Barre Syndrome were dismissed as "coincidental" or caused by other vaccines the children received by the 19 Kaiser Permanente and CDC authors -- nine of whom reported financial ties to flu vaccine manufacturers and all of whom received CDC funding.

"Vaccine studies are using increasingly complex statistical techniques rather than time-tested research designs," said NVIC Health Policy Analyst Vicky Debold, R.N., Ph.D. "The JAMA study is exactly the type of study criticized by the Cochrane Collaboration. There were so many limitations and exclusions in the study design that it is nearly impossible to interpret or replicate the findings. The true effect of the influenza vaccine on health outcomes cannot be identified in this single, flawed study, which should not be used as evidence that influenza vaccine is safe for infants and toddlers or to justify national vaccine policies."

The Cochrane Collaboration (http://www.cochrane.org), which maintains the Cochrane Library and is the world's leading producer of systematic reviews of scientific information about health care, is a UK registered international charity. Cochrane reviews are considered the gold standard for determining the effectiveness of health care interventions.

The National Vaccine Information Center (NVIC) is a non-profit, educational organization (http://www.nvic.org ) founded in 1982 and is dedicated to preventing vaccine injuries and deaths through public education and defending the informed consent ethic.

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Source: National Vaccine Information Center