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The Shocking Story of How Aspartame Became Legal

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Did you know that Aspartame was banned by the FDA twice? How is this product legal now?

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The bittersweet argument over whether Aspartame is safe or not has been going on for a long time. On one side we have medical evidence that suggests we should avoid using it and on the other side we lean on the FDA’s approval that suggests it is safe. Since generally that seems to be the factor that many continue to hold trust based upon, I thought we could look into the Aspartame story to find out how it came to be accepted as safe by the FDA. You would think that something so widely used and so well accepted would have quite the pristine story leading to its acceptance. I imagine one will discover otherwise after reading this post.

It all starts in the mid 1960’s with a company called G.D. Searle. One of their chemists accidentally creates aspartame while trying to create a cure for stomach ulcers. Searle decides to put aspartame through a testing process which eventually leads to its approval by the FDA. Not long after, serious health effects begin to arise and G.D. Searle comes under fire for their testing practices. It is revealed that the testing process of Aspartame was among the worst the investigators had ever seen and that in fact the product was unsafe for use. Aspartame triggers the first criminal investigation of a manufacturer put into place by the FDA in 1977. By 1980 the FDA bans aspartame from use after having 3 independent scientists study the sweetener. It was determined that one main health effects was that it had a high chance of inducing brain tumors. At this point it was clear that aspartame was not fit to be used in foods and banned is where it stayed, but not for long.

Early in 1981 Searle Chairman Donald Rumsfeld (who is a former Secretary of Defense.. surprise surprise) vowed to “call in his markers,” to get it approved. January 21, 1981, the day after Ronald Reagan’s inauguration, Searle took the steps to re-apply aspartame’s approval for use by the FDA. Ronald Reagans’ new FDA commissioner Arthur Hayes Hull, Jr., appointed a 5-person Scientific Commission to review the board of inquiry’s decision. It did not take long for the panel to decide 3-2 in favor of maintaining the ban of aspartame. Hull then decided to appoint a 6th member to the board, which created a tie in the voting, 3-3. Hull then decided to personally break the tie and approve aspartame for use. Hull later left the FDA under allegations of impropriety, served briefly as Provost at New York Medical College, and then took a position with Burston-Marsteller. Burstone-Marstella is the chief public relations firm for both Monsanto and GD Searle. Since that time he has never spoken publicly about aspartame.

It is clear to this point that if anything the safety of aspartame is incredibly shaky.  It has already been through a process of being banned and without the illegitimate un-banning of the product, it would not be being used today. Makes you wonder how much corruption and money was involved with names like Rumsfeld, Reagan and Hull involved so heavily. In 1985, Monsanto decides to purchase the aspartame patent from G.D. Searle. Remember that Arthur Hull now had the connection to Monsanto. Monsanto did not seem too concerned with the past challenges and ugly image aspartame had based on its past. I personally find this comical as Monsanto’s products are banned in many countries and of all companies to buy the product they seem to fit best as they are champions of producing incredibly unsafe and untested products and making sure they stay in the market place.

Since then, aspartame has been under a lot of attack by scientists, doctors, chemists and consumers about it’s safety and neurotoxic properties. Piles of comprehensive studies have been completed that show aspartame is a cause for over 90 serious health problems such as cancer, leukemia, headaches, seizures, fibromyalgia, and epilepsy just to name a few. We have written several articles discussing various affects of aspartame. Aspartame Leukemia Link. Aspartame and Brain Damage.

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For a full timeline on aspartame’s legal and safety battles, expand the box below.

[accordions align=”None”][accordion state=”close” title=”Full Aspartame Timeline”]

Timeline

December 1965– While working on an ulcer drug, James Schlatter, a chemist at G.D. Searle, accidentally discovers aspartame, a substance that is 180 times sweeter than sugar yet has no calories.

Spring 1967– Searle begins the safety tests on aspartame that are necessary for applying for FDA approval of food additives.

Fall 1967– Dr. Harold Waisman, a biochemist at the University of Wisconsin, conducts aspartame safety tests on infant monkeys on behalf of the Searle Company. Of the seven monkeys that were being fed aspartame mixed with milk, one dies and five others have grand mal seizures.

November 1970– Cyclamate, the reigning low-calorie artificial sweetener — is pulled off the market after some scientists associate it with cancer. Questions are also raised about safety of saccharin, the only other artificial sweetener on the market, leaving the field wide open for aspartame.

December 18, 1970– Searle Company executives lay out a “Food and Drug Sweetener Strategy’ that they feel will put the FDA into a positive frame of mind about aspartame. An internal policy memo describes psychological tactics the company should use to bring the FDA into a subconscious spirit of participation” with them on aspartame and get FDA regulators into the “habit of saying, “Yes”.”

Spring 1971– Neuroscientist Dr. John Olney (whose pioneering work with monosodium glutamate was responsible for having it removed from baby foods) informs Searle that his studies show that aspartic acid (one of the ingredients of aspartame) caused holes in the brains of infant mice. One of Searle’s own researchers confirmed Dr. Olney’s findings in a similar study.

February 1973– After spending tens of millions of dollars conducting safety tests, the G.D. Searle Company applies for FDA approval and submits over 100 studies they claim support aspartame’s safety.

March 5, 1973– One of the first FDA scientists to review the aspartame safety data states that “the information provided (by Searle) is inadequate to permit an evaluation of the potential toxicity of aspartame”. She says in her report that in order to be certain that aspartame is safe, further clinical tests are needed.

May 1974– Attorney, Jim Turner (consumer advocate who was instrumental in getting cyclamate taken off the market) meets with Searle representatives to discuss Dr. Olney’s 1971 study which showed that aspartic acid caused holes in the brains of infant mice.

July 26, 1974– The FDA grants aspartame its first approval for restricted use in dry foods.

August 1974– Jim Turner and Dr. John Olney file the first objections against aspartame’s approval.

March 24, 1976– Turner and Olney’s petition triggers an FDA investigation of the laboratory practices of aspartame’s manufacturer, G.D. Searle. The investigation finds Searle’s testing procedures shoddy, full of inaccuracies and “manipulated” test data. The investigators report they “had never seen anything as bad as Searle’s testing.”

January 10, 1977– The FDA formally requests the U.S. Attorney’s office to begin grand jury proceedings to investigate whether indictments should be filed against Searle for knowingly misrepresenting findings and “concealing material facts and making false statements” in aspartame safety tests. This is the first time in the FDA’s history that they request a criminal investigation of a manufacturer.

January 26, 1977– While the grand jury probe is underway, Sidley & Austin, the law firm representing Searle, begins job negotiations with the U.S. Attorney in charge of the investigation, Samuel Skinner.

March 8, 1977– G. D. Searle hires prominent Washington insider Donald Rumsfeld as the new CEO to try to turn the beleaguered company around. A former Member of Congress and Secretary of Defense in the Ford Administration, Rumsfeld brings in several of his Washington cronies as top management.

July 1, 1977– Samuel Skinner leaves the U.S. Attorney’s office and takes a job with Searle’s law firm. (see Jan. 26th)

August 1, 1977– The Bressler Report, compiled by FDA investigators and headed by Jerome Bressler, is released. The report finds that 98 of the 196 animals died during one of Searle’s studies and weren’t autopsied until later dates, in some cases over one year after death. Many other errors and inconsistencies are noted. For example, a rat was reported alive, then dead, then alive, then dead again; a mass, a uterine polyp, and ovarian neoplasms were found in animals but not reported or diagnosed in Searle’s reports.

December 8, 1977– U.S. Attorney Skinner’s withdrawal and resignation stalls the Searle grand jury investigation for so long that the statue of limitations on the aspartame charges runs out. The grand jury investigation is dropped.

June 1, 1979– The FDA established a Public Board of Inquiry (PBOI) to rule on safety issues surrounding NutraSweet.

September 30, 1980– The Public Board of Inquiry concludes NutraSweet should not be approved pending further investigations of brain tumors in animals. The board states it “has not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive.”

January 1981– Donald Rumsfeld, CEO of Searle, states in a sales meeting that he is going to make a big push to get aspartame approved within the year. Rumsfeld says he will use his political pull in Washington, rather than scientific means, to make sure it gets approved.

January 21, 1981– Ronald Reagan is sworn in as President of the United States. Reagan’s transition team, which includes Donald Rumsfeld, CEO of G. D. Searle, hand picks Dr. Arthur Hull Hayes Jr. to be the new FDA Commissioner.

March, 1981– An FDA commissioner’s panel is established to review issues raised by the Public Board of Inquiry.

May 19, 1981– Three of six in-house FDA scientists who were responsible for reviewing the brain tumor issues, Dr. Robert Condon, Dr. Satya Dubey, and Dr. Douglas Park, advise against approval of NutraSweet, stating on the record that the Searle tests are unreliable and not adequate to determine the safety of aspartame.

July 15, 1981– In one of his first official acts, Dr. Arthur Hayes Jr., the new FDA commissioner, overrules the Public Board of Inquiry, ignores the recommendations of his own internal FDA team and approves NutraSweet for dry products. Hayes says that aspartame has been shown to be safe for its’ proposed uses and says few compounds have withstood such detailed testing and repeated close scrutiny.

October 15, 1982– The FDA announces that Searle has filed a petition that aspartame be approved as a sweetener in carbonated beverages and other liquids.

July 1, 1983– The National Soft Drink Association (NSDA) urges the FDA to delay approval of aspartame for carbonated beverages pending further testing because aspartame is very unstable in liquid form. When liquid aspartame is stored in temperatures above 85 degrees Fahrenheit, it breaks down into DKP and formaldehyde, both of which are known toxins.

July 8, 1983– The National Soft Drink Association drafts an objection to the final ruling which permits the use of aspartame in carbonated beverages and syrup bases and requests a hearing on the objections. The association says that Searle has not provided responsible certainty that aspartame and its’ degradation products are safe for use in soft drinks.

August 8, 1983– Consumer Attorney, Jim Turner of the Community Nutrition Institute and Dr. Woodrow Monte, Arizona State University’s Director of Food Science and Nutritional Laboratories, file suit with the FDA objecting to aspartame approval based on unresolved safety issues.

September, 1983– FDA Commissioner Hayes resigns under a cloud of controversy about his taking unauthorized rides aboard a General Foods jet. (General foods is a major customer of NutraSweet) Burson-Marsteller, Searle’s public relation firm (which also represented several of NutraSweet’s major users), immediately hires Hayes as senior scientific consultant.

Fall 1983– The first carbonated beverages containing aspartame are sold for public consumption.

November 1984– Center for Disease Control (CDC) “Evaluation of consumer complaints related to aspartame use.” (summary by B. Mullarkey)

November 3, 1987– U.S. hearing, “NutraSweet: Health and Safety Concerns,” Committee on Labor and Human Resources, Senator Howard Metzenbaum, chairman.

[/accordion][/accordions]

Sources:
http://www.sweetpoison.com/aspartame-side-effects.html
http://rense.com/general33/legal.htm
http://dorway.com/

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Awareness

Studies Show We Can Heal With Sound, Frequency & Vibration

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In Brief

  • The Facts:

    Multiple studies and examples have shown how sound, frequency and vibration can literally alter physical material matter. Research has also shown that sound, frequencies and vibration can be used as a significant healing method for various ailments.

  • Reflect On:

    How plausible would it be for these interventions to become a regular part of therapy, just as much as pharmaceutical drugs are now?

Cymatics is a very interesting topic. It illustrates how sound frequencies move through a particular medium such as water, air, or sand and as a result directly alter physical matter. There are a number of pictures all over the internet as well as youtube videos that demonstrate how matter (particles) adjust to different sounds and different frequencies of sound.

When it comes to ancient knowledge, sound, frequency and vibration have always been perceived as powerful forces that can influence and alter life all the way down to the cellular level. Sound healing methods are often used by Shamans, who employ drums and singing to access trance states. Research has even demonstrated that drumming and singing can can be used to slow fatal brain disease, and it can generate a sense of oneness with the universe . Sound therapy is getting more popular, and it can have many medical applications, especially within the psychological and mental health realms.

Sound, frequency and vibration are used all throughout the animal kingdom, and there are many examples. If we look at the wasp, they use antennal drumming to alter the caste development or phenotype of their larvae. Conventional thinking has held for quite some time that differential nutrition alone can explain why one larvae develops into a non-reproductive worker and one into a reproductive female (gyne).  However, this is not the case, according to a 2011 study:

“But nutrition level alone cannot explain how the first few females to be produced in a colony develop rapidly yet have small body sizes and worker phenotypes. Here, we provide evidence that a mechanical signal biases caste toward a worker phenotype. In Polistes fuscatus, the signal takes the form of antennal drumming (AD), wherein a female trills her antennae synchronously on the rims of nest cells while feeding prey-liquid to larvae. The frequency of AD occurrence is high early in the colony cycle, when larvae destined to become workers are being reared, and low late in the cycle, when gynes are being reared. Subjecting gyne-destined brood to simulated AD-frequency vibrations caused them to emerge as adults with reduced fat stores, a worker trait. This suggests that AD influences the larval developmental trajectory by inhibiting a physiological element that is necessary to trigger diapause, a gyne trait.”

This finding indicates that the acoustic signals produced through drumming within certain species carry biologically meaningful information (literally: ‘to put form into’) that operate epigenetically (i.e. working outside or above the genome to affect gene expression).

Pretty fascinating, isn’t it? Like many other ancient lines of thought, this has been backed by modern day scientific research.

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Cancer 

Another example comes from cancer research. In his Tedx talk, “Shattering Cancer with Resonant Frequencies,” Associate Professor and Director of Music at Skidmore College, Anthony Holland, tells the audience that he has a dream. That dream is to see a future where children no longer have to suffer from the effects of toxic cancer drugs or radiation treatment, and today he and his team believe they have found the answer, and that answer is sound. Holland and his team wondered if they could affect a cell by sending a specific electric signal, much like we do with LCD technology. After searching the patent database for a device that could accomplish this, they came across a therapeutic device invented by New Mexico physician Dr. James Bare. The device uses a plasma antenna that pulses on and off, which, as Holland explains, is important because a constant pulse of electricity would produce too much heat and therefore destroy the cell. For the next 15 months, Holland and his team searched for the exact frequency that would directly shatter a living microorganism. The magic number finally came in the form of two inputs, one high frequency and one low. The high frequency had to be exactly eleven times higher than the low, which in music is known as the 11th harmonic. At the 11th harmonic, micro organisms begin to shatter like crystal glass.

After consistently practicing until they became efficient at the procedure, Holland began working with a team of cancer researchers in an attempt to destroy targeted cancer cells. First they looked at pancreatic cancer cells, eventually discovering these cells were specifically vulnerable between 100,000 – 300,000 Hz.

Next they moved onto leukemia cells, and they were able to shatter the leukemia cells before they could divide. But, as Holland explains in his talk, he needed bigger stats in order to make the treatment a viable option for cancer patients.

In repeated and controlled experiments, the frequencies, known as oscillating pulsed electric field (OPEF) technology, killed an average of 25% to 40% of leukemia cells, going as high as 60% in some cases. Furthermore, the intervention even slowed cancer cell growth rates up to 65%.

You can read more about the story, find sources, and watch that TEDx talk here.

Another example occurred in  1981, when biologist Helene Grimal partnered with composer Fabien Maman to study the relationship of sound waves to living cells. For 18 months, the pair worked with the effects of 30-40 decibel sounds on human cells. With a camera mounted on a microscope, the researchers observed uterine cancer cells exposed to different acoustic instruments (guitar, gong, xylophone) as well as the human voice for 20-minute sessions.

They discovered that, when exposed to sound, cancer cells lost structural integrity until they exploded at the 14-minute mark. Far more dramatic was the sound of a human voice — the cells were destroyed at the nine-minute mark.

After this, they decided to work with two women with breast cancer. For one month, both of the women gave three-and-a-half-hours a day to “toning” or singing the scale. Apparently, the woman’s tumor became undetectable, and the other woman underwent surgery. Her surgeon reported that her tumor had shrunk dramatically and “dried up.” It was removed and the woman had a complete recovery and remission.

These are only a few out of multiple examples that are floating around out there.

Let’s not forget about when Royal Rife first identified the human cancer virus using the world’s most powerful microscope. After identifying and isolating the virus, he decided to culture it on salted pork. At the time this was a very good method for culturing a virus. He then took the culture and injected it into 400 rats, which, as you might expect, created cancer in all 400 rats very quickly. The next step for Rife was where things took an interesting turn. He later found a frequency of electromagnetic energy that would cause the cancer virus to diminish completely when entered into the energy field.  You can read more about that story here.

More Research

A 2014 study published in the Journal of Huntington’s Disease found that two months of drumming intervention in Huntington’s patients (considered an irreversible, lethal neurodegenerative disease) resulted in “improvements in executive function and changes in white matter microstructure, notably in the genu of the corpus callosum that connects prefrontal cortices of both hemispheres.” The study authors concluded that the pilot study provided novel preliminary evidence that drumming (or related targeted behavioral stimulation) may result in “cognitive enhancement and improvements in callosal white matter microstructure.”

A 2011 Finnish study observed that stroke patients who were given access to music as cognitive therapy had improved recovery. Other research has shown that patients suffering from loss of speech due to brain injury or stroke regain it more quickly by learning to sing before trying to speak. The phenomenon of music facilitating healing in the brain after a stroke is called the “Kenny Rogers Effect.”

A 2012 study published in Evolutionary Psychology found that active performance of music (singing, dancing and drumming) triggered endorphin release (measured by post-activity increases in pain tolerance), whereas merely listening to music did not. The researchers hypothesized that this may contribute to community bonding in activities involving dance and music-making.

According to a study published by the National Institute of Health, “Music effectively reduces anxiety for medical and surgical patients and often reduces surgical and chronic pain. [Also,] Providing music to caregivers may be a strategy to improve empathy, compassion, and care.” In other words, music is not only good for patients, it’s good for those who care for them as well.

Below is an interesting interview with Dr. Bruce Lipton. You can view his curriculum vitae here.

The Takeaway

The information presented in this article isn’t even the tip of the iceberg when it comes the the medical applications of sound, frequency and vibration, which are all obviously correlated. One thing is clear, however, which is that there are many more methods out there, like the ones discussed in this article, that should be taken more seriously and given more attention from the medical establishment. It seems all mainstream medicine is concerned about is making money and developing medications that don’t seem to be representative of our fullest potential to heal. “Alternative” therapies shouldn’t be labelled as alternative, they should be incorporated into the norm.

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Mental Health Problems—The Sad “New Normal” on College Campuses

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College campuses are witnessing record levels of student mental health problems, ranging from depression and anxiety disorders to self-injurious behaviors and worse. A clinician writing a few years ago in Psychology Today proclaimed it neither “exaggeration” nor “alarmist” to acknowledge that young Americans are experiencing “greater levels of stress and psychopathology than any time in the nation’s history”—with ramifications that are “difficult to overstate.”

The problems on college campuses are manifestations of challenges that begin sapping American children’s health at younger ages. For example, many students enter college with a crushing burden of chronic illness or a teen-onset mental health diagnosis that has made them dependent on psychotropic or other medications. The childhood prevalence of different forms of cognitive impairment has also increased and is associated with subsequent mental health difficulties. In addition, a majority of American students are now unprepared academically for their college careers, as evidenced by historically low levels of achievement on standardized tests. Once in college, large proportions of students—increasingly characterized as emotionally fragile—blame mental health challenges for significantly interfering with their ability to perform. The outcomes of these trends—including rising suicide rates among students and declining college completion rates—bode poorly for young people’s and our nation’s future.

… more than three in five (63%) respondents reported experiencing overwhelming anxiety in the past year, while two in five (42%) reported feeling so depressed that it was difficult to function.

Crippling anxiety and depression

A 2018 survey at 140 educational institutions asked almost 90,000 college students about their health over the past 12 months. The survey found that more than three in five (63%) respondents reported experiencing “overwhelming anxiety” in the past year, while two in five (42%) reported feeling “so depressed that it was difficult to function.” Students also reported that anxiety (27%), sleep difficulties (22%) and depression (19%) had adversely affected their academic performance.

In the same survey, 12% of college students reported having “seriously considered suicide.” Another study, which looked at college students with depression, anxiety and attention-deficit/hyperactivity disorder (ADHD) who had been referred by college counseling centers for psychopharmacological evaluation, found that the same proportion—12%—had actually made at least one suicide attempt. Half of the students in the latter study had previously received a prescription for medication, most often antidepressants.

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Colleges are feeling the squeeze, with demand growing nationally for campus mental health services. A study by Penn State’s Center for Collegiate Mental Health reported an average 30% to 40% increase in students’ use of counseling centers between 2009 and 2015 at a time when enrollment grew by just 5%. According to Penn State’s report, the “increase in demand is primarily characterized by a growing frequency of students with a lifetime prevalence of threat-to-self indicators.”

College vaccines

Most colleges expect new students to have had the full complement of CDC-recommended childhood vaccines and to top up before college matriculation with any vaccines or doses that they may have previously missed. In particular, universities are likely to emphasize tetanus-diphtheria-pertussis (Tdap) and measles-mumps-rubella (MMR) boosters; the human papillomavirus (HPV) vaccine; meningococcal vaccination; and annual flu shots.

… found particularly strong associations for three disorders common on college campuses—anorexia nervosa, obsessive-compulsive disorder and anxiety disorders—and observed a surge in diagnosed disorders after influenza vaccination (one of the vaccines that college students are most likely to get).

It is unlikely that clinics are issuing warnings to freshly vaccinated college students about potential adverse consequences to watch out for, yet two universities (Penn State and Yale) made news in 2017 when their researchers published a study showing a temporal relationship between newly diagnosed neuropsychiatric disorders and vaccines received in the previous three to twelve months. Although the researchers analyzed health records for 6- to 15-year-old children, not college students, they found particularly strong associations for three disorders common on college campuses—anorexia nervosa, obsessive-compulsive disorder and anxiety disorders—and observed a surge in diagnosed disorders after influenza vaccination (one of the vaccines that college students are most likely to get). They also detected significant temporal associations linking meningitis vaccination to both anorexia and chronic tic disorders.

To distance themselves from too strongly implicating vaccines, these researchers later proposed several less controversial mechanisms to explain their findings, including the presence of predisposing inflammatory or genetic factors. One of the researchers even suggested that the “trauma” of getting “stuck with needles” might be triggering the adverse neuropsychiatric outcomes.

This absurd sidestepping ignores considerable experimental evidence from both animals and humans linking the immune responses produced by vaccines (and vaccine adjuvants) to adverse mental health symptoms. In fact, some researchers vaccinate healthy animals or people on purpose just to study this phenomenon. For example:

  • A study intentionally injected mice with the vaccine used against tuberculosis (BCG vaccine) to induce “depression-like behavior,” finding that the vaccine-induced depression was resistant to treatment with standard antidepressants.
  • Another study in mice found that both the antigens and the aluminum adjuvant in the Gardasil HPV vaccine produced significantly more behavioral abnormalities, including depression, in the exposed mice compared to unexposed mice.
  • University of California researchers followed healthy undergraduates for one week before and one week after influenza vaccination; in the absence of any physical symptoms, they detected increased post-vaccination inflammation that was associated with more mood disturbances—especially “depressed mood and cognitive symptoms.”
  • Another study of influenza vaccination compared vaccine recipients who had preexisting depression and anxiety to “mentally healthy” recipients, finding that both groups had “decreased positive affect” following vaccination; however, the vaccine’s impact on mood was “more pronounced for those with anxiety or depression.”
  • Neuroscientists at Oxford injected healthy young adults with typhoid vaccine to explore “the link between inflammation, sleep and depression,” finding that the vaccine “produced significant impairment in several measures of sleep continuity” in the vaccine group compared to placebo; the researchers noted in their conclusions that impaired sleep is both a “hallmark” and “predictor” of major depression.
  • Another group of UK researchers who likewise injected healthy young adult males with the typhoid vaccine found that, within hours, the vaccine had produced measurable social-cognitive deficits.

Interestingly, a study conducted in 2014 found that vaccine-mental health effects may cut both ways. Researchers who assessed self-reported depression and anxiety (and other measures) in 11-year-olds before and up to six months after routine vaccination found that children who reported more initial depressive and anxious symptoms had a stronger vaccine response(defined by “elevated and persistently higher antibody responses”) and that this association remained even after controlling for confounders. Given that this type of overactive vaccine response can be a harbinger of autoimmunity, some researchers have urged more attention to these “bidirectional” effects.

… we are kidding ourselves if we ignore the possible contribution of a cumulative vaccine load that has children receiving dozens of doses by age 18 …

afe spaces or safe vaccines?

As “safe spaces” multiply on college campuses, and elite private institutions offer dumbed-down for-credit courses like “The Sociology of Miley Cyrus” or “Beginning Dungeons and Dragons,” it is time to take stock of the health challenges—both mental and physical—that are sabotaging college students’ chances of success. Researchers already have noted a disturbing mismatchbetween available cognitive abilities and the types of “non-routine analytical-cognitive” skills that our nation will increasingly need in the future. While variables such as student debt certainly factor into college students’ stress equation, we are kidding ourselves if we ignore the possible contribution of a cumulative vaccine load that has children receiving dozens of doses by age 18—and piles on even more when kids go off to college.


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Vaccine Rhetoric vs. Reality—Keeping Vaccination’s Unflattering Track Record Secret

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Note: This is Part VI in a series of articles adapted from the second Children’s Health Defense eBook: Conflicts of Interest Undermine Children’s Health. The first eBook, The Sickest Generation: The Facts Behind the Children’s Health Crisis and Why It Needs to End, described how children’s health began to worsen dramatically in the late 1980s following fateful changes in the childhood vaccine schedule.]

A concerted and “heavy-handed” effort is under way to censor information that contradicts the oversimplified sound bites put forth by public health agencies and the media about vaccines. However, while brazen, in-your-face censorship—and attacks on health freedom—have ratcheted up to an unprecedented degree,  officialdom’s wish to keep vaccination’s unflattering track record out of the public eye is nothing new.

There is a chasm between vaccine rhetoric and reality for most if not all vaccines, but four vaccines—varicella (chickenpox), rotavirus, human papillomavirus (HPV) and pertussis-containing vaccines—offer especially instructive before-and-after case studies. Analysis of the U.S. experience with these vaccines raises important questions. First, why did the Food and Drug Administration (FDA) race to approve—and why does the Centers for Disease Control and Prevention (CDC) heavily promote—vaccines such as varicella and rotavirus when there is little public health justification for them? Second, why are federal agencies ignoring the many serious risks that have surfaced in the vaccines’ wake—problems unheard of before the vaccines’ introduction?

With the rollout of mass varicella vaccination, shingles started cropping up to an unprecedented extent in both children and adults, eliminating boosting for adults and shifting downward the average age at which shingles occurs.

Varicella and rotavirus vaccines

The rationale for the varicella and rotavirus vaccines was dubious from the start. In the U.S. and other wealthy countries, varicella and rotavirus were nearly universal and mostly benign childhood infections; in those settings, the pre-vaccine impact of the two conditions was largely measured in terms of “healthcare costs, missed daycare, and loss of time from work for parents/guardians” rather than in terms of serious illness or mortality.

Childhood chickenpox infections served an important purpose for all, conferring lifelong immunity to infected children while boosting adult immunity to the related shingles (herpes zoster) virus. With the rollout of mass varicella vaccination, shingles started cropping up to an unprecedented extent in both children and adults, eliminating boosting for adults and shifting downward the average age at which shingles occurs. Vaccine waning also began increasing young adults’ risk for varicella outbreaks and complications later in life, presenting “perverse public health implications.” Meanwhile, the CDC and its local public health partners worked hard to conceal these unwanted chickenpox vaccine outcomes from the public.

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Rotavirus vaccines have had a similarly checkered history. Soon after their introduction in the U.S., reports emerged of a substantially increased risk in infants of an otherwise rare bowel complication called intussusception. The FDA knew about the problem during the prelicensing regulatory review process but ignored it. Although the agency subsequently withdrew its approval for one of the problematic rotavirus vaccines, it was not until after an estimated 500,000 children received at least one million doses. The FDA never explained the “precise mechanism” by which the discontinued vaccine caused intussusception.

Two rotavirus vaccines that display the same intussusception risks are still on the U.S. market. Both are contaminated with foreign DNA from porcine viruses capable of causing severe immunodeficiency in pigs. Had the presence of these “adventitious agents” been discovered prior to vaccine licensure, the FDA probably would have been forced to shelve the vaccines, yet they remain on the vaccine schedule to this day.

The speed with which the FDA gave them [HPV vaccines Gardasil and Gardasil-9] the go-ahead—despite obvious red flags regarding their safety—illustrates the insincerity of the agency’s assertions that its vaccine approval process is committed to minimizing risks.

HPV vaccines

The HPV vaccines Gardasil and Gardasil-9 (manufactured by Merck) represent perhaps an even more compelling case study of risk-laden vaccines that should have attracted strong up-front regulatory scrutiny—but didn’t. The speed with which the FDA gave them the go-ahead—despite obvious red flags regarding their safety—illustrates the insincerity of the agency’s assertions that its vaccine approval process is committed to minimizing risks.

The FDA not only gave the quadrivalent Gardasil a free pass but has repeatedly reapproved it and the nine-valent Gardasil-9 for wider use. (Gardasil-9 is a newer formulation that contains more than twice the amount of neurotoxic aluminum adjuvant as Gardasil.) In 2009, the FDA also okayed GlaxoSmithKline’s HPV vaccine, Cervarix, but Merck’s FDA-facilitated stranglehold on the market prompted the company to withdraw Cervarix from the U.S. in 2016. Merck is now aggressively expanding its Gardasil “franchise” into other countries, generating unprecedentedworldwide demand, while continuing to “rev up” U.S. sales.

Since 2006, the FDA’s Gardasil-related decisions have included:

  • 2006: Granting fast-tracked approval for the original quadrivalent Gardasil vaccine (girls and women aged 9 to 26 years)
  • 2009: Approving Gardasil’s use in boys and men (ages 9-26)
  • 2014: Approving Gardasil-9 (girls ages 9-26, boys ages 9-15)
  • 2015: Approving Gardasil-9 for boys ages 16-26
  • 2018: Approving Gardasil-9 for older women and men (ages 27-45)

An eight-month investigation by Slate identified numerous troubling aspects of the clinical trials that encouraged U.S. and European regulators to approve Gardasil. The Slate reporter also criticized regulators for allowing “unreliable methods to be used to test the vaccine’s safety.” These included Merck’s use of “a convoluted method” that made it difficult to objectively evaluate and report side effects; its failure to document “symptom severity, duration, outcome, or overall seriousness”; restriction of adverse event reporting to just 14 days following each injection; and reliance on the subjective opinion of clinical trial investigators regarding “whether or not to report any medical problem as an adverse event.” Not infrequently, clinical trial participants who shared complaints of debilitating symptoms with trial investigators were dismissed with the response, “This is not the kind of side effects we see with this vaccine.”

The author of the Slate investigation reported:

Experts I talked to were baffled by the way Merck handled safety data in its trials. According to…a professor…who studies side effects, letting investigators judge whether adverse events should be reported is “not a very safe method of doing things, because it allows bias to creep in.” …Of the short follow-up…,“It’s not going to pick up serious long-term issues, which is a pity. Presumably, the regulators believe that the vaccine is so safe that they don’t need to worry beyond 14 days.”

Two years after Gardasil’s initial approval, Judicial Watch pronounced it a “large-scale public health experiment.” Post-licensure studies carried out since then confirm that HPV vaccines have grave risks, including impaired fertilitydemyelinating diseasechronic limb paincirculatory abnormalities and autoimmune illness, to name just some of the disabilities reported in the aftermath of HPV vaccines’ introduction. Overall, the “rate of reported serious adverse reactions (including deaths) from HPV vaccination” is many times higher than the cervical cancer mortality rate.

Recent data suggest that HPV vaccines may be increasing cervical cancer risks.

In a February 2019 letter to the CDC, Children’s Health Defense Chairman Robert F. Kennedy, Jr. noted, “During Gardasil’s clinical trials, an extraordinary 49.5% of the subjects receiving Gardasil reported serious medical conditions within seven months of the start of the clinical trials. Because Merck did not use a true placebo in its clinical trials, its researchers were able to dismiss these injuries as sad coincidences.” A current civil case brought on behalf of a 24-year-old who has suffered from systemic autoimmune dysregulation since receiving her third Gardasil vaccine at age 16 alleges that Merck “committed fraud during its clinical trials and then failed to warn [vaccine recipients] about the high risks and meager benefits of the vaccine.” The trial’s legal team is benefiting from the support of an “A-team” of plaintiffs’ law firms and attorneys, including Kennedy, Jr.

Recent data suggest that HPV vaccines may be increasing cervical cancer risks. A 2017 study out of Australia—which has heavily promoted routine HPV vaccination since 2007—reported an increased risk of difficult-to-detect malignant cervical lesions among the HPV-vaccinated. In all countries where HPV vaccination coverage is high, including Australia, official cancer registries show “an increase in the incidence of invasive cervical cancer” in the vaccinated age groups. In England, “2016 national statistics showed a worrying and substantial increase in the rate of cervical cancer…at ages 20-24”—the first HPV-vaccinated cohort.

The proper decision would be to take HPV vaccines off the market, but the FDA and CDC continue to look the other way. Both agencies’ unwavering support for Gardasil has clearly helped Merck’s commercial bottom line, so much so that the CDC director at the time of Gardasil’s approval (Julie Gerberding) went on to be appointed president of Merck’s profitable vaccine division (worth $5 billion globally) in 2009. The agencies’ willingness to aggressively promote HPV vaccination despite its readily apparent dangers illustrates a “public health flimflam” of the first order. Before the U.S. introduction of HPV vaccination, a decades-long pattern of declining cervical cancer rates was already well underway, thanks to routine cervical cancer screening. HPV vaccines have never even been proven to prevent cervical cancer. In 2016, researchers admitted that they would be unable to ascertain HPV vaccines’ long-term efficacy for “at least another 15-20 years.”

Officials also seem to have little interest in modern evidence documenting many vaccines’ inability to provide the promised protection, even when vaccine coverage is widespread.

Pertussis-containing vaccines

Alongside their many misplaced claims about various vaccines’ rationale and safety record, the FDA and CDC—as echo chambers for the vaccine industry—also have misinformed the public about vaccine effectiveness. Back in 1899, doctor William Bailey (vaccination enthusiast and member of the State Board of Health in Louisville, Kentucky) was more honest, cautioning that “nothing is gained by claiming too much” about vaccine-induced immunity and stating that “the degree of immunity may vary with time and circumstance”—presaging the troublesome modern phenomena of vaccine failure and waning immunity. In the present day, officials are only too willing to “claim too much,” conveniently ignoring historical evidence that reductions in infectious disease had little to do with vaccines and far more to do with improvements in sanitation and nutrition. Officials also seem to have little interest in modern evidence documenting many vaccines’ inability to provide the promised protection, even when vaccine coverage is widespread.

The acellular version of pertussis (whooping cough)—a component of U.S. vaccines such as DTaP and Tdap—is one of the vaccines noted for its abysmal effectiveness. The vaccine is supposed to protect against the respiratory infection caused by Bordetella pertussis. Instead, according to recent studies, pertussis is making a “surprising” comeback; between 1990 and 2005, pertussis epidemics increased in the U.S. “in both size and frequency,” and over half of all cases occurred in highly vaccinated adolescents aged 10 to 20 years old. In fact, not only is pertussis at its highest level since the mid-1950s, but, according to CDC researchers, it is showing signs of being vaccine-resistant. The CDC researchers also note “substantial heterogeneity among vaccine recipients in terms of the durability of the protection they receive.”

… the researchers concluded in 2017 that all currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis …

West Africa has used the DTP vaccine since the 1980s—formulated with a whole-cell pertussis component instead of acellular pertussis—and it has an even more horrifying safety and effectiveness record than its acellular counterparts. Research published in 2017 by a prestigious team of international scientists and led by vaccinology expert Dr. Peter Aaby found that DTP vaccination had a negative effect on child survival, with fivefold higher mortality in young DTP-vaccinated infants (ages three to five months) compared to as-yet-unvaccinated infants. When the researchers published results in 2018 for slightly older DTP-vaccinated children (ages six months to three years), they continued to observe more than double the risk of death as similarly situated unvaccinated children. Explaining that vaccines can increase susceptibility to other infections, the researchers concluded in 2017 that “all currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis” and added in 2018 that “all studies of the introduction of DTP have found increased overall mortality.”

Learning from history

Efforts to counter the official vaccine narrative with evidence about negative consequences date back to the days of smallpox. A doctor practicing in the 1870s observed that smallpox mortality doubled (from roughly 7% to 15%) after adoption of smallpox vaccination. During an outbreak in 1871 and 1872, this doctor stated, faith in vaccination received a “rude…shock” when “[e]very country in Europe was invaded with a severity greater than had ever been witnessed during the three preceding centuries.” The doctor also noted that “many vaccinated persons in almost every place were attacked by small-pox before any unvaccinated persons took the disease.” In this individual’s estimation, these facts were “sufficient to overthrow the entire theory of the protective efficacy of vaccination.”

In the present era, federal agencies continue to tout difficult-to-justify but money-spinning vaccines as beneficial, even in the face of substantial evidence to the contrary. Now, more than ever, it is important to illuminate the risks and downsides that public health agencies do not want us to know about.

Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.

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