When people misrepresent facts on the record, journalists are in a tough spot — especially when that information can be harmful.

Which brings me to STAT’s recent interview with Robert F. Kennedy Jr., conducted by Helen Branswell. STAT wanted to interview Kennedy about his claim in January 2017 that Donald Trump would soon appoint him to head a commission on vaccine safety and scientific integrity. Seven months had passed since Kennedy had made the claim and no announcement had been made. STAT wanted to find out where things stood.

Branswell began her interview by asking Kennedy eight different times and in eight different ways where things stood on his commission. Each time, he failed to confirm or deny whether the White House was about to appoint him.

advertisement

That clearly wasn’t what Kennedy wanted to talk about. Instead, he wanted to talk about his belief that mercury in vaccines is poisoning America’s children and that no one in the federal government seems to care. By insisting that the interview be conducted in the question-and-answer format, Kennedy effectively tied STAT’s hands, which had to print what he said without editorial comment or opposing views.

I feel compelled to oppose Kennedy’s claims.

advertisement

During the interview, Kennedy said that some babies were being injected with 25 micrograms of ethylmercury, which is part of a preservative called thimerosol that is used in multi-dose vials of influenza vaccine. He claimed that amount to be “100 times” greater than the amount considered to be safe.

As an environmentalist, Kennedy should know that mercury is a natural part of the Earth’s crust. As a consequence, methylmercury (environmental mercury) is contained in water and anything made from water, like breast milk and infant formula. The human body eliminates ethylmercury from vaccines far more efficiently than it eliminates naturally occurring methylmercury.

Babies typically ingest about 360 micrograms of methylmercury during the first 6 months of life, well before they will ever receive their first dose of influenza vaccine. If the 25 micrograms of ethylmercury in vaccines is 100 times greater than what Kennedy claimed is safe, then simply by living on Earth, by 6 months of age babies will have ingested an amount of mercury that is 1,440 times greater than Kennedy’s safety limit.

According to Kennedy’s calculations, all of us are massively intoxicated with mercury. The only way to avoid this would be to move to another planet.

Kennedy also said that he wanted to ensure “that vaccines are subject to the same kind of safety scrutiny and safety testing that other drugs are subject to.” In fact, vaccines are subjected to greater scrutiny than drugs. Much greater. For example, the CDC spends tens of millions of dollars every year on the Vaccine Safety Datalink, a system of linked computerized medical records from several major health maintenance organizations that represents about 7 million Americans, 500,000 of whom are children. Nothing like this exists on the drug side. Frankly, if a Drug Safety Datalink existed, the problem with Vioxx as a cause of heart attacks might have been picked up much sooner.

Kennedy said, “We need to, prior to licensing vaccines, do gold standard safety testing, like every other drug approval requires. We need to do double-blind placebo testing.” Branswell knew that the FDA does require placebo-controlled trials before licensure. So she pushed back. “Sir, that’s done all the time,” she said. “That is done all the time.”

Branswell was right. Here’s an example of the kind of testing that vaccines are put through. One of the currently licensed vaccines against rotavirus was tested in a placebo-controlled, prospective, 11-country, four-year trial of more than 70,000 infants before being approved. That’s fairly typical of most pre-licensure trials. But STAT was stuck having to report Kennedy’s remarks as is, even though Branswell knew they were false. That was the deal. The interview had to be printed without contradiction.

Perhaps most outrageous was Kennedy’s claim that “the hepatitis B vaccines that are currently approved had fewer than five days of safety testing. That means that if the child has a seizure on the sixth day, it’s never seen. If the child dies, it’s never seen.” Safety monitoring for the hepatitis B vaccine, like all vaccines tested before being licensed, involved determining side effects in the vaccinated and unvaccinated group for weeks after each dose. Indeed, some subsets of vaccinated individuals have been monitored for 30 years after hepatitis B vaccination.

Throughout the interview, Kennedy never adequately addressed the new commission. Creating such a commission doesn’t make sense to me for two main reasons.

First, a vaccine safety commission already exists. It’s called the Centers for Disease Control and Prevention. Staffed by epidemiologists, microbiologists, virologists, statisticians, molecular biologists, and clinicians, the CDC supervises the Vaccine Safety Datalink, which I described earlier. Whenever a new vaccine is licensed, this system quickly determines who’s been vaccinated and who hasn’t and detects any side effects that might be occurring more frequently in the vaccinated group.

Second, a commission for scientific integrity also already exists. Independent of the CDC, it’s called the Office for Research Integrity, and is housed in the Department of Health and Human Services.

It’s unfortunate that our culture, and our media, sometimes give celebrities a chance to comment without opposition on subjects about which they are often misinformed. It’s invariably the listener or reader who suffers this advice. Maybe journalists could at the very least add a cigarette-style caution to interviews like the one that STAT did with Robert F. Kennedy, Jr. Something like “CAUTION: Reading this article might be dangerous to your health.”

Paul A. Offit, M.D., is a professor of pediatrics and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. His most recent book is “Pandora’s Lab: Seven Stories of Science Gone Wrong” (National Geographic Press, April 2017).

  • The real issue is that vaccines play a causal role in autism and other harmful outcomes in individuals with genetic or acquired susceptibilities.

    How misleading of Paul Offit and Dorit Reiss to argue instead against the red herring/strawman “vaccines don’t cause autism.”

    The science overwhelmingly supports that vaccines can both trigger and exacerbate predispositions, thereby causing great harm.

    Offit and Reiss should be clamoring for pre-screening for all known predispositions to vaccine reaction, like MTHFR genetic mutations, celiac disease and other inflammatory intestinal issues that cause malabsorption, vitamin deficiencies, glutathione deficiencies, and predispositions to seizures.

    But instead, they’re clamoring for mandatory medical interventions for all, in complete violation of Article 6 of the 2006 UNESCO Statement on Bioethics and Human Rights.

    When a vaccinologist and a law professor team up to violate human rights, that speaks volumes.

    • It’s absolutely shocking that Dorit Reiss would ignore Article 6 of the 2005 UNESCO Statement on Bioethics and Human Rights, which clearly state:
      ” Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.”

      Turning down highly-profitable preventive medical interventions with known failures, and with both known and unknown risks, is not in any way a failure to protect from disease, and Dorit Reiss, as an attorney, knows this.

      This is WHY we have the UNESCO Statement on Bioethics and Human Rights–to protect us against the massively-powerful pharmaceutical industries and their unofficial spokespeople, who would try to convince us that their products are safer, more effective, and more “necessary” than they really are.

      Since there have been no studies on the safety of vaccinating people with MTHFR genetic mutations, Dorit Reiss has absolutely no scientific or legal basis for her claims that they can be safely vaccinated with every vaccine on the schedule, or even with ANY vaccines on the schedule. Again, shocking that she would make such claims.

      Quoting invalid sources like skeptical raptor (a BLOG!) just makes her look even less credible.

    • Oh yes Liz…its “bigotry” to not want my freedom stolen from me by someone who should go back to where she came from if she can’t accept how we live here. PS. We’re fighting for your freedom too. How will you feel when vaccine injuries or death impact your life and you’re still forced to make the same sacrifice again?

    • I’m not American either or in the US so I’m sure you’re not doing anything on my behalf. Funny though, I know more about US law than you do.

    • Again, the right to informed consent does not include a parent’s right to sacrifice a child to preventable diseases. The child is not consenting to be left unprotected, and the parent’s bodily autonomy is not violated by the requirement to protect the child because the child had a separate body.

      Vaccines are supported by all health authorities because tens of thousands of studies show that they are safe and effective.

      Buying into misinformation does not turn the choice to fail to protect children into a human right.

  • Ted, Offit can’t produce evidence that thimerosal is safe for infants, because it does not exist. Kathy, DR, can either of you produce a single human study that shows that thimerosal is safe at vaccine dose levels in human infants? Enough with “JLW cites bad studies”. Where’s your study showing that injecting Ethyl mercury in human infants is safe?

  • “Dr. Offit’s Vaccine Education Center”? It’s mis-titled.

    “Dr. Offit’s Vaccine Misinformation Center”

    Dr. Paul A. Offit is not credible source of information on vaccine risk, or vaccine safety, or aluminum toxicity. The misinformation he spreads is dangerous to millions. The list goes on and one.

    • Dr. Offit is an acknowledged expert on vaccines at an international level. He received many awards, is one of the authors of the professional textbook, and is a sought after speaker. The scientific community acknowledges his expertise, and finds him very credible.

      Since he speaks to correct anti-vaccine misinformation, it’s natural for anti-vaccine activists whose claims he counters to find him non-credible, especially if they really believe the misinformation they promote (hard to know).

      Doesn’t change his expertise or credibility.

    • I will add that the Vaccine Education Center is on the WHO’s list of credible sites, since it has been verified and certified as credible. The WHO lists credible sources on vaccines.

    • As Offit has saved millions of lives and James “Cherry Pickin” Weiler may be directly responsible for multiple deaths in Europe this year alone with his hateful & harmful misinformation he preaches for your own pocketbook & agenda, I’ll leave it up to the readers to decide who is a credible source of information.

      It’s obvious James envisioned his life becoming more like Offit’s & being nationally recognized as a scientist who people respect. Because it has gone the opposite way he is extremely jealous of Offit & is now lashing out with angry, frustrated personal attacks.

      It is sad to see James unravel this far. I pray for him and his family.

    • Dr. Offit is not an immunologist. He is a “vaccinologist.” He is not an expert on adverse reactions to vaccines. He has no background on autoimmune issues, which may cause people with autoimmune disorders to react differently than others to vaccines. He has no background on genetic mutations that might predispose individuals to health issues impacting their ability to properly excrete the supposedly “tiny” amounts of neurotoxins in vaccines.

      He does, however, have a strong background of enormous financial support from Merck.

      That’s known as a conflict of interest.

  • DR wrote: “At any rate, vaccines are not experimental.”

    This is another reason why I block people. Disingenuous posts like this. DR is denying that post-market surveillance is a bedrock of vaccine safety “science”.

    She is denying that any vaccine must be tested and are subject to FDA approval before they come to market. In studies that use human subjects. Under all Federal classifications of human subjects research, vaccines are experimental.

    Pity the violations of informed consent.

    • I expect most people understand that having additional monitoring in place after vaccines were licensed does not make them experimental. Yes, vaccines must be tested and licensed before they come to market. Those clinical trials require informed consent.

      Once they are licensed, they are no longer experimental. I hope that helps. If the author needs more detailed explanation of the licensing and testing process, he can ask.

    • Wow, James “Cherry Pickin” Weiler is completely losing it.

      Now he is claiming vaccines aren’t tested on human subjects? Seriously? Most vaccines are tested for 10-25 years before approval my friend.

      I suggest you completely start over with your research on vaccines. You simply are too ignorant of basic concepts. How are you not embarrassed by this display?

    • Here is evidence of the experimental nature of vaccines:
      “The startling global resurgence of pertussis, or whooping cough, in recent years can largely be attributed to the immunological failures of acellular vaccines, School of Public Health researchers argue in a new journal article.”

      Got that? They just admitted that whooping cough outbreaks are due to vaccine failure.

      So let’s discuss how public health officials insisted that everyone should submit to repeated administration of a medical intervention that didn’t work, and posed unnecessary risks.

      Administering these medical interventions when you don’t know in advance that the outcome will be different from what you’d hoped–that’s experimental, even if you don’t admit that it’s an experiment.

    • Here is evidence of the experimental nature of vaccines:
      “The startling global resurgence of pertussis, or whooping cough, in recent years can largely be attributed to the immunological failures of acellular vaccines, School of Public Health researchers argue in a new journal article.”
      http://www.bu.edu/sph/2017/09/21/resurgence-of-whooping-cough-may-owe-to-vaccines-inability-to-prevent-infections/

      Got that? They just admitted that whooping cough outbreaks are due to vaccine failure.

      So let’s discuss how public health officials insisted that everyone should submit to repeated administration of a medical intervention that didn’t work, and posed unnecessary risks.

      Administering these medical interventions when you don’t know in advance that the outcome will be different from what you’d hoped–that’s experimental, even if you don’t admit that it’s an experiment.

  • Dorit Reiss would like us to believe that coercing people into accepting invasive medical intervention is Constitutional, but it’s not. Note she has not provided anything in the Constitution to support that, but instead repeats misleading industry talking points using industry claims of safety and efficacy–claims that have been proven untrue.

    She also ignores the 2095 UNESVO Statement on Bioethics and Human Rights:

    Article 6 Consent
    1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

    • This is a repeat of the comment below, so let me repost part of my answer:
      The commenter, again unable to respond to the points in the article, is now quoting a letter by a distressed father unhappy that Dr. Offit pointed to the problems with the claim that his daughter’s problems were vaccine related.

      I’m not sure what the commenter thinks this shows. That two people disagreed about the facts? It might be helpful to remember that the 5,000 cases mentioned here were rejected in long decisions that concluded vaccines don’t cause ASD, and were not remotely close: the evidence was clear against the cases.

    • A. International conventions are not constitutional documents. To remind you, the classic case of Jacobson v. Massachusetts found criminalizing vaccine refusal constitutional.

      B. I would agree that a court would likely find force vaccinating an adult today unconstitutional. It would also almost certainly find requiring a child be vaccinated constitutional. Parents don’t have absolute rights to refuse to protect their children from disease. Here is the long version.

      http://www.buffalolawreview.org/past_issues/63_4/Reiss.pdf

  • The commenter, unable, again, to address the actual points, is trying to attack the speaker again, this time by reference to a 2008 letter to the editor by distressed parents of a child who was compensated in vaccine court. The letter is inaccurate in several ways. First, the concession in question clearly acknowledged that the child’s problem was a preexisting genetic disorder, that was not caused by vaccines.

    But that inaccuracy apart, there is actually evidence that vaccine combinations are safe. They are tested. So here, too, the letter is wrong. https://www.skepticalraptor.com/skepticalraptorblog.php/vaccines-tested-myth-vs-science-updated/

  • The commenter, again, is trying to attack Dr. Offit rather than rebut any of the points made. This time he is digging deep to find an old letter from 2008, relating to an unusual concession in Vaccine Court (one the court since explains does not show vaccines cause ASD: https://leftbrainrightbrain.co.uk/2016/07/08/court-clarifies-hannah-poling-case-does-not-afford-any-support-to-the-notion-that-vaccinations-can-contribute-to-the-causation-of-autism/).

    The concession did actually emphasized a mitochondrial disorder that existed before vaccines – a genetic one.

    But that inaccuracy apart, there is actually evidence that vaccine combinations are safe. They are tested. So here, too, the letter is wrong. https://www.skepticalraptor.com/skepticalraptorblog.php/vaccines-tested-myth-vs-science-updated/

  • “By omitting critical information from my March 6, 2008, statement, Offit misrepresents my position. I said, “Many in the autism community and their champions believe that the result in this case may well signify a landmark decision as it pertains to children developing autism following vaccinations. This still remains to be seen, but currently there are almost 5,000 other cases pending.”
    Offit’s remarks about Hannah’s case are not evidence-based. He has no access to my daughter’s personal medical records, legal documents, or affidavits. In contrast, physicians from the Department of Health and Human Services (DHHS) who studied this information recommended that the government concede Hannah’s case. The clinical history Offit presents contains significant inaccuracies, and the resulting conclusions are consequently flawed.
    Offit confuses issues by comparing Hannah’s case with unrelated decisions in “vaccine court.” The Office of the Secretary of DHHS, through the Department of Justice, conceded Hannah’s case. There was no courtroom hearing and no decision from the “unusual vaccine court.”
    Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe. His opinion is unsupported by clinical trials, much less investigations in potentially susceptible subpopulations.”

    http://www.nejm.org/doi/full/10.1056/NEJMc086269

  • Who is Offit? Does STAT bother to research a persons credentials before presenting him/her a an expert?
    “By omitting critical information from my March 6, 2008, statement, Offit misrepresents my position. I said, “Many in the autism community and their champions believe that the result in this case may well signify a landmark decision as it pertains to children developing autism following vaccinations. This still remains to be seen, but currently there are almost 5,000 other cases pending.”
    Offit’s remarks about Hannah’s case are not evidence-based. He has no access to my daughter’s personal medical records, legal documents, or affidavits. In contrast, physicians from the Department of Health and Human Services (DHHS) who studied this information recommended that the government concede Hannah’s case. The clinical history Offit presents contains significant inaccuracies, and the resulting conclusions are consequently flawed.
    Offit confuses issues by comparing Hannah’s case with unrelated decisions in “vaccine court.” The Office of the Secretary of DHHS, through the Department of Justice, conceded Hannah’s case. There was no courtroom hearing and no decision from the “unusual vaccine court.”
    Offit is frequently cited regarding the “biologically plausible” theory that simultaneous administration of multiple vaccines is safe. His opinion is unsupported by clinical trials, much less investigations in potentially susceptible subpopulations.”

    http://www.nejm.org/doi/full/10.1056/NEJMc086269

  • Kathy wrote: “You get informed consent because you can say no to any vaccine and because all participants in vaccine studies are volunteers”.

    NO patient who injury, or lack of injury, was included in retrospective studies using data from VAERS or from VSD were consented. NONE. CDC and Pharma have been violating the Nuremberg code and US Federal regulations routinely on vaccines, and look at the result. It’s a disaster. Epidemics of autoimmunity, food allergies, ADHD, ASD, the list goes on and on. Those regulation are in place to protect the unwitting against exactly this. Being expert in study design, and having taught courses to both MDs and PhDs on study design (with bioethics as the central theme of the course), and being schooled and tested on the regulations on informed consent for both medical procedures and for clinical research, I am well positioned to offer my professional opinion that human subject research has been going on without informed consent. My children were completely vaccinated – never once were they, or I, asked if we wanted to be part of post-market surveillance studies. The 21st C “Cures” act has a provision that we can all be enrolled in clinical studies without informed consent if those running the study have determined that the risk to those enrolled is low. Since it is impossible to determine the long-term safety of vaccines before the studies are conducted (otherwise why do the studies), long-term “pharmcovigilence” post-marketing retrospective, correlational studies are not covered by the 21C Cures act. Anyone who does further research without prior consent is at risk of being prosecuted for serious violations of the Common Rule, and the regulations that add special protections for children and pregnant women, and fetuses. The “Common Rule” disallows coercion for consent completely vs. [21 CFR 50.24]: “Common Federal Policy for the Protection of Human Subjects (“Common Rule”) [10 CFR 745] Sec 745.103(b)(3), none of these rights were revoked by any subsequent legislation, including [21 CFR 50.24], which allows the relaxation of requirements for informed consent during emergencies. In fact the Common Rule re-asserted safeguards both for informed consent, and for special protections against coercion:
    §46.116 General requirements for informed consent.
    Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

    Vaccine Risk Denialists are apologists for individual, corporations and agencies who are conducting illegal and, more importantly, unethical, human subjects research.

Comments are closed.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy