The weaponization of this world continues as the globalist elite continue their campaign to “cull” the human population through the genome-destroying technologies of nuke power, GMOs and the toxins found in environment, drugs and especially vaccines. Here Dr. Rima discusses some of the latest vaccine atrocities.
Dr. Rima’s Dispatches from the Vaccine Wars:
Vaxocrats know the deal: Vaccines are neither safe nor effective, as they must be under the laws governing them in the US. That makes, according to my understanding, EVERY vaccine used in the US an illegal, improperly registered and approved drug. What’s new here is that the unreliability of the DPT vaccine has been confirmed by the CDC itself. … read the whole article below.
CDC Vaxocrats Know DPT Cannot Be Trusted! Now You Know It, Too!
Not Safe, Not Effective and CDC Knows It!
Dr. Rima’s Dispatches from the Vaccine Wars:
Vaxocrats know the deal: Vaccines are neither safe nor effective, as they must be under the laws governing them in the US. That makes, according to my understanding, EVERY vaccine used in the US an illegal, improperly registered and approved drug. What’s new here is that the unreliability of the DPT vaccine has been confirmed by the CDC itself. The good news is that this is important data to help us spread the wisdom of refusing ALL vaccines. The bad news is that I predict that it will be used to mandate useless and dangerous DPT vaccines in an every-three-year-booster schedule. No: don’t trust the Vacocrats!
No: don’t accept vaccines, an uninsurably risky behavior!
No: don’t accept vaccine mandates!
Yes, Take Action Here: http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=5708m (http://tinyurl.com/noforcedvax) and forward this link to everyone you know so they can do the same!
Your Health & Food Freedom Portal: www.HealthFreedomPortal.org
The Global Voice of Health & Food Freedom™ Dr. Rima Reports, live chat, updates, Action Items and more…
October 4, 2010
Action eBlasts 3 Times Weekly Until the Election!
United Action Amplifies Our Push Back!
Please 1. Open Each eBlast, 2. Visit Candidates With Talking Points, 3. Spread Information to Mobilize Others!
It’s Time to Educate the Candidates
HEALTH & FOOD FREEDOM TALKING POINTS
The House passed the so-called “Food Safety” bill, HR 2749, in July 2009, sending it to the Senate where it is being considered as S. 510. After your strong Push Back opposition, a companion bill, S. 3002, touting so-called “Dietary Supplement Safety” was abandoned by its own sponsor, Sen. John McCain. HR 2749’s criminalization of true food health-related speech was left out of S. 510 but S. 3767, with an unprecedented extension of criminal penalties for “food crimes” was rushed forward in the last days of the September Senate session to correct that “oversight”.
The Senate HELP committee “marked-up” S. 510 and the Manager’s Amendments revision was sent to the Floor just as the Senate went into recess, with the threat that the bills would be pushed after the Election by the ‘lame-duck” Congress.
You and I know that these bills, both S. 510 and S. 3767, must not pass. To rush them through the lamest of lame duck sessions is a true abuse of power.
Despite Congressional maneuvering, to make them into “non-controversial” bills that can be rammed through via “Unanimous Congressional Approval”, these bills remains very controversial and should reconsidered by the new Congress being elected this year. The Congress is in recess, campaigning for their own, or party members’ reelection — so NOW is the time to educate those new members-to-be and NOW is the time to get their public commitment to support health and food freedom!
We, together, can do that by visiting your candidates and incumbents, especially the Senate ones, with groups of people who all come armed with the following “Talking Points” and who discuss them rationally, briefly and very, very directly. Print out one Talking Point copy for each member of your group and half a dozen for the Congressman or candidate and his/her staff. And mention that you are part of the largest Health Freedom Organization in the world. As I write this, there are more than 305,000 supporters on our primary list. Each of them has contacts and are willing to share this information to preserve our health freedom.
Take the Above Talking Points to Your Congressional Candidates
Now is the time to secure their commitment to Health & Food Freedom!
Now is the time to promote the Food Freedom Amendment!
Please let us know what happens: email firstname.lastname@example.org with “Talking” in the subject line.
Please take a moment to read our current Valley of the Moon™ Restaurant and Cafe doings and see what Natural Solutions Foundation is up to at the “Boots on the Ground” Level with its Eco Demonstration Project reclaiming the production of clean food – and so much more! Be sure to check out our growing list of extraordinary Seminars and webinars!
And please remember to make your tax deductible donations to support the Natural Solutions Foundation. We can’t do our work without your support. Click below to set up a recurring donation now. http://drrimatruthreports.com/?page_id=189
You are invited! Participate in the “Landfill Health Program” video satire contest.
Visit http://drrimatruthreports.com/?p=6889 and let your creative juices sizzle;
You could be the big winner…
Thanks for your support.
Yours in health and freedom,
Rima E. Laibow, MD
Natural Solutions Foundation www.Dr.Rima.net
Dr. Rima Reports
Every Sunday 10 AM to 1 PM Eastern Time
Listen and Chat: www.HealthFreedomPortal.org
Listen or Ask Questions: 512-904-8014 or Toll Free 866-841-1065
Guest This Sunday Will be: Eileen Danniman, Dead Babies and Flu Vaccines Part II
Sunday, 10 AM to 1 PM Eastern
October 10, 2010: Eileen Danniman, Dead Babies and Flu Vaccines Part II
Click Here For More Information on Dr. Rima Reports: http://drrimatruthreports.com/?p=4850
H1N1 Rears its Ugly Head… via Vaccination!
Do you believe… un-safety tested vaccinations for a “potential comeback”?
“Government launches a countrywide anti-HiN1 vaccination campaign in an effort to stifle a potential comeback of the pandemic influenza recently certified to be on the drastic decrease by…WHO.”
So says The Nation of Malawi http://www.nationmw.net/index.php?option=com_content&view=article&id=6911:h1n1-campaign-starts-monday&catid=28:health&Itemid=22
—————————— Do We Have a Right to Know If Our Food Has Been Genetically Modified?
“The FDA is close to approving genetically modified (gm) salmon… We know that at least some genetically modified foods may harm the environment… And serious questions have been raised about whether some gm foods might increase allergies or cause other health problems in humans… Indeed, as Mother Jones pointed out last week, gm salmon may itself increase allergies…”
——————————– GM Superbug Risk!
‘GM formula poses superbug risk’ (AAP Newsfeed, 9/30/10) – “Baby milk formula containing untested genetically modified ingredients poses a potential risk of creating antibiotic resistant superbugs, a leading medical researcher says. Professor Peter Collignon, from the Australian National University medical school, says many GM foods contained antibiotic resistance genes which needlessly placed people, animals and the environment at a risk. ‘Why expose the environment, animals, people to antibiotics resistance genes that could potentially be taken up by bacteria and develop superbug properties when we don’t have to?’ he said at a demonstration in front of Parliament House. This was part of a Greenpeace campaign that has included supermarket sit-ins and a number of arrests after analysis of the popular infant formula S-26 revealed traces of GM soy and corn. …The Greens Party plan to introduce legislation requiring food labeling to reveal GM content….”
——————— Valley of the Moon Report http://drrimatruthreports.com/?p=6896
Backscatter “Naked Body Scanners” Protecting Us From Terrorists in Airports, City Streets, Sporting Events, etc., As They Rip Our DNA Apart and Give Us Cancer
Boian Alexandrov, of the Center for Nonlinear Studies at Los Alamos National Laboratory, however, has a very decided opinion regarding the dangers of T-rays: He tells us that T-rays tear apart human DNA.
Alexandrov, and his team at Los Alamos, say that although the forces that T-rays exert are small, their resonant effects can “unzip” DNA strands, tearing them apart, thus creating bubbles in the strands that significantly interfere with gene expression and DNA replication. And whatever that means, it doesn’t sound good.
Moreover, it seems these T-ray scanners will be operated by non-healthcare, hourly wage-earners, not trained in radiation medicine or imaging. And who is to prevent massive radiation overdoses?
What protection will be offered to pregnant women, children, or our reproductive organs?
Also, whether you fly or not, the dark powers that have subjugated our federal government are intent on repeatedly lashing you with deadly radiation … all for your own good, mind you.
“Our government has bought hundreds of mobile Z Backscatter Vans (ZBVs) to hunt you down, so they can shoot you with deadly radiation.
These vans, that look innocuous enough, are carriers of radiation-death-machines that take no quarter, while they are driven through out our neighborhoods radiating pets, children, women, and men, alike, while they are in the privacy of their own homes.
These ZBVs also drive through city streets, irradiating other vehicles, and passengers, with strong enough radiation to penetrate steel and destroy the cells of human bodies, all on the flimsy pretense of protecting us from terrorists, who may be carrying bombs or drugs in their vehicles.
But who will protect us from the terrorists in our own government, who are so wantonly radiating us onto death?”
11 Year Old Lays Our Food Supply’s Contamination on the Line – and Tells Us How to Fix It! MUST WATCH!
1. CAUTIONS FOR CAM PRACTITIONERS – Ralph Fucetola JD (1.5 hr – $99)
Includes 32 slides, 20 page ebook with forms and private forum.
If You are an Advanced Health Care “CAM” Practitioner You Need This Webinar! http://drrimatruthreports.com/?p=6588#cautions
“Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients? Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices” – Ralph Fucetola JD
2. Local Organizing Webinar posted (32 minutes – free) http://drrimatruthreports.com/?p=6588#local
3. How are Music, Color, Organs, Food and Qi Energy Related?
Come to the Valley of the Moon’s Natural Solutions Center and Find Out!
Starting with a Five Elements BeyondOrganic™ Welcome Dinner on January 9, 2011
we’ll spend 5 days focusing on each of the Five Elements, its food, color, strengths, weaknesses, characteristics, sounds and uses. Each day will include 3 outstanding meals and snacks (including food preparation in our teaching kitchen), lectures and participation, all in the lovely Valley of the Moon™ in temperate, tranquil, beautiful, bountiful Chiriqui, Panama.
With direct flights starting this December from the US to David, just 45 minutes away, getting there is easy. Being there is really easy: you’ll be in one of the most beautiful places in the world at the most beautiful time of year.
If you want a unique get-away or want to find out if the Valley of the Moon Eco Demonstration Community is for you or just want to experience this intensive program to learn more about the Five Element system, then mark the week on your calendar.
Welcome Banquet January 9 to Final Breakfast on January 15, 2011. It’s a week you won’t forget.
Write to us at email@example.com with 5 ELEMENTS as the subject line to make sure you are in line for this limited space program in Panama.
4. Experience Karma Singh’s Energy Transmissions, Then Tell Us What You Think:
Valley of the Moon™ Coffee
Health Freedom’s Coffee
It’s GMO Free, Toxin Free and Helps Keep You Free!
Order 8 bags or more and we’ll send you one of our beautiful Valley of the Moon Cups as our “Thank You!”
Don’t forget to get yourself some of our exceptional Valley of the Moon(TM) Coffee, www.ValleyoftheMoonCoffee.org, and remember to give this delightful health brew as your gift for birthdays, Christmas, Hanukkah, corporate gifts, Holiday corporate and private gift giving! etc. Clean, toxin-free coffee helps coffee drinkers, it helps the Natural Solutions Foundation at the same time and it tastes WONDERFUL!!! In fact, we want you to try, and then keep on buying, our wonderful Valley of the Moon Coffee(TM) so we have a coffee special for you: Purchase a 1/2 pound bag of our spectacular coffee for $18.87 plus shipping. This same bag normally requires a donation of $25.00 (a savings of $6.13). Now, purchase 5 bags or more (including your gifts) and your price drops to $17.57 per bag – a savings of $37.15!
Purchase 8 bags or more and we’ll send you one of our beautiful Valley of the Moon Cups so you can enjoy your coffee in yet another way: with your eyes!
Just make sure that you enter “RbR01C” in the Comments Area to receive our special price!
And don’t forget the universal remedy, Nano Silver, www.Nutronix.com/naturalsolutions, and supplementing with Cognitive Enhancement Nutrition to keep your brain healthy and focused…
Yours in health and freedom,
The Trustees of the Natural Solutions Foundation
Maj. Gen. Albert N. Stubblebine III (US Army, Ret.) President – www.FoodFreedomeJournal.org
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This long, detailed and immensely important article makes it crystal clear where the lies and distortions are about vaccines, whether they work, whether they cause chronic illnesses and whether they are safe.
Before you allow yourself or your wards, children, family, elders or others to take another vaccination, read this article. Listen to Dr. King discuss this article on the Dr. Rima Reports live (www.HealthFreedomPortal.org to join the chat and listen to the show or at www.OracleBroadcasting.com to listen to the show or in the archives at www.OracleBroadcasting.com following the broadcast on Sunday, October 3, 2010, 10 AM to 1 PM Eastern time.
Dr. King knows full well that vaccines are intentionally used to create disease and profit while they do nothing to prevent disease. Listen to him, read the article below and share this article as widely as possible.
Thanks for your activism. Yours in health and freedom,
Vaccines, Vaccination Programs and Knowing1 Misrepresentations
Paul G. King, PhD
Facility Automation Management Engineering (FAME) Systems
33A Hoffman Avenue, Lake Hiawatha, NJ 07034-1922
Before discussing the subjects in the title of this article, this commenter would be remiss if
he did not first set forth his biases and conflicts concerning the issues discussed in the sections and
paragraphs that follow this introduction.
As a scientist who understands that:
? Terms must be clearly defined,
? Statements must be supported by factual evidence and, where that evidence is not
readily available, appropriate citations thereto,
? Much of the information on vaccines and vaccination programs available in the
mainstream media and publications backed by the Establishment and its minions is
more propaganda, cant and Orwellian newspeak than sound science, and
? Vaccines or vaccination programs where the vaccine is reasonably safe and the
protection provided is either life saving (e.g., the rabies vaccines) or the prophylactic
vaccine is reasonably safe and effective in protecting almost all (i.e., >90 %) of those
vaccinated, long-lasting (i.e., protects that not less than 90 % of those vaccinated for
a period of not less than 50 years), and medically cost-effective, for example, the
measles only vaccine and vaccination program) should be supported,
this commenter must stand against: a) the misrepresentation of vaccines and vaccination programs
in any manner, and b) vaccination programs in which: i) those inoculated with the vaccine are not
protected or ii) more who are vaccinated suffer serious adverse injury from the vaccine than there
are disease cases in the population segments that are being vaccinated (e.g., the early childhood
hepatitis B vaccination program).
In addition, since the Establishment continually spews out a never-ending stream of near-
religious vaccine and vaccination apologia, this author sees no need to spend any time discussing
the inflated and often deceptive presentation of vaccines and vaccination programs as the
“salvation” of mankind – because such discussions belong in the realm of religion and not science.
With the preceding in mind, this author will now begin to address fundamental vaccine and
vaccination-program misrepresentations that stand in the way of our right to choose or decline any
prophylactic medical treatment, including any prophylactic inoculation with any vaccine or serum
as we, and not society, sees fit for ourselves and the minors and non-competent persons in our care.
1. “Vaccines Are Safe”
The first misrepresentation about vaccines and by far the worst is that, as a group (or
individually), “vaccines are the safest of medicines” or, more simplistically, “vaccines are safe”.
The factual evidence and the legislation protecting the vaccine makers, vaccine providers
Where the term “knowing” is used in the “knowingly” or “knew” sense that is defined in 21 U.S.C. § 321(bb) “The
term “knowingly” or “knew” means that a person, with respect to information – (1) has actual knowledge of the
information, or (2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information”.
and the healthcare establishment clearly exposes a different reality, which, in its most telling form,
can be found in the National Vaccine Injury Compensation Program (NVICP2; Title 42 of the
United States Code in Sections 300aa-10 through 300aa-34 [42 U.S.C. § 300aa-10 – 300aa-34]) in §
300aa-22(b)(1) which, under: a) the umbrella of “Standards of Responsibility” (§ 300aa-22.) and b)
the heading at § 300aa-22(b), “Unavoidable adverse side effects; warnings”, states:
“No vaccine manufacturer shall be liable in a civil action for damages arising from a
vaccine-related injury or death associated with the administration of a vaccine after
October 1, 1988, if the injury or death resulted from side effects that were unavoidable even
though the vaccine was properly prepared and was accompanied by proper directions and
warnings”. [Emphasis added]
If vaccines were truly safe, then there would be no need for: a) any NVICP legislation to
protect the vaccine makers or the healthcare providers from civil lawsuits for damages, or b) any “if
the injury or death resulted from side effects that were unavoidable” language to absolve vaccine
manufacturers from damages that include “vaccine-related injury or death”.
Clearly, unbiased scientists, the federal lawmakers, and the informed public know that, as a
group or, in most instances, individually, vaccines are not the safest medicines.
2. “Vaccines Are Effective”
If vaccines were truly effective, then there would be:
a. No need for any State to mandate any vaccination program for any vaccine –
everyone would be demanding inoculations for themselves and their loved ones,
b. No need for any mention of the unproven theory of “herd immunity”, which, in
reality, can only be a theory of “herd protection” because vaccines do not provide
blanket immunity (defined as lifetime [>50 year] protection from disease) to even
those who have been inoculated with the recommended vaccines from 2 to 6 or more
times, depending upon the vaccine, and
c. No need to license vaccines based on their manufacturers’ claimed levels of
“efficacy” as measured by some minimum-antibody-level surrogate for
Given the preceding factual realities, it is clear to any rational person that unqualified
phrases, like “vaccines are safe” and “vaccination programs are effective”, are simply propaganda
slogans that vaccine makers, the healthcare establishment, pro-vaccine academics, pro-vaccine US
governmental agencies (e.g., Department of Health and Human Services [DHHS], the Centers for
Disease Control and Prevention [CDC], the Food and Drug Administration [FDA], the National
Institutes of Health [NIH] and the Public Health Service [PHS], to name a few) and other vaccine
apologists continually use in their efforts to both brainwash and coerce the public into accepting
whatever vaccines and vaccination programs that “these groups” have decided, at a given point in
time, are “good” for the public as a whole with little or no regard for the fiscal or physical health of
The full title of the NVICP in the United States Code is: TITLE 42 – THE PUBLIC HEALTH AND
WELFARE, CHAPTER 6A – PUBLIC HEALTH SERVICE, SUBCHAPTER XIX – VACCINES, Part 2 –
National Vaccine Injury Compensation Program.
any individual or individuals that such vaccination programs may harm, maim or kill or, for that
matter, the fiscal and physical health of the people of the United States Of America (USA).
3. “Vaccine Panacea: The More Vaccines We Get, The Healthier We Will Be”
a. The Legacy (Pre-NVICP) Vaccination Programs
Reviewing the history of vaccines and vaccination programs in the USA, up until the early
1900s, the only widely used human prophylactic (disease-preventive) vaccine was the live-virus
cowpox vaccine, vaccina; the only other general human-use vaccine was the attenuated rabies
vaccine used to treat people who had been bitten by a rabid animal; and the only large-scale mass
“vaccination” program was the “smallpox” inoculation program.
In the 1920s, a diphtheria vaccine was introduced and its use spread; in the 1950s, the use of
pertussis vaccines became widespread but these morphed into the first combination the DTP
vaccine, which was to become the first Thimerosal-preserved combination vaccine to be used in a
mass vaccination program.
In the 1950s, the Salk inactivated-polio vaccines were introduced for mass use without
adequate testing and purity leading to: a) an initial increase in paralytic polio cases until the clinical
definition of paralytic polio was changed and b) the introduction of SV-40 and other animal viruses
which were, to varying degrees and levels, contaminants of all the polio vaccines produced for the
next three decades; and, a few years later in the early 1960s, the live-virus Sabin oral polio vaccines
displaced the Salk inactivated-polio vaccines – the Sabin oral polio vaccines were used in the USA
until 2000 when, because all paralytic polio cases were cases caused by exposure to the vaccine-
strains of the live vaccine, the US switched back to a Salk-type inactivated-virus polio vaccines,
which is still in use today.
In 1963, a live-virus measles vaccine was introduced and put into mass use shortly after its
introduction; the measles-only vaccine was followed by a measles-rubella (Merck’s measles-rubella
vaccines, MR® and MR® II, that have been discontinued); then a measles-mumps-rubella vaccine
(Merck’s MMR® vaccine); and finally an improved measles-mumps-rubella vaccine (Merck’s
MMR® II vaccine)3.
In the early 1980s, though some other vaccines were being licensed, they were not being
recommended for mass use in childhood vaccination programs because of the increasing number of
lawsuits where the parents of vaccine-injured children, principally by the DTP vaccines and the
Polio vaccines but also by the measles and MMR vaccines, were winning ever larger monetary
judgments against the vaccine companies.
Faced with decreasing profit from the lawsuits, the major vaccine makers threatened to stop
making vaccines unless the government passed legislation that protected them from most all direct
civil legal actions for the harm their vaccines caused in some of the children who were being
inoculated with these vaccines.
In addition to the combination measles-mumps-rubella vaccines (MMR® and then MMR® II), Merck continued to
make the individual component vaccines, Attenuvax®, Mumpsvac®, and Meruvax® II until the mid-2000s. In 2010,
Merck announced that, in spite of customer demand for the individual vaccines, Merck would not resume
producing these vaccines.
from the pen of Paul G. King, PhD
In late 1986, comprehensive legislation was enacted that included the National Vaccine
Injury Compensation Program (NVICP) that was codified in 42 U.S.C. §§ 300aa-10 through 300aa-
34 and, in stages, became effective in 1987 and 1988.
This legislation was originally supposed to: a) provide a speedy, “no fault”, non-litigious,
fair compensation program for vaccine-injured children and their families, which, after initial
appropriations to start the program, was to be paid for by a tax on each disease component in each
dose of vaccine administered, and b) shield the vaccine makers from being easily sued.
In return for this protection, the vaccine manufacturers were supposed to make ever-safer
vaccines that caused less adverse reactions under strict governmental oversight that would not only
compel vaccine makers to make safer vaccines but punish them when they did not make vaccines as
safe as possible and reduce the risk of adverse reactions.
In actuality, all that the NVICP has done is shield the vaccine makers from being sued and,
through an increasingly slow, litigious, convoluted, and unfairly administered “compensation
program”, its administrative hearings have only compensated a very small percentage of those who
are damaged by adverse reactions to vaccines even though the program has been expanded to
include adults in many instances.
In 1987, Congress took the first action to decrease the fairness of the program and reduce the
financial burden on the federal government and the vaccine makers for any violation by repealing §
300aa-18, which indexed the compensation for both vaccine-related death and the vaccine
manufacturers’ fines to the rate of inflation.
Next, the NVICP program administrators started making it harder for children’s families to
collect for vaccine injuries by, in the 1990s, removing many of the indications from the “Vaccine
Injury Table” (see: Sec. 300aa-14. Vaccine Injury Table) without any independent scientifically
sound justification for removing them, which forced many more cases to be heard in a proceeding
that has become increasingly litigious and unfair4.
In the late 1980s, though it was clear that the diphtheria, tetanus, acellular pertussis (DTaP)
vaccines produced a lower rate of adverse reactions in children given them than the corresponding
diphtheria, tetanus, whole-cell pertussis (DTwP) vaccine, based on the data from Japan, which
introduced the DTaP vaccine in 1981 and saw a sharp decline in both diphtheria-tetanus-pertussis-
vaccine-related adverse reactions and vaccine-related deaths, the DTwP vaccines were still licensed
and being given in the USA until 1997, when the vaccine makers finally switched to making the
This continual indication reduction process has gone beyond the absurd, removing the rotavirus vaccine indication
for intussusception even though all of the rotaviruses have been shown to cause intussusception in some vaccinated
children and two new rotaviruses (a 5-component bovine-human hybrid rotavirus vaccine [RotaTeq®] and an
attenuated human rotavirus vaccine [Rotarix®]) have been licensed and approved for mass use instead of amending
the table entry for the withdrawn RotaShield ® rhesus-monkey/human hybrid rotavirus vaccine and, most recently,
proposing to further alter the allowable time windows for the few remaining indications in the Vaccine Injury Table
(see: Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Proposed Rules / 55503 – 55507).
As one article correctly reports, “4) The old whole-cell version of DPT, given until about 1997 in the US, was bad. It
had a high rate of serious reactions, and these researchers calculated its effectiveness at only around 48%. But for the
previous 20 years, parents in the US were being told their children must have this vaccine. The real truth about a
After all, after 1986, the vaccine maker’s principal goad to make safer vaccines, the
monetary awards to successful plaintiffs in civil court cases seeking compensation for the injuries
caused by their vaccines, had been removed.
By comparison, the legal replacement for this goad was a weak and obviously ineffectual
federal governmental bureaucracy over which the vaccine makers obviously had significant
influence, and, given Merck’s Gardasil HPV vaccines’ problems and the federal government’s
failure to take any substantial action against the vaccine or the vaccine maker, currently have even
b. The NVICP and Post-NVICP Vaccination Programs
With the passage of the NVICP legislation, the stream of vaccines from a growing number
of vaccine makers and/or their subsidiaries has increased to a veritable river.
Discarding any semblance of a need for cost-effectiveness in any mass vaccination program,
the Establishment has moved to not only add more doses of vaccines that were already marginally
cost-effective or not even cost effective but also to propagandize vaccination programs where the
underlying vaccine is not even truly effective or, in some cases, not even reasonably safe.
In addition, the Establishment, using a hired Institute of Medicine (IOM) committee as its
surrogate, redefined the allowable “placebo” in a vaccine clinical safety trial from only a pH-
buffered sterile isotonic saline solution to include: a) the entire vaccine formulation without the
active antigens, b) some other experimental vaccine or c) some other licensed vaccine, and
convinced the regulators to look at relative incidence of adverse events instead of their absolute
incidence in determining that a given vaccine is “reasonably safe”.
Together, these changes altered the basis for “safety” in phase 3 clinical trials and, by
increasing the adverse reactions in the “placebo” group, reduced the relative level of each adverse
reaction in the candidate vaccine compared to that adverse reaction in the “placebo” group.
Thus, when “three” children in the test group for Merck’s RotaTeq® vaccine in as clinical
trial (conducted in an overall population where sanitation is poor) developed intussusception and
“one” child in the control group developed intussusception, the RotaTeq vaccine was still
approvable and approved because the rate of intussusception was not significantly higher (on a
statistical basis) than the rate in the controls because of the small size of the groups in phase 3 trial
that Merck had conducted.
On this basis, the FDA licensed Merck’s genetically engineered, bovine-human-hybridized,
pentavalent, oral, live-virus rotavirus vaccine, RotaTeq, even though this vaccine’s actual rate of
intussusception was 3 times that found in the control group.
Of course, after its approval in February of 2006, the pediatricians were told that, unlike the
previous “intussusception prone” rotavirus vaccine, Wyeth’s RotaShield®, which was withdrawn
shortly after its introduction in 1998, RotaTeq’s on-label use would not cause intussusception.
Even after being told that RotaTeq does not cause intussusception, the RotaTeq-related
intussusception signal in the voluntary Vaccine Adverse-Event Reporting System (VAERS) [where
particular vaccine being kind of dangerous and ineffective doesn’t come out until the pharmaceuticals decide they
have something better” (emphasis added). [See: http://www.exploringvaccines.com/?p=686]
typically less than 10% of actual adverse events for a given vaccine are reported] was even larger
after RotaTeq began to be used than the signal seen from the previous, now-withdrawn
“intussusception prone” RotaShield rotavirus vaccine and, in addition, RotaTeq-related cases of
Kawasaki’s disease were also reported6.
Additionally, after the NVICP was enacted, several patently unsafe or problematic vaccines
were licensed (e.g., LymeRX™ for Lyme disease and RotaShield® for rotavirus) and, after causing
horrendous or significant harm to those vaccinated with them from which the Establishment
profited, simply withdrawn from the market.
Thus, in addition to the pre-NVICP childhood vaccination programs for DTP, MMR and
Polio, we now have ineffective and/or less-than-effective vaccines and less-than-effective and/or
non-cost-effective mass vaccination programs for: a) late-childhood/adult diphtheria-pertussis-
tetanus (Tdap), b) childhood Haemophilus influenzae, type B (Hib), c) early childhood/adult
Hepatitis B (Hep B), d) childhood chickenpox, e) childhood/adult Hepatitis A (Hep A), f)
childhood/adult meningococcal meningitis (Sanofi Pasteur’s Menomune® and Menactra® vaccines),
g) Streptococcus pneumoniae (Wyeth’s Prevnar® and Prevnar ® 13[childhood] and Merck’s 23-
valent Pneumovax® [adult]), h) childhood rotavirus (Merck’s RotaTeq® and GlaxoSmithKline’s
(GSK’s Rotarix®), i) adult Shingles, and j) mid-childhood/young-adult human papilloma virus
(HPV; Merck’s Gardasil® and GSK’s Cevarix®) as well as k) ineffective annual vaccines and
annual vaccination programs for viral influenza in children and adults with “11” different vaccine
formulations currently being produced in “eight” manufacturing sites.
Moreover, not only does this require more and more vaccines to be given during childhood
but also, further unmasking the reality that vaccination is not immunization, to increase “coverage”
(in reality, market size and market penetration), adults are increasingly recommended to: a) get
“boosters” doses or “booster” vaccines, b) get periodic Tdap boosters in lieu of tetanus boosters,
and c) accept additional vaccine doses whenever there is a disease outbreak of a “vaccine
preventable” disease in their community regardless of their disease status.
In addition, no meaningful action has been taken against the vaccine makers for their failure
to expeditiously safen US vaccines by removing all preservatives and reducing the level of
adjuvants used or, where possible, eliminating the use of adjuvants altogether.
Instead, though there currently is a limit on the permitted level of aluminum adjuvant in
each vaccine7, the total level of aluminum adjuvants administered is being allowed to increase
without limit and the vaccine makers are increasingly demanding that they be permitted to use so-
called “oil-in-water” adjuvant systems even though, based on animal usage, these are known to be
more serious immune-system disruptors than the current long-used aluminum adjuvants whose
long-term safety for use in human vaccines has not been proven individually much less collectively.
Geier DA, King PG, Sykes LK, Geier MR RotaTeq vaccine adverse events and policy considerations. Med Sci
Monit. 2008 Mar; 14(3): PH9-PH16.
If the FDA’s proposed changes to 21 CFR § 610.15. Requirements for constituent material as published in the
Federal Register (see: Federal Register 2010 March 30; 75(60): 15639-15642) are adopted by the FDA, the FDA
will be able to waive all of the current limits, including those for preservatives and adjuvants as it sees fit even
though doing so is a subversion of the foundation upon which the regulation o all drugs is based – the applicable
regulations as set forth in 21 CFR Parts 600-680 are current good manufacturing practice (CGMP) minimums,
which every covered biological drug product must meet.
Finally, in spite of being sued for the failure of the Secretary of the Department of Health
and Human Services (hereinafter, the Secretary) to make vaccines safer and reduce the risk of
adverse reactions, as required by 42 U.S.C. § 300aa-27(a), by removing Thimerosal (49.55 %
mercury by weight) from the list of approved chemicals that can be used to manufacture vaccine,
the federal government has yet to ban the use of Thimerosal, a chemical that is known to induce
anaphylactic shock in some and mercury poison susceptible developing children, in the manufacture
c. The Number of Vaccine ‘Doses’ Reality
Increasingly the public is being told that they must submit to ever-expanding vaccination
programs for themselves and their children without regard for the risks to their own health or the
health of their children because complying is for the “greater good”.
For children up to 6 years of age, the recommended vaccination program reached a new high
in 2009 when, in addition to all of the 38 vaccines in the 2007 and 2008 vaccination programs, three
more doses of an 2009-A-H1N1 influenza vaccine was added for a nominal total of 41 doses of
Relative to 1983, the maximum relative level of mercury from possibly Thimerosal-
preserved vaccines (marked in red in Table 1 on the next page) was 1.6 times the nominal level of
exposure in 1983 and, roughly correcting for 10-or-more-times-larger effect of the prenatal
mercury dose, effectively up to 5-plus times the level of adverse impact relative to the vaccine
exposure to injected Thimerosal (49.55% mercury by weight) in 1983.
d. The Continuing Use of Mercury (Thimerosal, 49.55% Mercury by Weight) Reality
When it comes to the issues surrounding the serious adverse health impacts of Thimerosal
(49.55% mercury by weight) on those vaccinated with vaccines containing it, the public is
continually propagandized with one of two misleading and inaccurate slogans:
1. “Mercury has been removed from all childhood vaccines” or
2. “All vaccines given to children, except some flu vaccines, no longer contain any added
The reality is that the Establishment, faced with a growing public outcry against the use of
Thimerosal as a preservative in childhood vaccines, did gradually reduce the level of Thimerosal in
the previously Thimerosal-preserved vaccines from nominally 25 micrograms of mercury per 0.5-
mL dose to about 1 mcg of mercury per 0.5-mL dose (a reduced-Thimerosal or “trace”-Thimerosal
vaccine formulation) in the period from 2001 to 2005 and then starting in 2004, phased out the use
of Thimerosal in childhood vaccines.
However, to offset this reduction in mercury exposure from childhood vaccines (and the
serum Rho(D) products), the Establishment-controlled CDC began publishing recommendations in
April of 2002 that, during the annual flu season: a) pregnant women who would be in their second
and third trimesters and b) children 6 months to 23 months of age should get a flu shot (see
Prevention and Control of Influenza Recommendations of the Advisory Committee on
Immunization Practices [ACIP]. MMWR 2002 April 12; 51(RR03): 1-31) at a time when all FDA-
approved influenza vaccines were Thimerosal-preserved vaccines.
Table 1: The CDC-Recommended Vaccine Schedule Comparison in Children
from Conception to 6 Years of Age, By Year (Recommended Month)
Year USA 1983 USA 2007 USA 2009
Before Birth — Influenza shot
Seasonal influenza &
Birth through 1 Year DTP (2) Hep B (birth) Hep B (birth)
OPV (2) Hep B (1) Hep B (1)
DTP (4) DTaP (2) DTaP (2)
OPV (4) Hib (2) Hib (2)
DTP (6) IPV (2) IPV (2)
[5 total] PCV (2) PCV (2)
[75 mcg Hg] Rotavirus (2) Rotavirus (2)
Hep B (4) Hep B (4)
DTaP (4) DTaP (4)
Hib (4) Hib (4)
IPV (4) IPV (4)
PCV (4) PCV (4)
Rotavirus (4) Rotavirus (4)
Hep B (6) Hep B (6)
DTaP (6) DTaP (6)
Hib (6) Hib (6)
IPV (6) IPV (6)
PCV (6) PCV (6)
Influenza (6) Seasonal Influenza (6)
Rotavirus (6) 2009-A-H1N1 (6)
Influenza (7) Rotavirus (6)
 Seasonal Influenza (7)
[25; 50 mcg Hg] 2009-A-H1N1 (7)
[50; 100 mcg Hg]
1 through 2 years MMR (15) Hib (12) Hib (12)
DTP (18) MMR (12) MMR (12)
OPV (18) Varicella (12) Varicella (12)
[3; 8] PCV (12) PCV (12)
[25; 100 mcg Hg] Hep A (12) Hep A (12)
DTaP (15) DTaP (15)
Hep A (18) Hep A (18)
Influenza (18) Influenza (18)
[8; 30] [8; 33]
[12.5; 62.5 Hg] [12.5; 112.5 Hg]
2 through 3 years Influenza (30 Influenza (30
Influenza (42) Influenza (42)
[2; 32] [2; 35]
[37.5; 100 mcg Hg] [37.5; 150 mcg Hg]
4 through 6 years DTP (48) MMR (48) MMR (48)
OPV (48) DTaP (48) DTaP (48)
[2; 10] IPV (48) IPV (48)
Varicella (48-60) Varicella (48-60)
[25; 125 mcg Hg] Influenza (54) Influenza (54)
Influenza (66) Influenza (66)
[6; 38] [6; 41]
[50; 150 mcg Hg] [50; 200 mcg Hg]
Vaccines and values in a red font are for vaccines that were, in 1983, or, in the 2000s, may still
The CDC made these recommendations in spite of the fact that the flu vaccines were
“Pregnancy Category C” vaccines with no proof:
a. Of non-teratogenicity for the fetus or reproductive safety for the pregnant women;
b. That the flu vaccines were not mutagenic or carcinogenic; or
c. That the flu vaccines were in-use effective in preventing those vaccinated from
There was, as is the case today, also no proof that flu vaccines, of any kind, are more in-use
effective than a placebo injection in preventing those children under 2 years of age who are
inoculated with a flu vaccine from contracting influenza.
As: 1) the level in the childhood vaccines continued to declined, 2) some doses of “trace”-
Thimerosal flu vaccines became available, and c) a live-virus flu vaccine was introduced, the CDC
recommendations continued to try to maintain the adverse effects of the average level of mercury
exposure to Thimerosal by: a) removing the restriction as to when, during pregnancy in the flu
season, flu shots could be given; b) increasing the upper limit on children to first 35 months, then to
59 months, then to 107 months, and, finally, to 18 years of age; and c) requiring children to get two
flu shots (a month apart) the first time they were vaccinated.
In 2009, the maximum level of Thimerosal exposure was doubled in utero and at 6 months
and 7 months when the CDC: a) added the “pandemic”, “swine flu”, 2009-A-H1N1 influenza to the
vaccines recommended to be given once to pregnant women and twice to children under 9 years of
age, and b) also designated pregnant women and young children as targeted “high risk” groups.
? Most of the doses of available influenza vaccines are Thimerosal-preserved doses,
? The CDC steadfastly refuses to even express a preference for pregnant women and
young children to get “no Thimerosal” influenza vaccine doses and
? The FDA continues to illegally license Thimerosal-preserved vaccines for which the
vaccine manufacturer has never proven that the level of Thimerosal used as a
preservative in said inactivated-influenza vaccines is “sufficiently nontoxic …” as
required by the applicable portion of the current good manufacturing practice
(CGMP) safety regulations set forth in 21 CFR § 610.15(a),
pregnant women and children are continuing to be injected with toxic levels of mercury from
these adulterated drugs8
Moreover, given the CDC’s decision to increase the upper age limit for children to 18 years
and recommend that all adults be vaccinated annually, if Thimerosal-preserved flu shots continue to
be administered and some children and their mothers during pregnancy only get Thimerosal-
preserved flu shots, clearly the total dose of mercury exposure will continue to exceed the
maximum level that children born in the 1990s would have received from the three Thimerosal-
preserved childhood vaccines, DTaP, Hib, and Hep B, given to all children before 2001 and to some
Thimerosal-preserved vaccines for which the manufacturer has failed to meet the applicable clear CGMP minimum
“sufficiently nontoxic …” requirement for the vaccine dose set forth in 21 CFR § 610.15(a) are adulterated drugs
under 21 U.S.C. § 351(a)(2)(B).
from the pen of Paul G. King, PhD
children into the 2004 – 2005 timeframe, if no changes had been made to the Thimerosal-preserved
childhood vaccines or in the recommendations for the use of Thimerosal-preserved inactivated-
influenza vaccine formulations to inoculate pregnant women and developing children.
As long as the preceding realities continue to exist, any claim that there can be no link
between: a) the level of mercury exposure and b) the risk of neurodevelopmental disorders, chronic
illnesses and abnormal behaviors is obviously a specious claim because the maximum level of
mercury has not dropped from the 2000 level but rather the maximum exposure level has increased.
At the same time, the levels of neurodevelopmental disorders, chronic medical conditions,
and abnormal behaviors have not dropped but rather these levels have also collectively increased.
Based on the preceding and other key facts (e.g., the several-fold excess level of males as
compared to females in the neurodevelopmental disorders and the fact that increases in these
disorders were noticed a couple of years after the 3-dose regimens for Thimerosal-preserved Hep B
and for Hib were implemented in the late 1980s in the USA and in the 2000s after similar program
changes were implemented in New Delhi, India9), this author knows that mercury exposure from
Thimerosal in vaccines and other drugs is the major causative factor in many, if not all, of the
epidemic-level increases in neurodevelopmental disorders, chronic medical conditions, and
4. “The Benefits Outweigh The Risks”
Pointing to our current increased life expectancies and ignoring their projected future
decline, the Establishment continually tells Americans that the benefits of each new vaccination
program outweigh the risks.
Unfortunately, there has been epidemic increases in many chronic diseases (e.g., asthma in
children from < 1 in 1,000 children in the 1970s to > 1 in 10 children in the 2000s) and the
morphing of previous chronic diseases only seen in adults (e.g., type 2 diabetes) into chronic
diseases seen in children to the point that, in 2006, more than 26 % of American children have one
or more chronic diseases (up from 12.8 % in 1994)10 that they most probably will have over their
Thus, the “greater good” for whom each of us is supposed to sacrifice ourselves and our
loved ones is, in actuality, the “greater good” for one or more segments of an Establishment that
feeds on us and grows ever stronger as more of us weaken and become chronically ill and/or
financially and physically drained trying to care for our chronically ill loved ones.
Worse, there is increasing evidence that those who are effectively in control of this
Establishment decided have, unconsciously or consciously, that they need to:
The reality of this linkage was recently strongly reinforced by the emergence of a similar pattern’s being observed
in a New Delhi, India nursery school after the New Delhi pediatricians began recommending the addition of 3-
doses each Thimerosal-preserved Hib and Hep B vaccination programs to the Indian government’s recommended
Thimerosal-preserved DTP vaccination program in 2000 and the worsening of the outcomes when these programs,
originally designed to finish the 9-shot vaccination series by the time the children are 6 months of age, were
shortened to be completed by 4.5 months of age and the incidence of neurodevelopmental dysfunction doubled.
Van Cleave J, Gortmaker SL, Perrin JM. Dynamics of Obesity and Chronic Health Conditions Among Children
and Youth. JAMA 2010 February 17; 303(7): 623-630.
? Increase the harm,
? Further drain our fiscal and physical strength, and
? Reduce our numbers and our life expectancy, while feeding on our fiscal and physical
To that end, increasingly expensive vaccines (e.g., Merck’s Gardasil and GSK’s Cervarix,
where the private-sector list price for each dose is than US $125.0011) that: a) are less-and-less
curative and/or effective and b) seem to be more-and-more harmful are being approved and
delivered to the public as preventives for conditions whose incidence, in many instances, may have
been caused or aggravated by other vaccines, drugs, processed and genetically altered foods, and
chemicals that the Establishment markets to the public as “safe” without any real proofs of the
short-term and, more importantly, true long-term safety for any of these Establishment products.
To sell these less-than-effective, less-than-proven-safe, and much-more-expensive vaccines,
the Establishment continually reminds the public of the horrors of the deaths from “vaccine-
preventable disease” for certain highly contagious and lethal diseases from the era before vaccines
(e.g., smallpox, polio and measles), diseases that have disappeared (e.g., smallpox) or only occur at
low levels (e.g., measles) in the USA today, while ignoring or minimizing the following critical
? Clean water, sanitation, basic food safety, improved housing, and antibiotics did
more to reduce the level of the disease-related injuries and fatalities from the highly
contagious and lethal diseases than the vaccines for them have done,
? Without any vaccine, scarlet fever, a highly contagious and lethal disease, has
? Many of today’s vaccines are for diseases that: a) are not highly contagious (e.g.,
influenza and hepatitis B) or b) do not have any significant mortality levels (e.g.,
chickenpox, mumps, rubella, and tetanus).
? The obviously vaccine-related increases in chronic diseases, especially chronic
diseases that have a significant autoimmune component, like asthma, multiple
sclerosis, chronic fatigue syndrome, lupus, and diabetes, to name a few, as well as
epidemic increases in abnormal childhood neurodevelopment, abnormal behaviors,
other developmental abnormalities and bowel disorders.
In addition, when we were first being sold on mass vaccination programs as a means to
protect the health of the public, we were told that a mass vaccination program for any vaccine
depended on the vaccine’s being effective and the mass vaccination program’s being cost effective.
Consider the “chickenpox” vaccination program where the vaccine, Merck’s Varivax®, is a
live-virus vaccine that infects every one inoculated with it with a certain strain, the Oka/Merck
strain, of herpes varicella zoster (HVZ) – a vaccine strain that is not effective in preventing
CDC Vaccine Price List (Prices last reviewed/updated: September 24, 2010): Merck’s HPV-Quadrivalent (Types 6,
11, 16 and 18) Recombinant Vaccine, Gardasil, US$ 130.27/dose; GSK’s HPV-Bivalent (Types 16 and 18)
Recombinant Vaccine, Cervarix, $ 128.75/dose, where both process include a US$ 0.75 excise tax nominally
collected for the NVICP in 10-dose vials: $1302.70 plus shipping and handling for each Gardasil vial and $1287.50
vial. The commercial list price costs of the two 3-dose series are US$ 390.81 and US$ 386.25, respectively.
from the pen of Paul G. King, PhD
everyone vaccinated, or even all of those with a “sufficient” vaccine-strain antibody titer level, from
also being infected by the “native”/“wild” strains of HVZ circulating in the USA.
When the initial licensing for this vaccine was sought in the 1990s, the justification for
licensing a chickenpox vaccine for a normally mild and innocuous childhood disease was that
vaccination was marginally cost-effectiveness on a societal productivity-loss basis under the
presumptions that: a) one dose of vaccine would provide lifetime protection for most young
children inoculated with the vaccine and b) there would be no serious adverse reactions to being
inoculated with the vaccine.
Yet, today, two doses of Varivax® are the minimum recommended for all children, and older
adults are being recommended to receive a dose of Merck’s Zostavax®, a higher-concentration Oka-
strain HVZ vaccine to “prevent” a recurrence of the HVZ (native or vaccine-strain) with which they
have been infected.
Without even considering the costs to treat those who have severe adverse reactions to the
Varivax or Zostavax vaccines, a conservative 2009 cost analysis placed the US excess shingles’
cases’ costs, caused by the US childhood chickenpox vaccination program, at US$ 700 million
Clearly, the Establishment has discarded the requirements for vaccine effectiveness and
In their place, Establishment profitability seems to have: a) overruled the federal
government’s concern for public’s fiscal and physical health and b) trumped the significant costs
from the collective long-term vaccination-induced physical harm, including maiming and death,
that some of those who are vaccinated suffer12 when the serious adverse effects caused by the initial
vaccine, Varivax® (which was claimed to cause no serious adverse effects in the FDA-
licensing/approval process), Merck’s MMR-Varicella vaccine, ProQuad® (which has a significantly
higher risk of serious adverse effects), and Merck’s shingles HVZ vaccine, Zostavax®, are factored
Currently, the Establishment is engaged in introducing vaccines, like Merck’s Gardasil® and
GlaxoSmithKline’s Cervarix®, with no proof of long-term effectiveness and self-generated, self-
serving “cost effectiveness”, which clearly ignore the costs to those who have had, are having and
will have serious adverse reactions
Furthermore, after their approval, the CDC immediately recommended mass vaccination
programs for these vaccines with almost no in-use proof of safety and no in-use proof of
effectiveness in preventing cervical cancer.
Worse, both the CDC and the FDA seem almost total indifferent to the hundreds of reported
vaccine-induced injuries as well as the tens of vaccine-linked deaths, which, quite predictably, the
Establishment attributes to mere coincidence.
In addition, the Establishment has introduced vaccines, like the current rotavirus vaccines,
that have clearly negative US cost-effectiveness (where the cost of the vaccination program far
Tellingly, before Merck’s Gardasil® HPV vaccine was introduced, Varivax consistently had the highest incidence
of adverse-event reports in the VAERS database in the 1990s and early 2000s.
exceeds the costs of the background level of rotavirus in the USA) and, for Merck’s genetically
engineered RotaTeq®, have clearly increased US rotavirus disease risk in those children and adults
who were previously “immune” to the native human rotavirus strains to which they have been
exposed during their childhood but are not protected from being infected by the genetically
engineered bovine-human hybridized viruses in Rotateq.
Moreover, the standards for licensing a vaccine in the USA have been reduced from the
vaccine: a) must be truly effective in preventing the disease in most of those who have been
vaccinated and b) must reduce the harm from the disease in those who are vaccinated and still
contract the disease as well as c) reduce the transmission of the disease to:
? In the case of the rotavirus vaccines, for the limited and biased clinical trials
conducted, the vaccines were approved based on a finding that the risk of the serious
harm caused by the vaccines is not statistically higher than the risk of harm caused
by the natural disease in the control population used in the phase-3 clinical trials.
? In the case of the human papilloma virus (HPV) vaccines, the vaccines were
approved based on claims that the vaccines may, in this instance, prevent some
vaccine-associated cervical cancers in some of the vaccinated women three to five
decades after they complete the initial 3-dose vaccination schedule, even though:
a. There is no proof that HPV infection causes cervical cancer — only proof that
HPV infection levels are associated with cervical cancer,
b. The “efficacy” data indicates a post-vaccination loss of efficacy in less than a
c. The strains of HPV in either vaccine (HPV types 6, 11, 16, and 18 in Gardasil
and types 16 and 18) are not even the major strains of the disease prevalent in
the USA – in fact the type 11 strain is almost non-existent (“0.1%”) in the US
d. The approvals are not questioned when the levels of adverse-event reports,
including serious maiming and death, currently far exceeds the level of the
other vaccines even though only a small percentage of the eligible population is
being vaccinated with these vaccines while the level of vaccination in most of
Dunne EF, Unger ER, Sternberg M, McQuillan G, Swan DC, Patel SS, Markowitz LE. Prevalence of HPV
Infection Among Females in the United States. JAMA. 2007 February 28; 297(8): 813-819.
The most common HPV types detected were HPV-62 (3.3%; 95% CI, 2.2%-5.1%) and HPV-84 (3.3%; 95% CI, 2.2%-
5.1%), HPV-53 (2.8%; 95% CI, 2.1%-3.7%), and HPV-89 (2.4%; 95% CI, 1.4%-4.3%) and HPV-61 (2.4%; 95% CI,
1.6%-3.8%) (FIGURE 2). HPV-16 was detected in 1.5% (95% CI, 0.9%-2.6%) of females aged 14 to 59 years. There
was no statistically significant difference in the prevalence of HPV-16 and the 13 more commonly detected types, except
for HPV-84 and HPV-62. HPV-6 was detected in 1.3% (95% CI, 0.8%-2.3%), HPV-11 in 0.1% (95% CI, 0.0 %-0.3%;
relative SE_30%), and HPV-18 in 0.8% (95% CI, 0.4%-1.5%) of female participants. Most participants infected with
HPV (60.1%) had only 1 HPV type detected (95% CI, 53.2%-67.9%); however, 23.9% had 2 types (95% CI, 18.3%-
31.3%) and 16% had 3 or more types detected (95% CI, 12.0%-21.2%). Overall, HPV types 6, 11, 16, or 18 were
detected in 3.4% of the study participants, corresponding with 3.1 million females with prevalent infection with HPV
types included in the quadrivalent HPV vaccine. Few participants (0.10%) had both HPV types 16 and 18 and none had
all 4 HPV vaccine types. At least 1 of these 4 HPV types was detected in 6.2% (95% CI, 3.8%-10.3%) of females aged
14 to 19 years.”
… Our data indicate that the burden of prevalent HPV infection among women was higher than previous estimates.
However, the prevalence of HPV vaccine types was relatively low”. [Emphasis added.]
the other vaccine programs that generate significant levels of serious adverse
events generally exceed 75 % of the population segments covered by the
5. “The Establishment’s Efforts To Increase Their Protection From Civil Lawsuits Are
Furthermore, through an appeal in Bruesewitz v. Wyeth being heard by the US Supreme
Court this Fall, the vaccine makers and the rest of the Establishment are essentially attempting to
have the Supreme Court rule that the 7th Amendment14 of the Constitution of the United States of
America, an integral part of the “Bill of Rights” reserved to the people of the United States of
America, does not apply to those who have suffered, or are the guardians of those who have
suffered, a vaccine-induced injury.
The artifice being used to carry this argument is that 42 U.S.C. § 300aa-22. Standards of
responsibility is an issue that can be decided once, and for all, by the judiciary, outside of a civil
trial by jury on the facts of each case.
This argument is being advanced even though, under the NVICP, the vaccine maker’s lack
of liability under § 300aa-22 is supposed to be the issue decided in the first phase of any vaccine-
related civil jury trial.
That such liability decisions belong to the trial jury is clearly set forth in § 300aa-23. Trial,
which at § 300aa-23(b), states:
The first stage of such a civil action shall be held to determine if a vaccine
manufacturer is liable under section 300aa-22 of this title”. [Emphasis added.]
Moreover, the Establishment’s arguments knowingly ignore § 300aa-22(b) with respect
“warnings”, in general, and § 300aa-22(b)(2), which states:
“For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper
directions and warnings if the vaccine manufacturer shows that it complied in all
material respects with all requirements under the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued
under such provisions) applicable to the vaccine and related to vaccine-related injury
or death for which the civil action was brought unless the plaintiff shows – …”
? As the putative causative DTP vaccine in question is a Thimerosal-preserved vaccine
given to the child and
? The vaccine manufacturers have admitted knowingly failing to comply with Title 21
of the Code of Federal Regulations (21 CFR) as set forth in section 610.15(a) (21
CFR § 610.15(a)), which requires the level of preservative must be proven to be
“In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall
be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than
according to the rules of the common law”.
“sufficiently nontoxic so that the amount present in the recommended dose of the
product will not be toxic to the recipient”, in testimony given before a Congressional
committee which investigated the vaccine makers and the US Food and Drug
Administration’ actions from 1999 and which subsequently published a formal
Congressional report, “Mercury in Medicine – Taking Unnecessary Risks” in 200315
and the requirement in question is a material requirement under the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as well as a safety regulation issued
under the provisions in “section 262 of this title”16 [emphasis added],
the Wyeth defendant is clearly guilty of failing to comply “in all material respects with all
requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section
262 of this title (including regulations issued under such provisions) applicable to the vaccine and
related to vaccine-related injury or death for which the civil action was brought”.
Moreover, recognizing defendant Wyeth’s knowing and intentional failure to comply with
the black letter law, the US Supreme Court should, when it hears the case this Fall: a) find for the
Bruesewitz plaintiffs and b) take whatever actions needed to ensure that the Bruesewitz plaintiffs
are awarded appropriate punitive damages for defendant Wyeth’s knowing and willful failure to
comply with 21 CFR § 610.15(a) for the preservative Thimerosal in the vaccine that caused the
harm to the Bruesewitz child.
However, given the Establishment’s denial of reality of vaccine-induced mercury toxicity in
susceptible children, like the Bruesewitz child, who were, and are still being, given vaccines
preserved with Thimerosal (49.55% mercury by weight) and the power that the Establishment
wields, the people will be lucky if the US Supreme Court finds for the Bruesewitz plaintiffs.
Finally, should the US Supreme Court find for Wyeth, then, the people will most assuredly
know that both the Establishment and the US Supreme Court are knowingly severing those who
bring vaccine cases against the vaccine manufacturers in the legal manner provided by NVICP from
the right to a civil jury trial for damages that is supposedly guaranteed by the 7th Amendment to the
Constitution of the USA.
6. “The ‘Life Saving’ Annual Influenza Vaccination Program”
Factually, there is no scientific proof that the influenza vaccine prevents even most (> 50%)
of those who are “vaccinated” with an influenza vaccine from contracting and spreading influenza
during the “flu season” – none whatsoever (see, for example, Geier DA, King PG, Geier MR.
Influenza Vaccine: Review of Effectiveness of the U.S. Immunization Program, and Policy
Considerations. J. Am. Physicians and Surgeons 2006 Fall; 11: 69-74 [the only US-population-
See Finding 3, “3. Manufacturers of vaccines and thimerosal, (an ethylmercury compound used in vaccines), have never
conducted adequate testing on the safety of thimerosal. The FDA has never required manufacturers to conduct adequate safety
testing on thimerosal and ethylmercury compounds” (page 6), in May 2003, Subcommittee on Human Rights &
Wellness of the Government Reform Committee, US House of Representatives (Chairman Dan Burton – following
a 3 year congressional investigation), “Mercury in Medicine – Taking Unnecessary Risks” pgs 1-80 and, in
abbreviated form, published in the Extended Congressional Record: Subcommittee on Human Rights and Wellness,
Committee on Government Reform of the House of Representatives, “Mercury in Medicine Report,” Washington,
DC, as published in the Congressional Record, pgs. E1011-E1030, May 21, 2003
Here, “this title” is “TITLE 42 – THE PUBLIC HEALTH AND WELFARE” of the United States Code.
wide retrospective of in-use effectiveness evaluation – not model – for the influenza vaccination
programs in the USA for the years 1979 through 2001]); and other unbiased independent studies as
well as the independent reviews of the published studies (see, for example: Jefferson T, Di
Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing
influenza in healthy adults. Cochrane Database of Systematic Reviews 2010, Issue 7. Art. No.:
CD001269), which clearly show that the inoculation of populations with influenza vaccines, both
inactivated- and, more recently, live-virus, is not effective in preventing those who are inoculated
from getting “influenza” during the “flu season”.
Furthermore, there is some evidence that getting an influenza inoculation in one year may
increase the inoculated individual’s risk of contracting an influenza infection in a subsequent year
Additionally, a recent double-blind clinical trial study found that supplementation with
vitamin D-3 was much more effective in preventing influenza-type-A infections than influenza
vaccination (see: Urashima M, Segawa T, Okazaki M, Kurihara M, Wada Y, Ida H. Randomized
trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin
Nutr. 2010 May; 91(5): 1255-1260. Epub 2010 Mar 10. PMID: 20219962).
Finally, as is usually the case, Establishment’s fear mongering and propagandizing carefully
hides the fact that influenza is not a highly contagious disease (see: Cannell JJ, Zasloff M, Garland
CF, Scragg R, Giovannucci E. On the epidemiology of influenza. Virol J. 2008 Feb 25; 5: 29 [Note:
Among the issues this electronically published review article addresses is the absence of any valid value for the sick-to-well infectivity for human influenza in spite of numerous attempts to determine even a valid estimate, which clearly establishes that influenza is not highly infective.]).
Thus, the Establishment is recommending mandates for various groups of people, and the
State of New Jersey is currently mandating, a non-effective vaccination program for a disease that is
not highly contagious on the grounds that, to say the least, this less-than-scientifically-sound, non-
effective prophylactic treatment, influenza vaccination, will somehow protect those who submit to it
from spreading a disease that it does not prevent them from contracting, and, when those inoculated
get the live-virus vaccine, a disease with which those receiving it not only are directly infected by
three strains of live viral influenza but have also been shown to shed the live virus for at least 21
days after being inoculated with said live-virus vaccine.
Furthermore, in spite of an ever-increasing body of evidence that vitamin D-3
supplementation is a more effective preventive for type “A” influenza than any influenza vaccine,
this Establishment continues to ignoring this proven and highly effective prophylactic use of
vitamin D-3, which protects all against contracting all strains of type “A” human influenza, instead
of suboptimal protection from getting the two (2) type A strains of flu in the flu vaccine.
Obviously, the Establishment’s recommendations and actions are not grounded in sound
science nor based on public health concerns; they are clearly driven by other imperatives.
7. “Medical Mandates Are Required For The ‘Greater Good’”
Whenever this author hears any group or zealot, including any vaccine apologist,
recommending that any person should surrender his or her right to make his or her own informed
medical decisions to some “higher authority” (be it employer, state or nation) “for the greater
good”, this commenter knows that the group or person advocating for such is a medical fascist17
who is seeking to take away our personal freedom to make medical choices for ourselves and those
for whom we are responsible and who is advocating for a “religious cult”, the cult of the “public
health” vaccinationists, who seek to mandate that all must sacrifice or risk sacrificing some aspect
of their own or their children’s health on the vaccine altar “for the greater good” – the good of the
Establishment – of which the group or individual demanding the surrender of the rights to informed
choice and consent is a well-paid member, who depends on promoting these sacrifices for his or her
status, position, and/or livelihood.
8. “Vaccines, the Safest of Prophylactic Healthcare Measures”
We are repeatedly sold the myth that “vaccines are the safest disease-preventive medicines”,
when the truth is that, as a group, they are the least safe of disease-preventive medicines (see: Neil
Z. Miller’s Vaccine Safety Manual For Concerned Families and Health Practitioners, 2nd
edition (2010), ISBN 978-188121737-4) and the only class of prophylactic medicines for which
there are no long-term safety studies and, increasingly, not true-placebo-controlled short-term large-
scale safety studies (in a vaccinated versus totally unvaccinated [using sterile isotonic pH-balanced
saline for the controls] with > 50,000 in each arm of the study).
In addition, instead of proof of effectiveness and long-term (lifetime [> 50-year protection])
effectiveness, we are given antibody-titer-based measures of claimed efficacy of limited duration
(typically, 10 years or less) for “most vaccines” after typically 2 to 5 inoculations for most
(typically, > 60%) of those who are initially inoculated multiple times, with a carefully concealed
reality that each such inoculation campaign kills a few18 who are inoculated and harms some
additional multiple of that number each year to varying degrees.
9. “Vaccines Do Not Cause Autism Or Any Other Chronic Medical Condition”
How much longer will Americans tolerate the increasingly obvious lie that the
Establishment’s vaccination programs are not a causal factor in ‘Autism’ and other chronic
childhood medical conditions that once were rare (< 1 to 2 instances in every 10,000 children) but
are now at epidemic levels (> 1 instance in every 10 to 1,000 children)?
How much longer will the American public continue to tolerate the epidemics of chronic
diseases; and epidemic rates of chronic disease that, for asthma, now exceed 10 % of our children
and, in the aggregate, have brought us to a nation where, in 2006, more than 25%19 of our children
have at least one chronic lifetime medical condition so that the Establishment may continue to grow
Defined here as any member of medical community who favors dictatorial medicine where all medical decisions
are under the control of the “medical police” and “medical courts”; and the individual has no rights to make his or
her own informed medical decisions without fear of any retribution, ostracism or oppression.
Based on the reality that vaccination accounts for most of our excess infant mortality rate over that infant mortality
rate in Japan in the first year of life, this “few” deaths per vaccination collectively translates to about 2 per 1,000
live births or about 8,000 – 9,000 newborn babies in the USA each year.
“The rate of chronic health conditions among children in the United States increased from 12.8% in 1994 to 26.6%
in 2006”. [http://www.medscape.com/viewarticle/717030?sssdmh=dm1.591574&src=nldne&uac=140083MY] [Note: 26.8/12.8 is about a
factor of 2.1 – without considering the increase in population of children by about 50% – making the population
percentage increase not 210 % but rather 300+ %.]
and profit at the expense of the increasing damage to the fiscal and physical health of ourselves and
How much longer will the American public be blinded by the propaganda spewed forth
daily by these servants of greed who have been and are knowingly sacrificing our health and
prosperity so that the Establishment they serve may continue to grow in size and profit while our
fiscal and physical health is stolen from us?
Even though this commenter cannot answer for those who read these questions, his past and
on-going efforts clearly point out the reality that he has lost his tolerance for the status quo and, with
eyes wide open, he is seeking to open the eyes of the public to the preceding realities and to march
with that informed and enlightened public to change the USA, not for the “greater good”, but rather
for a return to a system of laws in which the rights of every competent citizen are respected and
everyone has the freedom to freely choose, or reject, all prophylactic vaccination programs without
any penalty, stigma, or recriminations from those who do not share the same views.
In addition, this commenter is: 1) seeking to change the laws protecting the Establishment’s
vaccine purveyors from being held directly accountable for the harm their vaccine products cause
and the lack of safety and/or appropriate effectiveness of many of their vaccine products and 2)
hoping that, after reading this commentary, those who ‘get it’ will join with this commenter in
demanding: a) direct vaccine purveyor accountability and b) the absolute right to choose which, if
any, vaccination programs and when, if ever, the vaccines chosen should be administered – or,
simply, “opt in” vaccination laws in every State, which would repeal the current mandates and
eliminate any and all need for an exemption of any type from any prophylactic or other vaccination
About Paul G. King, PhD
Paul G. King, PhD Analytical Chemist, is a scientist who has studied both vaccines and
vaccination programs intensively for more than a decade and has sorted out the underlying science
to the extent that he could find such from all of the published information available from those with
differing views about vaccination and vaccination programs.
If any, after reading this article, any reader finds any significant error for which there is
unbiased science that clearly supports your alternative views, then, by all means, send your
alternative view or views and their supporting documentation to me through firstname.lastname@example.org and, if
your studies are truly unbiased, this author will be glad to: a) modify his views accordingly and b)
publish an updated article. If you find areas where the text has grammatical, spelling or word-
usage errors, please let the author know so that he may appropriately correct them and published a
revised version of this article.
For additional information about Dr. King and his interests, the reader can visit his
personal web site, http://www.dr-king.com/.
I really like the work that the Environmental Working Group does and often applaud them publicly. Until today.
Today, this environmental and social policy group took a giant step backwards and fell off the cliff into the filth below,as far as I am concerned.
I read with distress and disgust that they were supporting the passage of S. 510, the phony “PHUDE” “Safety” Bill and decided that I had to urge them to review and revise their anti-health, anti-freedom, pro totalitarian policy in support of S. 510.
Shortly after I wrote and sent it, I saw that another group, NJPRIG, is also endorsing this awful bill. Having just spell checked this one, I had it ready to go.
Please feel free to use this letter, or the material contained in it, to send letters to persons and organizations endorsing these bills, to modify so that they become letters to the Editor, etc. Use it or we ALL lose it!
I am disappointed and deeply concerned that your organization has decided to support the draconian, dangerous and destructive fake Food “Safety” Bill, S. 510. The estimated cost of first year implementation will be $825,000,000 (Section 401).
Since factory food, not local, organic and family farm food, is responsible for the atrocious level of food safety in the US food supply, it is the de-industrialization of our food supply which will protect our health and increase food safety, not the reverse. The bill, of course, gives more power to the FDA to abuse, more money to that organization to spend on policies which have shown no success in the past in controlling food-borne illnesses and new resources to damage clean food source operations and their ability to remain in business legally.
The bill also brings into force the complete HARMonization of the US with Codex Alimentarius, an international body led by the US demands for corporitization and industrialization of the global food supply to the degradation of that food supply through irradiation, chemical contamination and unproven, unsafe GMOs.
Specifically, the bill as written, in effect, incorporates the “HARMonization” provisions of the discredited “Dietary Supplement Safety Act” S.3002 and actually calls upon the FDA to recommend harmonization of American nutritional freedoms with Codex Alimentarius’ restrictions.
– Section 404: “Nothing in this Act… shall be construed in a manner inconsistent with… any …treaty or international agreement to which the United States is a party.”
– Section 306(c)(5): “Recommendations on whether and how to harmonize requirements under the Codex Alimentarius.”
While I concur that the amendment re: BPA is a good idea, the bill to which it is attached will not increase food safety, but rather will cataclysmically diminish food safety by industrializing the entire US food supply.
Small, local and organic farmers, whose food is not the source of food-born illnesses, will be forced out of business if they cannot meet the expensive, ineffective and unnecessary standards of reporting, seed sorting facilities and other equipment requirements and so forth which Agribiz is capable of meeting.
For example, the ancient, and vital practice of seed saving to improve stock will only be possible under this bad bill if there is a facility devoted to each species of plant, say, one for tomato, one for broccoli, one for eggplant, on the farmer’s property: each such facility will cost between $1M and $1.5M. Clearly, this is a purposeful maneuver to make the act of seed saving a crime for the small farmer.
The bill as written threatens small farm, home, local/organic and community food production with onerous rules that, while perhaps appropriate for industrialized food production, will create impossible “barriers against entry” that will rapidly destroy such local and natural production. No protective language is included in the Senate bill that satisfies these concerns.
Heretofore, food and drug regulations in the United States have been public documents of record and, as such, available to the public. S. 510 changes that and in Section 106 provides in part for the regulations issued to be kept secret from the public, “In the interest of national security, the Secretary … may determine the time and manner in which the guidance documents issued under paragraph (1) are made public…”
As the Medical Director of the Natural Solutions Foundation, www.HealthFreedomUSA.org and www.GlobalHealthFreedom.org, the world’s largest health freedom organization, and as a personal supporter of your previous work and positions, I must urge you to carefully reconsider the position your organization has taken on this dangerous, unnecessary, expensive and destructive bill.
Rather than support it, the Natural Solutions Foundation has urged Health Freedom Advocates and Activists to correspond with their Senators and other decision makers to oppose this legislation, making sure that it is NOT passed by Unanimous Congressional Consent or by any other means. Our Action Item is here: Stop S.510! http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=4613
To date, our supporters have sent 358,700 emails urging the defeat of S. 510.
We invite you to revise your organizational policy and urge your supporters to join ours in doing the same.
Please feel free to contact me for additional information or dialogue on this vitally important and timely issue.
Yours in health and freedom,
Rima E. Laibow, MD
Natural Solutions Foundation
Half of All FDA Approved Drugs are Quietly Withdrawn Within 5 Years of Approval
“FDA approved” drugs means “safe”, right? Clinical trials show that drugs and vaccines are safe or they wouldn’t be allowed to be marketed, right? Drug companies have to report what actually happens in a clinical trial, right? Once a drug is approved by the FDA for market release it stays available for a long time, right?
Lethal and potentially lethal side effects from FDA approved drugs are rare, right?
The answer to these questions is one big collective, “NO!!!!!”
Here are the facts: Drug companies are free to suppress negative clinical trial information with impunity. That is not how the system is designed to work, at least on paper, but it is the way things work in the real world.
Drugs, all drugs and vaccines, enter Phase IV clinical trials when they are released for general use. Depending on how many people they kill, maim, blind or cause to suffer once doctors start prescribing the drug for whatever the FDA has approved it for, although they can use the drug for anything they want to (called “off label prescribing”). Even the callous, corrupt and conflict-of-interest-riddled FDA withdraws approximately 50% of all approved drugs within 5 years of approval because they are just too toxic to continue on the market.
How did they get approved in the first place? Well, as you will see when you read the articles below, drug companies disregard the requirements to be honest in reporting data as they choose. Given that it can cost up to a billion dollars (yes, you read that right, a billion US dollars) to research a drug and bring it to market, there is an enormous amount of pressure to get the drug into the patients’ hands by putting it in the doctor’s mind and getting it onto his/her prescription pad – no matter what.
One of the may ways drug companies accomplish what they want – drug sales, is to lie about how many people die or drop out in drug trials.
Another way is by literally purchasing the decision-makers for stock options, research grants and other inducements plucked fresh from the abundant and ever self-replenishing FDA Corruption Tree.
The results? Pharmaceutical Mayhem. Drugs are the leading cause of death in the US and every other “developed” nation. But, not to worry, the FDA is on the job.! Oh, good. I was worried there for a moment!
You know, insultingly enough, the FDA expects you to believe that these deadly drugs released to the public to see what happens (and what happens is mayhem and murder much of the time) could possibly be an accident? Neither do I. Remember, these same drug companies are big players at Codex. They are the heirs and legatees of the German genocidalists who created Codex Alimentarius, now degrading the world’s food supply as a stepping side to “the Great Culling”, the death of 90% of the world’s population.
Bottom line, from where I stand? If you are not in an Emergency Room, there is, in my experience and belief, no reason to take drugs when inexpensive, gentle, effective and powerful natural options exist through orthomolecular medicine, homeopathy, naturopathy, chiropractic, acupuncture, Bio Acoustics, NeuroBioFeedback, Frequency Medicine, chelation, detoxification and a host of other helpful, safe techniques await your decision-making. But that is the very point, isn’t it? If you are an immensely powerful drug company and you know that your drugs are toxic, expensive, dangerous, poorly conceived and poorly tested, grossly dishonestly marketed what would you do? Jeopardize your cash bonus and tell the truth, wasting a billion bucks? Probably not. Probably you would do what the drug companies (and the BioTech companies which make GMOs and are usually one and the same as the drug companies!). You would lie, and lie big!
“These drugs are safe.” “The clinical trials show it.” “People do not get sick from our drugs.” “We followed the rules.” “You can trust us!”
Stuff and nonsense!
Yours in health and freedom,
Rima E. Laibow, MD
Ana Cantu was a Human Guinea Pig in a Drug Trial for $4,800
Vera Hassner Sharav
Monday, 26 July 2010
“The study started out with 20 subjects…For about a week there were 14 subjects. Then they started dropping…Now, we’re down to 7.”
Below, a testimonial by Ana Cantu who was one of the healthy volunteers –“a human guinea pig” as she describes herself– in a month long study that tested the effects of Norvir, an HIV drug made by Abbott Laboratories, when coupled with the antidepressant Wellbutrin, made by GlaxoSmithKline.”
Her first-hand experience provides insight about the immense “pressure for positive results in clinical trials,” the level of discomfort a human subject is expected to endure from the adverse effects of the tested drug (or combination of drugs), and the dilemma for drug manufacturers whose drug causes adverse effects so severe, the test subjects in pre-marketing trials drop out in droves. The FDA accepts study results–even if only 7 of 20 subjects complete the study. Companies are loathe to scrap a negative study: they hold on to the last 7 subjects despite severe adverse effects. The “volunteers” suffer for the payment which they would forfeit if they quit.
Ana describes how and why corporate sponsors–in her case, GSK and Abbott Labs–conceal adverse event data that may damage a drug’s chances for approval.
Despite federal law requiring companies to fully disclose to the FDA all adverse events in pre-marketing clinical trials, drug companies have repeatedly violated the law with impunity: they have failed to include in their submission of data to the FDA, the worst adverse events suffered by subjects who, as a result, dropped out of the trials.
Her observations, published in The American Statesman (below) are disturbing and insightful:
“The study started out with 20 subjects, but 6 were eliminated during the in-patient stay by the drug company sponsoring the trial for various reasons (including drinking caffeine within 24 hours of check-in). For about a week, there were 14 subjects. Then they started dropping. The first one to go was a girl with a pronounced Texas twang named Denise, who had severe jaw and tooth pain. Then extreme nausea and emesis (the clinical term for vomiting, I discovered) claimed April. Jo Kay, Paula, Amy, Alyssa and Carrie went one after another. Now we’re down to 7.”
Ana experienced severe black outs–clearly an adverse effect of the experimental drug–but she was kept in the trial against her best interest:
“The day got off to a bumpy start when I started to black out while reporting my side effects. Darkness closed in from my peripheral vision and then I saw nothing but big colored spots.
“That morning, we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor. I knew I hadn’t fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn’t on my feet for too long. The doctor cleared me to keep dosing.”
Ana explains why her continued “participation” in the trial–disregarding the danger the black outs posed to her well-being–was to accommodate the sponsoring company’s need to maintain a minimum of 7 subjects in the trial:
“The drug company had a dilemma. To submit trial results to the FDA, the study couldn’t fall below seven participants. But, unfortunately, one showed signs of serious side effects and if those results were submitted, approval was highly unlikely. If my results were dropped, the FDA would never know about the problem and the drug company could start fresh with a third trial. However, the first clinical trial had to be scrapped because too many subjects dropped out as a result of their side effects, and it looked like the second study could soon follow the same path. To gather enough healthy volunteers who fit the protocol for a third trial would require a lot of time and money, and it wasn’t something the sponsor was willing to do. So, in the end, my results and I stayed in the study.”
“Because the trial ended with the magic number of seven volunteers, the results could be submitted for review and the FDA had the opportunity to see the data. But what happens in the trials in which drug companies drop some of the subjects with the worst side effects?”
Ana Cantu’s first-hand experience confirms the finding reported by FDA’s safety officer, Dr. Thomas Marciniak, who analyzed the raw data from GSK’s Avandia trial, and found that the company concealed from the FDA the worst adverse event data, resulting in its approval precipitating preventable heart attacks and deaths.
An editorial in today’s New York Times, calls upon the FDA to revoke its questionable approval of Avastin for breast cancer because it failed to extend patients’ lives while it caused serious side effects. The drug had gained “accelerated approval” without adequate testing.
Cantú: Anatomy of a drug trial
By Ana Cantú
AMERICAN-STATESMAN Friday, July 23, 2010
Exactly five years ago, in exchange for the most miserable month of my life, I got paid $4,800 to test the effects of a drug made by GlaxoSmithKline.
You know where you’ve heard the name GlaxoSmithKline recently, right? That’s the company on the verge of losing the approval of the Food and Drug Administration for the diabetes medication Avandia after regulators discovered omissions in a key clinical trial report. On Wednesday, the FDA ordered Glaxo to stop enrolling people in another Avandia trial.
According to a review reassessing the drug’s safety by the FDA’s Dr. Thomas Marciniak, a number of patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events, otherwise known as side effects.
Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” he wrote.
It can cost hundreds of millions of dollars — in some cases, close to a billion — in research and development for a drug company to secure FDA approval.
By the time a drug gets to point where it can be tested in humans, the pressure for positive results in clinical trials is immense. And I found that out first-hand when as one of the healthy volunteers — a human guinea pig — in a study that tested the effects of Norvir, an HIV drug made by Abbott Laboratories, when coupled with the antidepressant Wellbutrin, made by GlaxoSmithKline.
In exchange for that $4,800 paycheck, I spent about a month going in and out of a blocky silver building in an office park not far from Austin-Bergstrom International Airport, the site of a contract research lab that conducts medical studies.
During the lab’s second clinical trial of the Norvir-Wellbutrin combination, which I chronicled in a personal blog, I was known only subject No. 40.
July 12: I check in tomorrow for 4 days. I’ll be taking an antidepressant and an AIDS drug in combination for about a month.
July 13: The facility is freezing. We’re still waiting on blankets. I should’ve brought a hat and gloves. You can tell the people who do studies regularly by their baggage — they bring extra pillows and blankets and huge rolling suitcases. The building is pretty new and it’s painted in all kinds of “modern” colors like bile, which complement the black-and-white tiled floors nicely. Subjects sleep 8 to a room in bunk beds, though there are only 3 people in my room. …
My first dose of Wellbutrin is tomorrow. I hear it gives you crazy dreams.
July 14: I’ve been stuck so many times today I feel like a junkie. I had to be up by 6:12 a.m. to check vital signs and get a pre-dose blood draw. Then I had breakfast, which I had to finish: two potato, egg and cheese tacos with pico de gallo and a carton of 2% milk, which I don’t like. I took the Wellbutrin at 7:27, so precisely every hour after that I’ve been having blood drawn. For the rest of the day, it’s blood draws only every 2 hours. I carry around a clipboard that has all my procedures and meals scheduled — everything has to be done exactly as it says on the sheet or they can dock pay off your study-completion bonus.
Amusing sign near the toilets: Please do NOT use cellphones in urine monitoring stations.
July 15: Dinner was decent — teriyaki chicken, rice, salad with Italian dressing, a hunk of zucchini bread and a sugar cookie. I tried the cookie and didn’t like the aftertaste so I hid it in a spare napkin and arranged everything else on the tray to conceal it. The cafeteria workers check how much of our food we eat — we’re supposed to finish at least 50% of everything. Sometimes it’s hard, like with yesterday’s trail mix. I hope we get a good snack, which I will take my first bite of at precisely 9:32 p.m.
About half of the subjects have done trials before and say that ours isn’t so bad, even with all the blood draws. Apparently, there are some where you have them every 15 minutes. …The people who usually play Monopoly switched to Uno.
July 18: Yesterday I had my first bad blood draw.
July 20: Tomorrow I start my doses of Norvir, the AIDS drug. Fun, fun.
July 23: I started on the AIDS drug on Thursday — 300 mg twice a day. The dosage gets upped to 400 mg tomorrow. I don’t feel bad yet, though I’m sleeping less than normal. And today my stomach objected to the egg facsimile we had to eat.
July 25: I was pretty excited that I didn’t get sick after my dosings. … I think the secret is to not drink the milk. And not to eat more than 50% of the food. I’m becoming an expert in artfully rearranging things on my plate so it looks like I’ve eaten. They (try to) make us eat after taking the giant AIDS pills, but since we get the same few meals over and over, it’s gotten really hard to do. Plus, there’s a chance you’ll get sick after so you really don’t want to see nasty food twice, if you get my meaning.
July 28: I discovered that I feel better if I don’t eat after taking the horse pills. This morning, I refused to eat the breakfast tacos and felt fine. So I followed the same strategy at dinner — I did eat the peas and carrots and drank some caffeine-free root beer, but most of the meal was untouched.
Over the course of the trial, as a result of a near-constant state of nausea, I lost about 10 percent of my body weight.
To keep up my strength, for lunch, I’d go to a fast-food restaurant and order the heaviest combo on the menu (double bacon cheeseburger, fries and a huge non-caffeinated beverage) and eat as much as I could before I started to feel sick again.
Every night, insomnia cut my sleep to three hours.
Aug. 1: The study started out with 20 subjects, but 6 were eliminated during the in-patient stay by the drug company sponsoring the trial for various reasons (including drinking caffeine within 24 hours of check-in). For about a week, there were 14 subjects. Then they started dropping. The first one to go was a girl with a pronounced Texas twang named Denise, who had severe jaw and tooth pain. Then extreme nausea and emesis (the clinical term for vomiting, I discovered) claimed April. Jo Kay, Paula, Amy, Alyssa and Carrie went one after another. Now we’re down to 7. In what I view as biological injustice, none of the males have shown noticeable symptoms.
Aug. 2: I had to go see an opthamologist today, just for my safety, since I reported a migraine with aura a few days ago. Unfortunately, I’m fine. Curses. I was hoping I could get medically excused from the study — that way I’d still get paid. But it looks like I’m going to have to finish it. Only 10 more days of dosing to go. My current side effects include oral numbness and tingling in my extremities.
Aug. 6: It’s another day in lockup: cloudy skies (I think) and cold air conditioning. The day got off to a bumpy start when I started to black out while reporting my side effects. Darkness closed in from my peripheral vision and then I saw nothing but big colored spots.
That morning, we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor. I knew I hadn’t fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn’t on my feet for too long. The doctor cleared me to keep dosing.
A few days after my first blackout episode, during a scheduled outpatient visit, one of the study coordinators said I had to be examined by the on-staff doctor. “Why?” “The sponsor is concerned about your side effects,” she said.
The drug company had a dilemma. To submit trial results to the FDA, the study couldn’t fall below seven participants. But, unfortunately, one showed signs of serious side effects and if those results were submitted, approval was highly unlikely. If my results were dropped, the FDA would never know about the problem and the drug company could start fresh with a third trial. However, the first clinical trial had to be scrapped because too many subjects dropped out as a result of their side effects, and it looked like the second study could soon follow the same path. To gather enough healthy volunteers who fit the protocol for a third trial would require a lot of time and money, and it wasn’t something the sponsor was willing to do. So, in the end, my results and I stayed in the study.
Aug. 21: So yesterday I had the exit screening/physical for my drug study. I had to have my blood pressure checked 3 times because it was low, even for me. The paramedic checked me, but I was asymptomatic. She asked how I was feeling. “Fine, especially now that I’m off the drugs.” She said, “Well, it was for the good of mankind.” “I guess … and the money.”
Because the trial ended with the magic number of seven volunteers, the results could be submitted for review and the FDA had the opportunity to see the data. But what happens in the trials in which drug companies drop some of the subjects with the worst side effects?
Actually, we’ve seen what happens — with Avandia.
When a Drug Fails
THE NEW YORK TIMES July 25, 2010
The flameout of an enormously expensive drug to treat advanced breast cancer will pose a critical test for the Food and Drug Administration. Will the agency have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up studies?
Two years ago, the F.D.A. gave Avastin, which is made by the Genentech unit of Roche, “accelerated approval” as a treatment for breast cancers that have spread to other parts of the body. Such cancers are essentially incurable so the best that current treatments can do is extend a patient’s life.
The hurry-up mechanism allows approval of a drug that has not yet been proved safe and effective in thorough clinical trials but has shown promise that it might benefit patients with life-threatening diseases. Rather than make such patients wait, they are treated with the drug while the manufacturer completes additional tests.
When Avastin was granted “accelerated approval” to treat advanced breast cancer, the primary evidence was a single clinical trial. It found that Avastin, when used with another drug, slowed progression of the disease but did not significantly extend patients’ lives.
Now two follow-up trials by the manufacturer have failed to confirm even those meager gains. In the initial trial, Avastin held tumor progression at bay for five and a half months. In the two new trials, pairing Avastin with different chemotherapy drugs, the delay in tumor worsening was much shorter: up to three months in one trial and less than a month in the other. The Avastin combinations also caused serious side effects.
Britain’s National Institute for Health and Clinical Excellence, a pace-setter in evaluating medical advances, issued draft guidance this month against using Avastin for advanced breast cancer patients in the National Health Service. It called the clinical trial data “disappointing” and the cost “too high for the limited and uncertain benefit it may offer patients.”
By a 12-to-1 vote last week, an F.D.A. advisory committee quite sensibly urged the agency to revoke Avastin’s approval for breast cancer. That would not affect its other approvals, gained through the standard regulatory process, for treating colon, lung, kidney and brain cancers. Avastin would remain available to doctors for off-label use against breast cancer. Many insurers, however, might refuse to cover an unapproved use.
The cost of Avastin has always seemed outrageously high for the medical benefits it confers. The wholesale price for a typical breast cancer patient is about $88,000 a year. Genentech has been capping annual spending at $57,000 for patients with incomes below $100,000.
The F.D.A. has rarely removed drugs that were given accelerated approval and sometimes has failed even to compel completion of follow-up studies. But there are signs it may get tougher. In June, the agency finally forced a leukemia drug off the market that had been given accelerated approval a decade ago, after a long- delayed follow-up study showed no clinical benefit and an increased risk of death. With Avastin, the follow-up studies were completed in a timely manner — with such meager results that withdrawal seems the right response.