This article about the Andrew Wakefield movie, 1986: The Act, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
In 1986: The Act, Andrew Wakefield has created a very long parade of anti-vaccine claims from the past forty years or longer. The movie combines half-truths, facts taken out of context, and blatant misrepresentations to try and mislead people into refusing to vaccinate and protect their children.
In his post on the topic, my friend and colleague Dr. Vince Ilannelli addressed the potential motivations behind 1986: The Act from Andrew Wakefield, the problems with the credibility of the director and many of the main actors, the problematic nature of the sources in the movie, and some of the inaccuracies surrounding DTP.
In this post, I will cover some of the same ground, but my main focus will be to show why the film is unreliable. Obviously, I cannot cover every detail of the long film and keep this manageable, but I can cover many of the highlights, and I hope to make it clear why I think it’s unreliable.
Before starting on those, however, readers deserve a reminder that Andrew Wakefield, the creator of the film, has a well-earned reputation as a dishonest scientist. Wakefield misrepresented information about MMR and hid conflicts of interests, and as a result, outbreaks of measles in Europe and the United States harmed and killed children.
1986: The Act is no different.
The movie is framed as a discovery journey of a couple from the point where the woman discovers she’s pregnant to the point where she gives birth, during which they go through a lot of anti-vaccine sources and become thoroughly and extremely anti-vaccine, ending the movie as participants in an anti-vaccine event. It is, as I mentioned, a parade of greatest hits of the anti-vaccine movement – mostly claims that have been addressed again and again over the years, some twenty years old, some almost forty years old, some older still. There is little new in 1986: The Act.
Andrew Wakefield ignores vaccine benefits
There is a glaring, obvious omission in 1986: The Act: It passes in silence over vaccines’ extensive benefits, aside from a few scenes towards the end in which it tries to discount the benefits of two vaccines for pertussis and polio.
Vaccines are one of the greatest advances in medicines because they prevent deaths and harms. They are also cost-effective – they save individuals and society costs by preventing diseases:
Among 78.6 million children born during 1994–2013, routine childhood immunization was estimated to prevent 322 million illnesses (averaging 4.1 illnesses per child) and 21 million hospitalizations (0.27 per child) over the course of their lifetimes and avert 732,000 premature deaths from vaccine-preventable illnesses … The routine childhood vaccines introduced during the VFC era (excluding influenza and hepatitis A) together will prevent about 1.4 million hospitalizations and 56,300 deaths.
Vaccination will potentially avert $402 billion in direct costs and $1.5 trillion in societal costs because of illnesses prevented in these birth cohorts.
Worldwide, the lives saved are in the millions each year.
This Andrew Wakefield movie presents vaccines as a crime and a wrong against children while it completely ignores vaccines’ benefits for them. Anti-vaccine speakers in the movie describe the vaccine program as “wreaking havoc on a generation of children” (Blaxill), a motif repeated in it. In that alone, it is both misleading and anti-vaccine.
But the movie goes further. It also misleads by misrepresenting the benefits of two vaccines (the movie’s claims about the risks of these vaccines are explored below).
Towards the end of the movie, the movie claims that polio eradication was a failure, by referring to vaccine-derived polio and headlines that polio is coming back. But when the global effort to eradicate polio started in the mid-1980s, there were over 350,000 cases of paralytic polio each year (and that’s a drop after richer countries used vaccines to eliminate polio inside their boundaries).
There is a concern that some of these gains will be lost. Polio comes back when immunization rates drop. Covid-19 interrupted immunization efforts. But the problem there is a lack of vaccines.
The Andrew Wakefield movie also mentions pertussis outbreaks in schools that have 100% vaccination rates, implying that the pertussis vaccine has no benefits. But before vaccines, the United States saw over 200,000 reported cases of pertussis each year and thousands of deaths, mostly in young babies.
We are nowhere near that. We do not have hundreds of thousands of identified cases, and deaths are generally in the single-digits. While the acellular pertussis vaccine (which the movie recommends as the better option, as discussed below) is less effective than expected and desired, it is much better than no vaccine and has substantial benefits. By implying it does nothing, the movie is misleading.
The movie’s claims are generally incorrect
Because the Andrew Wakefield movie makes so many incorrect claims, I’ve broken them down into separate sections.
Polio vaccines are safe, old scandals notwithstanding
In the movie, the man, who pretends to start as sympathetic to vaccines (but gives that position up very easily) asks “but what about polio”. The movie tries to present the polio vaccines as bad by referring to two old scandals – the Cutter Incident and the SV40 contamination.
In the Cutter Incident in the 1950s an improperly inactivated polio vaccine harmed children, as described in a book on the topic written by vaccine expert Paul Offit. It was a tragedy and scandal that should not have happened. It also led to dramatic changes in vaccine safety regulation that prevented a recurrence.
In the 1960s, scientists discovered that a large number of polio vaccines, especially live polio vaccines, were contaminated with a simian virus from the monkey kidney cells used to grow the vaccine virus. Because the virus was shown to cause cancer in hamsters, and the virus was found in cancers, there was a real concern that the contamination may cause cancer.
Luckily, studies did not show a higher rate of cancer in recipients of the contaminated vaccine. Nonetheless, the contamination could have led to harm, and should not have happened. Again, changes to regulation were made.
The movie presents these two decades-old scandals, which are acknowledged history, as evidence of a problem in current polio vaccines – but they are not. They do show that regulation systems can have problems – but also that they can learn from them. These old scandals were steps on the development of today’s robust system of regulating vaccine safety. The movie has not – and apparently cannot – point to an actual problem with the modern polio vaccine.
The question “what about polio” – which vaccines eliminated from the United States, and which is currently prevented with safe, effective vaccines in most of the world – was not answered in the movie.
DTP vaccines are safe, and in the 1980s, there wasn’t a realistic alternative
Much of this Andrew Wakefield movie is devoted to attacking DTP vaccines because these vaccines were a large part of the story of the act. The short version is that a number of things combined in the early 1980s to create an impression that DTP vaccines caused brain damage and seizure disorders.
This was later shown incorrect, but the damage was done – lawsuits led to vaccine makers leaving the market, and Congress, concerned about the already visible vaccine shortages, created the National Vaccine Injury Compensation Program to stop that.
A detailed discussion of these events can be found in Dr. Paul Offit’s book, Deadly Choices.
Obviously, that is not the story the Andrew Wakefield movie tells. The movie claims that DTP vaccines cause brain damage and deaths, that the manufacturers knew that, that they had a safer alternative available, and that they intentionally chose to hide the risks and let children be harmed and killed for profit.
The movie draws on documents from the 1980s and from the movie Vaccine Roulette to create the appearance of a conspiracy.
I cannot go over all the details but will address several of the important points.
The most important is that while in the 1980s, scientists and doctors – as well as laypeople – could reasonably believe that the pertussis vaccine caused brain damage, SIDS, and seizure disorder; however, the evidence since showed that was not the case.
The main scientific evidence connecting DTP to brain damage was a large study by Miller, in the UK. However, that study was misanalyzed by Miller. Actually looking at the evidence showed, as explained in Deadly Choices (quoted in Vaxopedia):
In his study David Miller maintained that seven children had developed brain damage within a week of receiving DTP. But a closer look showed that these cases weren’t what they were claimed to be. Three of the children had been incorrectly labeled as brain damaged when in fact they were normal both before and after vaccination. Three others had suffered viral infections and one Reye’s Syndrome (a severe neurological problem found later to be caused by aspirin, not vaccines.) Miller’s conclusions lay in ruins.
Basically, the study’s conclusions mischaracterized the data. Other studies reinforced that conclusion:
The results of a number of controlled studies between 1979 and 2004 indicated that no risk of severe neurologic disease after DTwP vaccinations existed [66–76]. It was noted by myself and Shields  (a pediatric neurologist) that what was being called pertussis vaccine encephalopathy was not an encephalitis-like event but, instead, the first seizure or seizures of infantile epilepsy.
These studies are also detailed in Dr. Offit’s Deadly Choices.
The movie makes much of a study it attributes to Dr. Larry Baraff from UCLA. The movie also suggests that a report by an industry representative – Dr. Deitch – based on a visit to the doctor, a report that showed high rates of harms in the preliminary results, shows the industry interfered in the results and led to the final study not matching them.
At that point, the movie said, Dr. Baraff has looked at 1500 out of the 15,000 vaccines to be in the study. But note that the report itself shows no such thing: it, at most, mentioned the high rates of harm, suggested this was concerning, and did not imply Deitch achieved anything: if anything, the report would suggest Deitch, by sounding the alarm, was anticipating the results to be unchanged.
Further, a look at the actual study would show that the study was co-authored by a team that included, in order, Dr. Cody, Dr. Baraff, Dr. Cherry, Dr. Marcy, Dr. Manclark. To get anything changed, at least the first and last author, and likely all, would have to be reached – not trivial. Dr. Baraff was a middle author.
A more natural conclusion from the change from early results is that early results in a fraction of the vaccines did not reflect the actual, full data – the group in the first batch may well not have been representative. Smaller datasets are less powerful exactly because they can lead to incorrect results.
At any rate, the final study – looking at over 15,000 – did not find serious risks. Nine children in the study had “convulsions” and nine had “hypotonic hyporesponsive episodes” – but none of these led to sequelae or continuing harm. The study goes against the picture the movie is trying to draw.
In the 1980s, there were also concerns that pertussis vaccines increased the risk of SIDS. But studies since have shown that vaccines generally, and pertussis-containing vaccines specifically, do not cause SIDS. In fact, an ecological study found an inverse relationship between DTP immunization coverage and SIDS rates – meaning more DTP vaccines given, less SIDS – and though such studies need to be approached with caution, it wasn’t the only study to find a protective effect from such vaccines
Finally, regarding seizure disorders, the movie ignores the discovery of Dravet syndrome, a genetic disorder that predisposes children to have seizures, starting at six months – and the finding that most of the children who have, previously, been thought to have seizure disorders because of vaccines were found to have a genetic cause for their seizures – and that though the vaccine may trigger the first seizure, the clinical picture would be the same with or without the vaccine.
The Andrew Wakefield movie also claimed that there were already safer alternatives to DTP vaccines, referring to acellular vaccines. One vaccine they referred to was Trisolgen, from 1963, Eli Lilly. In 1988, the American Academy of Pediatrics’ Task Force on Pertussis and Pertussis immunization said, in its report:
An extracted pertussis vaccine (TriSolgen manufactured by Eli Lilly Co) was marketed in the United States from 1962 until 1977. There are few published data evaluating this product. … Two published small field trials provided information regarding reaction data and agglutinin titers. Only one of these trials was carried out in a randomized, double-blind fashion, and in this study the difference between the reaction rates following the extracted vaccine varied only slightly from the comparative whole-cell vaccines. The local reactions were less frequent with extracted vaccine, although the systemic reactions were not significantly different.
In addition, there are no specific data concerning efficacy or frequency of uncommon temporally related severe neurologic events with this extracted vaccine.
Decades before the movie, the claims about acellular vaccines were examined. They did not support the existence of a viable safer alternative in 1988.
The acellular vaccine is not always safer, and certainly not always better if it means more children get pertussis. In fact, in a paragraph before the one above, the report referred to another acellular vaccine that, in large trials in the U.K., “caused significantly more systemic reactions than available conventional whole-cell vaccines.”
Current evidence, therefore, does not support the view that DTP vaccines cause brain damage, seizure disorders, or SIDS. Maybe people believed they did in the 1980s, but the evidence doesn’t show that. Further, the evidence does not show the existence of viable alternative vaccines.
Finally, the movie strongly suggests that manufacturers blackmailed Congress into giving immunity by threatening they were leaving the market. But manufacturers were not threatening. They simply left the market, in the wake of lawsuits – not because they were losing most, but because lawsuits made it non-profitable to make vaccines. That is why, in the early 1980s, there was an actual DTP vaccine shortage.
Congress was rightly concerned, because although the movie does not consider this as a harm, diphtheria, tetanus, and pertussis are dangerous diseases, with a history of harming and killing children. Not having the vaccine, far from protecting and saving children – as the movie suggests – could put children at risk.
An effective acellular vaccine could prevent that risk, and acellular vaccines have been developed in the 1990s. But that wasn’t easy. The pertussis report above discussed the difficulties, pointing out that the process “proved to be exceedingly difficult in the face of the array of biologically active products that could be derived from B pertussis organisms.”
The first acellular pertussis vaccines were licensed in the United States in late 1991 and 1992. The reality is that it is difficult to provide safer vaccines when those do not exist.
The movie also stated that “Some batches of the DTP vaccine were known as hot lots, and they frequently caused severe reactions.”
I then asked two vaccine experts whether that was true. Dr. Paul Offit said –
No. There is no such thing as a hot lot of vaccines. The FDA has a consistency requirement for manufacture. (Skeptical Raptor note – if there was a “hot lot,” whatever that is, the only way anyone would know about it is if it were reported to the FDA. Once that happens, the FDA would review the data and probably require that the lot is destroyed. However, the company would destroy the lot while reporting it to the FDA. This conspiracy makes zero sense.)
Dr. James Cherry said:
The simple answer is no. I know I investigated this but at present I can’t find where it is published. It may have been presented at either the 3rd, 4th or 5th international pertussis meetings at NIH, WHO, and NIH respectively. I have those in my office and the next time I go in I can look at them.
As I recall we looked at 50 lots from different manufactures and their use in children and didn’t find any hot lots although the children who received one lot may have had more high temperatures but I don’t think it was a statistically significant finding.
Vaccines are not associated with autism
Much of the Andrew Wakefield movie is dedicated to claiming vaccines cause autism. But this section can likely be dealt with more shortly than the rest.
The movie claims MMR caused autism, referring to the study that was the focus of the claim of the conspiracy theory known as CDC Whistleblower. Those claims were taken apart by many, and the post I linked to lists these responses – but even apart from that, this is a relatively small study, and there are many large studies on MMR and autism, and they found no link.
These were mostly ignored by the movie. The only other study it addressed is a 2002 study from Denmark. In relation to that study, Dr. Brian Hooker said:
…this was done by statistical sleight of hand. The average age of autism diagnosis in Denmark at the time was just over four years old. The children who were unvaccinated were followed up to an average age of 5 years old, and that captured that average age of diagnosis. But children who did get MMR vaccine they were followed up until 3.5 years of age, before the average age. So you would expect that if you follow up children for a longer time they were going to have a greater likelihood of diagnosis. Fully over half of the children in the MMR vaccinated were not accounted for. They were not followed up to autism diagnosis. So the study was trumped up.
I am honestly unsure where Dr. Hooker got this from. The study says:
Follow-up for the diagnosis of autistic disorder or another autistic-spectrum disorder began for all children on the day they reached one year of age and continued until the diagnosis of autism or an associated condition (the fragile X syndrome, Angelman’s syndrome, tuberous sclerosis, or congenital rubella), emigration, death, or the end of follow-up, on December 31, 1999, whichever occurred first.
Table 1 includes children who were diagnosed with autism past 6, and had a category of 3-5, both for vaccinated and unvaccinated children; table 2 includes children followed who were diagnosed more than 60 months after vaccination. It seems very clear the study did not cut off vaccinated children at 3.5. As best as I can tell, Hooker’s claim is simply untrue.
The movie revived the old claims about thimerosal in vaccines, raising old anti-vaccine conspiracy theories on that. The short answer is that evidence from all around the world shows that countries that removed thimerosal from their vaccines see similar autism rates – or increasing rates – after removal. There is no link there.
The movie tried to claim that as thimerosal was removed from childhood vaccines, it was brought back in by vaccinating pregnant women and infants against influenza. This, too, does not hold. First, most pregnant women don’t get influenza vaccines, even today. And many children do not, either. Second, most influenza vaccines today don’t contain thimerosal. Third, in some states, laws were passed prohibiting the use of thimerosal-containing vaccines in pregnant women and young children (for example, California). Rates of autism have increased regardless. This claim, too, does not hold.
The movie from Andrew Wakefield devotes extensive time to reviving the old claim that the Poling concession from 2008 shows that in children with mitochondrial issues, vaccines cause autism. This claim was recently addressed, as anti-vaccine people have tried to revive it as late as 2018. The short version is that there is no evidence that children with mitochondrial disorders are more at risk from vaccines than other children; there is evidence that those children are at high risk if they get a preventable disease. And using them to scare parents from protecting children – which can reduce vaccination rates – puts them at risk. It is extremely jarring to use these children in an effort to create an environment that increases their already substantial risk. (More information about the Poling case can be found here, here, and here.)
In short, the movie repeats in a dramatic fashion already addressed and disproven anti-vaccine claims that vaccines cause autism and that there was a conspiracy to hide it. Vaccines still don’t cause autism.
The NVICP is not a conspiracy
The last set of claims address the creation and functioning of the National Vaccine Injury Compensation Program. First, I would encourage readers to consider, if they are interested in this, to read Anna Kirkland’s wonderful book Vaccine Court. Second, the only part in the movie that is, likely, true is the claim that the program today probably does not look like its creators envisioned – but that is not unusual in administrative programs.
As discussed by Anna Kirkland, the program was created as a compromise in response to problems with the situation before it. Congress was concerned that manufacturers leaving the market will leave United States children unprotected against diphtheria, tetanus, or pertussis.
The movie states that the program harms children and denies compensation to children who deserve it. It says, at some point, that the issue was “compensation of a generation of injured children”, that “injured children have no right to bring a claim for vaccine injury.”
But the compensation program provides an easier path to compensation than regular courts.
- In regular courts, plaintiffs would have to show more than causation and damages; in vaccine court that is all they have to show.
- The standards for causation are relaxed. In civil court, a plaintiff would have to show, with scientific evidence, that the product could cause her harm. In Vaccine Court. At least one scholar criticized the standard as too broad.
The claim in the movie, therefore, that having to prove off-table claims “creates a nearly insurmountable burden for the injured parties” is problematic – unless, as with the autism claim, there is strong evidence against the claim.
NVICP also covers lawyers’ fees and costs and reasonable expert fees – even if the petitioner loses, as long as the claim was reasonable.
In other words, rather than denying compensation, the NVICP makes it easier for people with valid claims to be compensated. The real issue is that most of the claims that anti-vaccine activists want to bring are for things science shows vaccines don’t cause – like autism. But the program shouldn’t compensate in such cases – and civil courts shouldn’t, either.
The movie claims that the lack of discovery is unfair to plaintiffs. But the program does allow for discovery in some cases (discovery was allowed during the Omnibus Autism Proceedings), and the reality is that when the question is scientific causation, whether a vaccine can cause something, the evidence in question is not usually private documents manufacturers have – but medical records and scientific evidence that is often public.
I do agree that the statute of limitations should be lengthened, but I will point out that 3 years is not unusual in torts, and that for administrative programs – unlike courts – it is not usually tolled, put on hold (e.g. http://www.christian-attorney.net/exceptions_to_statute_of_limitations_tolling_california.html).
The movie criticizes the choice to change the table in the mid-1990s and remove, for example, seizure disorder. But the table was changed because growing scientific evidence went against these links – and that evidence has increased since. For example, the change relied on a 1994 report that found no link between vaccines and residual seizure disorder.
Since then, as mentioned above, the evidence against the link to seizure disorders only increased.
The movie suggests the autism cases were flawed because they did not change in response to the Poling concession. I addressed that claim here. In essence, the petitioners in the vaccine court knew about the Poling concession long before the cases were decided. They decided not to change their claims to mitochondrial because they thought they had enough evidence to show a link between MMR or thimerosal-containing vaccines and autism – and they failed to do that. Later petitions tried to argue the mitochondrial issue (the claim that special masters refused to allow those is against the evidence) – and those were repeatedly rejected.
It’s not clear that if Hannah’s case was fully litigated as an off-table claim, it would have won – at least one commenter at the time thought it should not. At any rate, the mitochondrial disorders issue was thoroughly litigated since.
The movie also ignores the thoroughness of the decisions in the Omnibus Autism Proceedings. Those looked at each child and at extensive scientific evidence – and as one special master put it, those decisions were “not even close” – they thoroughly rejected the claims that MMR or thimerosal in vaccines caused autism. Two of these decisions were appealed all the way to the circuit court – and those courts rejected them.
The last issue I will address here is the movie’s claim that the Supreme Court erred in finding that design defects were preempted by the National Childhood Vaccine Injury Act – in other words, that for design defects, the program is the only venue and you cannot go to state courts after it. The movie based it on a claim that at the time the act was passed, several major players thought it did not preempt later claims of vaccine injury.
That’s not how statutory interpretation works. Legislative intent can be one part of interpreting, and the decisions in the case at hand – Bruesewitz v. Wyeth – referred to it. But it’s not the only part. In this case, three courts of appeals judges and six justices of the Supreme Court – across party lines – disagreed with that interpretation. Their decisions were reasoned.
Andrew Wakefield and the moviemakers can certainly disagree, but the decision stands.
The decision only limits bringing design defects. It does not stop other claims – for example, manufacturing defects, negligence, or fraud. Even in Bruesewitz itself, plaintiffs brought an alternative claim of manufacturing defects. But they did not have evidence for it.
Further, with today’s well-funded, litigation-prone anti-vaccine movement, Bruesewitz is well justified. It does not harm children; it protects them.
There are other claims in the movie, but this post is already getting too long. In essence, 1986: The Act from Andrew Wakefield is a parade of claims by anti-vaccine groups that have been made – and addressed – repeatedly. There is little new and much misleading in it.
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