rfk, jr.: gardasil “the science” video and other facts  robert f. kennedy, jr.—“many of the things i’m going to say today would be slanderous if they weren’t true. and, if they are not true, then merck should sue me. but merck won’t do that. and they won’t do that because in the united states, truth is an absolute defense against slander.”  this must-watch video details the many problems with the development and safety of merck’s third-highest grossing product, gardasil. children’s health defense chd and robert f. kennedy, jr., chd’s chairman and chief legal counsel, ask that you watch and share this video so that you, and others, may make an informed decision of whether or not to give your child, boy or girl, a gardasil vaccine. it can also be a useful tool for pediatricians who are trying to understand how this vaccine, that is actually causing health problems with young people, could have been approved by fda and then recommended by cdc. the video is full of jaw-dropping facts about gardasil and the clinical trials leading up to its release upon an unsuspecting public.  transcript of “the science” presentation:  download “the science” transcript  children’s health defense and robert f. kennedy jr.—science day presentation for gardasil  hi, i’m robert f. kennedy, jr. and i’m making this video for the sake of parents who are trying to make an informed decision of whether or not to give their child, their boy or girl the gardasil vaccine.  i’m also making this video as a tool for pediatricians who are trying to understand how this vaccine—if it’s actually causing all of these problems with young girls—could have been approved by fda and then mandated by cdc.  virtually all of the things that i’m going to talk about in this video are available to the public on public documents as i’m going to show.  finally, i want to say this about merck which is the company that makes the gardasil vaccine.  many of the things that i’m going to say today would be slanderous if they were not true. and if they’re not true then merck should sue me. but merck won’t do that and they won’t do it because in the united states truth is an absolute defense to slander. and second of all merck knows that if they sue me, i’m going to immediately file a discovery request, and many, many, more documents are going to emerge that illustrate even more fraud by this company on the american public and the people all over the world.  finally, as a footnote i’m not going to talk today about the specific biological mechanisms that allow this vaccine to cause harm in human beings. that information is out there it’s in dozens of peer-reviewed, published scientific documents. many of these are described on our website and i urge people to go to the children’s health defense website to educate themselves on those issues.  today we’re going to talk about the clinical trial about merck’s fraud in that process…and this is merck’s claim:  the hpv vaccine will “eliminate cervical cancers and other hpv associated cancers.”  the danger of dying from hpv cancer in this country is 1 death in 43.5 thousand people.  imagine you have a deck of cards but instead of 50 cards. there’s 43,500 on a on a big, big table and one of those cards is a black card. if you get that, you die.  so, merck’s deal is that it’s going to remove that black card from the deck. but in order to play the game and make sure that merck removes the black card, everybody who participates has to put in $420 because that’s the cost of the three-dose gardasil vaccine.  so, here’s gardasil by the numbers. so, the cost of the three-jab series average is about $420. there are 76 million children who essentially have been mandated by cdc to receive these vaccines. a blockbuster product from merck, and global revenues from this vaccine today are about $2.3 billion dollars. it’s the third largest product in the company’s inventory.  the cost of saving one american life is 18.3 million dollars. people could argue whether or not that’s a reasonable value of a human life. what i would say was is that the criteria that we should use for evaluating reasonableness—is there a cheaper way to save more lives? and people would argue that pap smears are the most effective way that 80 percent of cervical cancer deaths have already been eliminated by pap smears. and this is the most effective technology.  incidentally in another context hhs has already put a value on human life and the value is $250k. that is the maximum number that the vaccine compensation program will pay for killing an american citizen.  prior to marketing the vaccine, the fda licenses the vaccine, and in that licensing process merck had to show that the vaccine was safe. according to federal regulations the word “safety” means “relative freedom from harmful effects, taking into consideration the character of the product in relationship to the condition of the recipient at that time.”  so, what is the condition of the recipients of that target group for this vaccine. and this vaccine targets millions of preteens and teens, for whom the risk of dying from cervical cancer is practically zero. cervical cancer’s median age of death is 58. it is first diagnosed at age 50 median.  a teenage girl or boy has zero chance of dying of this illness. which means the threshold for giving this medication is very, very high.  secondly it is mandated in some jurisdictions so the government is actually—government officials are actually—coming in and ordering people to take this medical intervention. so, we have to be sure that the threshold for risk, “the risk profile” for that medical intervention should be very, very low.  third, unlike other medical interventions gardasil recipients are perfectly healthy. so, when you give medication to a healthy individual you have to make sure that the risk profile is practically zero. and in order to determine risk, there is a standardized protocol. and it’s called double-blind placebo studies. what does that mean?  it means that the drug company that’s trying to license this product gives the medication to one group of people, maybe 5,000 or 10,000 people, and gives a placebo, an inert placebo, either an identical looking pill that is inert—it’s either saline or sugar—to a similarly situated group of 5,000 or 10,000 people and it’s double blind meaning that neither the patients nor the researchers knew who got the placebo and who got the actual medication.  and you can see here, here’s what the nih says about the national institute for health placebos: an inactive substance that looks like a drug.  so here are typical examples:  lipitor was given during its study phase to about 17k subjects. half of them received lipitor half of them received a sugar pill that looked identical to lipitor and they were observed and studied for up to 3.3 years.  why for so long? because many of the injuries that are caused by medication are latent—they don’t show up for two or three or four or five years cancer for example may not show up for four or five years after the exposure. autoimmune diseases and allergies and these kind of things take a long time to diagnose. enbrel for that reason was delayed for 6.6 years and against a control group that received a saline injection.  botox, there was a national emergency to get botox to market so people could get their wrinkles cured, was studied for 51 weeks and it was studied against a saline injection.  now i’m going to show you one of the really outrageous frauds that merck committed during the clinical trials. this is an insert that is part of every vaccine package. and you can go on the internet right now and look up that merck product and search and find these two tables.  in the initial table you can see a there are three columns and this is a table that just looks at injuries at the vaccine site for redness and itching and bruising and pain at the vaccine site and they use one…there were 5,000 girls—5,088 girls who got the gardasil vaccine.  number two, there were 3,470 girls who got the aahs control, what is that? that is the adjuvant in the vaccine. that is a toxic neurotoxin, that’s put in the vaccine to make it more long-lasting to provoke an immune response in the subject of the vaccine.  and most people believe that it is that aluminum adjuvant that is causing all of these injuries in the girls who are getting the vaccine. and there were 3,470 people who received just the neurotoxin with no antigens and no other vaccine components.  and you have a third group which is the placebo group. what i want you to look at is at these numbers. that in the gardasil and aahs control there is virtually the same number of injuries.  and when you get to the saline placebo, that injury rate is cut in half.  now let’s go to the table where they talk about real systemic injuries…autoimmune diseases, and instead of showing us real science, which is to show us what happened to the saline group, they hide the saline group as a way of fooling you, your pediatrician and the regulatory agency by compressing it into the aluminum group and they never tell us. they say this is a combination of the aluminum adjuvant and the saline placebo. they don’t tell us how many in each category were compressed there. the real thing that you need to watch here is what happened.  these are all very, very serious injuries. these are injuries that in some cases people would feel were worse than death—and that affect people and debilitate for a lifetime in many cases.  and if you look at the bottom of the gardasil group an astonishing 2.3 percent of the girls in the clinical study who received the gardasil vaccine got ill from autoimmune diseases, many within seven months of taking the vaccine.  and look what happened in the aluminum group—the same number exactly. 2.3 percent.  nobody, no parent would allow their daughter to take a substance that had a one-in-40 chance of giving them a lifetime disability.  world health organization says that using a spiked placebo, or a faux-cebo as merck did with gardasil, puts you at a methodological disadvantage that “it may be difficult or impossible to assess vaccine safety.”  dr. stanley plotkin, who developed the polio vaccine…who developed the pertussis vaccine, who developed the rotavirus vaccine—the stanley plotkin award is the nobel prize of vaccinology it’s given to the top vaccinologist every year—and what he says is:  unless you have a true control group you are in la la land.  finally, the american medical association says the absence of double-blind placebo testing and short-term studies of chronic disease are “the indicia of marketing masquerading as science.”  and that’s what merck gave us.  the cochrane collaboration—thirty thousand scientists from all over the world who came together to create an independent assessment of medical protocols which they saw as being increasingly controlled by the industry—the cochrane collaboration said the use of active comparators probably increased the occurrence of harms and the comparative group thereby masking harms created by the hpv vaccine.  and that indeed was merck’s point…to hide those harms.  so, if you do the math women are 100 times more likely to suffer serious adverse events from the gardasil vaccine than they are to be protected from cervical cancer.  so now we have a very different bargain in this card game that we’re playing with merck.  if 43 thousand cards and the black card—the death card is gone—but now, there are a thousand blue cards which if you pick one of those by mistake you have a good chance of getting an autoimmune disease. nobody would take that bargain.  so, in order to get the fda license to market this vaccine merck did a number of studies, which are called protocols. we don’t know how many they did because they’re not telling us they never disclosed it.  the one we’re most concerned with is protocol 18. the reason protocol 18 is critical is because that was the basis for fda giving merck the license to produce and market the vaccine.  why is that? because protocol 18 is the only one in which the target audience for this vaccine. 11- and 12-year old girls was actually tested, and had a control group. the other ones looked at big cohorts of women were 16 to 25-year old and 16 to 26-year old women.  protocol 18 looked at girls and boys from ages 9 to 15. it was a total of 1200 children. and almost 600 controls. that is a very, very, tiny group of people to study in order to determine the safety of a product is going to be marketed to billions of children around the world.  now i’m going to show you one of the key fraudulent flimflams that merck used to get this license. fda said they approved gardasil based on protocol 18 because protocol 18 was of particular interest because it’s the only protocol in which merck used a true saline placebo instead of the aluminum adjuvant as a control.  that’s what merck told fda and the cdc but merck was lying. it actually did not use a true saline placebo. it used what merck called the “carrier solution.” which is all of the components of the vaccine except for the aluminum and the viral particles the antigen.  among the compounds that we know were in the carrier solution are polysorbate 80 which we have no idea what the safety profile is because it’s never been tested for safety independently in vaccines. sodium borate which is borax which is banned by fda in food products and all food products in the united states, and is banned altogether in europe, genetically modified yeast, there’s no safety test ever been done on it in vaccines l-histidine, the same, and possibly dna fragments.  i say possibly because we know there are dna fragments in the final vaccine, we don’t know how they got there. and merck has lied about the dna fragments from the outset.  and despite these potentially toxic components of compounds that are in the vaccine, the 596 children that were given the carrier solution fared much better in the other than any other cohort in the study. the girls and boys who receive the carrier solution were the only significant cohorts with no serious adverse events for the first 15 days.  and here’s another one of the gravamen of the fraud that merck committed in its gardasil trials, but it turns out in the protocol 18 study, it appears merck cut the amount of aluminum that was given to the vaccine group in half. they tested a completely different formulation. if true, we theorize that they took the aluminum out to reduce the number of injuries and to mask the really bad safety profile of this vaccine.  and since the protocol 18 data are not based on the gardasil vaccine formulation, the trial itself constitutes rank scientific fraud.  here’s another bag of tricks that was used by merck in order to skew the clinical trials results in favor of gardasil.  merck and its researchers use what they call exclusion criteria—for example people who had zero allergies, people who had prior genital infections were thrown out of the clinical trials. people who had over four sex partners in their entire lives were excluded from the trials. anybody who had a history of immunological or nervous system disorders, people with chronic illnesses and seizure disorders, people with other medical conditions, people who had reactions to vaccine ingredients including the aluminum, yeast and the benzonase. or anybody with a history of alcohol and drug abuse.  if you really wanted to know whether the vaccine was helping people—if it was effective—wouldn’t you want those people in your study wouldn’t you want people who had a genetic vulnerability to cancer in your study to see if it actually was capable of preventing cancer.  then merck had one catch all exclusion category which was any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives. well, that gave merck and its paid investigators complete control to throw people out of the study who they thought might make the study look not successful. all of these exclusionary categories gave merck the ability to limit the study to people who were like all of these exclusionary categories gave merck the ability to limit this study to people who were like an elite club of superheroes…the people who get the vaccine are not the same people they tested on. they tested it on the avengers. they didn’t test it on, you know, joe bag-of-donuts … the people are actually receiving this vaccine in day to day life. and by doing that they were able to mask whatever injury might show up in a larger and more vulnerable population who are actually receiving the vaccine.  experts used an arsenal of sloppy protocols to again, hide vaccine injuries. among these, merck gave report cards—the daily journal report cards— only to 10 percent of the people who they tested the vaccine on and told those people only make reports for 14 days after the injection. and the report cards were only designed to collect jab site information. so, redness, itching, bruising, fever.  and they ignored altogether the autoimmune diseases and menstrual cycle problems and fertility problems and pain and dizziness and seizures and all of the other things that we’ve now seen are associated with the vaccine. in fact, there are numerous girls who report that they were injured that they attempted to report those injuries to merck, and that merck rebuffed them.  furthermore, merck gave extraordinary discretion to its researchers to determine what was a vaccine injury in what was not a vaccine injury and because there was no inert placebo, it was completely within their discretion. if a girl came back with seizures or autoimmune disease or menstrual cycle problems they could just say to the girl, well that’s not related to the vaccine.  in some cases, we know that merck actively covered up and lied about injuries that it had a duty to report to the vaccine adverse event reporting system. for example, in the case of christina tarsell, a maryland girl, who died from the gardasil vaccine, merck lied about that death in its official reports of the vaccine adverse event reporting system. it told the system that christina’s doctor had told merck that her death was the result of a virus.  and the doctor adamantly denies that. merck has refused to remove the misinformation from the vaers system.  furthermore, merck lied to the girls who participated in these studies, telling them no.1, that the placebo was saline and that it contained no other ingredients. and no. 2, that the study in which they were participating was not a safety study. they were told that there had already been safety studies and that the vaccine had been proven safe.  what did this do for merck? it made it so the girls were less likely to report injuries associated with the vaccine. because they believed that the vaccine that they were receiving had already been proven safe and that any injuries they did experience maybe a month or two months or three months after the vaccine must be simply coincidental and had nothing to do with the vaccine.  despite all of these efforts by merck to discourage those from reporting vaccine injuries during the clinical trials, half of the girls in the gardasil group and half of them in the aluminum adjuvant group reported serious injuries after receiving the vaccine.  in order to conceal the link between these injuries and the vaccine, merck invented a brand new medical metric that had never been heard of before called “new medical conditions” and it dismissed all of these new injuries which affected 50 percent of the girls who received the vaccine and the adjuvant as “new medical conditions”, unrelated to the vaccines, simply sad coincidences.  many of these diseases were serious diseases—blood lymphatic diseases, anemia, endocrine diseases, autoimmune diseases, g.i., crohn’s disease, ulcerative colitis, vaginal infections musculoskeletal injuries, arthritis, neoplasm, hodgkin’s disease, neurological diseases, psychiatric diseases, depression, reproductive and breast disorders, menstrual irregularities, and pain. over 3 percent of the girls—1 in 30—in both groups required surgical and medical procedures.  so, this card game that we’re playing with merck has now become a really bad bet.  merck has removed the one black card but you now have a 1 in 40 chance of drawing a blue card and getting an autoimmune disease that may afflict you for the rest of your life and you have a 1 in 2 chance of having some other serious medical condition.  so now let’s look at merck’s central claim which is that the gardasil vaccine will prevent cervical cancer.  merck’s in a sweet position here, let’s face it because the target group vaccine is 11-year olds, and the median age of death for cervical cancer is age 58. merck essentially is making this bargain.  it’s telling the 11-year old girl if you take our vaccine 47 years from now you won’t die of cervical cancer. and of course, that truth is you can’t make a vaccine that proves that it’s going to prevent cancer 47 years from now. there’s no way to test for that.  so, merck used a shortcut. it said we’re going to prove that it prevents these what it called surrogate end points. the best thing that merck had come up with was cin2 and cin3 lesions which it called precancerous lesions even though most of those lesions never mature into cancer.  so how can you call something precancerous when it was never going to turn into cancer?  and here’s what a study published in the american journal of epidemiology said about merck’s scheme: cin3 is an imperfect diagnosis of precancer, and an intermediate surrogate for cancer.  their own attorneys told them for these products, the indication is the surrogate, not the ultimate. promotion cannot make any claim, vis-a-vis the ultimate end point, based upon the fate of a surrogate endpoint.  merck has another problem. recent peer reviewed scientific studies indicate that perhaps only a third of cervical cancer cases are even associated with the hpv vaccine. that would completely put the lie to merck’s claims that gardasil is going to eliminate cervical cancer altogether.  so now we have a really dubious deal because we need to put that black card back in the deck because now, we have doubts about whether or not this vaccine can prevent cervical cancer at all.  but the news gets worse. gardasil may actually cause cancer. gardasil’s insert states gardasil has never been evaluated for potential to cause carcinogenicity or genotoxicity. and gardasil’s ingredients include possible carcinogens including human dna.  and look at this…this is merck’s own pre-clinical trial records and those records show that girls or women, who already had hpv—had been exposed at some point in their life to it—actually had a negative efficacy of 44.6 percent.  what is negative efficacy? it means those girls had a 44.6 increased risk of getting those precancerous lesions. to make things even worse, there are recent scientific studies that suggest a phenomena of what is known as type replacement—some 200 different strands of hpv, some of them are more cancerous than others, and the current hpv vaccine goes after 9 of those 200 viral types. what these studies indicate is by eliminating those particular strains of the virus it opens up an ecological niche in the woman so that more lethal and virulent viruses can actually colonize that spot and dramatically increase the risk of cervical cancer.  so now merck’s deal is looking really grim. not only do we have a one-in-40 chance of getting an autoimmune disease and a 50 percent chance of getting some serious medical condition but now the cancer risk has been reinserted and actually amplified.  and now let’s look at some of the non-cancer injuries that merck found in its preclinical studies.  the miscarriage rate in the preclinical studies after gardasil doubled the background rate. the birth defects in the gardasil group were five times the rate of birth defects from the control group. as to reproductive disorders an astonishing 10.9 percent of the women in the pool group reported reproductive disorders within seven months of receiving gardasil compared to 1.2 percent in the placebo group. the death rate in the gardasil group and the clinical trials was 8.5 per 10 thousand.  death risk from this vaccine according to merck’s own studies is 37 times the risk of dying from cervical cancer.  oh, now look at the deal that merck has offered us they’ve actually increased our risk of dying by 37 times.  so now let’s look at post-licensing surveillance. so, merck can argue that we might have missed something in our pre-licensing studies but surely if there were any injuries being caused by this vaccine we would see them in post-licensing surveillance.  and the problem with that is that the post-licensing surveillance system, the principle one, is called the vaccine adverse event reporting system. the system is a voluntary system that simply does not work. it’s broken. in fact, in 2010 hhs hired another federal agency the agency for healthcare research quality and a group of harvard researchers to study vaccine adverse event reporting system and those researchers found fewer than 1 percent of adverse events of vaccines are ever reported.  but even under that system, gardasil has distinguished itself as the most dangerous vaccine ever invented.  in fact, when you compare it to menactra which is a meningitis vaccine that’s given to the same age group—teenagers—gardasil had an 8.5 times more emergency room visits, 12.5 times more hospitalizations, 10 times more life-threatening events and 26.5 times more disabilities than menactra.  the vaccine court which is within hhs has made awards for numerous deaths and very, very serious injuries from the gardasil vaccine. so, hhs itself admits that this vaccine kills people and it’s given compensation to the families that were injured.  the same wave of serious injuries and deaths that have been seen in nations around the globe, when they adopt mandates for the gardasil vaccine. even gardasil’s own insert, the package insert that the company provides, acknowledges that the injuries that can be caused by this vaccine include death, pancreatitis, fatigue, malaise, immune system disorders, autoimmune diseases, anaphylaxis, musculoskeletal and connective tissue disorders, nervous system disorders, acute disseminated encephalomyelitis, that’s brain injuries, guillain-barré syndrome, and other neuron diseases, paralysis, seizures, transverse myelitis, and vascular disorders.  in australia, in 2015, the australian department of health therapeutic goods administration reported that the adverse rates in girls is 17 times the incidental rate for cervical cancer throughout their lifespan. the country only looked at a handful of conditions including demyelinating disorders, complex regional pain syndrome and premature ovarian failure. there are many, many other injuries that included hospitalizations that were not subject to that study.  india suspended its gardasil trials after numerous deaths and serious injuries.  a south asian journal of cancer found that “a healthy 16-year old is at zero immediate risk of dying from cervical cancer but is faced with a small, but real risk of death or serious disability from a vaccine that has yet to prevent a single case of cervical cancer.”  japan de-recommended gardasil three months after it had added the vaccine to the immunization schedule. japan’s health ministry discovered adverse events reported after gardasil’s approval were many times higher than other vaccines on the recommended schedule—these included seizures severe headaches partial paralysis complex regional pain syndrome and an undeniable causal relationship between persistent pain and the vaccination.  japanese researchers found that the adverse event rate for the hpv vaccine was as high as nine percent and that pregnant women injected with the vaccine aborted or miscarried 30 percent of their babies.  in 2015 the japanese association for medical sciences issued official guidelines for managing symptoms of injuries caused by the gardasil vaccine and the association announced there was no proof that this vaccine even prevents cervical cancer.  alarmingly merck’s own studies indicate that the gardasil vaccine may disproportionately impact asian women. for example, in protocol 19 there were 8 deaths among 3800 women and 7 those were asians. that was 87 percent for asian women, while only 31 percent of study participants were asian.  denmark in 2015 announced the opening of five new hpv clinics to treat women who were injured by the gardasil vaccine. the day that they announced that opening there were 1300 applicants for treatment in those clinics.  in colombia in 2014 800 girls in the town carmen de bolivar were grievously injured by gardasil vaccine. protests erupted all over columbia. the attorney general of colombia ordered the national health service of that country to immediately begin treating girls who were injured by the gardasil vaccine and 2017 colombia’s highest constitutional court ruled that the hpv vaccine would no longer be considered mandatory in colombia and ordered that girls who showed symptoms after receiving the vaccine be given appropriate medical care.  pompilio martinez, who now teaches at the national university of colombia, described the hpv vaccine as “a crime against humanity.”  recent studies have shown that in nations with robust hpv vaccination programs and heavily vaccinated populations—in the uk and sweden and australia—were actually seeing dramatic upticks rises in the rate of cervical cancer rather than the downtrends that merck promised everybody.  now i’m going to show you some of the reasons why your pediatrician is insisting despite all of this evidence that your daughter or son gets the hpv vaccine. and the reason is the pediatrician is getting his information from agencies that have compromised through financial entanglements with merck.  this is what the fda is telling the public about vaccine safety: it says that vaccines are regulated by fda and undergo a rigorous review of laboratory and clinical data to ensure the safety efficacy and purity and potency of these products.  but this is a very different story the fda is acknowledging in-house, and this comes from a 2007 document—this is the year that gardasil got its license from the fda, fda’s inability to keep up with scientific advances mean that american lives are at risk. fda is evaluations and methods have remained largely unchanged over the last half century. the world looks to fda as a leader today. not only can the agency not lead, it cannot even keep up with the advances in science.  but, the most troubling problem at fda is it has nothing to do with incompetence. it has to do with corruption. the panel within fda that licenses new vaccines and anoints them as safe is called the vaccine and related biological products advisory committee, the acronym is vrbpac. and in 2000 congress investigated vrbpac because of charges of corruption from outside the agency.  and here’s what the congressional committee found: the overwhelming majority of members, both voting members and consultants have substantial ties to the pharmaceutical industry.  conflicts of interest rules employed by fda have been weak enforcement has been lax. committee members with substantial ties to pharmaceutical companies are given waivers to participate in committee proceedings. in many cases significant conflicts of interest are deemed to be in conflict at all.  and here are some specific examples of the conflict of the advisory committee that approves vaccines:  three out of five fda advisory committee members who voted to approve the rotavirus vaccine in december of 1997 had financial ties to the pharmaceutical companies that were developing different versions of the vaccine.  one of the five voting members had a 9 plus million dollar contract for a rotavirus vaccine.  one of the five voting members was the principal investigator for a merck grant to develop the rotavirus vaccine.  one of the five voting members received approximately a million dollars from vaccine manufacturers toward vaccine development.  once they get by fda, vaccine companies then go to cdc, where another committee, which is called acip advisory committee on immunization practices, will then take that vaccine that fda has licensed and they will put it on the recommended list which means it becomes essentially mandatory for 76 million american children.  a listing on cdc’s recommended list is the holy grail for vaccine companies. it
rfk, jr.: gardasil “the science” video and other facts • children's health defense