Del Bigtree is stubborn

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.

 

Del Bigtree is not a scientist

On October 12, 2017, Del Bigtree,  a former producer of the television talk show, The Doctors, producer of the film Vaxxed, and founder of something called the Informed Consent Action Network (ICANDecide), sent a letter to the U.S. Department of Health and Human Services (HHS) wherein he outlined what he perceives as their “failure of HHS to conduct the proper science required to demonstrate vaccine safety.” This letter accuses HHS of everything from ignoring vaccine risks to not doing proper safety testing. For those of us who understand vaccine science, this letter almost seems like a parody. Alas, it was not only real but Del threatened HHS with a civil suit if they did not make the changes he suggested in the letter. He also made demands, such as wanting “vaccine safety advocates” to comprise half of HHS’s vaccine committees.  The letter was co-signed by 58 antivaccine organizations, including Weston A Price Foundation and World Mercury Project.

After October 12, nothing much happened at ICANDecide. In fact, not much has been heard from ICANDecide in a while.  Even their Facebook page has been quiet.

Until now.

Earlier this week, a notorious antivax crusader (I will refer to him as Pant) who despises Del Bigtree posted a link to a pdf he had created with the response from HHS to Del Bigtree. Pant claimed he was able to get the response through a Freedom of Information Act (FOIA) request.  The response is from Melinda Wharton, MD, MPH, Acting Director of the National Vaccine Program Office, whom I have confirmed is real. The letter includes responses to all of Del’s claims and accusations, every single one of them proving Del knows nothing at all about vaccine safety.  All of his claims were disproven and all of his requests were denied.

This letter is a glorious piece of vaccine gold and when you read it you will understand completely why Del let this ball completely drop, pop, fizzle into nothing, and fade away.

For your reading pleasure, I bring you the HHS response to Del Bigtree.

 

Happy reading!

Kathy

Matt Carey discusses Vaxxed, the film.

Today, I had the pleasure of listening to a pre-recorded conference call between Karen Ernst, the Director of Voices for Vaccines, and Matt Carey, PhD in physics, autism parent, autism advocate and blogger at Left Brain, Right Brain (LBRB). I have been reading LBRB for years, since back when it was run by Kevin Leitch. It is one of my favorite blogs.

Today’s conversation was recorded live and there was an opportunity to call in and ask questions about the film Vaxxed. For those of us who missed the live version, you can listen to the recorded version at this link. You will want to open it with music player for google or podcast app or something similar.

To remind you, Vaxxed is the film Andrew Wakefield, Polly Tommey, and Del Bigtree made about the “cdcwhistleblower” controversy. I saw it and wrote my own review, which you can read here. You can also read the full facts (or lack thereof) in Vaxxed at Harpocrates Speaks Blog. 

I am not going to transcribe the whole conversation but here are some of my notes. It was definitely worth a listen.

Matt and Karen discussed the facts from the film and the controversy, including going in-depth into what William Thompson actually said and what he did not say. Matt also discussed the idea that the data was thrown away (it was not). Matt has written quite extensively about all of this, on LBRB. For example, herein he writes about how there was not really any whistle to blow.

The first caller was antivaxer Sherry Saunders who came on at about minute 37:00.  She stated that she used to work as a security guard at Huntsville [sic] Hospital and claimed it was part of her job to take care of hysterical parents who had brought a child in having seizures after a vaccine. She asked how she could convince parents the vaccine is not the problem and that the doctors and nurses are not at fault. My first reaction was that she could not be telling the truth because she stated she used to work at the hospital but then asked the question as if she still does work at the hospital.  She switched back and forth in tenses a lot, as if this is not a real story.  She went on to say that she was the security supervisor in the ICU and had to restrain the parents because they were hysterical about their child’s vaccine reaction. She claimed she had to restrain them and call the police and  that she had a stun gun. Because the parents were hysterical. Had. All past tense. Then, she asked what she is supposed to say to the parents since she is being told by doctors to keep them far away from the child in ICU and call the police. Present tense. 

At this point, I am making my “what the….” face and I can hear Matt, in the background, laughing. Here is what my “what the….” face looks like:

Matt answered by telling her the doctors need to be the ones talking to the parents, not her, and Sherry responded by saying the hospital told her to keep the parents far away from the kids and call the police. At this point, Matt and Karen told her they did not believe her story and they hung up on her. 

A few more calls and questions were taken, including a nice discussion about how most parents of children with autism know vaccines don’t cause autism and how The Thinking Person’s Guide to Autism is a great Facebook page and has a marvelous website for respectful talk about vaccines, autism, and advocacy. Matt also explained thoroughly how the idea that African American boys have a greater risk of autism is simply not backed up by data.

The last caller was Joshua Coleman, who identified himself as a member of the Vaxxed team.  Joshua is, in fact, the videographer who went on tour with the Vaxxed team in their bus for the last few months.  He was up at minute 66:34. Joshua is the person who recently ambushed Dr Paul Offit at breakfast and video recorded him without permission.  Joshua began to talk about Del Bigtree showing the film to Senator Ben Allen, but Karen redirected him to stay on the topic of the content of the film Vaxxed.  So, he brought up how we only know MMR and thimerosal don’t cause autism, that the rest of the ingredients and other vaccines, he said, have not been tested. Joshua mentioned the (now retracted) Wakefield 1998 paper. He stated that provaxers often use that paper as proof that Andrew Wakefield said vaccines cause autism. Joshua said these two facts, that vaccines don’t cause autism and Wakefield says they do, are both blatent lies.  This, he says, was his first clue that provaxers lie. He asked Matt to explain to him how this is okay and not a major red flag that there is some deceit going on here. 

Matt responded first by making the point that he, Matt, has published over 100 papers and none have ever been retracted.  Matt then brought up how many papers Wakefield has had retracted and then made a very valid point that the Vaxxed fans and team tend to forget to bring up how many papers Wakefield has had retracted.  Matt explained how Wakefield went in to the press conference for the 1998 paper and made statements that were “wildly extrapolated and wildly irresponsible” and antivaxers never explain about this fact. Matt also reminded Joshua that we can easily go through Wakefield’s public records and find many statements where he has stated, in one form or the other, that vaccines cause autism.  The 1998 Lancet article, Matt states, tends to be the only thing antivaxers want to talk about, not the fact that the work he did for that paper was a result of the ethics violations that were found proved and which cost him his medical license.  We are not talking about an upstanding researcher, said Matt.  

After Matt answered Josh’s question, Josh ignored him and began to argue with Matt. Basically, Matt answered the question in full but, somehow, Josh missed it and claimed his question was not addressed. He was arguing so much, that Karen hung up on him. 

This led to a nice conversation between Karen and Matt about how antivaxers tend to distract and divert by arguing “itty bitty” details.

The final comment made by Matt is that he is not provax, he is an autism parent and wants to counter misinformation that is used to damage his community. He feels antivaxers use vaccines as a tool to damage the autism community.

Karen made very good point that we need to make a place at the table for parents of autists who are harmed by this assault, by this myth getting perpetuated that vaccines cause autism. Matt agreed and pointed out that autists are more medically fragile than the general public and his own child has been hospitalized many times because a minor infection which set off his epilepsy. He made the point that a serious infection like measles could kill his son and not vaccinating puts everyone in danger. Matt concluded by saying how he got into this provax fight not because of vaccines but because of wanting to protect his own son and others in the autism community from the harm that antivaxers cause by not vaccinating and also by thinking of autism as damage. 

All in all, this was a very worthwhile listen.  Thanks Karen and Matt.

Remember to always think for yourself!

Kathy

ETA: For another look at this call and the output connected with it, here is a storification from @jkellyca of twitter responses using the hashtag,  #vfvcall.

 

 

 

 

Hepatitis B vaccine is safe & necessary

There is a reason one should not take healthcare or medical advice from daytime talk show producers with no college education: they don’t do science. And this is a real problem when they have some influence among people who do not vaccinate.

Yes, that is this week’s message from Del B.  He crashed the Assembly Select Committee on Infectious Diseases in High Risk Disadvantaged Communities meeting, this week, in Sacramento, California, hosted by Assemblyman Mike A Gipson. State Senator Dr. Richard Pan was a speaker, as were numerous other experts on Hepatitis infections. Towards one hour, 40 minutes, the public were allowed to make 2 minute comments and that is when Del Bigtree speaks first. He questions the statistic that 10,000 kids under age 10 were infected, not by their mother,  with Hepatitis B before the vaccine was introduced. Del goes so far to imply Dr Pan made this up this data about Hepatitis B risk and that as long as women are tested for the disease, and are not carriers themselves, then newborns do not need this vaccine at all. Further, he makes some pretty outrageous claims that might lead someone to not choose this vaccine for their child:

1. He infers the vaccine is the cause of USA having “highest infant infant death rate than all other western nations combined” and asks why we are not investigating that risk;
2. Education alone could reduce Hepatitis B risk;
3. The vaccine was only tested for 4 days during pre-licensing phase;
4. The vaccine has 5X the recommended amount of aluminum;
5. The vaccine wears off after 6 years;
6. Saving 10,000 children a year (pre-vaccine numbers) from Hep B is not worth risking millions of other children’s lives by giving them this “dangerous” vaccine.

I am not sure why Del thinks this statistic is Dr Pan’s making ( he seems to think the science behind the California vaccine mandate law, SB277, all originates from Dr Pan) but I have taken some time to help Del understand the Hepatitis B risk and the vaccine safety.

What is Hep B?

Hepatitis B is a bloodborne pathogen transmitted through contact with blood or other bodily fluids. It can also be sexually transmitted but to say it is only transmitted via drugs or sex is incorrect.  It is a potentially life-threatening liver infection and a major global health problem.  An estimated 850,000–2.2 million persons in the United States have chronic hepatitis B virus infection. The rate of new HBV infections has declined by approximately 82% since 1991, when a national strategy to eliminate HBV infection was implemented in the United States. The decline has been greatest among children born since 1991, when routine vaccination of children was first recommended.

(source)

Del’s concern 1: first day death

Del is concerned the vaccine is the cause of USA having “highest infant infant death rate than all other western nations combined” and asks why we are not investigating that risk.  Currently, the USA ranks 168 out of 224 countries in the infant mortality statistics (224 being the best infant mortality rate).  Monaco has the best IMR, at 1.82 deaths per 1000 live births, Afghanistan is the worst at 115.08 deaths per 1000 live births, and USA is in the top 1/3rd at 5.77 deaths per 1000 live births. Looking at the list, there are many countries in the 3-5 deaths per 1000 live births range, so USA is absolutely not faring the worst of all western countries nor has the highest IMR of all western nations combined. The CIA defines IMR as infants dying before age one.

For first day of life deaths, I looked at a report by published by Save the Children in 2013 that was funded by Johnson and Johnson, Gates Foundation, and Mattel. Having googled, this is the source cited by many news reports and likely what Del is quoting from. According to the report, the USA does have a high first day death rate with 11,300 newborn deaths a year. “This is 50% more first day deaths than all other industrialized countries combined.” Poverty and racial/ethnic makeup are linked to prematurity, low birth rate, and high first-day death rate. Prematurity is the single largest cause of first day death.  By far the most first day deaths occur in India, with several African countries, China, and Afghanistan also in the top ten worst countries. Somalia has the worst first day mortality statistic, at 18 deaths per 1000 live births. Being a larger country, India has more deaths but a lower statistic, at 11 deaths per 1000 live births. Iceland, Sweden, Singapore, Estonia, Cyprus, and Luxembourg have the best statistics, at less than 0.5 deaths per 1000 live births.

And where is the USA?  Three first day deaths per 1000 live births. We share that ranking with 19 other countries.  Yes, we could do better but it is not THAT bad. I would be more than willing to pay higher taxes to offset poverty and racial issues, insuring that all Americans have access to good food, decent living conditions, and universal healthcare. That would improve our IMR and first day death statistics tremendously.

The single greatest reason cited for our first day death statistic is poverty and race, both of which are also risk factors for prematurity. This has absolutely nothing to do with vaccines. 

Del’s concern 2: education

This is inexplicable to me. Does he really think education will prevent toddlers from biting each other and sharing their teething toys? Will education alone lead to people telling their partners about their disease status instead of hiding it and inadvertently spreading it? Education will do nothing for women who test negative for Hep B but really are positive. False tests results is a real issue.

Del’s concern 3: safety testing

Del is concerned that the Hep B vaccine was only tested for 4 days during 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 do 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.

Del’s concern 4: The vaccine has 5X the recommended amount of aluminum

The Hep B vaccine has between 0.225 to 0.5 mg/dose of aluminum. An FDA study found that the maximum amount of aluminum an infant could be exposed to over the first year of life would be 4.225 milligrams (mg), based on the recommended schedule of vaccines.  According to the Vaccine Eduction Center,  “infants receive about 4.4 milligrams of aluminum in the first six months of life from vaccines, they receive more than that in their diet. Breast-fed infants ingest about 7 milligrams, formula-fed infants ingest about 38 milligrams, and infants who are fed soy formula ingest almost 117 milligrams of aluminum during the first six months of life.” Thus, the vaccine does not have 5X the recommended amount of aluminum. It is likely Del is thinking of the recommended amount of aluminum for intravenous solutions. This is comparing apples to oranges. Vaccines are not IVs.  Here is information about IV feeding solutions and aluminum and here is the information about aluminum in vaccines. As you can see, antivaxers often get these confused.

Del’s concern 5: The vaccine wears off after 6 years

Del need not worry. “Studies indicate that immunologic memory remains intact for at least 20 years among healthy vaccinated individuals who initiated hepatitis B vaccination >6 months of age. The vaccine confers long-term protection against clinical illness and chronic hepatitis B virus infection. Cellular immunity appears to persist even though antibody levels might become low or decline below detectable levels.” (source)  The populations at risk for Hep B as adults are being studied to determine actual immunity rate. The first infants vaccinated with this vaccine are now in their early 20s and 30s, a great age to begin studying them for risk of Hepatitis B and duration of immunity with vaccination. To test immunity, scientists have to study those with Hep B infection to see if they were vaccinated. Del does not understand how this is done because he is, after all, a former producer of a day time talk show. One would not expect him to have any actual knowledge in science.

Del’s concern 6: This is a dangerous vaccine

The ACIP study included analysis of reports of adverse events and found no association between the vaccine and reports of chronic illness, alopecia, diabetes, Guillain-Barré syndrome, arthritis, multiple sclerosis, or SIDS.  In other words, the Hepatitis B vaccine does not cause any of those health issues. The study also mentions the possibility of a yeast allergy connection. “Hepatitis B vaccination is contraindicated for persons with a history of hypersensitivity to yeast or to any vaccine component (92,189–191). Despite a theoretic risk for allergic reaction to vaccination in persons with allergy to Saccharomyces cerevisiae (baker’s yeast), no evidence exists that documents adverse reactions after vaccination of persons with a history of yeast allergy.”  So, there is no reason to worry about a yeast allergy with the Hep B vaccine.

Del also wondered at the veracity of the number, 10,000, of children who were found to have Hepatitis B yearly, not from their mothers, pre-vaccine. This data comes from a study called Childhood Hepatitis B virus infections in the United States before Hepatitis B immunization.  If you have access to the full document, as I do through my university, you will see that vaccination for at-risk infants began in 1982 and was broadened to include all children in 1994.   Before the vaccine was recommended for all children in 1994,  30% of infected adults had no risk factors. Vaccinating only those infants from at-risk groups was not halting the spread of the infection to children. This was because of incomplete maternal screening and a “substantial proportion of infections occurred in children of Hepatitis B surface antigen (HBsAG)-negative mothers.” Let that sink in a bit. A substantial number of infections in children came from mothers who had tested negative. You got it. Testing all mothers doesn’t help. The study estimates that 16,000 children under the age of ten were infected with Hep B a year and that does not include the additional 15,000 children a year who acquired Hep B from their mothers, perinatally. Most of these 16,000 children had clinically silent infections that will lead to chronic liver infections later in life, with 25% leading to death.  The study concludes that routine vaccination of infants will save 2700 deaths a year.

Conclusion

It is clear to me, in reading all of the above, that the Hepatitis B vaccine has a strong safety record, does not contribute to US first day death rate nor SIDS rate nor infant mortality rate and does very much lead to healthier lives for American children.  What are the actual risks associated with the vaccine? Minor soreness for a few days or a mild fever are most common. Anaphylaxis (severe allergic reaction) is possible with anything but they are very rare with this vaccine and would occur within a few hours.

As always, remember to think for yourself!

 

Kathy

 

 

 

 

 

 

 

 

 

James Lyons-Weiler and the HPV ad controversy

Have you heard of the appeal to authority logical fallacy? It refers to an appeal from a someone based on his or her presumed expertise merely by being a self-described authority.  Authority or not, all contentions should be proven, particularly when one is not actually an authority in a given topic.

Such is the case of James Lyons-Weiler, PhD  when it comes HPV vaccines. Who is Dr Lyons-Weiler? That is a difficult question to answer because he has moved through a variety of areas of study. Looking at his Linkedin account, he has a Master’s in zoology, with a focus on paeloecology, a PhD in ecology and biology, where he studied wild flowers and computational statistics, and he did postdoctoral work in computational molecular biology related to evolutionary genetics. Since then, he has worked on a variety of data analysis and modelling projects, including lung cancer gene expression and protein evolution.  He has been on the faculty at three different universities, most recently the University of Pittsburgh, where he directed the Bioinformatics Analysis Core.  In the past few years, he has written several books. One is about ebola, another about autism, and the third about how he believes medicine is more motivated by profit than cures. Most recently, he founded something called The Institute for pure and applied knowledge and he has begun to be a voice in the antivaccine movement. He even has Mary Holland, famous antivax advocate and attorney, on his advisory board. He has several current projects, including the CDC Accountability Project and the FTC petition re: HPV tv ad.

The appeal to authority I am concerned with is his issue with the HPV ad, which centers around a television ad for Merck’s HPV vaccine. The ad was created by BBDO Worldwide and can be watched here, on ispot dot tv. The gist of the commercial is a man and a woman discussing that they have cancer caused by the human papillomavirus (HPV) and wouldn’t it have been nice if they could have done something as teens to prevent that virus. The point made is that the HPV vaccine can prevent HPV which then can protect the person from getting cancers associated with the virus. The viewer is directed to www.hpv.com for more information.

 

source

As part of the Vaxxed film tour, producer Del Bigtree has been posting periscope videos (made with handheld smart phones) with people all over the country. He recently sat down with James Lyons-Weiler to discuss the FTC petition and the ad. You can watch their conversation here (thank you to Karen Halabura for helping me get the video off Facebook). Dr Lyons-Weiler tells Bigtree that the ad is emotionally manipulative and makes claims not supported by science. You can view the petition and transcript of the tv ad here. Lyons-Weiler thinks the ad is false advertising and the Federal Trade Commission should remove it because of seven errors he feels Merck makes in the ad, all of which point to false advertising. The video, as of writing of this blog, has 22,000 views and nearly 800 shares.  I feel it is worthwhile pointing out the mistakes Lyons-Weiler makes in this contentions because his assertions are influential enough that they are now showing up in online discussions about HPV vaccines.

Italicized points are from Lyons-Weiler while bold are from me.

(a) the knowledge that HPV vaccination does not protect against all HPV types, which could lead vaccinated consumers to act as though they are in fact protected from HPV infection in general, when, in reality, they are not;  As per the provider information for Gardasil 9, the most recently available HPV vaccine in USA, it protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and, 58. These represent 81% of the viruses that cause cervical cancer, 74% of the other HPV-associated cancers, and 90% of the HPV types which cause anogenital warts. The ad clearly uses the word ‘could’ when they postulate that the person ‘could’ have protected from HPV back at age 11 or 12. Therefore, no false advertising.

(b) the knowledge that has resulted from numerous studies that indicate that HPV vaccination using any of the available HPV vaccines only provides partial protection against 2, 4 or 9 types of HPV, when in reality there are at least 100 HPV viral types that can replace those that the vaccination removes from an individual or from the population; Gardasil 9 offers protection from most of the HPV types that cause cancer.  Therefore, no false advertising.

(c) the knowledge that women should continue to get Pap smears after HPV vaccination to screen for infection (as expected given type replacement); The Merck ad is aimed at both men and women, boys and girls, and states that everyone should talk to their doctor. The implication is the doctor will tell the patient the benefit of yearly exams, both for men and women. The ad does not imply nor state that the vaccine should replace yearly wellness exams. Therefore, no false advertising.

(d) the knowledge that HPV vaccine has been found to fail to lead to a decrease in overall HPV infection rates, according to study by the US Centers for Disease Control and Prevention (Markowitz et al., 2016); Strangely, Lyons-Weiler’s own source proves him wrong. Markowitz, et al, concluded that, 6 years after vaccine introduction, there was a 64% decrease in 4xHPV type prevalence in females aged 14 to 19. Therefore, no false advertising.

(e) the knowledge of side effects of HPV vaccination, including death, paralysis, premature ovarian failure, seizures and blindness; There have been many large studies of HPV vaccine safety, in various countries, and none have found any significant relationship between the vaccine and serious adverse events. As the ad clearly states to get more information from your doctor, and you get a vaccine information sheet with reach vaccine which clearly outlines risks and benefits, then again, There is no false advertising.

(f) the knowledge of alternatives to the vaccines for protection against HPV; Del and Lyons-Weiler spend a great deal of time talking about safe sex in the interview. Lyons-Weiler stays that HPV is a lifestyle disease and practicing unsafe sex is what needs to change. Since 95% of women clear the virus in the first two years, and there is a drug, according to him, in clinical trials that will completely cure the virus, there is no need to vaccinate. He does not seem to notice his statements are contradictory. He wants women to abstain from sex but then he also wants women not to worry about the virus because there is a cure for it coming soon. Del claims that pap smears stop HPV in it’s tracks, which is completely untrue. A pap smear can only (hopefully) detect if you have cancer or not. It is not a cure nor a treatment for cancer. They both routinely fail to tell their audience how this virus also affects men and they fail to inform that nearly all sexually active people will, at some point in their life, usually in early adulthood, acquire HPV infection. Yes, HPV is passed as a sexually transmitted infection but you can pass it via oral, anal, or vaginal sex or even just contact with sexual fluids (what my mother’s generation called heavy petting). Condoms do not prevent HPV as it can infect areas a condom does not cover. The only way to guarantee you will never get HPV is to never engage in any sexual activity with anyone other than the one partner you will have and keep for your entire life, assuming they also have only had one partner their entire life. As this is not a reasonable goal for most people, and sex is a natural, biological function, this vaccine is an important part of having a HEALTHY life. Vaccination is one key part of staying healthy. The only alternative to vaccination is abstinence and that is not a valid choice for all. Furthermore, human papillomaviruses can also cause oral and anal cancers, none of which are detectable by pap smears.  Therefore,  no false advertising.

(g) the knowledge that indiscriminate use of HPV vaccination in a population not screened for HPV infection may increase (double) the risk of HPV-associated cancer. Lyons-Weiler does not qualify this statement with any details so one must conclude this allegation is false. In the film interview with Bigtree, Lyons-Weiler states he believes that getting the HPV vaccine while already infected may be a problem but he, again, does not qualify this statement with any supporting evidence. Therefore, no false advertising.

The conversation between Del Bigtree and James Lyons-Weiler, regarding HPV vaccine, is rife with dangerous myths about both human papillomaviruses and the HPV vaccine. In just the few days since it first aired, I have noticed comments online being made that bear striking resemblance to those of Lyons-Weiler. He has influenced people. This vaccine already has so many dangerous myths associated with it that it is a shame to now have more. As a person who lost a lovely cousin to cervical cancer, a cousin who did have yearly pap smears, I know that Bigtree and Lyons-Weiler are doing is going to cost lives that could have been prevented. My own children are or will be protected with this vaccine. Like tens of millions world-wide, they have had no serious side effects to any vaccine, ever, in their lives.

Why is Lyons-Weiler engaged in this battle against HPV vaccine? On his website, he discusses a great many different projects, including several related to vaccines. It is troubling to me that he is spreading myths and lies about vaccines while, at the same time, asking for donations for his multiple projects. Usually, scientists with his level of education work for a research institute or university and they write grants to fund their projects. I have no real idea why Lyons-Weiler is no longer involved in the standard type of research, but I find it deeply troubling that he is stirring up vaccine waters.

As always, be sure to think for yourself!

 

 

Kathy

 

My sources for information and facts on HPV vaccine and cancers related to HPV.

 

1. Gardasil 9 – provider information sheet
2. Pink Book chapter on Human Papillomavirus
3. Gardasil Myths debunked at Skeptical Raptor blog
4. Prevalence of HPV After Introduction of the Vaccination
5. CDC page on human papillomavirus information
6. Ways to prevent HPV infection

 

 

A provaxer watched Vaxxed

 

Yes, I did. I watched it. And, I am still provax.  Here is my review and commentary.

 

I am going to assume that readers know a lot about the CDC Whistleblower. But, if you need a refresher, here is a complete guide by my fellow blogger friend. Please refer to this guide for the evidence that most, if not all, of the claims made in Vaxxed have been proven false. There is no isolated autism, there is no greater risk of autism in African American boys, the data was not thrown away. It is notable that the filmmakers took only Dr Thompsons’s word about the issues, via uncorroborated and possibly highly edited taped conversations with Dr Brian Hooker. Nowhere in the film are any other autism/vaccine scientists interviewed.

 

If you need to know more about the cast of characters, Dawn has created a short bio for each of them.

 

The film opens with news clips about vaccines and measles and then switches to someone typing on a keyboard and producer Del Bigtree’s voice quoting from William Thompson.  We then hear taped recordings from Thompson’s conversations with Brian Hooker and Hooker begins to tell the story of his child, who is now autistic. Of course, the recent “vaccine court” opinion on Hooker’s son’s case concluded that his child was most definitely not vaccine injured, there were clear signs of autism as young as four months of age, as documented in in his medical records.  This is not mentioned in the film. In fact, Hooker actually shows samples of studies he has authored, studies that were proven to lack validity in his court case. To me, this is disturbing. It is just the first of many lies in the film.

Hooker goes on to explain more of his take on the recordings of conversations with Thompson. He claims he had been trying talk to the CDC for years about the research he had been doing that showed vaccines could cause autism but had hit a wall until they assigned Thompson to talk to him. Throughout the film, we see Hooker explaining how he came to participate in phone conversations with Thompson, why they were recorded without Thompson’s permission, and how he, Hooker, analyzed the data. It should be noted that Hooker is a biochemical engineer and biology professor but that does not give him expertise in this kind of data analysis.

We then switch to Andy Wakefield telling his story. Wakefield claims he got the impetus to study vaccines, autism and gastrointestinal diseases when a mother of an autist called him out of the blue.  Bill Gates is shown discussing how Wakefield’s findings were fraudulent and have been disproven but Wakefield goes on to repeat that he made significant scientific findings. The voiceover from Wakefield is accompanied by more footage of children with autism. These videos are repeatedly show autistic children in crisis, hitting themselves, crying, in diapers, or worse. Throughout the film, neurotypical children are shown in a very positive light and autistic children are shown in crisis situations.

Jonathon and Polly Tommey talk about their story. Their first child, Bella, is shown as a lovely, happy child. Their second child, Billy, apparently got sick after his 6 month vaccines. He was put on antibiotics. The film repeatedly returns to Polly and Jonathon Tommey talking about the day Billy got the MMR. They claim Billy was shaking uncontrollably, in his cot, so they rushed him to the hospital.  They were told he was having a “normal” febrile seizure as a side effect.  They claim the Billy they had before never returned. Other parents, with similar stories, are shown, including Mark Blaxil, Jeanna Reed and Sheila Lewis Ealey.  Their autistic children are shown in very sad circumstances, including crying, being violent, in diapers, while their not autistic children are shown in lovely clothing, performing on the piano and playing. Jon and Polly talk about Billy’s vacancy, his lack of smiling, his blankness and other health problems that impaired Billy after his autism months regression. Billy was “gone,” in their words. They discuss the “tragedy” of Billy regressing into an autistic state. Polly and Jon talk about the television show they were featured on, when Billy was a toddler, and how they started The Autism File magazine as a result of the stories they heard from other parents with autistic children. These events led them to move to the USA and continue to be involved in this kind of autism advocacy.

Wakefield returns to ask if MMR is a risk, if it can lead to autism. He discusses the MMR vaccine that was withdrawn from Canada because it had a higher risk for meningitis. He claims that vaccine was shipped to the UK and then to developing countries, where it was used until meningitis rates were proven too high and it was removed. He claims age of MMR was part of the reason for the increased risk of meningitis and that it is plausible that age of MMR could be the reason for autism regression. This led to the IOM recommending the CDC do a study on the timing the MMR is given. Hooker returns and he and Wakefield claim that Thompson found a legal loophole which enabled him to get the data the CDC wanted hidden to Hooker for analysis. This data came from the study the CDC did on MMR age, the one authored by De Stefano and Thompson. The loophole is called a citizen’s request, according to Wakefield.

It should be noted that the mumps vaccine that had the meningitis issues was the Urabe strain of mumps, which we never used in USA. In the USA, we have used the Jeryl Lynn strain.  This is not mentioned in the film.

Wakefield goes into more details about his study. Still no mention from him as to how and why his study was retracted. He treats the study as valid throughout the film. He makes the point that when they had the press conference for his study, the Dean of the college deflected questions about what to do next to him, Wakefield, knowing full well he would recommend the single vaccines in lieu of MMR as triple jab. Wakefield says this was followed up by the single vaccines being discontinued and option taken away from parents. He says the concern was for the protection of the program over and above protection of children. If you read his book, Callous Disregard, this is one of many claims he made about his now-retracted study.

Hooker talks about how he analyzed the Thompson data. He fails to mention how he has no background in this type of analysis and his paper published on the data has since been retracted. A graph is shown wherein two lines, representing autistic children and not autistic, but no mention is made of the significance of the interval between the two lines. The difference is not valid unless that interval is analyzed. The confidence interval is a range of values so defined that there is a specified probability that the value of a parameter lies within it. But, Wakefield and Hooker do not mention this aspect of data analysis and most people do not understand data analysis at all. This is either a huge error, on their part, or a hugely devious action. Did they leave this information out on purpose?  At this point, Wakefield claims he advised Hooker to tape record Thompson in case the whistleblower, as he is now called, disappears or is killed.

Bigtree then explains the analysis plan. I have to remind myself this explanation is coming from a person who has no college education and makes a living producing cable television shows. Bigtree and Wakefield explain that the analysis plan was mainly written by Thompson and that deviating from an analysis plan is fraud. To remind you, the reality of the analysis plan is fully explained in this blog post.

Note: It is annoying that most of Thompson’s words are accompanied by a rather strange video image of smokey, colored lines moving across the screen. It is so inexplicable that I took a screen shot to share with readers.

Another part of the problem, in the minds of the film makers, is that the CDC is complicit with “big pharma” in controlling the pharmaceuticals markets. Brandy Vaughn, former Merck salesperson, claims vaccines have less safety testing than other pharmaceuticals. Strangely, this is a lie and it was put into the film without question. Vaughn has no background or training in any science, so it is strange that the filmmakers would use her opinion.

Several “experts” appear in the film. Dr. Doreen Granpeesheh, who runs an autism center called CARD, talks about the signs of autism as videos are shown of children exhibiting these symptoms.  Granpeesheh returns to discuss antibiotic use and regression after vaccines.  We see video footage of Yates Hazelhurt before and after autism diagnosis.  Granpeesheh claims autism is the result of toxic overload, the inability of some children to detoxify. Video of Billy Tommey is shown while Granpeesheh describes how autists become violent as a result of the toxins.

Stephanie Seneff, computer scientist at MIT, comes on to discuss her analysis of the growth of autism. Seneff claims autism rate is going to continue to rise, that it is a perfect exponential curve. She predicts that by 2032, 80% of boys, 50% of all children, will be on the autism spectrum. Respectful Insolence blog has done a nice job of debunking Seneff’s claims.  

Throughout the film, Bigtree speaks to his own self-described expertise as a “medical journalist” and claims that patient stories of autistic regression are ignored by doctors.  He discusses how the CDC “refuses” to do a vaxed versus unvaxed study. He claims the MMR risks would be astronomical and CDC is afraid to do the study. He also discusses how much he does not understand. Yet, even though a great deal of writing about the whistleblower issue had already been done BEFORE the film was made, Bigtree does not bother to interview other scientists, including Dr Matt Carey, for their opinion of the data analysis. He does not say anything about trying to contact Dr Carey or any of the study authors other than Thompson. Further, he makes no mention whatsoever of the autism and vaccine science done by other researchers in and out of the USA. These are all lies by omission.

Debunking a few of Vaxxed’s other lies:

1. Vaccines are not adequately tested for safety. Wrong. They are more highly tested than other drugs.
2. The law for vaccine compensation only benefits drug companies. Wrong. The law was written to benefit families and enable a legal climate to exist such that vaccine makers did not stop making vaccines all together.
3. The vaccine omnibus hearings were defeated by the fraudulent study from the CDC. This is a corruption of justice. Wrong. You can also read more here.
4. Not one mainstream media source ran the CDC whistleblower story. Wrong.  Stories were run by Time, CNN, Fox, ABC and The Daily Beast.
5. Autism rate is rising. Wrong. It has stabilized in the last few years.

 

 

So, the film did not open my eyes. The controversy has been swirling since August 2014 and nothing new has changed. The data has been available for download since January 2014. The data was never thrown away as it was always online as part of a large data set called MADDS.

So, why did the filmmakers not mention these facts? Why are they lying? Around the time the film was released, Brian Hooker’s claim for vaccine injury compensation, for his son, was completely denied. I have read the full 58 page opinion and it is damning. Why did the filmmakers not tell the audience about this opinion? I can only guess that they are never going to accept the idea that vaccines do not cause autism, no matter what the science tells them. My guess is that they are going to cling to any “proof” they can find to implicate vaccines as dangerous, whether it is valid or not.

 

Thanks for reading and remember to think for yourself!

 

Kathy