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. (http://0www.cdc.gov.mill1.sjlibrary.org/mmwr/preview/mmwrhtml/rr5407a1.htm)

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. (http://www.blogger.com/(http://www.fda.gov/cber/label/mpdtsan033007LB.pdf).). 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. (http://www.fda.gov/bbs/topics/NEWS/2005/NEW01238.html) By October 2006, 15 cases of GBS had been reported. (http://www.fda.gov/cber/safety/gbs102006.htm). 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. (http://www.nvic.org/Diseases/HPV/HPV_Vaccine_Safety_Report_-_Part_III_(081507_revised)[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.” (http://www.msnbc.msn.com/id/7231440/page/2)

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.