So, I took another one for the team. Happy reading.
Well, I got a bit famous this week as Del Bigtree not only seems to have read my blog but mentioned me, by name, and my blog on a recent show. The post he mentions is entitled Del Bigtree is not a scientist and is about how Del’s antivax organization, Informed Consent Action Network, wrote to the USA’s Health and Human Services department about vaccine safety concerns and the HHS reply was rather stunning. My friend Dorit also wrote about it over at Skeptical Raptor.
Now, Del has replied to HHS and, in his video about it, he mentions my blog and Dorit’s. Kinda made me giggle to be so famous so I have watched the video and read his document. You can find a copy of Del’s letter to HHS here. This is his second letter to HHS. If you get confused, links to all letters are at the end of this post.
First of all, he thinks he did not get answers to his original questions.
HHS’s letter begins with the incorrect claim that the safety of many pediatric vaccines was investigated in clinical trials that included a placebo, and falsely implies these trials are typically longer than mere days or weeks. (Section I below). It then fails to support the safety of injecting babies with the Hepatitis B vaccine (Section II) and reaffirms HHS’s refusal to: automate VAERS reporting (Section III); research the most commonly claimed vaccine-injury pairs (Section IV); identify which children will suffer a serious vaccine injury (Section V); pause claiming “Vaccines Do Not Cause Autism” until it has the studies to support this claim (Section VI); conduct vaccinated versus unvaccinated studies (Section VII); purge itself of conflicts of interest (Section VIII); or use the Vaccine Safety Datalink and PRISM to actually improve vaccine safety (Section IX).
Del’s first complaint is that many vaccines were tested without a placebo. What he means is that not all vaccines were tested with saline placebo. For example, the Boostrix vaccine for tetanus, pertussis, and diphtheria, a tetanus-diphtheria vaccine was used as the placebo. He goes on to list other vaccines which use an older vaccine or an adjuvant as placebo instead of saline. This is a common source of concern amongst antivaxers who don’t realize or don’t understand how placebos can be other than saline and be a valid placebo. The World Health Organization has a great document detailing the ethical framework for use of placebos in vaccine trials.
Placebo use in vaccine trials is clearly acceptable when (a) no efficacious and safe vaccine exists and (b) the vaccine under consideration is intended to benefit the population in which the vaccine is to be tested. In this situation, a placebo-controlled trial addresses the locally relevant question regarding the extent to which the new vaccine is better than nothing, and participants in the placebo arm of the trial are not deprived of the clinical benefits of an existing efficacious vaccine.
Placebo use in vaccine trials is clearly unacceptable when (a) a highly efficacious and safe vaccine exists and is currently accessible in the public health system of the country in which the trial is planned and (b) the risks to participants of delaying or foregoing the available vaccine cannot be adequately minimized or mitigated (e.g. by providing counselling and education on behavioural disease prevention strategies, or ensuring adequate treatment for the condition under study to prevent serious harm). In this situation, a placebo-controlled trial would not address a question that is relevant in the local context, namely how the new vaccine compares to the one that is currently in use, and participants would be exposed to unacceptable levels of risk from delaying or foregoing a safe and effective vaccine that is accessible through the public health system.
The World Health Organization clearly considers that saline placebos are not required or even ethical in most vaccine trials. The original response to Del from HHS mentioned that inert placebos are not required. Del is not learning.
At this point, I am able to skip over the next 17 pages of Del’s document as his argument about saline placebos is not valid.
His next concern is that hepatitis b vaccine trials were only 4-5 days long. As I pointed in my post, Hepatitis B Vaccine is safe and necessary,
Del is concerned that the Hep B vaccine was only tested for 4 days during the pre-licensing phase. This comes from the insert, of course, and it is actually stated that children in the clinical trial were monitored for 5 days after the vaccine. Of course, we know the limitations of vaccine inserts. Del, however, seems to be unaware of the safety and efficacy testing that is done after the insert was written. Let me give you a little research hint. If you want to find studies related to a vaccine, go to the CDC’s page for that vaccine and click on the information for providers and healthcare professionals. This is where they list the safety and efficacy studies. The parent information section is written much more simply. In the provider section, you can find a lot of research information, including the link to the recommendations of the Advisory Committee on Immunization (ACIP)’s document on Hepatitis B virus and vaccination. This document has a long list of safety and efficacy data, including data analysis from the vaccine safety datalink (VSD) and the Vaccine Adverse Events Reporting System (VAERS). A great deal of safety study has been done AFTER the clinical trial.
This is exactly what the first HHS letter told Del. Del just doesn’t believe in facts. But, Del, I have to tell that you just because you don’t like the answers does not make them wrong. It makes you stubborn.
Del’s next concern is that because saline placebos are not used he feels HHS has abandoned this duty by not requiring long-term placebo-controlled clinical trials. Without such trials, the actual safety profile of each pediatric vaccine, or any combination thereof, cannot be determined before they are – pursuant to HHS’s childhood vaccine schedule – injected into millions of American children. Once that happens, HHS becomes utterly conflicted from funding or conducting research that may find that a vaccine HHS previously licensed and recommended does, in fact, cause significant harm to more than a few children.
This is again an example of Del not liking the answers he gets. But, that does not make him right. Vaccines go through a minimum of 10-15 years of testing at many levels, but Del focuses only on the clinical trial phase. There is a great deal more to vaccine safety study, including post-licensure monitoring of vaccines. You can read more about all the stages here.
Del’s next questions are about VAERS, the Vaccine Adverse Event Reporting System. (note that Del calls it the “report” system, misspelling it.) In the original response to Del, he was told the recent improvements HHS had made to VAERS. HHS tells Del that they are studying and exploring options to link VAERS with health centers around the country. Del implies, in his second letter, that HHS refused to cooperate with a health system called Harvard Pilgrim. Del feels vaccine safety efforts should be moved forward swiftly but connecting a government database to medical center databases around the country seems like such a huge job to me that I can see why HHS is moving slowly.
Again, Del is criticizing the answers he is getting. That does not make the answers wrong.
A good bulk of the next part of letter 2 is about more criticisms of vaccine safety. Del believes vaccines have not been studied enough and HHS disagrees.
The next section of Del’s letter is about HHS not funding enough research to determine who is at risk for vaccine injury. HHS gave him two links to read but he is not satisfied with them and he finds pharmaceutical funding linked to one of the scientists involved thus, in his mind, tainting the findings. Del’s concern is that Between 2015 and 2017, HHS spent over $14 billion purchasing and promoting the universal use of HHS recommended vaccines. 281 During this same time period, HHS certainly could and should have funded more than two studies seeking to identify which children should be excluded from receiving one or more vaccines in order to prevent a serious vaccine injury.282 This research should also not be conducted by individuals who receive funding from the pharmaceutical company whose vaccine product is being reviewed.
I will say that it could go further to appease antivaxers if HHS did conduct more than two studies in this area and if they helped to fund a study from a large health organization of vaccinated versus unvaccinated patients and health outcomes. I don’t agree with Del that the science is lacking nor do I think 10,000 studies would change his mind but a few more would be good. Vaccine injury is very rare but if we knew more about it antivaxers might feel better.
Del’s 9th concern is that the vaccine-autism connection has not been fully studied. He wants HHS to study the connection between DTaP (diphtheria, tetanus, and pertussis vaccine) and autism. He also feels the hepatitis b vaccine given at birth should be studied for a relationship to autism. His latter concern is based on a very badly done “study” which correlated hep b vaccine with autism. This is a very weak study that has been widely discredited. Apparently, Del missed that memo. Del did not specify why he wants DTaP studied but my guess is the aluminum adjuvant, which is widely touted by antivaxers as causing autoimmunity and autism. Of course, that has also been widely discredited. You can find info on that here and here and here. Del also brings up the long-ago debunked “cdc whistleblower” nonsense. Seriously Del? We are all getting pretty tired of that dead horse. If you want more reading on that dead horse, you can go here and here.
I guess Del has a minor point here that saying vaccines do not cause autism isn’t 100% valid as not all vaccines have been studied. Perhaps we needed a better way to put it that vaccines have been extensively studied and enough evidence has been found that unvaccinated get autism and that MMR (measles mumps rubella vaccine) is not linked with autism that it is time to move on from the idea that vaccines cause autism. Antivaxers first thought mercury caused autism. When thimerosal, a mercury-containing preservative was removed from pediatric vaccines, autism rate did not drop. They then moved on to blaming MMR because of the timing of the most notable symptoms of autism. That has been debunked so now they want to blame aluminum adjuvants. This comes from Claire Dwoskin whose Dwoskin Foundation funds the Children’s Medical Safety Research Institute (CMSRI). CMSRI is the funding agent behind most of the recent (shoddy) research linking aluminum to autism. You can read about that here here here and here.
Del is further concerned that HHS has supposedly ignored something from a Dr. Andrew Zimmerman about autism and vaccines. Del claims that Department of Justice lawyers misled Vaccine Court by presenting a report from Dr. Andrew Zimmerman in which he stated MMR and thimerosal-containing vaccines do not cause autism, even though Dr. Zimmerman has told them that there are exceptions in which vaccines may cause autism. However, as my friend Dorit explains here, there is no new evidence that vaccines cause autism so Dr. Zimmerman’s words mean nothing.
The rest of Del’s second letter is about how he feels HHS has bias and they should study children’s health issues with regard to vaccines more. This is all his opinion and it comes from a place of passionately believing children would be 100% healthy if we had no vaccines at all. People like Del believe all children’s health problems stem from vaccines and are vaccine injuries. Rising rates of autism, learning disabilities, special services, allergies, and you name it are all the fault of vaccines, to Del. This is irrational and there is no reason for HHS to take his complaints seriously.
The stated purpose of vaccination is to improve the overall quality of health of Americans and reduce mortality. Yet, the increase in HHS’s childhood vaccine schedule over the last 30 years from 8 vaccine injections to 50 vaccine injections (plus 2 injections during pregnancy) has occurred in lockstep with the increase in the rate of autoimmune, developmental and neurological disorders in children from 12.8% to 54%. HHS has no explanation for why U.S. children today are plagued with a chronic disease and disability epidemic.
This 54% claim comes from a study of referrals to insurance companies for services. This study was originally published on the Age of Autism blog in 2011 and has since become a huge part of the antivax rhetoric machine. You can read the full study here. Someday, I am going to write a blog post just about this study but the gist is here in this figure.
Most of the children in the study who required special services are obese. 43.2% as of May 2011 when this study was published. That has nothing whatsoever to do with vaccines. Risk of developmental delay is likely linked to the number of premature babies surviving birth and the number of drug-addicted babies surviving birth, not vaccines. This study was conducted with children born before vaccines were recommended in pregnancy so there is no link there. Allergies and asthma have been proven not to be caused by vaccines and are more likely resulting from the late introduction of solid foods, air pollution, and over cleaning (the hygiene hypothesis). When I was a child in the 1970s, there were definitely children who should have been treated for what we now call learning disabilities, ADD, ADHD, autism, anxiety, depression, Asperger’s, PDD, and Tourette but they were ignored. There was no special education! The first special education law was enacted in 1975 in USA and took decades and numerous lawsuits to get to where we are today. These things are not new. We are just only now defining, diagnosing, and treating them. High school graduation rate in USA has gone up from 41% in 1960 to 89% in 2017. Why don’t antivaxers pay attention to that statistic? Between 1980 and 2009, premature infant birth rate rose 36%, but again antivaxers don’t pay attention to details. They just want to blame everything on vaccines because that sounds easy. They passionately want to believe that humans would be perfectly healthy if we had clean water, flush toilets, some CBD oil, some Plexus Pink drink, a small fortune in supplements, weekly chiropractic adjustments, and some magic crystals. (I am not kidding, that is the impression I get from them)
But infant mortality and SIDS rates are at all-time lows in USA. I blogged about that here and linked to the data. Child hospitalization rates are down. Child cancer rate has not changed much since 1970 but the cancer survival rate is higher.
Why don’t antivaxers pay attention to these statistics? From the perspective of this mom, autism mom, special education teacher, and informed human, LIFE IS BETTER NOW THAN EVER. (aside from Trump but that’s another topic)
Del’s final plea to HHS is that he wants an independent board to review vaccine safety. He does not agree that the Advisory Committee on Immunization Practices (ACIP) or the Institute of Medicine (IOM) groups are good enough for the American people. He thinks the Vaccine Safety Datalink studies are not good enough because when a VSD study is conducted by HHS, in violation of basic scientific standards and process, the underlying raw data is almost never available for inspection by the public and other scientists. Refusal to make this data available raises serious concerns regarding reproducibility and transparency. HHS regulations, in fact, provide severe penalties if researchers, using HHS funding, refuse to share data underlying their studies, but HHS does not apply this same standard to their own VSD studies. Third, the secret studies that HHS performs using the VSD with secret data are virtually all squarely aimed at increasing vaccine uptake, even for uses and in populations not approved by the FDA. This concern about Vaccine Safety Datalink (VSD) studies is interesting to me because he is basically asking our government to violate the privacy act, HIPAA. The VSD members can study reports to VAERS made from their own patients because they can access the medical records. Del wants our government to allow independent researchers to access people’s medical records? Sorry, Del, but that is not going to happen.
The other vaccine safety study database is called PRISM and Del is concerned about that, as well, saying Like the VSD, it is unlikely HHS will use PRISM to publish a study that confirms any serious widespread harm from vaccination. If it did, HHS would be developing the very science that would then be used against it in Vaccine Court, potentially resulting in crippling financial liability as well as loss of reputation. Thus, he is saying that the government is colluding with the pharmaceutical industry to hide vaccine injuries because the pharmaceutical industry would be crippled by the liability. Del, if there was any hint that vaccine makers would be held liable for more claims, they would just stop making vaccines. That is what happened in the 1980s and why we have the National Childhood Vaccine Injury Act in the first place.
Furthermore, special needs children cost the US government a lot of money. They would save a lot of money if something as simple as not vaccinating could prevent special needs from existing. I think it is irrational to conclude that our government would collude with pharmaceutical companies so much that they get more money from pharma than special needs children cost. Just completely irrational.
At this point, I am stunned that Del believes his own misinterpretations. I think ZdoggMD is right here, that antivaxers lack critical thinking skills and are stuck in the concrete stage of thinking.
I sincerely hope HHS ignores this letter Del sent them because he does not deserve a reply. He will never learn from them, no matter what they say. Del Bigtree has issues with vaccines because he is as stubborn as a mule and won’t learn he is wrong.
With one large sigh, I bid you adieu
Kathy
HHS reponse to Del’s First letter to HHS
Del’s Second letter to HHS
All letters to and from Del and HHS
PS By the way Del, one of your fans once contacted me on Twitter and asked me to debate you. I replied that if you ever want to come to Bellingham, WA, I will gladly sit down with you for coffee, off the record, not cameras or recording. Why? Because I am always up for a chat but I don’t want to risk having my image or words edited in a way that could be used against me.
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