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Posts for tag: Vaccine Safety Datalink

By contactus@priority-pediatrics.com
October 07, 2017
Category: Immunizations

Correcting Robert F. Kennedy Jr.’S Vaccine ‘Facts’

 

September 22, 2017Original Article  By Paul A Offit

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.

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.

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).