Poor Robert F. Kennedy, Jr. He went from admired environmental activist to reviled antivaccine campaigner so quickly. It began when he outed himself in 2005 with his infamous conspiracy mongering screed about thimerosal in Salon.com and Rolling Stone. Basically, RFK Jr. is a member of what we used to call the mercury militia, a branch of the antivaccine movement that believes, more than anything else, that it is the mercury-containing preservative thimerosal that used to be in several childhood vaccines until 2002 drove an “epidemic” of autism. He’s still a member, too, having recently written with Dr. Mark Hyman a book entitled Thimerosal: Let the Science Speak: Mercury Toxicity in Vaccines and the Political, Regulatory, and Media Failures That Continue to Threaten Public Health. Not surprisingly, it was chock full of antivaccine misinformation and claims that thimerosal in vaccines caused all sorts of horrible neurological problems in children. It didn’t, nor did it cause autism. The idea that thimerosal-containing vaccines cause autism is a failed hypothesis. Just this year, he even went full crank once again and offered a “challenge” worthy of Jock Doubleday’s bizarre vaccine challenge to prove that thimerosal is safe. It was rigged, naturally. Basically, RFK Jr., his denials notwithstanding, is antivaccine to the core.
Early in 2017, when President-Elect Donald Trump and his team were working on the transition of administrations, RFK, Jr. was invited to Trump Tower to meet with him. RFK Jr., being RFK Jr., he immediately blabbed to the press that Trump had asked him to form and chair a presidential commission on vaccine safety, or autism, or…something. It wasn’t exactly clear what. Of course, those of us who were pro-vaccine were alarmed, as this seemed to signal that as President Trump would act on his oft-expressed idea that vaccines cause autism, particularly in wake of the revelations that he had met with a bunch of antivaccine activists including Andrew Wakefield while campaigning in Florida in August. Fortunately, however, the Trump administration thus far hasn’t acted on any “presidential commission” on vaccine safety or autism. Indeed, Trump has appointed pro-vaccine advocates to run both the FDA and CDC.
So I was amused to see an article in STAT News about the vaccine commission that RFK Jr. so much wants to chair. How’ve things been going on that score? Not so well, it turns out:
Robert Kennedy Jr., the environmental activist and leading vaccine skeptic, says that it has been months since he has talked with White House officials about chairing a vaccine safety commission — and that the idea of such a panel may no longer be under consideration.
“I’ve had no discussions specifically about the vaccine safety commission, probably since February,” Kennedy told STAT. “You’d have to ask the White House. It may be that it’s evolved.”
Before I go on, let me just give Helen Branswell, who wrote this otherwise excellent report, a word of advice: RFK Jr. is not a “vaccine skeptic,” leading or otherwise. He is antivaccine to the core and has been spewing antivaccine pseudoscience since at least 2005. Skepticism does not mean reflex rejection of the scientific consensus in favor of pseudoscience, but that is exactly what RFK Jr. does: Reject the scientific consensus and embrace pseudoscience. If there’s something that reporters do that really grate on me, it’s to use language like this to describe antivaxers. It gives them far more credibility than they deserve.
Of course, this is just RFK Jr. being RFK Jr. He’s publicity whoring. He wants attention. He wants you to know how important he is. Unfortunately, the Kennedy name goes a long way. Kennedy met with Dr. Peter Marks, head of the Center for Biologics Evaluation and Research, which regulates vaccines, and other FDA staff on March 30, as he has bragged in his interview with STAT:
Well, I’ve met with high-level officials in the White House. They’ve arranged meetings for me with HHS and White House officials and agency officials. Various agency officials, including [NIH Director] Francis Collins and his deputy, Lawrence Tabak, I think. And I met with Tony Fauci, who’s at the National Institute of Allergy and Infectious Diseases. Linda Birnbaum, who’s at the National Institute of Environmental Health Sciences. Diana Bianchi, at the Eunice Kennedy Shriver National Institute of Child Health and Human Development at NIH. And over at FDA I’ve met with Peter Marks, the director of [the Center for Biologics Evaluation and Research] and some other officials there. I can’t remember everybody at this point, all of the people that we’ve met with.
He even met with NIH Director Francis Collins and other NIH staff, who, appropriately, pushed back:
Kennedy met on May 31 with top leaders of the NIH. Director Francis Collins and Deputy Director Lawrence Tabak attended the meeting, along with the heads of the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Environmental Health Sciences.
Kennedy laid out his concerns about vaccines at the meeting, presenting the information he views as supporting evidence, according to an official familiar with the discussion who spoke on condition of anonymity. But the NIH participants countered, the agency suggested in an email.
“In the meeting, NIH noted that there is strong and extensive scientific data that support the safety and efficacy of vaccines,” a spokesman said. “NIH reaffirmed with Mr. Kennedy that vaccines are among the most beneficial health interventions in history in terms of the number of lives that have been saved over decades, have been shown to be very safe, and are vital to the public health goal of preventing diseases.”
In his interview, Kennedy claims that the Trump administration asked him to meet with these officials. Given that Kennedy is an inveterate self-promoter who’s been known to—shall we say?—stretch the truth on occasion, I wonder if his version of events is reliable. On the other hand, this is the Trump administration. it wouldn’t surprise me at all if the administration did ask him to meet with these people, and, given that, these officials could not refuse. I’m glad, though that NIH leaders and, from what I can gather, everyone else forced to meet with Kennedy pushed back at his= pseudoscience and fear mongering about vaccines. The good news is that the message I’m getting from this report and interview with RFK Jr. is that pursuing antivaccine policies—excuse me, investigating “vaccine safety”— does not appear to be a priority for Trump, which means that his appointees to key positions at the CDC, NIH, and FDA have been unequivocally pro-vaccine. For instance:
Vaccines save lives. #vaccineswork https://t.co/oWol1N5wXh
— Scott Gottlieb, M.D. (@SGottliebFDA) August 18, 2017
And:
Vaccines are one of the greatest #publichealth achievements. Immunization gives us the power to protect. #NIAM17 http://pic.twitter.com/smGLrd6k8y
— Dr Brenda Fitzgerald (@CDCDirector) August 3, 2017
Oh, how antivaxers howled with outrage!
It’s also amusing to read Kennedy as he is asked multiple times if the commission will go forward or if it might go forward with someone else leading it, every time provoking a response along the lines of, “You’d have to ask the White House”:
You’d have to ask the White House. It may be that it’s evolved. I’ve been told that the president is still interested in this issue and that he wants me to have further meetings with the regulatory agencies and with the White House. Like I said, I have not talked to anybody in the White House about the commission.
All of this leads me to believe that most of this is just Kennedy promoting himself, as he is very good at doing. Most likely what happened is that when Branswell contacted him to find out if, seven months later, anything had happened regarding the Presidential commission, he saw his chance to blow his own horn.
I do give Branswell props for pushing back against Kennedy’s misinformation, though. For instance, Kennedy claims:
We need to do double-blind placebo testing. Because particularly when it comes to injecting aluminum or mercury into babies, the consequences may be latent. In other words, they may not manifest or diagnosed to age 3 or 4. So the current protocols, which require testing for vaccines of sometimes as little as 48 hours, are not going to disclose the kind of dangers that the public and the regulators ought to know about.
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. If the child gets food allergies or ADD or ADHD, which don’t manifest for four or five years or aren’t diagnosed or autism, which usually isn’t diagnosed until age 4, the regulators will never see that prior to licensing the vaccine.
This bit about the hepatitis B vaccine is basically a distortion. For instance, the thimerosal-free version of EngerixB relied on clinical trials that looked at the “occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms during the 4-day follow-up period. However, that ignores all the other evidence for the safety of hepatitis B vaccination, of which there is plenty.
Here’s what Kennedy is doing. He’s ignoring all the epidemiological studies that show that vaccines are not associated with autism, a veritable mountain of evidence, and trying to argue that the FDA should assume that it might and require years and years of followup in the double-blind placebo-controlled randomized clinical trials (RCTs) used to license vaccines. This is simply impractical and, more importantly, not scientifically or ethically justified given what we know from epidemiological studies. I’m sure that Kennedy also knows that such a requirement would enormously increase the cost of doing the pre-licensure clinical trials needed for the FDA to approve vaccines.
Branswell, to her credit, pushes back:
Vaccines are tested that way all the time.
You’re wrong about that. It is not required for vaccines. So most of the vaccines — and I know this is surprising to you, and it’s shocking to most people, because journalists like yourself assume that vaccines are encountering the same kind of rigorous safety testing as other drugs, including multiyear double-blind placebo testing. But the fact is that vaccines don’t. And the reason for that is they’re classified as biologics.
I’ve read a lot of vaccine studies. And they are double-blind placebo tested.
No, you’re wrong about that. … But in any case, none of them have more than a few months of double-blind placebo testing, which will not allow you to spot illnesses like autism that aren’t diagnosed before five years. Second of all, in most vaccines, for example the Gardasil vaccine, they don’t use true placebos.
Ha! I just discussed that last one about Gardasil not using “true placeboes” and what utter BS it is. I also like how, right after saying that double-blind, placebo controlled trials aren’t required for FDA licensure, Kennedy quickly pivots to admitting, basically, “Well, yes they are, but they don’t go on years and years and years and years to detect differences in autism prevalence.” Did I also mention that, given that autism prevalence is one in 50, each such trial, to be adequately powered, would require an incredibly large number of subjects. I’ve written about this issue before in the context of epidemiological studies. Basically, to be adequately powered to detect anything other than large differences in autism prevalence between control and experimental groups would require much larger clinical trials than we have now, likely so large as to be impractical. Also, once again, scientifically it’s not justified, taken in context with the totality of the evidence.
I’m happy that nothing much has come of the “presidential commission.” I’m also happy to see RFK Jr. remains no more believable or competent at spreading antivaccine misinformation than he’s ever been. I am not, however, happy to see that he’s still meeting with federal officials in charge of public health, medical research, and vaccine approval. As long as that’s still happening, we pro-science public health advocates need to stay frosty.
from ScienceBlogs http://ift.tt/2v9QBu1
Poor Robert F. Kennedy, Jr. He went from admired environmental activist to reviled antivaccine campaigner so quickly. It began when he outed himself in 2005 with his infamous conspiracy mongering screed about thimerosal in Salon.com and Rolling Stone. Basically, RFK Jr. is a member of what we used to call the mercury militia, a branch of the antivaccine movement that believes, more than anything else, that it is the mercury-containing preservative thimerosal that used to be in several childhood vaccines until 2002 drove an “epidemic” of autism. He’s still a member, too, having recently written with Dr. Mark Hyman a book entitled Thimerosal: Let the Science Speak: Mercury Toxicity in Vaccines and the Political, Regulatory, and Media Failures That Continue to Threaten Public Health. Not surprisingly, it was chock full of antivaccine misinformation and claims that thimerosal in vaccines caused all sorts of horrible neurological problems in children. It didn’t, nor did it cause autism. The idea that thimerosal-containing vaccines cause autism is a failed hypothesis. Just this year, he even went full crank once again and offered a “challenge” worthy of Jock Doubleday’s bizarre vaccine challenge to prove that thimerosal is safe. It was rigged, naturally. Basically, RFK Jr., his denials notwithstanding, is antivaccine to the core.
Early in 2017, when President-Elect Donald Trump and his team were working on the transition of administrations, RFK, Jr. was invited to Trump Tower to meet with him. RFK Jr., being RFK Jr., he immediately blabbed to the press that Trump had asked him to form and chair a presidential commission on vaccine safety, or autism, or…something. It wasn’t exactly clear what. Of course, those of us who were pro-vaccine were alarmed, as this seemed to signal that as President Trump would act on his oft-expressed idea that vaccines cause autism, particularly in wake of the revelations that he had met with a bunch of antivaccine activists including Andrew Wakefield while campaigning in Florida in August. Fortunately, however, the Trump administration thus far hasn’t acted on any “presidential commission” on vaccine safety or autism. Indeed, Trump has appointed pro-vaccine advocates to run both the FDA and CDC.
So I was amused to see an article in STAT News about the vaccine commission that RFK Jr. so much wants to chair. How’ve things been going on that score? Not so well, it turns out:
Robert Kennedy Jr., the environmental activist and leading vaccine skeptic, says that it has been months since he has talked with White House officials about chairing a vaccine safety commission — and that the idea of such a panel may no longer be under consideration.
“I’ve had no discussions specifically about the vaccine safety commission, probably since February,” Kennedy told STAT. “You’d have to ask the White House. It may be that it’s evolved.”
Before I go on, let me just give Helen Branswell, who wrote this otherwise excellent report, a word of advice: RFK Jr. is not a “vaccine skeptic,” leading or otherwise. He is antivaccine to the core and has been spewing antivaccine pseudoscience since at least 2005. Skepticism does not mean reflex rejection of the scientific consensus in favor of pseudoscience, but that is exactly what RFK Jr. does: Reject the scientific consensus and embrace pseudoscience. If there’s something that reporters do that really grate on me, it’s to use language like this to describe antivaxers. It gives them far more credibility than they deserve.
Of course, this is just RFK Jr. being RFK Jr. He’s publicity whoring. He wants attention. He wants you to know how important he is. Unfortunately, the Kennedy name goes a long way. Kennedy met with Dr. Peter Marks, head of the Center for Biologics Evaluation and Research, which regulates vaccines, and other FDA staff on March 30, as he has bragged in his interview with STAT:
Well, I’ve met with high-level officials in the White House. They’ve arranged meetings for me with HHS and White House officials and agency officials. Various agency officials, including [NIH Director] Francis Collins and his deputy, Lawrence Tabak, I think. And I met with Tony Fauci, who’s at the National Institute of Allergy and Infectious Diseases. Linda Birnbaum, who’s at the National Institute of Environmental Health Sciences. Diana Bianchi, at the Eunice Kennedy Shriver National Institute of Child Health and Human Development at NIH. And over at FDA I’ve met with Peter Marks, the director of [the Center for Biologics Evaluation and Research] and some other officials there. I can’t remember everybody at this point, all of the people that we’ve met with.
He even met with NIH Director Francis Collins and other NIH staff, who, appropriately, pushed back:
Kennedy met on May 31 with top leaders of the NIH. Director Francis Collins and Deputy Director Lawrence Tabak attended the meeting, along with the heads of the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Environmental Health Sciences.
Kennedy laid out his concerns about vaccines at the meeting, presenting the information he views as supporting evidence, according to an official familiar with the discussion who spoke on condition of anonymity. But the NIH participants countered, the agency suggested in an email.
“In the meeting, NIH noted that there is strong and extensive scientific data that support the safety and efficacy of vaccines,” a spokesman said. “NIH reaffirmed with Mr. Kennedy that vaccines are among the most beneficial health interventions in history in terms of the number of lives that have been saved over decades, have been shown to be very safe, and are vital to the public health goal of preventing diseases.”
In his interview, Kennedy claims that the Trump administration asked him to meet with these officials. Given that Kennedy is an inveterate self-promoter who’s been known to—shall we say?—stretch the truth on occasion, I wonder if his version of events is reliable. On the other hand, this is the Trump administration. it wouldn’t surprise me at all if the administration did ask him to meet with these people, and, given that, these officials could not refuse. I’m glad, though that NIH leaders and, from what I can gather, everyone else forced to meet with Kennedy pushed back at his= pseudoscience and fear mongering about vaccines. The good news is that the message I’m getting from this report and interview with RFK Jr. is that pursuing antivaccine policies—excuse me, investigating “vaccine safety”— does not appear to be a priority for Trump, which means that his appointees to key positions at the CDC, NIH, and FDA have been unequivocally pro-vaccine. For instance:
Vaccines save lives. #vaccineswork https://t.co/oWol1N5wXh
— Scott Gottlieb, M.D. (@SGottliebFDA) August 18, 2017
And:
Vaccines are one of the greatest #publichealth achievements. Immunization gives us the power to protect. #NIAM17 http://pic.twitter.com/smGLrd6k8y
— Dr Brenda Fitzgerald (@CDCDirector) August 3, 2017
Oh, how antivaxers howled with outrage!
It’s also amusing to read Kennedy as he is asked multiple times if the commission will go forward or if it might go forward with someone else leading it, every time provoking a response along the lines of, “You’d have to ask the White House”:
You’d have to ask the White House. It may be that it’s evolved. I’ve been told that the president is still interested in this issue and that he wants me to have further meetings with the regulatory agencies and with the White House. Like I said, I have not talked to anybody in the White House about the commission.
All of this leads me to believe that most of this is just Kennedy promoting himself, as he is very good at doing. Most likely what happened is that when Branswell contacted him to find out if, seven months later, anything had happened regarding the Presidential commission, he saw his chance to blow his own horn.
I do give Branswell props for pushing back against Kennedy’s misinformation, though. For instance, Kennedy claims:
We need to do double-blind placebo testing. Because particularly when it comes to injecting aluminum or mercury into babies, the consequences may be latent. In other words, they may not manifest or diagnosed to age 3 or 4. So the current protocols, which require testing for vaccines of sometimes as little as 48 hours, are not going to disclose the kind of dangers that the public and the regulators ought to know about.
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. If the child gets food allergies or ADD or ADHD, which don’t manifest for four or five years or aren’t diagnosed or autism, which usually isn’t diagnosed until age 4, the regulators will never see that prior to licensing the vaccine.
This bit about the hepatitis B vaccine is basically a distortion. For instance, the thimerosal-free version of EngerixB relied on clinical trials that looked at the “occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms during the 4-day follow-up period. However, that ignores all the other evidence for the safety of hepatitis B vaccination, of which there is plenty.
Here’s what Kennedy is doing. He’s ignoring all the epidemiological studies that show that vaccines are not associated with autism, a veritable mountain of evidence, and trying to argue that the FDA should assume that it might and require years and years of followup in the double-blind placebo-controlled randomized clinical trials (RCTs) used to license vaccines. This is simply impractical and, more importantly, not scientifically or ethically justified given what we know from epidemiological studies. I’m sure that Kennedy also knows that such a requirement would enormously increase the cost of doing the pre-licensure clinical trials needed for the FDA to approve vaccines.
Branswell, to her credit, pushes back:
Vaccines are tested that way all the time.
You’re wrong about that. It is not required for vaccines. So most of the vaccines — and I know this is surprising to you, and it’s shocking to most people, because journalists like yourself assume that vaccines are encountering the same kind of rigorous safety testing as other drugs, including multiyear double-blind placebo testing. But the fact is that vaccines don’t. And the reason for that is they’re classified as biologics.
I’ve read a lot of vaccine studies. And they are double-blind placebo tested.
No, you’re wrong about that. … But in any case, none of them have more than a few months of double-blind placebo testing, which will not allow you to spot illnesses like autism that aren’t diagnosed before five years. Second of all, in most vaccines, for example the Gardasil vaccine, they don’t use true placebos.
Ha! I just discussed that last one about Gardasil not using “true placeboes” and what utter BS it is. I also like how, right after saying that double-blind, placebo controlled trials aren’t required for FDA licensure, Kennedy quickly pivots to admitting, basically, “Well, yes they are, but they don’t go on years and years and years and years to detect differences in autism prevalence.” Did I also mention that, given that autism prevalence is one in 50, each such trial, to be adequately powered, would require an incredibly large number of subjects. I’ve written about this issue before in the context of epidemiological studies. Basically, to be adequately powered to detect anything other than large differences in autism prevalence between control and experimental groups would require much larger clinical trials than we have now, likely so large as to be impractical. Also, once again, scientifically it’s not justified, taken in context with the totality of the evidence.
I’m happy that nothing much has come of the “presidential commission.” I’m also happy to see RFK Jr. remains no more believable or competent at spreading antivaccine misinformation than he’s ever been. I am not, however, happy to see that he’s still meeting with federal officials in charge of public health, medical research, and vaccine approval. As long as that’s still happening, we pro-science public health advocates need to stay frosty.
from ScienceBlogs http://ift.tt/2v9QBu1
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