Three of my Kennedy relatives published an article criticizing my advocacy for safe vaccines. Our contentious family dispute highlights the fierce national donnybrook over vaccinations that has divided communities and raised doubts about the Democratic Party’s commitment to some of its defining values: abhorrence of censorship, wariness toward excessive corporate power, support for free speech, religious freedom, and personal sovereignty over our bodies, and the rights of citizens (codified in the Nuremberg Code and other treaties to which we are signatories) to decline unwanted government-mandated medical interventions. The debate has also raised questions about the independence of our press and its role as a champion of free speech, and First Amendment rights as a bulwark against overreaching by government and corporations.
I love my family and sympathize with their anxieties when I call out government officials for corruption. The Kennedys have a long, close, and continuing relationship with public health agencies so it is understandably difficult for us to believe that powerful regulators would lie about vaccines. “All issues are simple,” the saw goes, “until you study them.”
I’ve arrived at my skepticism after 15 years spent researching and litigating this issue. I have watched financial conflicts and institutional self-interest transform key sectors of our public health bureaucracies into appendages of the very pharmaceutical companies that Congress charged them to regulate.
Multiple investigations by Congress and the HHS Inspector General have consistently found that an overwhelming majority of the FDA officials directly charged with licensing vaccines, and the CDC officials who effectively mandate them for children, have personal financial entanglements with vaccine manufacturers. These public servants are often shareholders in, grant recipients from, and paid consultants to vaccine manufacturers, and, occasionally, patent holders of the very vaccines they vote to approve. Those conflicts motivate them to recommend ever more vaccines with minimal support from evidence-based science.
The pharmaceutical industry also enforces policy discipline through agency budgets. FDA receives 45% of its annual budget from industry. The World Health Organization (WHO) gets roughly half its budget from private sources, including Pharma and its allied foundations. And CDC, frankly, is a vaccine company; it owns 56 vaccine patents and buys and distributes $4.6 billion in vaccines annually through the Vaccines for Children program, which is over 40% of its total budget. Further, Pharma directly funds, populates and controls dozens of CDC programs through the CDC foundation. A British Medical Journal editorial excoriates CDC’s sweetheart relationship with pharma quotes UCLA Professor of Medicine Jerome R. Hoffman “most of us were shocked to learn the CDC takes funding from industry… It is outrageous that industry is apparently allowed to punish the CDC if the agency conducts research that has potential to cut into profits.”
HHS partners with vaccine makers to develop, approve, recommend, and pass mandates for new products and then shares profits from vaccine sales. HHS employees can personally collect up to $150,000 annually in royalties for products they work on. For example, key HHS officials collect money on every sale of Merck’s controversial HPV vaccine Gardasil, which also yields tens of millions annually for the agency in patent royalties. Furthermore, under the 1986 Act that created the National Vaccine Injury Compensation Program, HHS is the defendant in Vaccine Court and is legally obligated to defend against any claim that a vaccine causes injury. Despite high hurdles for recovery, HHS pays out hundreds of millions of dollars annually (over $4 billion total) to Americans injured by vaccines. Hence, if HHS publishes any study acknowledging that a vaccine causes a harm, claimants can use that study against HHS in Vaccine Court. In June 2009, a high-level HHS official, Tom Insel, killed a $16 million-dollar budget item to study the relationship between vaccines and autism by the Interagency Autism Coordinating Committee. Insel argued that petitioners would use these studies against HHS in vaccine court.
Such conflicts are a formula for “agency capture” on steroids. “Instead of a regulator and a regulated industry, we now have a partnership,” says Dr. Michael Carome, a former HHS employee who is now the director of the advocacy group Public Citizen. Carome says that these financial entanglements have tilted HHS “away from a public health perspective to an industry-friendly perspective.”
In 1986, Congress—awash in Pharma money (the pharmaceutical industry is number one for both political contributions and lobbying spending over the past 20 years) enacted a law granting vaccine makers blanket immunity from liability for injuries caused by vaccines. If vaccines were as safe as my family members claim, would we need to give pharmaceutical companies immunity for the injuries they cause? The subsequent gold rush by pharmaceutical companies boosted the number of recommended inoculations from twelve shots of five vaccines in 1986 to 54 shots of 13 vaccines today. A billion-dollar sideline grew into the $50 billion vaccine industry behemoth.
Since vaccines are liability-free—and effectively compulsory to a captive market of 76 million children—there is meager market incentive for companies to make them safe. The public must rely on the moral scruples of Merck, GlaxoSmithKline, Sanofi, and Pfizer. But these companies have a long history of operating recklessly and dishonestly, even with products that they must market to the public and for which they can be sued for injuries. The four companies that make virtually all of the recommended vaccines are all convicted felons. Collectively they have paid over $35 billion since 2009 for defrauding regulators, lying to and bribing government officials and physicians, falsifying science, and leaving a trail of injuries and deaths from products they knew to be dangerous and sold under pretense of safety and efficacy.
Doesn’t it require a kind of cognitive dissonance to believe that vaccines are untainted by the greed, negligence, and corruption that bedevil every other pharmaceutical product?
No safety testing
Such concerns only deepen when one considers that, besides freedom from liability, vaccine makers enjoy another little-known lucrative loophole; vaccines are the only pharmaceutical or medical products that do not need to be rigorously safety tested. To win an FDA license, companies must safety test virtually every other drug for years in randomized comparisons against an inert placebo. Yet, not a single vaccine currently on the CDC’s childhood schedule was tested against an inert placebo before licensing. Without placebo testing, regulators have no capacity to assess a medicine’s risks. During a January 2018 deposition, Dr. Stanley Plotkin, the world’s most influential vaccinologist, acknowledged that researches who try to ascertain vaccine safety without a placebo are in “La La land”. According to Dr. Drummond Rennie, Deputy Editor of the Journal of the American Medical Association, “It is the marketing department, not the science, that is driving the research.” It seems plain wrong to me that Democratic-controlled legislatures across the country are frantically passing coercive mandates for pharmaceutical products for which no one knows the risks.
Furthermore, safety testing, which typically requires five or more years for other medical products, often lasts only a few days with vaccines—not nearly long enough to spot cancers or chronic conditions like autoimmune disease (e.g., juvenile diabetes, rheumatoid arthritis, multiple sclerosis), allergic illnesses (e.g., food allergies, allergic rhinitis, eczema, asthma), or neurological and neurodevelopmental injuries (e.g., ADD, ADHD, narcolepsy, epilepsy, seizure disorders, and autism). Manufacturers’ inserts accompanying every vial of mandated vaccines include warnings about these and over 400 other injuries including many serious immune, neurological, and chronic illnesses for which FDA suspects that vaccines may be the cause. Federal law requires that the package insert for each vaccine include “only those adverse events for which there is some basis to believe that there is a causal relationship between the drug and the occurrence of the adverse event.”
Many of these illnesses became epidemic in American children after 1986, coterminous with the exploding vaccine schedule. For American kids born in 1986, only 12.8% had chronic diseases. That number has grown to 54% among the vaccine generation (those born after 1986) in lockstep with the expanding schedule. Evidence including HHS’s own surveillance reports, manufacturers’ inserts, and peer-reviewed studies link all of these injuries to vaccines. However, the associations are not definitive because CDC has failed to conduct the necessary randomized studies to prove or disprove causation.
HHS has directed the Institute of Medicine (IOM, now the National Academy of Medicine) to oversee the CDC’s vaccine safety science. IOM has repeatedly rebuked the agency for failing to study whether vaccines are causing these epidemics. In my experience, vaccine proponents rarely cite specific peer-reviewed studies to support their assertions that all vaccines are safe, relying instead on appeals to authority; CDC, FDA, WHO, or the AAP. My relatives, for example, argue that vaccines are safe because WHO, HHS, CDC, and FDA say so. But HHS designated the IOM as the ultimate arbiter of vaccine safety. And IOM says that the existing scientific literature does not support these claims. Despite requests by the IOM, CDC has steadfastly refused to perform safety studies.
In total, three IOM reports (1991, 1994, and 2011/2012) investigated 231 adverse events associated with vaccines. For 34 conditions, IOM found that the evidence supported a causal connection between the vaccine and the adverse event. But for 184 adverse events, fully 80% of the conditions reviewed, the IOM found that HHS’s evidence was inadequate to accept or reject vaccine causation. How can our public health officials claim safety when there is no follow-up research on reported adverse events?
Autism and vaccines
Let’s drill down on bedrock dogma that science has thoroughly debunked any links between autism and vaccines. That assumption is so engrained that media ridicules anyone who questions this orthodoxy as a dangerous heretic. But, look for a moment, at the facts. In 1986, Congress specifically ordered CDC to determine if pertussis-containing vaccines (DTP, later DTaP) were causing autism. Then, as today, many parents with autistic children were claiming that vaccines were a cause of their child’s autism and DTP/DTaP vaccines were/are a popular suspect.
On its website, CDC declares that, “Vaccines don’t cause autism,” citing IOM’s comprehensive 2011/2012 literature review of vaccination safety science. However, the IOM study and the follow-up HHS study in 2014 both say that CDC has never performed a study to support CDC’s claim that DTaP does not cause autism. The same is true for Hep B, Hib, PCV 13, and IPV. The only vaccine actually studied with regard to autism is MMR, and a senior CDC scientist claims the CDC did find an increased rate of autism after MMR in the only MMR/autism study ever conducted by the CDC with American children. Moreover, HHS’s primary autism expert recently provided an affidavit to the DOJ explaining that vaccines can cause autism in some children.
Autism has grown from about 1 in 2,500 prior to 1986 to one in 36 among vaccine generation children today. Why are we content with the CDC’s claim that the exponential explosion of autism is a mystery? CDC spares no expense systematically tracking the source of 800 measles cases. But when asked about the cataclysmic epidemic of upwards of 68,000 new autism cases annually, CDC shrugs. Why are we not demanding answers? “CDC is paralyzed right now when it comes to anything to do with autism,” explains former senior vaccine safety scientist Dr. William Thompson, who is still a CDC employee. Thompson told Congressman Bill Posey under oath that CDC bigwigs ordered him to destroy data that showed a link between autism and vaccines and to publish a fraudulent study dismissing the link. Today, he is remorseful, “When I see a family with a child with autism, I feel great shame because I have been part of the problem.”
We are killing children
HHS has also ignored its statutory obligations to study vaccine injuries and improve vaccine safety. In 1986, Congress—recognizing that drug companies no longer had any incentive to make vaccines safe—ordered HHS to study vaccine injuries, work to improve vaccine safety, and report to Congress on its progress every two years. A year ago, I brought a lawsuit that forced HHS to admit that in 36 years it had never performed any of those critical studies.
Post-licensure vaccine safety surveillance is also in shambles. The CDC’s Vaccine Adverse Event Reporting System (VAERS), to which doctors and patients may voluntarily report adverse vaccine events, received 58,381 reports in 2018, including 412 deaths, 1,237 permanent disabilities, and 4,217 hospitalizations. An HHS-funded review of VAERS concluded that “fewer than 1% of vaccine adverse events are reported” to VAERS. This suggests that there are a hundredfold more adverse vaccine events than are reported. The CDC has nonetheless refused to mandate or automate VAERS reporting.
On March 9, 2019, Dr. Peter Aaby issued a scathing rebuke to the world’s public health agencies for continuing to allow pharmaceutical companies to sell vaccines without proper safety testing. Dr. Aaby, who has authored over 300 peer-reviewed studies, is one of world’s foremost authorities on WHO’s African vaccine program and the winner of Denmark’s highest honor for health care research. Dr. Aaby was one of five co-authors of a 2017 study of the diphtheria tetanus, and pertussis (DTP) vaccine, the most widely used vaccine on earth, which found that children who received DTP had ten times the risk of dying compared to DTP-unvaccinated children. For thirty years, doctors, including Aaby, never noticed the danger because vaccinated children were succumbing to illnesses and infections apparently unrelated to the vaccine. It turns out that while the vaccine protected children from diphtheria, tetanus, and pertussis, it so badly weakened their immune systems that they were dying in droves from unrelated infections. The researchers concluded: “The DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus and pertussis.” In March, an alarmed Aaby plead for a policy change, “Most of you think we know what our vaccines are doing. But we don’t…. We are killing children.”
The world’s most aggressive vaccine schedule has not given our country the world’s healthiest children. We now rank 35th in overall health outcomes—just behind Costa Rica, making the U.S., by most measures, including infant mortality, the sickest in the developed world. In addition to those 400 chronic diseases and injuries that FDA suspects may be vaccine related, the vaccine generation suffers unprecedented levels of anxiety and depression and behavioral disorders running the gamut from aggression to anorexia. Peer-reviewed animal and humanstudies have linked all these symptoms to vaccines. The present generation is the first in a century to lose I.Q., having suffered an extraordinary drop of seven points. Researchers concluded that some environmental cause is the trigger. In the U.S., SAT and, more recently, bar exam scores are plummeting. Could these declines be the outcome of injecting virtually every child with multiple doses of two of the world’s most potent neurotoxins—mercury and aluminum—in bolus doses beginning on the day of birth? Shouldn’t we be doing the research to reject this hypothesis? The logical approach to doing so would be to compare health outcomes between vaccinated and unvaccinated children. For years, public health officials, including the IOM, have urged CDC to conduct such studies.
In 2013, the IOM found that, “No studies have compared the differences in health outcomes… between entirely unimmunized populations of children and fully immunized children…. Furthermore, studies designed to examine the long-term effects of the cumulative number of vaccines or other aspects of the immunization schedule have not been conducted.” In a 2008 interview, former NIH Director Bernadette Healy explained that HHS refuses to perform safety studies out of fear that they will expose dangers, “that would scare the public away” from vaccines. Healy continued, “First of all, I think the public is smarter than that… I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show.”
The suppression of critical safety science documented by the IOM would not be possible without a mass epidemic of media malpractice. Mainstream and social media outlets which collectively received $9.6 billion in revenues from pharmaceutical companies in 2016 have convinced themselves they are protecting public health by aggressively censoring criticism of these coercively mandated, zero liability, and untested pharmaceutical products. But, the absence of press scrutiny leaves industry no incentive to improve vaccine safety. Muzzling discussions of government corruption and deficient safety science and abolishing vaccine injuries by fiat is not a strategy that will solve the growing chronic disease epidemic.
The children who comprise this badly injured generation are now aging out of schools that needed to build quiet rooms and autism wings, install wobble chairs, hire security guards and hike special ed spending to 25% to accommodate them. They are landing on the social safety net which they threaten to sink. As Democratic lawmakers vote to mandate more vaccines and call for censorship of safety concerns, Democratic Presidential candidates argue about how to fix America’s straining health care system. If we don’t address the chronic disease epidemic, such proposals are like rearranging the deck chairs on the Titanic. The good news for Pharma is that many of these children have lifelong dependencies on blockbuster products like Adderall, Epi-Pens, asthma inhalers, and diabetes, arthritis, and anti-seizure meds made by the same companies that made the vaccines.
My belief that all or some of these injuries might be vaccine related has been the catalyst that wrenched so much of my focus away from the environmental and energy work that I love, and prompted me to become an advocate for vaccine safety. I have sacrificed friendships, income, credibility, and family relationships in an often-lonely campaign to force these companies to perform the tests that will definitively answer these questions.
People will vaccinate when they have confidence in regulators and industry. When public confidence fails, coercion and censorship became the final options. Silencing critics and deploying police powers to force untested medicines upon an unwilling public is not an optimal strategy in a democracy.
My uncle and my father argued that in a free and open society, the response to difficult questions should never be to shut down debate. What we need is science, not censorship. I am not anti-vax. I am pro-safety and pro-science. I want robust, transparent safety studies and independent regulators. These do not seem like the kind of radical demands that should divide our party or our families. As Americans and Kennedys, we ought to be able to have a civil, science-based debate about these legitimate concerns.