Ethical Guidelines for Clinical Trials Prevent Many Vaccines From Being Adequately Tested For Safety

The CDC (Centers for Disease Control), the WHO (World Health Organization), the National Institutes of Health (NIH), and the FDA (Food and Drug Administration) are considered by most Americans to be the most credible, trusted sources of “unbiased” information regarding disease, medical treatment, and the safety of pharmaceuticals. Your doctor and the entire medical community base their decisions about your care on recommendations from these organizations, which are theoretically based on the studies brilliant, highly-qualified scientists perform for these organizations. These organizations publicly publish this information so that anyone who wishes to educate themselves can do so.

That is precisely what millions of Americans, including myself, are now doing when it comes to the subject of vaccine safety. Unfortunately we are finding that these “trusted” recommendations are not adding up with the information provided by their own sources and many times are blatantly at odds with this publicly published information. I’m going to clearly demonstrate that to you today.

The focus of this article is the following claim publicly stated by the CDC:

“Before vaccines are approved by the Food and Drug Administration (FDA), they are tested extensively by scientists to ensure they are effective and safe.”

How do scientists test vaccine safety?

There are 3 phases in prelicensure vaccine safety testing as described by the FDA. According to the FDA, “Clinical trials are conducted according to plans that FDA reviews to ensure the highest scientific and ethical standards. The results of the clinical trials are a part of FDA’s evaluation to assess the safety and effectiveness of each vaccine.” Herein lies the rub.

What are the highest scientific standards when it comes to determining safety?

According to the NIH, randomized double blind placebo control studies are the “gold standard.” The NIH goes on to state that, “RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect.”

The problem is, most vaccine studies are not RDBPC due to the ethical standards that must be maintained.

The fact is most vaccine safety clinical trials do not and cannot use a placebo in the truest sense of the word. According to the CDC’s own glossary of terms, a placebo is, “a substance or treatment that has no effect on human beings.” In the case of vaccine testing, a true placebo would have to be an injectable substance that is completely inert, such as saline solution for example. However, that is NOT what is predominantly used in vaccine trials.

If they aren’t using true placebos, what are they using?

According to the 2013 WHO Expert Consultation on the Use of Placebos in Vaccine Trials, the following replacements are used in lieu of a true placebo:

    • “In place of a placebo, a vaccine against a disease that is not the focus of the trial is given to participants who do not receive the trial vaccine.”

Or, an “add-on” vaccine can be used:

    • “In this design, the trial vaccine or placebo product is mixed with an existing vaccine not studied in the trial, and the subjects are given either (a) the trial vaccine mixed with the existing unrelated vaccine or (b) the combination of a placebo and the existing unrelated vaccine.”

Yes, you read those correctly! These vaccines are not being tested for safety against substances that are known to be safe. They are tested against other vaccines which contain the same or similar toxic ingredients common to all vaccines. Some trials are performed using “add-on” vaccines as a placebo. In these cases, potentially everyone in the trial is injected with the actual vaccine being tested! It doesn’t take a rocket scientist to deduce that these methods are unacceptable when the goal is to ascertain safety.

The WHO freely admits this:

“A methodological disadvantage, however, is that trials using these types of placebos provide a less perfect control. It may be difficult or impossible to assess fully the safety and reactogenicity of the trial vaccine, although its efficacy can usually be assessed satisfactorily.” (emphasis mine)

(Reactogenicity is the ability of the vaccine to cause adverse reactions.)

“Methodological disadvantage!?” That’s the understatement of the century!

Let’s look at some very disturbing clinical trial data for a few of the vaccines the CDC recommends. Each vaccine is linked to its package insert so that you can read this information for yourselves:

Engerix B Hepatitis B vaccine (Recombinant) GlaxoSmithKline

“Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines…All subjects were monitored for 4 days post-administration.”

This study doesn’t prove that this vaccine is safe. Plasma derived vaccines were used in the control group instead of a placebo. It demonstrates that this vaccine doesn’t cause any more or any worse adverse effects than other vaccines cause- at least within the 4 day time frame the subjects were monitored.

This vaccine is given to babies on their very first day of life whether they are at risk for Hep B or not. Only babies born to Hep B positive mothers are at risk for Hep B. For millions of babies this vaccine is a completely unnecessary risk that provides them with absolutely zero benefit.

Infanrix (DTaP) GlaxoSmithKline

Table 4, on page 18 shows that Infanrix was not compared to a placebo, it was compared to the whole cell DTP vaccine.

According to WHO, acellular vaccines (like Infanrix) were introduced “to address the adverse reactions observed with whole cell vaccines…” This WHO report also notes that acellular vaccines have replaced whole cell vaccines in industrialized countries. However, due to the increased cost of acellular vaccines, the whole cell is still used in many developing countries. This vaccine is being tested against a control vaccine that we already know to be more dangerous than the type of vaccine being studied!

**Note figure 8.1 on page 18: “Pregnancy Category C Animal reproduction studies have not been conducted with INFANRIX. It is not known whether INFANRIX can cause fetal harm when administered to pregnant women or can affect reproduction capacity.

Despite this information listed in the product packaging, the CDC routinely recommends the DTaP vaccine to pregnant women. You can read about that on the CDC’s website in their article, Pregnant? Get Tdap in your 3rd trimester.

The CDC recommends either the BOOSTRIX vaccine or the Adacel vaccine (both DTaP) to pregnant women. While BOOSTRIX is rated one category safer than Adacel (Category B),the packaging still notes, “A developmental toxicity study has been performed in female rats at a dose approximately 40 times the human dose (on a mL/kg basis) and revealed no evidence of harm to the fetus due to BOOSTRIX. Animal fertility studies have not been conducted with BOOSTRIX. There are no adequate and well controlled studies in pregnant women. Because animal production studies are not always predictive of human response, BOOSTRIX should be given to a pregnant woman only if clearly needed.”

Still feeling safe? Still feeling like the CDC has your back?

GARDASIL- Merck

In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]- controlled, and 1 uncontrolled), 18,083 individuals were administered GARDASIL or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccine report cards (VRC)- aided surveillance for 14 days after each injection of GARDASIL or AAHS control or saline placebo in these individuals.”

In these Gardasil trials, there actually WAS a control group which was given a true saline placebo. However there was another (much larger) control group given AAHS, which is the adjuvant in the Gardasil vaccine (the toxic portion that triggers immune response.) According to the insert, 15,706 subjects received Gardasil, 13,023 received AAHS and 594 received the placebo. However, they did not compare the three groups separately; they combined the AAHS and placebo group together and compared them to the Gardasil group. This means that the whole Gardasil vaccine was tested primarily against an injection containing its own toxic ingredients and determined to be “safe.”

Furthermore, 40 deaths occurred in the entire study which were broken down by cause. When you subtract the number of deaths that were due to car wrecks, overdoses/suicides and gunshot wounds, and compare the number of subjects who died: 18 subjects who were given either Gardasil or AAHS died and only 1 who had been given the placebo died.  Think about that! Subjects who received Gardasil or AAHS instead of placebo, died at a rate of 18 to 1!

Why Don’t Scientists Use Appropriate Placebos in Trials?

The “gold standard” in clinical trials cannot be implemented because the use of a placebo in many cases is unethical. The purpose of the 2013 WHO Expert Consultation on the Use of Placebos in Vaccine Trials was to detail the guidelines placed on the ethical use of placebos in vaccine trials. If using a traditional, inert placebo in the control group doesn’t “add any risk of serious or irreversible harm,” then clearly there is nothing unethical about using it. But what about when it does?

For example, according to WHO reports, in 2008 rotavirus was responsible for about 5% of all child deaths globally, with 90% of these deaths occurring in Africa and Asia. In a 2011-12 clinical trial in India for a new rotavirus vaccine, 2/3 of the infants received the test vaccine while 1/3 got a saline placebo injection. At the time, two approved oral rotavirus vaccines were already available. Not giving 1/3 of the Indian children in the trial a vaccine already known to be effective against rotavirus, constituted a human research violation that would not have been allowed in the US. Allowing preventable harm to occur in the name of research is unethical.

This means, for very legitimate ethical reasons, using true placebos according to the “gold standard” of clinical testing is not feasible. However, this in no way negates the fact that due to ethical constraints, it is impossible to accurately assess vaccine safety in many cases. It is also unethical to fail to provide this information to parents when discussing vaccine safety.

It crosses the line of unethical and meanders into the territory of illegal, when this information is intentionally censored from vaccine education sheets given to parents in the pediatrician’s office (as well as from conversations with your pediatrician) assuring that vaccines are “extensively tested for safety” knowing full well that safety and reactogenicity are “difficult or impossible to assess” by their own publicly published standards.

The next time someone tells you that vaccines have been proven safe in numerous extensive studies you can tell them that information is blatantly false, and the CDC, WHO, NIH, and FDA know it. Vaccines cannot be both adequately and ethically tested for safety.

If Everything You Know About the Civil War Era Comes From A Textbook, You Don’t Know Diddly About the South

I’m going to let you all in on a secret. If everything you know about the Civil War Era comes from a textbook, you don’t know diddly squat about the South- and you’re confused about the North as well.

Reading between the lines in our textbooks, after all of us colonists got together and told Mother England where she could stick her taxation without representation and formed a lovely little nation of our own, something odd happened. Apparently, in the years following, us brand new Americans divided ourselves into two factions and split geographically. All of the ignorant, bigoted, white supremacists congregated south of the Mason Dixon Line and the enlightened, equality- minded, civil rights warriors gathered to the north of the line. Then, the loathsome southern crew all planted plantations full of cotton to give all of our legions of slaves something menial to do. Next, they built gigantic plantation houses for the women folk to traipse around in while wearing poofy dresses and sipping mimosas. All the while, the northerners made honest livings in factories waiting for Abraham Lincoln to come along and trounce some morality into that southern rabble.

Not so much. There are two things you need to know:

1. Your history book lied to you about the Civil War.

2. The Mason Dixon Line is a geographical boundary, not a moral one.

Your History Book Lied to You About the Civil War

Lincoln was not a “great emancipator” sending in Union troops to “make men free,” and the South wasn’t fighting primarily to be able to keep slaves. By the way, up to this point in history, slavery was a worldwide societal norm among all cultures. Humanity was finally beginning to “wake up” and slavery was on its way out in multiple civilizations around the globe- none of which resulted in massive Civil Wars. The South, though wrong in their general acceptance of the morality of slavery, was fighting overreaching authority of the federal government.

While slavery did play a part in the Civil War, it was not in the moral capacity that our history books so often paint it. Instead, the disagreement over slavery was an economic and political one. Federal laws leading to the increasing southern unrest date back 30 years prior to the Civil War which was fought from 1861-1865.

In 1828 and 1832, Congress passed tariff legislation which benefited the North’s industrial economy while damaging the South’s agricultural economy. The South produced raw materials and imported manufactured products. The southern economy was built on agriculture and many were dependent on slave labor to run the massive plantations that supplied raw materials to the factories in the north. These tariffs gave northern manufacturers an enormous advantage by decreasing foreign competition. The bulk of the South’s raw materials now went to the North instead of abroad, yet taxes were levied on the North’s finished products which made them, to a large extent, unaffordable in the South. This resulted in the South paying the bulk of federal taxes, while the taxes were spent predominantly in the North. When South Carolina Senator John C. Calhoun held a convention to nullify this law, President Andrew Jackson actually threatened to send troops to enforce it, but the Compromise of 1833 resulted in lowering the taxes for a period of four years and an altercation was avoided.

If you think our most recent presidential election was contentious, you’ve never read about Lincoln’s. Lincoln was backed exclusively by big industry in the North. In the 1860 election, he won with only 39% of the popular vote and not a single electoral vote from the South. The first thing Congress did when they met after the election was to pass the Morrill Tariff, which was the highest tariff in US history. The following quote is from the Northern British Review, Edinburgh, 1862, “…All Northern products are now protected: and the Morrill Tariff is a very masterpiece of folly and injustice. No wonder then that the citizens of the seceding States should feel for half a century they have sacrificed to enhance the powers and profits of the North; and should conclude, after much futile remonstrance that only in secession could they hope to find redress.”

Lincoln never saw the Civil War as an opportunity to bring about justice or free slaves. Lincoln’s single, intention throughout the Civil War was to hold the Union together. In his 1862 letter to Horace Greely of the New York Tribune, Lincoln famously wrote, “ My paramount objective in this struggle is to save the Union, and is not either to save or to destroy slavery. If I could save the Union without freeing any slave I would do it, and if I could save it by freeing all of the slaves I would do it; and if I could save it by freeing some and leaving others alone I would also do that. What I do about slavery, and the colored race, I do because I believe it helps to save the Union…” This letter can be viewed in its entirety at abrahamlincolnonline.org.

Now, whether or not you believe that the South had a constitutional right to secede, or if Lincoln was justified in his many questionable tactics to hold the Union together is a whole separate can of worms. But, if you find yourself sympathizing with the modern day “Calexit” movement, the least you can do is avoid being a hypocrite and admit that you actually have more in common with the Confederacy than you thought.

Most important lessons to take away: If you are ignorant of true Civil War history and engage in or applaud the ripping down of confederate monuments in a misguided protest of slavery or racism, expect opposition from individuals who aren’t ignorant of true Civil War history who have respect for these monuments to great men who put their lives on the line to fight federal government overreach. This is no way means they are racist or that they are sympathetic to the institution of slavery- much less fascist.

The Mason Dixon Line Is A Geographical Boundary, Not A Moral One

The South is not now nor has it ever been any more or less “racist” than the North.

Seriously. This old, tired, inaccurate stereotype of the South as a geographical collection of diversity hating, white supremacists doesn’t even have a historical leg to stand on. The North is not immune and has its own historically documented list of embarrassing and abhorrent racist sentiment.

According to the 1860 census, there were 451,021 slaves counted in states and territories that would make up the Union during the Civil War. This was an increase from the 1840 census 20 years earlier. Historian Douglas Harper notes, “The North failed to develop large-scale agrarian slavery, such as later arose in the Deep South, but that had little to do with morality and much to do with climate and economy.”

The North didn’t exactly have an attack of conscience and decide to emancipate all their slaves immediately following the Revolutionary War. The British helped out with that in tactics Lincoln later used on the South. Douglas Harper writes, “Since the North saw much longer, and more extensive, incursions by the British troops, its slave population drained away at a higher rate than the South’s. At the same time, the governments in northern American states began to offer financial incentives to slaveowners who freed their black men, if the emancipated slaves then served in the state regiments fighting the British… When the Northern states gave up the last remnants of legal slavery, in the generation after the Revolution, their motives were a mix of piety, morality, and ethics; fear of a growing black population; practical economics; and the fact that the Revolutionary War had broken the Northern slaveowners’ power and drained off much of the slave population…The business of emancipation in the North amounted to the simple matters of, 1. determining how to compensate slave owners for the few slaves they had left, and, 2. making sure newly freed slaves would be marginalized economically and politically in their home communities, and that nothing in the state’s constitution would encourage fugitive slaves from elsewhere to settle there.”

We’re not done with Lincoln yet. While he opposed slavery, Lincoln did not believe in racial equality in any way, shape, or form. The following quote is from the fourth Lincoln-Douglas debate (the full transcript can be viewed at this National Park Service link.)

“I will say then that I am not, nor ever have been, in favor of bringing about in any way the social or political equality of the white and black races, that I am not nor ever have been in favor of making voters or jurors of negroes, not qualifying them to hold office, not to intermarry with white people; and I will say in addition to this that there is a physical difference between the white and black races which I believe will forever forbid the two races living together on terms of social and political equality. And inasmuch as they cannot so live, while they do remain together there must be the position of superior and inferior, and I as much as any other man am in favor of having the superior position assigned to the white race.”

The most violent race riot in history actually occurred in Manhattan as a protest to the Union’s draft policy. Freed blacks were exempt from the draft, while whites had to pay $300 to buy their way out of it. Poor whites who couldn’t afford to buy their way out of the draft rioted for four days. This horrific riot resulted in the deaths of as many as 120 people, the lynching of at least 11 blacks, and the assault of many more. 4,000 troops from Gettysburg put down the uprising.

The North was full of raced based legislation in the years immediately post Civil War. The North had segregation laws. Free black men were not allowed to vote in all northern states and some states required that a black man own property in order to have the right to vote. In some states, blacks weren’t allowed to hold public office or testify against a white person in court. Many northern states had restrictions on the number of free blacks that could enter the state while some barred them from entering altogether.

Most important lesson to take away: The “racist, white-supremacist, Southerner” is an ignorant stereotype perpetuated by those who wish to divide the country along a racist boundary that never existed.

Racism has never been a geographical phenomenon. During the Civil Rights movements of the 60’s, we all joined together to promote equality and the vast majority of the population has been united in that endeavor ever since.

Today, white or black supremacist groups and terrorist organizations such as the KKK, BLM, Antifa, and the Black Panthers are all fringe groups. These groups are small in number with loud mouths and violent, attention- getting tactics. The mainstream media love to perpetuate the false narrative that large swathes of the United States population sympathizes with one group or another, and this propaganda is not arbitrary. It’s about time we all recognized this divisive propaganda for what it is- an orchestrated effort to divide us.

Step away from the monuments- the ghosts of the Confederacy are not your foes.

Do Vaccines Contain Aborted Fetal Cells?

Do vaccines contain aborted fetal cells?

The short answer is: Yes, some do, but not all. I’ve heard a lot of people actually argue about this. Some people will argue emphatically and call you an idiot if you truly believe the “conspiracy theory” that vaccines contain aborted fetal cells. These people have clearly never bothered to read the list of ingredients printed in the vaccine package inserts. Nor have they visited the CDC website where aborted fetal cells are listed in the ingredients lists of various vaccines.

I don’t know, maybe it’s because they are looking for the words, “aborted fetal cells” which obviously aren’t there. It takes a little reading into the subject to discover that the words you should be looking for are “human diploid fibroblast cell structures” (which come in two strains- WI-38 and MRC-5).

The following vaccines were developed using one of the two aborted fetal strains above and do contain DNA from them:

      • Hepatitis A
      • Rubella (Rubella is a part of the MMR combination vaccine)
      • Varicella (chicken pox)
      • Zoster (shingles)
      • Adenovirus
      • Rabies
      • Polio
      • Enbrel (Rheumatoid Arthritis)

The following vaccines that are in development come from additional aborted fetal strains and contain DNA:

    • Ebola
    • Flu and Avian Flu
    • HIV

Why are aborted babies needed to produce these vaccines?

In order to make a vaccine, scientists must be able to grow the bacteria or virus they wish to create a vaccine for. In order to grow the bacteria or virus, they must have tissue to grow it on. While many vaccines are created using the tissue of various animals (cows, monkeys, chickens to name a few) and animal products (such as eggs), the use of tissue from aborted babies is superior for a number of reasons.

Cowpox found on the udders of infected cows used to manufacture the smallpox vaccine.

*You can thank me later for posting a pic of an artist rendering instead of a photo…

First, vaccines derived from animal sources carry a higher risk of contamination from other bacteria and viruses. For example, the polio vaccines that our parents were vaccinated with in the 50’s and 60’s were later found to be contaminated with a monkey virus referred to as SV40 or Simian Virus 40. (Whoops!) Now, the CDC claims that SV40 didn’t cause any adverse effects. So, it’s very ironic that according to laboratory findings, “ SV40 DNA has been detected in several human tumors, including osteosarcoma, mesothelioma, and non-Hodgkin’s lymphoma. Similar tumors are induced by the virus in hamsters.” And no…the individuals whose tumors were found to contain SV40 DNA had no possible exposure to SV40 other than the polio vaccine. It’s not exactly something you come across on regular ole’ day in the US of A.

Rhesus Macaque. Monkey used to develop the polio vaccine used in the 50’s and 60’s. Later found to have been contaminated with Simian 40 virus.

Second, some pathogens just don’t grow as well on animal tissue (like chicken pox) because they don’t infect animals. However, the most important advantage to using tissue from aborted babies is that fetal cells can go through many more divisions than other cells before they die. A biologist named Hayflick determined that normal human cells can only reproduce a finite number of times (usually around 50) before they stop reproducing. Fetal cells, however, are capable of going through many more divisions before dying.

Let’s get acquainted with the two aborted babies that the vaccines we inject our children with are grown on. (I sincerely hope that sentence makes you cringe as much I did when I typed it.)Believe it or not, the background information is actually available. WI-38 is a 3 month old female fetus who belonged to two married parents living in Stockholm, Sweden in 1962. Reportedly, her father was a “drunk” who was “gone a lot.” According to Dr. Rene Leive in her “Brief History of Human Diploid Strains,” her parents “felt they already had too many children”, so they decided to abort her. MRC-5 is a fourteen week old male fetus who was murdered inside his 27 year old mother in 1970 for “psychiatric reasons.”

Before we continue, let’s take a minute to see what a 15 week old baby (the average age of the aborted babies used to create these fetal strains) looks like in utero.

15 week old fetus in utero

And here we come to the next misleading argument that is posited to rationalize or justify the use of aborted babies in the production of vaccines. If you’ll notice in the list of vaccine ingredients above, the vaccines that are currently in use today are all derived from two fetal cell strains: WI-38 and MRC-5. Our vaccines come from “only” two aborted babies. Again, Megan over at Whole Living puts it best with her “This Wasn’t Just a One-Night Stand” analogy, “You might have also heard that only two babies were used and it was a really long time ago, which justifies the continued use of shooting up live babies with dead babies.” Sometimes a little perspective goes a long way…

It may seem like common sense to some to realize that to arrive at WI number 38, numbers 1-37 logically preceded. You would be correct in this logical assumption. Hayflick also references WI-44 in his report, so you can be sure, very many more than one aborted baby has gone into the development of the WI-38 cell line that is still used today. The same holds true for the MRC-5 strain. Hayflick also makes mention of the MRC-9 strain which is derived from a 15 week old female fetus in 1974. Her mother was an unwed 14 year old who aborted her baby for “therapeutic” reasons according to the documentation (taken from the history of diploid strains linked above).

Our Rubella vaccine comes from another cell line, RA 27/3, which was developed by a man named Plotkin. It is derived from a female fetus whose mother contracted Rubella in 1964. She was aborted for this reason (rubella is only harmful to babies in utero and causes some severe birth defects). According to Plotkin’s documentation, over 40 aborted babies were cultured. RA 27/3 was not the first fetus to test positive for Rubella or the last and he doesn’t specify why he continued with the series. Interestingly, Dr. Leive notes, “It is documented that there were other effective virus strains already made at the time which had been obtained from other non-abortion-related methods.”

Can We Use These Same Cell Lines Forever?

No. They aren’t immortal and they’ll eventually die out. Scientists have never stopped developing new strains and new vaccines. In fact, they already have new human diploid cell strains to back up the current strains. IMR-90 is a 16 week old fetus from a 38 year old mother of six who decided the baby she was carrying in 1975 would be too inconvenient. Cell strain 293 is derived from kidney cells from a baby aborted in 1972. The PER C6 line, which is being used right now to develop the new ebola, flu, malaria, tuberculosis, and HIV vaccines, is derived from an 18 week old fetus aborted in 1985. The main researcher for the PER C6 line, Van der Eb, stated that, “the woman wanted to get rid of the fetus and the father was unkown.”

In fact, the American Congress of Obstetricians and Gynecologists is “distressed” that Congress is investigating fetal tissue researchers and procurement companies to make sure they aren’t profiting from the sale of tissue from aborted babies (which is illegal.) They released this statement, “Unfortunately, some state and federal politicians are working hard to obstruct- or even criminalize- fetal tissue research, limiting the ability of America’s leading scientists and researchers to develop new vaccines and medicines to prevent and treat disease. The ACOG warns that if this interference continues, “fetal research bans will stymie US based medical progress, leaving us to rely on other countries to develop medicines for our own patients.”

Apparently, without legal abortion to provide the scientific community with an endless supply of murdered babies, medical progress will virtually cease. Eye opening statement to say the least. There are some powerful players backing the pro-choice movement and their motivation has very little to do with a woman’s “right to choose.”

I’ll end with one last quote from Megan at Whole Living, “If science can’t advance without abortions, we need to go back to the drawing board.”