[NVIC] Menactra, Doctors in Denial & the Vaccine Police

[Guest guest]

I teach about all of these diseases and the reality of them, the reality

of risk of 'catching', predisposing factors, alternative treatment.

Sheri

http://www.wellwithin1.com/vaccineclass.htm

Next classes in October

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NVIC E-news

" 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 ie Milley, who have lost children to meningitis.

Nine years ago, her 18-year-old son, , 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. 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. " - 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. 's Hopkins Bloomburg School of Public

Health. www.vaccinesafety.edu/VAERS.htm; 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.fda.gov/cber/label/mpdtsan033007L B.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_Vaccin

e_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 GlaxoKline 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: s

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 Schiavo'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 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.

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Meningitis Threatens College Students

http://wwwnbc11.com/msnbchealth/14050674/detail.html

MSNBC

September 6, 2007

Dahl

Lee thought it was just the flu coming on. A little headache, an

upset stomach - nothing to skip a hometown frat party for, reasoned the

18-year-old as she cruised the 90 miles from Indiana University in

Bloomington back home to Terre Haute, Ind.

But at the party, the college freshman ran to the bathroom to vomit every

half hour and eventually headed home, where her parents figured she'd feel

better after a good night's sleep. The next day, she collapsed on her way

to the bathroom. Her dad carried her to their car, and they sped toward the

local hospital. At the emergency room, she lost her vision for several

terrifying seconds.

" That scared me half to death, " says. " I knew something wasn't right. "

Hours later, was diagnosed with meningococcal meningitis, a rare but

potentially deadly bacterial infection.

The doctor's words hit 's stepmom with a sickening thud. Sam Lee had

taken her daughter to the doctor just six weeks earlier to get vaccinated

against this very disease before sending her off to college. The doctor

didn't have it in stock right then. It's such a rare disease, though, he

had said, that could just get the shot once she got to campus.

Statistically speaking, the doctor was right. Meningococcal meningitis

strikes fewer than 3,000 people in the United States each year, many of

them college students or children under age 1. But while the bacterial

infection is relatively rare, it's also deadly, killing 10 to 12 percent of

those it infects, sometimes within hours. The disease attacks and shuts

down major organs and prevents blood from circulating to limbs, causing

tissue to die. Among survivors, 20 percent suffer brain damage, kidney

disease, loss of hearing or sight, limb amputations or other severe

complications.

The disease is spread through air droplets and direct contact with someone

who is infected. College students, particularly freshmen living in dorms,

are at increased risk because of their lifestyle. They're living away from

home for the first time and many share everything from drinks to drags off

each others' cigarettes. And too many late nights of studying and partying

can leave their immune systems run-down and vulnerable.

During her first weeks of college in 2005, was too busy with new

friends and a full class schedule to seek out the vaccine, and it didn't

seem like a big deal anyway.

" I just didn't know the severity of it. I thought it was just, like,

another vaccination, " recalls.

It wasn't until 's dad told her that the doctors were going to have

to take her left foot that she truly understood what meningitis meant.

Life and death debate

After the disease attacked , each of her family members was

vaccinated with Menactra, which is approved by the Food and Drug

Administration for those ages 11 and older. It's 83 percent effective in

preventing four of the five strands of bacterial meningitis.

" Why would you take the chance? " says Sam Lee.

That's a question that has sparked a national debate.

Twenty states now require college students to either get the vaccination or

sign a waiver that says they've read about the disease. Three more states

mandate the vaccination for college students, but allow exemptions for

religious or medical reasons. Eleven states require only that information

about the vaccine and the disease be provided on campus.

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

ie Milley, who have lost children to meningitis. Nine years ago, her

18-year-old son, , 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.

After visiting her son's grave recently, Milley wept during a phone

interview. Her memories of her only child are intertwined with regret and

anger. When was alive, she wasn't aware of the vaccination that could

have prevented the disease that killed him.

" The hardest thing was to walk to the cemetery, to see his name on a

gravestone, " Milley says. " His name shouldn't be on a gravestone. It should

be on a wedding invitation, a birth announcement. .....If he'd had that

vaccine he wouldn't be there. "

Dr. Jim , the executive director for the department of student health

at the University of Virginia, was skeptical in 2001 when Virginia passed a

law mandating that all students attending four-year universities must get

the vaccination or sign a waiver. He thought most students would just

choose to sign the waiver. But it seems that education about the disease

has motivated many to get the vaccine. He's seen the numbers climb from 55

percent of students getting vaccinated to 95 percent.

" It's a safe vaccination, it's an effective vaccination, and it's one of

those terrible, terrible risks - albeit extremely rare - that you can

really minimize by spending money on the vaccine, " says , who is also

the chair of the Vaccines Preventable Diseases Committee for the American

College Health Association. The vaccine is generally covered by insurance

and costs around $120 on most college campuses.

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. Dorman, a committee member of that same ACHA committee and a

clinical professor of medicine at Stanford University.

Like any vaccine, Menactra may carry side effects such as allergic reaction

and redness or pain around the injected area, according to the CDC.

Menactra has also been linked to a few cases of Guillain-Barre syndrome,

which attacks the peripheral nervous system and causes gradual, temporary

paralysis. Data from the Vaccine Adverse Event Reporting System suggests

this happens 1.25 times for every 1 million meningitis vaccines given.

Barbara Loe Fisher, president and co-founder of the National Vaccine

Information Center, believes more attention should be drawn to these

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. "

A rare disease

Those opposed to a mandatory meningitis vaccination also cite the low

occurrence of the disease in the United States.

" I guess I err on the side of wanting to make mandatory those things of

major public health significance, " Dorman says. " (Meningitis) isn't a

particularly common phenomenon. "

But the disease can be horrific when it does strike.

When Lynn Bozof's son Evan was a teenager, there was a meningitis outbreak

in a neighboring county. Evan was worried, and he asked his mom if he

should get the vaccination.

" Mom, how do I know if I've got meningitis? " Bozof recalls her son asking.

And she remembers her reply: " Oh Evan, you don't need to worry about

meningitis! "

But five years later, as a junior at Georgia Southwestern University in

1998, Evan called his mom complaining of a migraine. It got so bad that he

went to the emergency room, where he was diagnosed with meningitis and

placed in intensive care. His kidneys shut down. His liver stopped

functioning. Both arms and legs had to be amputated. After a 26-day fight

against the disease, Evan died.

As Bozof watched her son's losing battle, the memory of a teenage Evan

asking about meningitis cruelly replayed in her mind.

" I feel like that came back to haunt me because I didn't take the time to

find out about the disease, " Bozof says. " Just because this disease is rare

doesn't mean it's not going to affect you or someone you know. "

'It happens so quickly'

The disease's hard-to-spot symptoms and rapid progression make

meningococcal meningitis a " great fear " for doctors, says Dr. Tom , a

medical epidemiologist for the CDC's National Center for Immunization and

Respiratory Diseases. The symptoms are devastatingly easy to overlook, to

dismiss as something minor. The only way to definitively diagnose

meningococcal meningitis is through a spinal tap, he says, something not

routinely done on people who have flulike symptoms.

In 's case, the doctors at first assumed she was merely dehydrated

and tried to send her home, the family remembers. Even after a purplish

rash - a classic sign of meningitis - spread across her body,

emergency-room staff still had no idea what was wrong.

Terrified for his daughter, 's dad, Tom, demanded that she be

transferred to a larger hospital. screamed in pain the entire time

it took the ambulance to get to the hospital in Indianapolis, 77 miles away.

" It was a ride from hell, " recalls. " Now that I know about the

disease, I could almost feel the disease running through my body, just

eating at me. "

When she reached the second hospital, a doctor recognized the disease for

what it was. By that time, 's parents say her whole body had swelled

to twice its normal size, and the purple rash now covered her head to toe.

The disease had taken only a little over an hour to overtake her entire body.

" It's not unusual to hear a story of a kid not feeling well on a Friday

night and going to bed, and being dead on Saturday morning, " says the CDC's

. " It happens so quickly. "

Lingering effects

Even when a victim survives meningitis, the nightmarish battle against the

disease is far from over.

As fought for her life in the hospital, she and her father made the

devastating decision to let her doctors take her left foot and three of her

fingers.

They talked about it at length and cried about 's loss. But when she

woke up hours later, she had no memory of that conversation.

" She'd wake up after each surgery and say, 'Dad, what happened to my foot?'

Tom Lee remembers. Brokenhearted, he would tell her again.

Now, two years after she got sick, 20-year-old 's right arm is

scarred from skin grafts and she wears a prosthetic foot. Her other leg is

in a cast, following the latest of 11 surgeries.

At home in her bedroom painted two shades of pink, pictures of her physical

therapists sit among those of her friends and family. At first the

therapists were skeptical about whether she'd be able to walk at all. But

was determined to get back on her feet. Despite pain from the recent

surgery and a pronounced limp, she refuses to even use a cane for support,

walking instead entirely on her own.

spent last summer covering up the lasting marks of meningitis.

Despite the sweaty, humid Indiana summer, she wore shrugs and pants to keep

people from seeing her scars. But the following year when she returned to

school, she made a series of bold moves: She put on a tank top. She had her

seven remaining fingers professionally manicured. And she started to tell

her story.

She feels as if it's her responsibility to educate people about the

devastating effects of meningitis and to urge others to get the vaccine.

She works closely with the National Meningitis Association and has appeared

in an informational video the nonprofit group produced. On campus, where

she's majoring in biology in hopes of going to medical school, she plays

the video and speaks to classes about her experience. And she's fielded

technical questions about her condition from crowds of doctors and

researchers.

" It helps me; it's kind of like therapy for myself, " says.

She and her family still get angry at times, thinking about the vaccination

that she nearly received, the vaccination that could have prevented all

this. But she keeps her dad's advice in mind: Every day we have a choice,

he says. Either look forward, or look back.

But telling her story over and over again can be draining for . Every

time she walks a stranger through her story for the first time, she has to

relive the pain, the ambulance ride, the surgeries and every detail of her

nightmarish experience yet again. But it's worth it, she says, " even if I

can save just one person. "

Opinion: Meningitis Shots Should Be Required

http://www.nbc6.net/msnbchealth/14067639/detail.html

MSNBC

September 6, 2007

Arthur Caplan, Ph.D.

Which is scarier to you - coming down with deadly bacterial meningitis or

being required to get a vaccination against it? The disease itself should

scare the living daylights out of you, especially if you are an adolescent

or the parent of one. Yet it is the idea of mandatory vaccination that

strikes fear in many.

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.

Bacterial meningitis, an infection of the fluid in the spinal cord or the

tissues that surround the brain, can kill within hours. One in 10 victims

dies and up to 20 percent of those who survive suffer hearing loss,

deafness, brain damage, amputations or other serious complications. Around

3,000 people a year get the disease and it can kill within hours. Almost

all of that is preventable with a vaccine.

Teens and young adults ages 15 to 24 are at especially high risk for

bacterial meningitis since it can be spread by coughing, sneezing, kissing,

sharing drinking glasses and other behaviors where people are in very close

contact. College students are particularly at risk since they live in tight

quarters and often have weakened immune systems due to lack of sleep.

In January 2005, the Food and Drug Administration approved a new vaccine

against bacterial meningitis. The MCV4 Meningococcal Conjugate Vaccine,

marketed under the name Menactra, protects against four very common

bacterial strains and is longer lasting and more effective than earlier

meningitis vaccines. The Centers for Disease Control recommends that

everyone ages 11 to 18 should get it, 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.

When Menactra first appeared, some cases of Guillain-Barre syndrome were

reported. This is a serious disease in which the body's immune system

attacks nerves and leads to gradual, temporary paralysis.

Those opposed to vaccination - and there are many in the United States and

other countries - quickly pointed to the 20 cases that were reported as a

reason not to get vaccinated.

But Guillain-Barre occurs in about one in 100,000 people in the United

States. Vaccination is almost never the cause. In fact, when the 20 cases

cited by vaccine critics were closely examined, none were associated with

the meningitis vaccination.

23 states require shots

Today, 23 states mandate the vaccine for college freshmen.

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.

And if you don't get vaccinated then you are not only putting yourself at

risk but others whom you come in contact with on and off campus as well.

What is really startling is that mandating vaccines really only means

strongly urging young people to get them. Most states recognize the right

of anyone to refuse a vaccine on religious grounds. And even the states

that have required or mandated vaccination allow someone not to do so if

they sign a statement saying they have seen information about meningitis

vaccine but still don't want the shot.

Getting insurance to pay

The real reason to mandate meningitis vaccine is to get it into the heads

of kids and parents that this is an important thing to do and to help force

government and insurance companies to pay the cost. 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.

Americans do love choice. But they also hate to lose a child, a sister or a

granddaughter. Sometimes choice ought to yield to common sense and

evidence. We ought be doing all we can to get young people vaccinated

against meningitis and to make sure that the costs of doing so are covered.

Arthur Caplan, Ph.D., is director of the Center for Bioethics at the

University of Pennsylvania.

http://www.washingtonpost.com/wp-dyn/content/article/2007/08/24/AR2007082401

714.html?nav=rss_health

Is Your Doctor in Denial?

Survey Finds Physicians Often Dismiss Complaints About Drugs' Side Effects

The Washington Post

August 28, 2007

by Ishani Ganguli

On many online message boards and Internet chat rooms, anxious patients

share details about the muscle pain and memory loss they have noticed since

they started taking statins to lower their cholesterol. A new study

suggests these people may be seeking validation for good reason: Some of

their complaints might otherwise be going unheard.

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 such 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.

Researchers from the University of California at San Diego had been

investigating the side effects of statins when they noticed the problem.

" 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, " said Beatrice Golomb,

associate professor of medicine and the study's lead researcher.

Tens of millions of people worldwide take statins such as Lipitor and

Zocor. Many experts view them as something of a panacea for everything from

stroke and cancer to arthritis, although they do pose a risk of side

effects in some patients, ranging from muscle injury to liver and kidney

dysfunction.

Survey respondents, recruited via Web solicitations and other

advertisements, were in their early 60s on average and mostly from the

United States. Some of the solicitations were placed on Web sites where

patients had posted complaints, raising the possibility that respondents

were more apt to have had side effects than the average patient. Most said

they'd complained to their doctors about such possible side effects as

problems with memory or attention, or tingling or numbness in their hands

and feet.

According to experts, muscle pain and other side effects occur in up to 30

percent of statin patients, by some estimates, and often lead doctors to

stop or change a prescription. But 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, 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.

Golomb speculated that doctors' actions might reflect the relative dearth

of information on the downsides of statins. " Ad campaigns that preserve

statins' miracle drug image are more powerful than education about side

effects, " she said.

The findings raise important concerns about American drug safety

monitoring, said Harvard Medical School professor Jerry Avorn, author of

" Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs. "

" We already know that there is horrendous underreporting of side effects.

Ninety to 99 percent of serious side effects are not reported by doctors, "

he said.

Yet the FDA relies heavily on their reports. Tracking a drug's safety once

it hits pharmacies -- so- called post-market surveillance -- is a critical

part of keeping patients safe, particularly since clinical trials with

limited enrollees and a limited study period cannot catch every side effect.

M

anaged care deserves some of the blame, Avorn said. " Part of [the problem]

is that doctors are granted so few minutes to deal with patient visits.

It's not as if doctors don't care. "

Golomb and others worry that if even well- documented side effects aren't

being recognized by doctors, others will take much longer to surface. " A

fifth of all drugs that fully pass FDA approval will ultimately have black

box warnings or be withdrawn from market because of adverse effects, "

Golomb said.

Some say that the FDA and drug companies should work harder to get feedback

directly from patients. Getting drug surveillance reports from patients is

common practice in New Zealand and other countries.

U.S. patients can report side effects to the FDA themselves -- by logging

onto the MedWatch Web site ( http://www.fda.gov/ medwatch). But few know

about this option, Avorn said.

The new study " points out that doctor reports on side effects is a very

unreliable means of learning about the true extent of problems, " he said.

" We ought to have a [better] mechanism for gathering information from

patients. A lot of it will be noise, but there may be important signals

there as well. "

Ishani Ganguli is in her second year of studies at Harvard Medical School.

Comments:health@...

http://www.sciencedaily.com/releases/2007/09/070910132853.htm

Adverse Drug Events Reported To FDA Appear To Have Increased Markedly

Science Daily

September 10, 2007

Science Daily - 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.

A serious adverse drug event, as defined by the FDA, means an adverse event

that resulted in death, a birth defect, disability, hospitalization, or was

life- threatening or required intervention to prevent harm, according to

background information in the article. Such events are voluntarily reported

to the FDA through its Adverse Event Reporting System (AERS) and known as

" MedWatch " reports. The reports come to the FDA directly or through drug

manufacturers, who are then required to forward them.

J. , A.B., of the Institute for Safe Medication Practices,

Huntingdon Valley, Penn., and colleagues analyzed serious adverse drug

events reported to the FDA through AERS from 1998 through 2005.

During this period, a total of 467,809 serious adverse events were

reported. The annual number of reports increased 2.6-fold between 1998 and

2005, from 34,966 to 89,842. The number of fatal adverse drug events

increased from 5,519 to 15,107 in the same time frame, a 2.7-fold increase.

" 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. In the subset of 51 drugs with 500 or more reports in a

year, the percentage of reported events associated with drugs related to

safety withdrawals declined from 26 percent in 1999 to less than 1 percent

in 2005. " 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. "

Reference: Arch Intern Med. 2007;167 (16):1752-1759.

Note: This story has been adapted from a news release issued by JAMA and

Archives Journals.

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