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."

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.

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.

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)

"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) MedImmune Says FluMist Problems

Senate Vet Committee Looks At Anthrax Vaccine

Senate Vet Committee Looks At Anthrax Vaccine

by Barbara Loe Fisher

Tomorrow, Tuesday, Sept. 25 at 9:30 a.m. in the Dirksen Building, the Senate Committee on Veteran's Affairs will hold an oversight hearing on Persian Gulf War illness research and treatments. The goal of the hearing is to examine current research trends and identify new treatments. Maine physician and anthrax vaccine expert, Meryl Nass, M.D., will be testifying.

Meryl, who is the medical director for the Military and Biodefense Vaccine Project of the National Vaccine Information Center
( and a blogger at, has interviewed and helped many anthrax vaccine victims over the last decade. She is urging that citizens call or write a letter to Senators on the Veterans Affairs Committee listed below and urge that a hearing be held on the mandatory anthrax vaccine program, which has left thousands of soldiers suffering with chronic illness and disability. She says that many of the vaccine injured soldiers need better medical care and disability pensions.

Meryl is also a strong advocate for an end to the mandatory anthrax vaccination of all military personnel. In 2005, NVIC joined with Meryl and veterans groups in an amicus brief filed in a DC federal court lawsuit to stop the Defense Department from forcing soldiers to get anthrax vaccine without their voluntary, informed consent.

Soldiers who refuse to get the highly reactive anthrax vaccine, like Private First Class Leif Hamre, 22, are threatened and punished. According to an article in The Raw Story, Hamre said "The tactics they have used to coerce me into taking the shot are unregulated, unscrupulous and downright un- American," Hamre wrote in a recent open letter to family, friends and others who are campaigning against the military's mandatory anthrax vaccine program. "They have tried to turn my platoon against me in various ways (which is not totally unsuccessful). Along with the more common tactics like intimidation and threats (including the possibility of a forceful inoculation). I can only imagine what will come as I continue with this."

The demonization and persecution of soldiers, who are fighting for the right to exercise informed consent to vaccination in the military, is similar to the demonization and persecution of parents, who are fighting for the right to exercise informed consent to vaccination of their children. Civilian forced vaccination proponents like Paul Offit, Dan Salmon and Arthur Caplan, who advocate mandatory vaccination with every vaccine drug companies produce, are thinking up ways to punish the non-vaccinators. For the crime of refusing vaccination, they are talking about (1) posting the names of non-vaccinators on a public list; (2) prosecuting them; (3) fining them; (4) taxing them. What will be next? Imprisonment?

Perhaps these arrogant, ignorant bullies posing as healers and "ethicists" should take a look back in history to the times when the fine art of pitting citizen against citizen became the basis for branding minorities in society as a threat to the public welfare to justify taking away their civil liberties, then their jobs, then their homes, then their lives.

If the State can tag, track down and force individuals against their will to be injected with biologicals of unknown toxicity today, there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.

Following is a list of members of the Senate Veterans Affairs Committee:


Daniel K. Akaka, Hawaii

CHAIRMAN: John D. Rockefeller IV, West Virginia

Patty Murray, Washington

Barack Obama, Illinois

Sherrod Brown, Ohio

Jon Tester, Montana

Jim Webb, Virginia

Bernard Sanders, Vermont (Independent)


Richard Burr, North Carolina

RANKING MEMBER Senator: Arlen Specter, Pennsylvania

Larry Craig, Idaho

Kay Bailey Hutchison, Texas

Lindsey Graham, South Carolina

John Ensign, Nevada

Johnny Isakson, Georgia


"According to Hamre, 22, the military gave him an ultimatum in late June: Either take the mandated six- shot anthrax series or face military punishment. He was given 24 hours to decide. After conducting several hours of research into the drug and its history of triggering serious adverse reactions, the Minnesota native concluded that the "vaccine was dangerous" and "should probably still be in a lab right now for further testing." He decided to refuse it..... Hamre's mother, Mary, said that after her son refused the anthrax shot series he was assigned extra duty, taken off missions, significantly dropped in rank and pay scale, and confined to a certain area on the base - all while working an 18-hour work day, seven days a week. Making matters even worse, she said, is the difficulty the family has had in trying to communicate with Leif since he refused the shots. Baghdad remains a volatile and unstable city, and the electricity is still very unreliable, frequently cutting in and out, and is only on for certain portions of the day.....Facing the possibility that he could be permanently dismissed from the military because of his refusal to take the anthrax vaccine has been hard on her son, Mary said, especially since Leif has been proud to serve his country and follow in the footsteps of his father, who also was in the Army. Mary, 55, lives in Minnesota and works as a massage therapist. "They try to break them down..... but someone has got to take a stand," she said." - Julie Weisberg, The Raw Story (September 17, 2007)

Antibiotic & Vaccine Pushing Doctors Create "Superbugs"

Antibiotic & Vaccine Pushing Doctors Create "Superbug"

by Barbara Loe Fisher

In the post-World War II days of the 1950's, I remember our family doctor came to our house when I had strep throat and gave me a penicillan shot. By the early 1960's, doctors weren't making house calls anymore but every time my Mom took me to the doctor - whether it was for the stomach flu or a bad cold - the doctor wrote a prescription for a bottle of antibiotics. It didn't matter whether it was a viral or bacterial infection, at the end of the office visit he wrote a prescription for antibiotics.

Today, doctors who listened to drug company salesmen in the 1950's and 1960's and recklessly prescribed antibiotics for every sore throat or sniffle, are trying to blame the deadly increase in antibiotic- resistant superbugs cropping up around the world on the people they told to take the antibiotics in the first place. A quick Google search on the subject took me to a website operated by the Medical College of Wisconsin, which warns that "Antibiotic resistance occurs when bacteria change in some way that reduces or eliminates the effectiveness of the medicines designed to cure or prevent infections. Over time, some bacteria have developed ways to dodge the effects of antibiotics. Widespread use of antibiotics is thought to have spurred evolutionary changes in bacteria that allow them to survive these powerful drugs. The bacteria continue to multiply, causing more harm..... "Our first step toward correcting the problem is to build public knowledge and awareness of when antibiotics work -- and when they don't," said Richard Besser, MD, CDC's medical director of the campaign. "We want Americans to keep their families and communities healthy by getting smart about the proper use of antibiotics."

Hello, Dr. Besser! Antibiotics are prescribed by DOCTORS. People do not "use" antibiotics without a doctor's prescription. They don't wake up and say to themselves "I think I will take an antibiotic today and help bacteria evolve into superbugs that will kill thousands." No, that iatrogenic problem has been caused by a medical profession too narrow-minded, lazy and self-serving to look beyond drugs and vaccines to a more natural, less toxic and less expensive way to help people maintain wellness and heal from illness.

Antibiotics like penicillan should always have been reserved for the most life threatening bacterial infections. The rest of the time, doctors should have told us to get plenty of sleep, drink lots of fluids, eat nutritious food high in vitamin C and D and seek out non-pharmaceutical therapies so we could get well the old fashioned way and strengthen the natural healing ability of our immune systems.

It is too late for doctors to turn the clock back and refrain from pushing pricey antibiotics on patients for everything from an ear infection to a hangnail. The damage has been done.

However, doctors have an opportunity right now to stop making the same mistake with vaccines. The warning signs have been around for a long time but doctors have a habit of closing their eyes and putting their hands over their ears when they don't want to see the obvious: microorganisms which drug companies and government health officials have targeted for eradication by mandatory vaccine use are evolving into vaccine-resistant strains that may well end up killing and destroying the health of more people than would have been killed or made sick if the vaccines had never been used at all.

Case in point: Wyeth's pneumococcal vaccine, Prevnar.

Prevnar vaccine contains seven of the most antibiotic-resistant pneumococcal strains, although there are more than 80 strains of the organism, which live harmlessly in the noses and throats of most people and rarely cause disease. Why some people go on to develop serious pneumococcal disease is unknown but those with dysfunctional immune systems are thought to be at highest risk. In 2001, the CDC told America that pneumococcal infections cause approximately 700 cases of meningitis, 17,000 cases of blood stream infections and 200 deaths in American children under age five every year, with 35 of these deaths being caused by pneumococcal meningitis (Centers for Disease Control. Dec. 10,2001 press release: ACIP Votes to Temporarily Revise Recommendations for Pneumococcal Conjugate Vaccine).

Even before Prevnar was licensed by the FDA in February 2000 and the CDC immediately recommended all babies under two get four doses, drug company officials heavily promoted it as an "ear infection" vaccine. They did this even though their own clinical studies demonstrated a less than 7 percent efficacy for preventing ear infections (Wyeth-Ayerst Laboratories. Sept. 25, 1998 press release: New Investigational Vaccine Demonstrates High Efficacy Against Pneumococcal Disease in Children; Kaiser Permanente. May 4, 1999 press release: Investigational Vaccine Is First To Show Effectiveness Against Childhood Ear Infections).

Prevnar's safety was not scientifically well established, either. In the clinical trials that Wyeth conducted with the help of Kaiser Permanente, the experimental pneumococcal vaccine was compared against an experimental meningococcal vaccine. This meant the trial had no true placebo as the reaction profile was unknown for both experimental vaccines, fundamentally compromising the scientific validity of the safety trial. Children in the Prevnar group suffered more seizures, irritability, high fevers and other reactions. There were 12 deaths in the Prevnar group but they were dismissed by trial investigators as "Sudden Infant Death Syndrome." (Wyeth- Lederle Product Manufacturer Insert Pneumococcal 7- Valent Conjugate Vaccine (PREVNAR). Issued February 2000).

Wyeth remains the sole source for pneumococcal vaccine for American children today. Because company officials deliberately targeted the lucrative ear infection market, Prevnar became the best selling new pharmaceutical in 2000 and generated $461M for Wyeth that year. This spring, a Wall Street report entitled "Wyeth profit rises 12%, helped by vaccine sales" reported "First-quarter revenue for Prevnar, Wyeth's vaccine to prevent invasive pneumococcal disease in infants and young children, rose 43% to $617 million. U.S. net revenue increased 16% due to improvement in compliance rates, the addition of 250,000 doses to the CDC vaccine stockpile, as well as price increases."

Bottom line: The pneumococcal vaccine was developed because doctors had over-prescribed antibiotics for four decades and the most serious cases of pneumoccocal disease were no longer responding to antibiotics.

There is always a big price to pay when doctors fool around with Mother Nature. The Prevnar vaccine that was developed by doctors to solve a problem with antibiotic resistance created by doctors has now created another monster: a vaccine-resistant virulent strain of strep that is causing ear infections in children that cannot be treated with any known antibiotic safe for use in children. This week doctors in Rochester, NY report Prevnar vaccine is becoming "less effective" as vaccinated children are coming down with a new and really nasty type of pneumococcal disease.

An Associated Press article reporting on the new vaccine-induced and vaccine resistant pneumococcal strain of strep said "Because these bacteria easily swap gene components to become even more hardy, "new types may emerge that can both escape containment by vaccine and spread throughout the world," Dr. Daniel Musher of Baylor College of Medicine wrote in the New England Journal of Medicine last year."

Currently, 13 states mandate Prevnar vaccine for daycare entry: Colorado, Georgia, Indiana, Louisiana, Maine, Maryland, Michigan, Minnesota, New York, Pennsylvania, Rhode Island, Texas and Virginia. How many of the politicians who listened to doctors and voted for vaccine mandates in those states, knew that their action would contribute to creation of a "superbug" that may end up killing many more than the 200 children under five the CDC said died from pneumococcal infection every year when Prevnar was licensed?

The most sickening part of this story is that, according to the AP article "Wyeth anticipated this and is testing a second-generation vaccine. But it is at least two years from reaching the market, and the new strains could become a public health problem in the meantime if they spread hard-to-treat infections through day care centers and schools."

WYETH ANTICIPATED THIS WOULD HAPPEN? In 2000, when Wyeth was hyping Prenvar as an "ear infection" vaccine, why weren't parents told this would happen? Doctors at Wyeth must have been at work on "second and third generation" vaccines since 2000. Because, after all, there are more than 80 pneumococcal strains which presents scores of opportunities for lots of them to mutate into killer antibiotic and vaccine resistant "superbugs." That should keep pneumococcal vaccine creators and marketeers in the money for at least a century.

Ah, Brave New World. And when will the majority of Americans wake up, stand up, and "just say no" to laws forcing them to serve up their children as guinea pigs while vaccine-obsessed doctors and drug companies ignorantly destroy what remains of the earth's ecological balance and the biological integrity of the human race?

Menactra, Doctors in Denial and the Vaccine Police

" A growing grassroots movement is pushing for more states to require the shot. Currently, the Centers for Disease Control and Prevention recommends Menactra for kids ages 11 to 18, but only 12 percent of teenagers got the vaccine in 2006. Many of those advocating for mandatory vaccinations are parents, including Frankie Milley, who have lost children to meningitis. Nine years ago, her 18-year-old son, Ryan, died of the disease, and since then, she has worked in her home state of Texas to make meningitis education available to all families. She also supported a bill currently being considered by the Texas Legislature that would require college students to get the vaccine.....Others believe parents should be able to choose which vaccinations they - or their children - receive. Education about the vaccination is vital, but families should know the risks and be able to make their own decisions, says Dr. John Dorman, a committee member of that same American College Health Association (ACHA) committee and a clinical professor of medicine at Stanford University…..Barbara Loe Fisher, president and co-founder of the National Vaccine Information Center, believes more attention should be drawn to potential hazards. Her Washington, D.C.-based nonprofit works on the prevention of injuries and deaths caused by vaccinations. "I just I don't understand why we have to force people," Fisher says. "We should make [vaccinations] available at low or no cost, but forcing people is another issue." - Melissa Dahl, MSNBC (September 26, 2007)

" We need to get our priorities straight when it comes to mandating or requiring vaccines. When there is a fatal disease that is easily prevented by a safe vaccine, the shot ought to win out every time over our dislike of being told what to do.....The Centers for Disease Control recommends that everyone ages 11 to 18 should get [Menactra], as well as those headed off to live in college dorms or going into the military. But in 2006, only 12 percent of teenagers got the vaccine. So why isn't everyone in this age group getting vaccinated? The answers are the same ones that continue to haunt vaccines - unjustified safety concerns, resistance to mandates and cost.....Americans are generally leery of requiring or mandating vaccines. They value informed choice. But do you really want to leave an issue as important as vaccination left up to busy college freshmen to think about? Menectra is safe, so it's hard to know why anyone living in a dorm or close quarters would not want to get vaccinated.....If you don't mandate vaccines then insurers often won't pay for them. In our screwy world of health care, mandates have more to do with reimbursement then they do the police blocking access to the dorm until you show your vaccination card....Sometimes choice ought to yield to common sense and evidence….- Arthur Caplan, Ph.D., MSNBC (September 6, 2007)

"According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients' concerns about [statin] side effects. The study suggests this pattern of reaction goes beyond statins to other drugs. When doctors fail to recognize a patient's symptoms as drug side effects, more than that patient's care is put at risk. Because the doctor makes no "adverse event report" to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is....patients surveyed said their doctors rarely linked their symptoms to statins -- even when the symptoms were well-documented as side effects. "Overwhelmingly, it was the patient that initiated that conversation" making the connection between the statin and their symptoms, [survey author] Golomb said. Many doctors instead attributed the symptoms to the normal aging process, denied their connection to statins or dismissed the symptoms altogether -- missing opportunities to switch their patients' prescriptions or otherwise mitigate the side effects, Golomb said....The findings raise important concerns about American drug safety monitoring, said Harvard Medical School professor Jerry Avorn…." - Ishani Ganguli, The Washington Post (August 28, 2007)

"The number of serious adverse drug events reported to the U.S. Food and Drug Administration (FDA) more than doubled between 1998 and 2005, as did deaths associated with adverse drug events, according to a report in the September 10 issue of Archives of Internal Medicine .....The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion," the authors write. A total of 1,489 drugs were associated with adverse events, but a subset of 51 drugs that each had 500 or more reports in any year accounted for 203,957 or 43.6 percent of the total adverse event reports in the study....."Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time," the authors write....."Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system." ......These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period," they conclude. "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs." - Science Daily (September 10, 2007)

Barbara Loe Fisher Commentary:

After 25 years, the public debate about forced vaccination has become a passionate dialogue about children who have been hurt or died from infectious diseases and children who have been hurt or died from reactions to mandated vaccines. Mothers and fathers, armed with a memory of watching a beloved child regress into poor health after complications from an infectious disease or complications from a vaccination, describe how their children died or became crippled mentally and physically.

The only difference between them is that parents of children, whose injuries or deaths were due to infectious disease complications, are supported in their grief by influential leaders in academic medicine, government health agencies and the pharmaceutical industry while parents of children, whose injuries or deaths were due to vaccine complications, are ignored or criticized by opinion makers in society for speaking out about their grief. An injury or death, whether it is caused by a disease or a vaccine, is tragic and yet the response by society is different in large part because those who promote mandatory use of vaccines refuse to acknowledge or take any responsibility for the reality of vaccine induced injuries and deaths.

Doctors In Denial About Pharmaceutical Product Reactions

It is not new for doctors to stubbornly deny that medical interventions they prescribe for people cause harm. Blood letting, treating syphilis with arsenic and mercury, lobotomies, and prescribing thalidomide for morning sickness are just a few examples of medical treatments recommended by doctors over the centuries which have ended up crippling and killing people. As more prescription drugs and vaccines are produced by industry for doctors to routinely prescribe – or mandate - there are more drug and vaccine reactions being experienced by the people who follow their doctors’ orders. And the more people are being hurt, the deeper doctors retreat into denial.

Last month, a patient survey published in the journal, Drug Safety, found that doctors frequently ignored or dismissed concerns about side effects of prescribed statin drugs, which are supposed to lower cholesterol. The survey authors remarked “Person after person spontaneously [told] us that their doctors told them that symptoms like muscle pain couldn’t have come from the drug. We were surprised at how prevalent that experience was.”

Instead of investigating and taking their patient’s reports of statin-related illness seriously, the prescribing doctors either dismissed as unimportant the complaints by patients that they were suffering pain and “problems with memory or attention, or tingling or numbness in their hands and feet” or attributed these symptoms to “the normal aging process.” One Harvard Medical School professor observed “We already know that there is horrendous underreporting of [prescription drug] side effects. Ninety to 99 percent of serious side effects are not reported by doctors.”

The notorious underreporting by doctors of negative patient health outcomes after prescription drug use was highlighted by a report this week from the Institute for Safe Medication Practices, which revealed that the number of serious adverse drug events and deaths reported to the FDA more than doubled between 1998 and 2005. Most of the reaction reports were associated with drugs that remained on the market and were not withdrawn for safety reasons. The authors concluded that “The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risk of prescription drugs.” If less than 10 percent of all doctors do report prescription drug-associated health problems, then this recent doubling of reaction reports indicates a real problem, with many doctors denying the real risks of prescription drugs.

Doctors in Denial About Vaccine Reactions

Most doctors also fail to report serious health problems following vaccination to the federal Vaccine Adverse Event Reporting System (VAERS). The VAERS functions as a voluntary reporting system even though the National Childhood Vaccine Injury Act of 1986 mandated that doctors report hospitalizations, injuries and deaths (there were no legal sanctions attached to failing to report). Because vaccines are given to healthy people, the psychological and emotional barriers for doctors to admit that government mandated vaccines are causing harm is even greater than the reluctance of doctors to admit that drugs they prescribe for sick people are causing harm.

There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after vaccine use are ever reported to VAERS by doctors giving vaccines. Because doctors have advocated that vaccines be mandated, the numbers of doctors who report reactions to mandated vaccines is probably even less than the numbers of doctors who report prescription drug reactions. (The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85:1706-9.; Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. John’s Hopkins Bloomburg School of Public Health. Food and Drug Administration, Center for Drug Evaluation and Research. The clinical impact of adverse event reporting. MedWatch. October 1996.)

Doctors denying the reality of pharmaceutical product risks is a big problem when a newly licensed vaccine is promoted by federal health officials for mass use. Immediately other “experts” in academia, government and industry start beating the drums for states to mandate use of the new vaccine. Most frequently, the strategy used is to talk about serious complications of the disease while denying the vaccine has any serious complications.

Case in point: meningococcal disease and Menactra vaccine.

Meningococcal Disease

Meningococcal disease, which involves inflammation of the covering of the brain or spinal cord, is a serious bacterial infection that occurs rarely in the US. Out of our population of 300 million people, it is estimated to affect between 1400 and 2800 American children and adults (.05-1.1 per 100,000) per year. Death is estimated to occur in 10-14 percent of victims and leave 11-19 percent with chronic disability, including brain damage and loss of limbs. There are 13 meningococcal organism subgroups and five serotypes are responsible for nearly all cases of the disease worldwide: A, B, C, Y and W-135. Serotypes B, C and Y cause the majority of all cases in America. (

As many as 20 percent of all people carry the bacteria in the back of the nose and throat at any given time, especially in the winter, but remain healthy and asymptomatic. Transmission of the bacteria requires exchange of saliva or nasal secretions between people and so kissing, sharing eating utensils and other close personal contact is required.

It is unknown why only a very small number of people, who carry or come into contact with meningococcal bacteria, develop serious disease. Factors that affect the immune system’s ability to fight off infection are important and people at increased risk for the disease are those living in crowded and unsanitary conditions such as prisons; those with chronic illness or who have had recent respiratory infections; and those who drink alcohol and smoke or are exposed to smoke.

Symptoms of meningococcal disease can develop and move quickly: high fever, severe headache; neck stiffness and pain, especially when attempting to touch chin to chest; nausea and vomiting; extreme fatigue; unconsciousness; confusion and irritability; inability to look at bright lights; convulsions. In babies, symptoms of meningococcal disease are very similar to symptoms of brain inflammation complications after vaccination: high pitched screaming with arching back; staring expression; cold hands and feet; bulging fontanel, and unresponsiveness/inability to wake the baby.

Early diagnosis and antibiotic treatment of meningococcal disease are key to preventing severe complications that end in death and disability.

Menactra Vaccine

Menactra vaccine marketed by Sanofi was licensed in 2005 and immediately the CDC recommended it for universal use by 11 year old children entering sixth grade and 18 year olds entering college. This year, in an effort to increase vaccine uptake, the CDC directed doctors to give 40 million children between the ages of 11 and 18 a dose of Menactra, which costs between $85 and $100 per shot.

Menactra protects against serotypes A, C, Y and W-135. However, the vaccine does not contain serotype B, which causes about one-third of all cases of meningococcal disease in the US. and more than 50 percent of cases in young infants. Therefore, in terms of preventing meningococcal disease in America, Menactra is ineffective 30 to 50 percent of the time, depending upon age.

Menactra was evaluated by Sanofi in about 7,600 individuals aged 11-55 years in clinical trials comparing Menommune and Menactra vaccines and were followed up for 7 days; 28 days and 6 months. Vaccine adverse reactions among 11-18 year olds in clinical trials cited in the product manufacturer insert include local pain, swelling and redness (10-59%); headache (35%); fatigue (30%); aching joints (17%); diarrhea (12%); loss of appetite (10%); chills and fever (5-7%); vomiting (2%); and rash (1%). There have also been reports of vasovagal syncope (collapse); facial palsy; transverse myelitis; urticaria, and musculoskeletal and connective tissue disorders, including myalgia. ( Two deaths have been reported to VAERS after receipt of Menactra.

After five cases of Guillain Barre Syndrome were reported to VAERS in 2005, the FDA issued a warning for parents and doctors monitoring of vaccine recipients for signs of GBS. ( By October 2006, 15 cases of GBS had been reported. ( While federal health officials suggested the possibility of “a small increased risk of GBS” following receipt of Menactra, the implication was that most of the GBS cases occurring after Menactra were unrelated to the vaccine.

On August 15, 2007, the National Vaccine Information Center (NVIC) issued a report analyzing reports of GBS and other serious adverse events to VAERS after individuals received HPV (Gardasil) vaccine alone or administered simultaneously with Menactra. ([1].pdf) NVIC found a more than 1,000 percent statistically significant increased risk of reports of GBS to VAERS when Gardasil was administered simultaneously with Menactra. When Menactra was given simultaneously with Gardasil, NVIC also found a statistically significant increased risk of reports of other serious adverse events to VAERS:

· Respiratory problem reports increased by 114 percent;

· cardiac problem reports increased by 118 percent;

· neuromuscular and coordination problem reports increased by 234 percent;

· convulsions and central nervous system problem reports increased by 301 percent;

· reports of injuries from falls after unconsciousness (vasovagal syncope) increased by 674 percent;

Menactra and Gardasil were never studied in clinical trials to evaluate safety when both vaccines were given simultaneously.

The Bottom Line: The Disease and the Vaccine Have Risks

Both meningococcal disease and Menactra vaccine pose serious health risks. Your risk of contracting an infectious disease and dying or suffering long term health consequences depends upon the risk of exposure to the organism causing the disease, your genetic susceptibility and your general health that affects the ability of your immune system to deal with the challenge. You take a risk of suffering a vaccine reaction when you get vaccinated and that risk can be lesser or greater depending upon the vaccine(s) involved, your genetic susceptibility and your general health that affects the ability of your immune system to deal with the challenge.

Calls for Mandatory Vaccination with Menactra

In America, there are M.D.’s and Ph.D.’s who have placed themselves in positions of influence in academic and medical institutions, industry and government and who serve as advocates for mandatory vaccination. Some of these pro-forced vaccination proponents are vaccine developers and patent holders or consultants for drug companies that make and sell vaccines. Others are simply ideologically opposed to the concept that individuals have a right to informed consent to medical interventions, such as vaccination, which carry a risk of injury or death. These pro-forced vaccinators favor empowering government officials to use the heel of the boot of the State to compel citizens against their will to take vaccine risks with their lives and the lives of their children.

A common tactic used to advocate for mandatory vaccination is to deny that vaccines carry risks or, if they do, they are so minimal they are unworthy of anyone’s concern. If pro-forced vaccinators ever do acknowledge that “rare” injuries or deaths occur after vaccination, they usually invoke the utilitarian “greater good” defense to justify the “rare” casualties of forced vaccination policies.

This ignorant a priori denial of vaccine risks in order to justify forced vaccination makes it impossible, of course, for pro-forced vaccinators to ever admit vaccines carry significant risks. It is even harder for them to admit that genetic factors may play a role in making the vaccine risk greater for some than others because that would mean that mandatory vaccination is a de facto selection of the genetically vulnerable for sacrifice. And we don’t have to look too far back in history to realize what happens when the State gets into the business of deciding whose DNA is worthy of survival.

Which is it, Arthur? Informed Consent or Violating Human Rights?

Arthur Caplan got his Ph.D. in the history and philosophy of science at Columbia University and serves as a professor of bioethics for University of Pennsylvania. He is also a consultant for GlaxoSmithKline and commentator for MSNBC.

In 1992 Caplan wrote about forced medical experimentation by doctors on captive people in concentration camps during World War II, including typhus vaccine experiments. At the time, Caplan defended the Nuremberg Code, which was created by the judges of the Nuremberg Tribunal who presided over The Doctor’s Trial at which doctors were charged with crimes against humanity. The doctors on trial used a “greater good” utilitarian defense to justify the biomedical experiments they performed without the informed consent of their captives, saying they did it to further scientific knowledge and “benefit humanity.”

Caplan said “Those who created the [Nuremberg] Code realized that they had to find a powerful moral foundation for rejecting the crass utilitarianism so much in evidence in the arguments used by those on trial to justify their actions.The Nuremberg Code explicitly rejects the moral argument that the creation of benefits for many justifies the sacrifice of the few. Every experiment, no matter how important or valuable, requires the express voluntary consent of the individual. The right of individuals to control their bodies trumps the interest of others in obtaining knowledge or benefits from them,” said Caplan. (Caplan AL. The Doctor's Trial and Analogies to the Holocaust in Contemporary Bioethical Debates. In: Annas GJ, Grodin MA, eds. The Nazi Doctors and the Nuremberg Code. New York, NY: Oxford University Press; 1992: 258-275).

It was a ringing endorsement for the human right to informed consent by subjects participating in medical experiments. And although Caplan’s remarks addressed horrific medical experimentation performed on unconsenting individuals during the Holocaust, his statement appropriately suggests a broader rejection of the “argument that the creation of benefits for many justifies the sacrifice of the few” when it comes to forced medical risk taking.

In March 2005, Caplan advocated that Terri Sclavo’s husband be allowed to disconnect her feeding tube, which would lead to the death of his severely brain damaged wife. Defending the right of legal guardians to exercise informed consent for those who cannot exercise it themselves, Caplan said “We have had a consensus in this country that you have a right to refuse any and all medical care that you might not want. Christian Scientists do not have to accept medical care, nor do Jehovah’s Witnesses need to accept blood transfusions, or fundamentalist Protestants who would rather pray than get chemotherapy. Those who are disabled and cannot communicate have the exact same rights. Their closest family members have the power to speak for them.” (

Despite his earlier endorsement of the right for individuals or their guardians to exercise informed consent to medical interventions, lately Caplan has joined his University of Pennsylvania colleague, rotavirus vaccine patent holder Paul Offit, M.D., and become a vocal advocate of forced vaccination. Last week, in an MSNBC opinion piece Caplan sneered “We need to get our priorities straight when it comes to mandating or requiring vaccines. When there is a fatal disease that is easily prevented by a safe vaccine, the shot ought to win out every time over our dislike of being told what to do.”

Then Caplan went one step further. In an article in a recent Journal of Law, Medicine & Ethics, he said “States should encourage parents to get their homeschooled students vaccinated through enacting the same laws as those for public school students. This could be done by enforcing current laws through neglect petitions or by requiring that children be immunized before participating in school sponsored programs.” (Donna Khalili, Arthur Caplan (2007). Off the Grid: Vaccinations Among Homeschooled Children. The Journal of Law, Medicine & Ethics 35 (3), 471–477).)

Many parents homeschool their children because they want to provide them with a superior learning environment, which includes being protected from unnecessary toxic exposures from pharmaceutical products like vaccines. Other parents have children who are already vaccine injured and are trying to protect them from further harm. Children homeschooled from birth are among the brightest and healthiest in the country and often get scholarships to college, precisely because they have not been over-vaccinated and do not suffer with ADHD, learning disabilities, autism, asthma and diabetes like their highly vaccinated public school counterparts.

The forced vaccinators are plenty worried about the fact that the unvaccinated children in America are brighter and healthier than the highly vaccinated. They cannot tolerate that comparison and are apparently willing to do whatever it takes to turn government employees into the Vaccine Police, who can knock on parents' doors and charge them with child neglect for failing to salute CDC officials smartly and inject their children with 56 doses of 16 vaccines by age 12.

Any Man Who Takes the Liberty of Another…Is Bound to Become a Tyrant

American writer and philosopher, H.K. Mencken, who was an elitist critic of democracy and religious beliefs and many values Americans hold dear, was nevertheless a champion of personal liberty. His words are truer today than they have ever been, as Americans are assaulted by attacks on personal freedom in the area of health care choices by M.D./Ph.D. ideologues. Mencken said:

“I believe that liberty is the only genuinely valuable thing that men have invented, at least in the field of government, in a thousand years. I believe that it is better to be free than to be not free, even when the former is dangerous and the latter safe. I believe that the finest qualities of man can flourish only in free air – that progress made under the shadow of the policeman’s club is false progress, and of no permanent value. I believe that any man who takes the liberty of another into his keeping is bound to become a tyrant, and that any man who yields up his liberty, in however slight the measure, is bound to become a slave.”

Americans tend to take their individual freedoms for granted, as if our nation’s founders guaranteed them for us in the U.S. Constitution. Unfortunately, in the Age of Scientism, it is the arrogant, power-hungry pharmaceutical product peddlers hiding behind letters written after their names who are working diligently to take those freedoms away. How much longer are we going to let them do it?

If the State can tag, track down and force individuals against their will to be injected with biologicals of unknown toxicity today, there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.

Going for the Throat: Hyping HPV Vaccine for Young Boys

"Gardasil may generate more than $3 billion in annual sales for Whitehouse Station, New Jersey- based Merck, analysts say. The best way to reduce cancer-causing HPV is to widen the pool of children vaccinated with Gardasil, the researchers say. Merck is studying the shot in boys and plans to seek U.S. approval for that use, said spokeswoman Kelly Dougherty. ``We would encourage industry and scientists to study the efficacy in boys and men so the vaccination program can be expanded,'' said Erich Sturgis, associate professor of head and neck surgery at M.D. Anderson and the report's lead author, in an interview..... ``Changing sexual practices such as more frequent oral sex in adolescents and young adults could contribute to an increase in oncogenic HPV- associated oropharyngeal cancers,'' researchers said in the report. Tonsil cancers have increased 4 percent and tongue cancers 2 percent a year in the past 30 years among adults younger than 45, according to studies cited in the review. Many of the cancers were among non-smokers, which points to HPV as the culprit behind the rise in the cancers, M.D. Anderson researchers said.....Approved in June 2006, Gardasil generated $723 million in sales during the first half of this year. Head and neck cancers are the latest malignancies tied to HPV infection generating attention from health experts that would like to see broader use of the Merck vaccine." - Angela Zimm, Bloomberg News (August 27, 2007)

"Almost all cervical cancers are caused by the sexually transmitted human papillomavirus, or HPV. Merck's Gardasil targets strains responsible for 70 percent to 80 percent of these cancers. Vaccinating girls before they are sexually active is useful because it can prevent infection from developing into cancer later in life. Mandating the shot may ensure wider use. ``Effective education programs and mandatory vaccination will probably provide the greatest and fastest reduction in the incidence of cervical cancer,'' Hopkins scientists Richard Roden and T.C. Wu wrote in the scientific journal Nature Reviews Cancer, published on line today..... The Hopkins scientists join a growing number of health and government experts calling for mandated HPV vaccination programs....``If you want to have a significant reduction, making the vaccine mandatory would generate the better impact,'' co-author Wu, a professor of pathology at Hopkins, said in an interview....." - Angela Zimm, Bloomberg News (September 26, 2006)

"It is worth noting that HPV vaccine trials have demonstrated only protection against HPV- related genital pre-cancers, not cancer. Is spending public money on HPV vaccination of all girls and young women appropriate, when cash-strapped communities could put the funds to other uses? This may be the most difficult question of all. It leads immediately to another question: Does Merck need to charge $360 per person for the vaccine as it does now? According to Glenn McGee of Albany Medical College, Merck could recoup in several years its development costs for this and other vaccines that never made it to market by charging one-tenth the current price (assuming that sales continue at the current rate). Merck says it calculated the price taking into account research and development costs as well as what the vaccine could save in terms of HPV-related treatment expenses. It argues that the long-term cost savings justify the unusually high price for this vaccine. Other analyses (for example, a British Columbia Cancer Agency report) disagree with these calculations and conclude that the cost of vaccination greatly outweighs the amount saved by avoiding treatment of HPV-related disease. As we consider how to proceed on HPV vaccination, a clear understanding of the research -- not marketing claims or lobbying funds -- needs to guide both our individual decisions and our public policy." - Judy Norsigian and Heather Stephenson, Women's E-News (September 7, 2007)

Barbara Loe Fisher Commentary:

If vaccine manufacturers can't generate the profits they promised stockholders by persuading state legislators to mandate a newly licensed vaccine, then they will find another way to bring in the money. In this case, Merck and the doctors in academia and research, who are developing and promoting widespread use of HPV vaccines, are going after the young boy market following a failure this year to get HPV vaccine mandated for pre-teen girls in every state.

Almost exactly one year ago, scientists developing HPV vaccines at Johns Hopkins and elsewhere were joining with doctors in calling for mandatory vaccination of all young girls with Merck's newly licensed HPV vaccine, Gardasil. But the push for mandated use of Gardasil by all 11 year old girls was rejected by states due to parent protests against mandates after NVIC pointed out lack of scientific data proving Gardasil safety and efficacy in young girls and other parent groups protested mandates for a sexually transmitted disease that could not be acquired in the school setting.

Seeking to capture the numbers that will give them the projected profits they would have secured if they had succeeded in getting Gardasil mandated for all 11 year old girls in every state, Merck and HPV vaccine developers are attempting to widen the pool of vaccine candidates by alleging that more teens today are engaging in oral sex and that is why there has been an increase in HPV-associated cancers of the tongue, tonsils and throat in boys. This, say scientists at the M.D. Anderson Cancer Center, is reason enough to call for universal HPV vaccination of all young boys.

The call for all young boys to get a vaccine that was developed to prevent cervical cancer in women will help Merck out in its quest for the $3 billion dollar annual market it dreamed of when it tried to get the vaccine mandated for all young girls. It will also potentially help secure profits for GlaxoSmithKline when its HPV vaccine, Cervarix, is licensed. One of the authors of a recent article in Cancer, which pointed out that oral cancer increases among boys makes them perfect candidates for HPV vaccination, has been a consultant for Sanofi-Aventis, GlaxoSmithKline, Xemova and Pfizer.

I remember admiring scientists and doctors when I was growing up in the 1950's and 1960's. Everyone knew they worked hard to help people and make the world better even though they were not paid very much money. Now doctors and scientists are paid a lot of money and they have assumed positions of power in government, industry and academia, where they lobby in the media and state legislatures to secure predictable and lucrative markets for the pharmaceutical products they create or profit from promoting either directly or indirectly.

It is highly inappropriate for doctors or scientists to lobby for forced use of vaccines or any other pharmaceutical product. The people deserve better from the men and women we pay to provide us with wise and unbiased counsel about making informed health care choices for ourselves and our children. We should not feel like we need to check out their stock portfolio or origin of their university's research grants before deciding whether we should trust their advice or not.

Sept. 7: Montel Williams on Anthrax Vaccine Risks

"We will be exposing some of the military's darkest secrets including a mandatory vaccine program that many experts claim is literally killing our troops. Montel will speak with Kelli Donley, a female air force captain and military lawyer who suffered brain damage after receiving the anthrax vaccine. Filmmaker Scott Miller will discuss his film "A Call to Arms," which demonstrates how destructive and pervasive the anthrax vaccine is. He will show numerous clips, including a very powerful interview from a female top gun pilot who is now too ill to even travel. Montel will speak with two of the film's main subjects, Lieutenant Colonel Jay Lacklen and Sergeant Jeff Moore, who both say they are chronically ill from the vaccine. Find out what harmful consequences this vaccine may have had on soldiers' wives and children." - Description of "Dying to Serve," Friday, Sept. 7, 2007 Montel Williams Show

"For the first time, a federal judge last month declared six U.S. defense personnel the definitive winners in a four-year court battle over the anthrax vaccine. The Aug. 21 decision, which revolves around payment of attorneys' fees, is the latest chapter in a protracted struggle over whether the Defense Department can require service members to take the anthrax vaccine. U.S. District Court Judge Emmet Sullivan decided the government defendants must pay the plaintiffs' expenses because the plaintiffs won the case.....Known as "Anthrax II," the latest lawsuit alleges that the December 2005 FDA certification was invalid and that the Pentagon has resumed administering treatments inconsistent with the approved drug license. Zaid and Michels are asking the federal judge hearing that case, Rosemary Collyer, to impose another ban on the defense effort until the vaccine is properly tested and licensed for Pentagon use. In last month's decision, Sullivan bolstered from the bench the arguments the new set of eight plaintiffs make in their lawsuit. The judge clearly rejected the government's long-standing contention that the original drug license allowed the vaccine to be used for the prevention of anthrax regardless of the route of exposure, including disease contracted through the lungs...." - Elaine Grossman, Global Security Newswire, September 5, 2007

"Todd Sanders says he and thousands of other Gulf War veterans may be running out of time to live. Sanders believes that's because of the mandatory anthrax vaccine he and others received in the Army. Late last year, at age 41, the Kingsport resident had a pacemaker installed to keep his heart rate and blood pressure up, but he still blacks out from low blood pressure from a condition called sinus bradycardia neurocardiogenic syncope. His other medical problems include chronic fatigue, neurological symptoms, muscle deterioration, memory loss, ringing in the ears, double vision, confusion, depression, anxiety, incontinence, sleep apnea, respiratory distress, and extreme muscle and joint pain.....Dr. Meryl Nass of Bar Harbor, Maine in late July testified at a hearing of the House Committee on Veterans Affairs, Subcommittee on Health. Nass said Gulf War Syndrome symptoms overlap closely with chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity and irritable bowel syndrome...." - Rick Wagner, Kingsport Times News, September 3, 2007

Barbara Loe Fisher Commentary:

On Friday, Sept. 7, Montel Williams will broadcast a show on anthrax vaccine risks entitled "Dying to Serve." Check your local listings for time and station. Excerpts from a documentary "A Call to Arms" produced by Scott Miller will be shown (click here to view a trailer ). Scott premiered an earlier version of his excellent documentary at NVIC's Third International Public Conference on Vaccination in 2002.

Last week, U.S. District Court Judge Emmet Sullivan ruled that the federal government must pay the legal fees of the lawyers representing the soldiers who brought a lawsuit against the secretaries of the Departments of Defense and Health and Human Services for illegally ordering soldiers to take an experimental anthrax vaccine that had not been approved by the FDA for use against weaponized (inhalation) anthrax. In October 2004 Judge Sullivan ordered the DOD to stop forcing soldiers to take the anthrax vaccine, which had resulted in many vaccine injuries and deaths among military personnel, without their informed consent. In 2005, NVIC joined with veterans groups in an amicus brief protesting the DOD's invocation of the "Emergency Use Authorization" under Project Bioshield legislation to get around informed consent protections pertaining to experimental vaccines. The DOD re-instituted forced anthrax vaccinations after the FDA approved the vaccine for use against inhalation anthrax.

Congratulations to attorneys Mark Zaid and Lou Michels for continuing their defense of soldiers hurt by the anthrax vaccine and filing another lawsuit to stop DOD from forcing soldiers to get a vaccine that has not been properly tested and proven safe and effective for use against inhalation anthrax. Attorneys who take on powerful government agencies and drug companies manufacturing and forcing use of vaccines that carry significant risks without our voluntary, informed consent are heroes and deserve public support and praise.