MMR vaccine controversy
Encyclopedia
The MMR vaccine controversy was a case of scientific misconduct
which triggered a health scare
. It followed the publication in 1998 of a paper in the medical journal The Lancet
which presented apparent evidence that autism spectrum disorders could be caused by the MMR vaccine
, an immunization
against measles
, mumps
and rubella
.
Investigations by Sunday Times
journalist Brian Deer
revealed that the lead author of the article, Andrew Wakefield
, had multiple undeclared conflicts of interest
, had manipulated evidence, and had broken other ethical codes. The Lancet paper was partially retracted in 2004 and fully retracted in 2010, and Wakefield was found guilty by the General Medical Council
of serious professional misconduct in May 2010 and was struck off the Medical Register, meaning he could no longer practice as a doctor. The research was declared fraudulent in 2011 by the BMJ
. The scientific consensus
is that no evidence
links the vaccine to the development of autism, and that the vaccine's benefits greatly outweigh its risks.
Following the initial claims in 1998, multiple large epidemiological studies were undertaken. Reviews of the evidence by the Centers for Disease Control and Prevention
, the American Academy of Pediatrics
, the Institute of Medicine
of the US National Academy of Sciences
, the UK National Health Service
, and the Cochrane Library
all found no link between the vaccine and autism. While the Cochrane review expressed a need for improved design and reporting of safety outcomes in MMR vaccine studies, it concluded that the evidence of the safety and effectiveness of MMR in the prevention of diseases that still carry a heavy burden of morbidity and mortality
justifies its global use, and that the lack of confidence in the vaccine has damaged public health. A special court convened in the United States to review claims under the National Vaccine Injury Compensation Program rejected compensation claims from parents of autistic children.
The claims in Wakefield's 1998 The Lancet article were widely reported; vaccination rates in the UK and Ireland dropped sharply, which in turn led to greatly increased incidence of measles and mumps, resulting in deaths and severe and permanent injuries. Physicians, medical journals, and editors have made statements tying Wakefield's fraudulent actions to various epidemics and deaths.
strain including rare adverse events of aseptic meningitis
, a transient mild form of viral meningitis. A late-1980s trial in Britain of a form of the MMR vaccine containing the Urabe mumps strain produced three cases of probably associated febrile convulsions per 1,000 vaccinations. Concerns about adverse reactions to the vaccine were raised by American and Canadian authorities based on reports from Japan linking Urabe MMR with meningoencephalitis
. In early 1988, Canadian authorities suspended distribution of the Urabe-based MMR and eventually recalled the product.
The UK National Health Service
introduced an MMR vaccine using the Urabe mumps strain in 1988, replacing it entirely with the Jeryl Lynn strain in September 1992 following the identification of an unacceptable risk of aseptic meningitis
15–35 days after vaccination. Decisions taken by British authorities at this time were to be criticized later following documents delivered by FOIA. With no such risk seen in vaccines using the Jeryl Lynn
mumps strain, the UK NHS withdrew two of the three MMR vaccine then available (Immravax, made by Merieux UK, and Pluserix, made by SmithKline Beecham
) in favor of Merck Sharp and Dohme's MMR II brand, based on the Jeryl Lynn strain. Although MMR administration did continue with MMR II, the MMR vaccination rate first began to fall after 1996, following claims by Wakefield that it was linked to the inflammatory bowel disease
, Crohn's disease
.
The Urabe strain remains in use in a number of countries; MMR with the Urabe strain is much cheaper to manufacture than with the Jeryl Lynn
strain, and a strain with higher efficacy
along with a somewhat higher rate of mild side effects may still have the advantage of reduced incidence of overall adverse events.
. The class action case was aimed at Aventis Pasteur, SmithKlineBeecham, and Merck
, manufacturers respectively of Immravax, Pluserix-MMR and MMR II. This suit, based on a claim that MMR is a defective product and should not have been used, was the first big class action lawsuit funded by the Legal Aid Board (now the Legal Services Commission
) after its formation in 1988. Noticing two publications from Andrew Wakefield that explored the role of measles virus in Crohn's disease
and inflammatory bowel disease
, Barr contacted Wakefield for his expertise. According to Wakefield supporters, the two men first met on 6 January 1996. The Legal Services Commission halted proceedings in September 2003, citing a high probability of failure based on the medical evidence, bringing an end to the first case of research funding by the LSC.
published a controversial paper in the respected British medical journal The Lancet
, supported by a press conference at the Royal Free Hospital
in London. This paper reported on twelve children with developmental disorders referred to the Royal Free Hospital. The parents or physicians of eight of these children were said to have linked the start of behavioral symptoms to MMR vaccination. The paper described a collection of bowel symptoms, endoscopy
findings and biopsy
findings that were said to be evidence of a possible novel syndrome that Wakefield would later call autistic enterocolitis
, and recommended further study into the possible link between the condition and the MMR vaccine. The paper suggested that the connection between autism and the gastrointestinal pathologies was real, but said it did not prove an association between the MMR vaccine and autism.
At the press conference before the paper's publication, later criticized as 'science by press conference
', Wakefield said that he thought it prudent to use single vaccines instead of the MMR triple vaccine until this could be ruled out as an environmental trigger; parents of eight of the twelve children studied were said to have blamed the MMR vaccine, saying that symptoms of autism had set in within days of vaccination at approximately 14 months. Wakefield said, "I can't support the continued use of these three vaccines given in combination until this issue has been resolved." In a video news release issued by the hospital to broadcasters in advance of the press conference, he called for MMR to be "suspended in favour of the single vaccines." In a BBC interview Wakefield's mentor Roy Pounder
, who was not a coauthor, "admitted the study was controversial". He added: "In hindsight it may be a better solution to give the vaccinations separately,... When the vaccinations were given individually there was no problem." These suggestions were not supported by Wakefield's coauthors nor by any scientific evidence.
The limited initial press coverage of the story was reasonable for a small and not very significant study. The Guardian and the Independent reported it on their front pages, while the Daily Mail only gave the story a minor mention in the middle of the paper, and the Sun didn't cover it.
Tony Blair
reveal whether his infant son Leo had been given the vaccine. It was the biggest science story of 2002, with 1257 articles mostly written by non-expert commentators. In the period January to September 2002, 32% of the stories written about MMR mentioned Leo Blair, as opposed to only 25% which mentioned Wakefield. Less than a third of the stories mentioned the overwhelming evidence that MMR is safe. The paper, press conference and video sparked a major health
scare in the United Kingdom. As a result of the scare, full confidence in MMR fell from 59% to 41% after publication of the Wakefield research. In 2001, 26% of family doctors felt the government had failed to prove there was no link between MMR and autism and bowel disease. In his book Bad Science
, Ben Goldacre
describes the MMR vaccine scare as one of the "three all-time classic bogus science stories" by the British newspapers (the other two are the Arpad Pusztai affair
about genetically modified crops, and Chris Malyszewicz and the MRSA hoax).
Confidence in the MMR vaccine increased as it became clearer that Wakefield's claims were unsupported by scientific evidence. A 2003 survey of 366 family doctors in the UK reported that 77% of them would advise giving the MMR vaccine to a child with a close family history of autism, and that 3% of them thought that autism could sometimes be caused by the MMR vaccine. A similar survey in 2004 found that these percentages changed to 82% and at most 2%, respectively, and that confidence in MMR had been increasing over the previous two years.
A factor in the controversy is that only the combined vaccine is available through the UK National Health Service. The importation license for the single measles vaccine was withdrawn in 1988, and as of 2010 there are no single vaccines for measles, mumps and rubella licensed for use in the UK. Prime minister Tony Blair gave support to the programme, and said that "the vaccine was safe enough for his young son, Leo", but refused on privacy grounds to state whether Leo had received the vaccine; in contrast, the subsequent Prime Minister, Gordon Brown
, explicitly confirmed that his son has been immunised. The privacy concerns of the Blairs were later undermined when Cherie Blair
mentioned Leo's vaccination history when promoting her autobiography.
Administration of the combined vaccine instead of separate vaccines decreases the risk of children catching the disease while waiting for full immunisation coverage. The combined vaccine's two injections results in less pain and distress to the child than the six injections required by separate vaccines, and the extra clinic visits required by separate vaccinations increases the likelihood of some being delayed or missed altogether; vaccination uptake significantly increased in the UK when MMR was introduced in 1988. Health professionals have heavily criticized media coverage of the controversy for triggering a decline in vaccination rates. There is no scientific basis for preferring separate vaccines, or for using any particular interval between separate vaccines.
John Walker-Smith, a coauthor of Wakefield's report and a supporter of the MMR vaccine, wrote in 2002 that epidemiology has shown that MMR is safe in most children, but observed that epidemiology is a blunt tool and studies can miss at-risk groups that have a real link between MMR and autism. However, if a rare subtype of autism were reliably identified by clinical or pathological characteristics, epidemiological research could address the question whether MMR causes that autism subtype. There is no scientific evidence that MMR causes damage to the infant immune system, and there is much evidence to the contrary.
In 2001, Berelowitz, one of the co-authors of the paper, said "I am certainly not aware of any convincing evidence for the hypothesis of a link between MMR and autism". The Canadian Paediatric Society
, the Centers for Disease Control and Prevention
, the Institute of Medicine
of the National Academy of Sciences
, and the UK National Health Service
have all concluded that there is no evidence of a link between the MMR vaccine and autism.
wrote in The Sunday Times
of London that Wakefield had received £
55,000 funding from Legal Aid Board
solicitors seeking evidence to use against vaccine manufacturers, that several of the parents quoted as saying that MMR had damaged their children were also litigants, and that Wakefield did not inform colleagues or medical authorities of the conflict of interest. When the editors of The Lancet learned about this, they said that based on Deer's evidence, Wakefield's paper should have never been published because its findings were "entirely flawed." Although Wakefield maintained that the legal aid funding was for a separate, unpublished study (a position later rejected by a panel of the UK General Medical Council
), the editors of The Lancet judged that the funding source should have been disclosed to them. Richard Horton, the editor-in-chief, wrote, "It seems obvious now that had we appreciated the full context in which the work reported in the 1998 Lancet paper by Wakefield and colleagues was done, publication would not have taken place in the way that it did." Several of Dr. Wakefield's co-researchers also strongly criticized the lack of disclosure.
Deer continued his reporting in a BBC
Dispatches
television documentary, MMR: What They Didn't Tell You, broadcast on November 18, 2004. This documentary alleged that Wakefield had applied for patents on a vaccine that was a rival of the MMR vaccine, and that he knew of test results from his own laboratory at the Royal Free Hospital
that contradicted his claims. Wakefield's patent application was also noted in the 2008 book Autism's False Prophets
by Paul Offit
.
In January 2005, Wakefield sued Channel 4, 20/20 Productions, and the investigative reporter Brian Deer, who presented the Dispatches programme. However, after two years of litigation, and the revelation of more than £400,000 in undisclosed payments by lawyers to Wakefield, he discontinued his action and paid all the defendants' costs.
In 2006, Deer reported in The Sunday Times that Wakefield had been paid £435,643, plus expenses, by British trial lawyers attempting to prove that the vaccine was dangerous, with the undisclosed payments beginning two years before the Lancet paper's publication. This funding came from the UK legal aid fund, a fund intended to provide legal services to the poor.
In March 2004, immediately following the news of the conflict of interest allegations, ten of Wakefield's 12 coauthors retracted this interpretation, while insisting that the possibility of a distinctive gastrointestinal condition in children with autism merited further investigation. However, a separate study of children with gastrointestinal disturbances found no difference between those with ASD
and those without, with respect to the presence of measles virus RNA
in the bowel; it also found that gastrointestinal symptoms and the onset of autism were unrelated in time to the administration of MMR vaccine.
that Wakefield had "fixed" results and "manipulated" patient data in his 1998 paper, creating the appearance of a link with autism. Wakefield denied these allegations, and even filed a complaint with the Press Complaints Commission
(PCC) over this article on 13 March 2009. The complaint was expanded by a 20 March 2009 addendum by Wakefield's publicist. In July 2009, the PCC stated that it was staying any investigation regarding the Times article, pending the conclusion of the GMC investigation. In the event, Wakefield did not pursue his complaint, which Deer published with a statement that he and The Sunday Times rejected it as "false and disingenuous in all material respects", and that the action had been suspended by the PCC in February 2010.
(GMC), which is responsible for licensing doctors and supervising medical ethics in the UK, investigated the affair. The GMC brought the case itself, not citing any specific complaints, claiming that an investigation was in the public interest. The then-secretary of state for health, John Reid MP, called for a GMC investigation, an investigation Wakefield seems himself to have wished. During a debate in the House of Commons, on 15 Mar 2004, Dr. Evan Harris, a Liberal Democrat MP, called for a judicial inquiry into the ethical aspects of the case, even suggesting it might be conducted by the CPS
. In June 2006 the GMC confirmed that they would hold a disciplinary hearing of Wakefield.
The GMC's Fitness to Practice Panel first met on 16 July 2007 to consider the cases of Dr. Wakefield, Professor John Angus Walker-Smith, and Professor Simon Harry Murch. All faced charges of serious professional misconduct. The GMC examined, among other ethical points, whether Wakefield and his colleagues obtained the required approvals for the tests they performed on the children; the data-manipulation charges reported in the Times, which surfaced after the case was prepared, were not at question in the hearings. The GMC stressed that it would not be assessing the validity of competing scientific theories on MMR and autism. The General Medical Council alleged that the trio acted unethically and dishonestly in preparing the research into the MMR vaccine. They denied the allegations. The case proceeded in front of a GMC fitness to practice panel of three medical and two lay members.
On 28 January 2010, the GMC panel gave its verdict on the facts of the case: Wakefield was found to have acted "dishonestly and irresponsibly" and to have acted with "callous disregard" for the children involved in his study, conducting unnecessary and invasive tests. The panel found that the trial was improperly conducted without the approval of an independent ethics committee
, and that Wakefield had multiple undeclared conflicts of interest
.
The Hansard
text for 16 March 2010 reported Lord McColl
asking the Government whether it had plans to recover legal aid money paid to the experts in connection with the measles, mumps and rubella/measles and rubella vaccine litigation. Lord Bach, Ministry of Justice dismissed this possibility.
In an April 2010 report in the BMJ
, Deer expanded on laboratory aspects of his findings recounting how normal clinical histopathology
results generated by the Royal Free Hospital
were later changed in the medical school to abnormal results, published in The Lancet. Wakefield responded to these accusations in a press release. Deer wrote an article in the BMJ casting doubt on the "autistic enterocolitis" which Wakefield claimed to have discovered. In the same edition, Deirdre Kelly, President of the European Society of Pediatric Gastroenterology and Nutrition and the Editor of the Journal of Pediatric Gastroenterology and Nutrition expressed some concern about the BMJ publishing this article while the GMC proceedings were underway.
On 24 May 2010, the GMC panel announced the sentences in the case: Wakefield was found guilty of serious professional misconduct on four counts of dishonesty and 12 involving the abuse of developmentally challenged children, and was ordered to be struck off the medical register. John Walker-Smith was also found guilty of serious professional misconduct and struck off the medical register. Simon Murch was found not guilty, despite having previously been found to not have ethical approvals for the study.
On 5 January 2011, the BMJ published the first of a series of articles by Brian Deer, detailing how Wakefield and his colleagues had faked some of the data behind the 1998 Lancet article. By looking at the records and interviewing the parents, Deer found that for all 12 children in the Wakefield study, diagnoses had been tweaked or dates changed to fit the article's conclusion. Continuing the BMJ series on 11 January 2011, Deer said that based upon documents he obtained under Freedom of information legislation
, Wakefield—in partnership with the father of one of the boys in the study—had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing". The Washington Post reported that Deer said that Wakefield predicted he "could make more than $43 million a year from diagnostic kits" for the new condition, autistic enterocolitis
. WebMD
reported on Deer's BMJ report, saying that the $43 million predicted yearly profits would come from marketing kits for "diagnosing patients with autism" and that "the initial market for the diagnostic will be litigation-driven testing of patients with AE [autistic enterocolitis, an unproven condition concocted by Wakefield] from both the UK and the USA". According to WebMD, the BMJ article also claimed that the venture would succeed in marketing products and developing a replacement vaccine if "public confidence in the MMR vaccine was damaged".
against manufacturers of vaccines, alleging the vaccines had caused a variety of physical and mental disorders
in children. While these lawsuits were unsuccessful they did lead to a large jump in the costs of the MMR vaccine, and pharmaceutical companies sought legislative protections. In 1993, Merck KGaA
became the only company willing to sell MMR vaccines in the United States and the United Kingdom
.
A pressure group called JABS (Justice, Awareness, Basic Support) was established to represent families with children who, their parents said, were "vaccine-damaged". £15 million in public legal aid funding was spent on the litigation, of which £9.7 million went to solicitor
s and barrister
s, and £4.3 million to expert witnesses.
Several British cases where parents claimed that their children had died as a result of Urabe MMR had received compensation under the “vaccine damage payment” scheme.
. It is structured to facilitate the handling of nearly 5000 vaccine petitions involving claims that children who have received certain vaccinations have developed autism. The Petitioners' Steering Committee have claimed that MMR vaccines can cause autism, possibly in combination with thiomersal-containing vaccines
. In 2007 three individual test cases were presented to test the claims about the combination; these test cases failed. The vaccine court ruled against the plaintiffs in all three cases, stating that the evidence presented did not validate their claims that vaccinations caused autism in these specific patients, or in general.
In some cases, the plaintiffs' attorneys opted out of the Omnibus Autism Proceedings, which were concerned solely with autism, and also issues concerned with bowel disorders, and argue their cases in the regular vaccine court:
On 30 July 2007, the family of Bailey Banks, a child with pervasive developmental delay, won their case versus the Department of Health and Human Services. Special Master Richard Abell ruled that the Banks had successfully demonstrated that "the MMR vaccine at issue actually caused the conditions from which Bailey suffered and continues to suffer." In his conclusion, he ruled that he was satisfied that MMR had caused a brain inflammation called acute disseminated encephalomyelitis (ADEM).
In other cases, attorneys also did not claim that vaccines caused autism, but sought compensation for encephalopathy, encephalitis, or seizure disorders.
and other low-level disorders, and it was replaced by the three different vaccines. The problems were caused by the anti-mumps component. The MMR scare caused a low percentage of mumps vaccination (less than 30%), which keeps causing outbreaks in Japan. Measles causes deaths in Japan while there are none in UK, but it's apparently due to Japan applying the vaccine at a later age; a spokesman for the Ministry of Health said that the discontinuation had no effect in measles, although also saying that there were more deaths by measles while MMR was being used. Forced by the 1993 MMR scare, the government had to drop in 1994 the vaccination requirement for measles and rubella. Japan is nowadays the only developed country with large measles epidemics, and it has been called a "measles exporter" by the US Centers for Disease Control and Prevention. As another consequence of the scare, in 2003, 7 million schoolchildren had not been vaccinated against rubella.
Autism rates continued to rise in Japan after the discontinuation of the MMR vaccine, which discards any large scale effect of vaccination, and means that the withdrawal of MMR on other countries is unlikely to cause a reduction in autism cases. The Japanese Government doesn't think that there is any link between MMR and autism and by 2003 it was still trying to find a combined vaccine to replace MMR.
It was later discovered that some of the vaccines were administered after their expiry date, and that the MMR compulsory vaccination was only retracted after the death of three children and more than 2000 reports of adverse effects. By 1993 the Japanese Government had paid $160,000 in compensation to the families of each of the three dead children. Other parents received no compensation because the government said that it was unproven that the MMR vaccine had been the cause, and they decided to sue the manufacturer instead of suing the government. The Osaka district court in Japan ruled on March 13, 2003 that the death of two children (among numerous other serious conditions) had been indeed caused by Japan's strain of Urabe MMR. In 2006, the Osaka High Court stated in another ruling that the state was responsible for failing to properly supervise a manufacturer of the measles-mumps-rubella vaccine, which caused severe side effects in children.
, and no causal connection to the MMR vaccine has been demonstrated. The following were published after the 1998 Wakefield et al. paper:
After vaccination rates dropped, the incidence of two of the three diseases increased greatly in the UK. In 1998 there were 56 confirmed cases of measles in the UK; in 2006 there were 449 in the first five months of the year, with the first death since 1992; cases occurred in inadequately vaccinated children. Mumps cases began rising in 1999 after years of very few cases, and by 2005 the United Kingdom was in a mumps epidemic with almost 5000 notifications in the first month of 2005 alone. The age group affected was too old to have received the routine MMR immunisations around the time the paper by Wakefield et al. was published, and too young to have contracted natural mumps as a child, and thus to achieve a herd immunity
effect. With the decline in mumps that followed the introduction of the MMR vaccine, these individuals had not been exposed to the disease, but still had no immunity, either natural or vaccine induced. Therefore, as immunisation rates declined following the controversy and the disease re-emerged, they were susceptible to infection. Measles and mumps cases continued in 2006, at incidence rates 13 and 37 times greater than respective 1998 levels. Two children were severely and permanently injured by measles encephalitis
despite undergoing kidney transplantation
in London.
Disease outbreaks also caused casualties in nearby countries. Three deaths and 1,500 cases were reported in the Irish outbreak of 2000, which occurred as a direct result of decreased vaccination rates following the MMR scare.
In 2008, for the first time in 14 years, measles was declared endemic
in the UK, meaning that the disease was sustained within the population; this was caused by the preceding decade's low MMR vaccination rates, which created a population of susceptible children who could spread the disease. MMR vaccination rates for English children were unchanged in 2007–08 from the year before, at too low a level to prevent serious measles outbreaks. In May 2008, a British 17-year-old with an underlying immunodeficiency
died of measles. In 2008 Europe also faced a measles epidemic, including large outbreaks in Austria, Italy, and Switzerland.
Following the January 2011 BMJ revelations of fraud by Wakefield, Paul Offit
, a pediatrician at Children's Hospital of Philadelphia
and a "long-time critic of the dangers of the anti-vaccine movement", said, "that paper killed children",
and Michael Smith of the University of Louisville
, an "infectious diseases expert who has studied the autism controversy's effect on immunization rates", who said "clearly, the results of this (Wakefield) study have had repercussions."
paper said that antivaccionationist activities resulted in a high cost to society, "including damage to individual and community well-being from outbreaks of previously controlled diseases, withdrawal of vaccine manufacturers from the market, compromising of national security (in the case of anthrax and smallpox vaccines), and lost productivity".
Costs to society from declining vaccination rates (in US dollars) were estimated by AOL's Daily Finance in 2011:
To offset increased insurance expenses, pediatrician
Rahul Parikh relates how he and a colleague have suggested how anti-vaccine parents should help to defray those expenses:
He then related some of the human impact caused by the 2008 measles outbreak in San Diego, California mentioned above:
in the controversy, what is known as 'science by press conference
', alleging that the media provided Wakefield's study with more credibility than it deserved. A March 2007 paper in BMC Public Health by Shona Hilton, Mark Petticrew, and Kate Hunt postulated that media reports on Wakefield's study had "created the misleading impression that the evidence for the link with autism was as substantial as the evidence against". Earlier papers in Communication in Medicine and British Medical Journal
concluded that media reports provided a misleading picture of the level of support for Wakefield's theory.
A 2007 editorial in Australian Doctor complained that some journalists had continued to defend Wakefield's study even after Lancet had published the retraction by 10 of the study's 12 original authors, but noted that it was an investigative journalist, Brian Deer, who had played a leading role in exposing weaknesses in the study. PRWeek noted that after Wakefield was removed from the general medical register for misconduct in May 2010, 62% of respondents to a poll regarding the MMR controversy stated they did not feel that the media conducted responsible reporting on health issues.
A New England Journal of Medicine
article examining the history of antivaccinationists said that opposition to vaccines has existed since the 19th century, but "now the antivaccinationists' media of choice are typically television and the Internet, including its social media outlets, which are used to sway public opinion and distract attention from scientific evidence". The editorial characterized anti-vaccionationists as people who "tend toward complete mistrust of government and manufacturers, conspiratorial thinking, denialism, low cognitive complexity in thinking patterns, reasoning flaws, and a habit of substituting emotional anecdotes for data", including people who range from those "unable to understand and incorporate concepts of risk and probability into science-grounded decision making" and those "who use deliberate mistruths, intimidation, falsified data, and threats of violence".
In a January 2011 editorial in The American Spectator
, Robert M. Goldberg contended that evidence from the scientific community of issues with Wakefield's research " ... were undermined because the media allowed Wakefield and his followers to discredit the findings just by saying so".
Fiona Godlee
, editor of the BMJ said in January 2011:
Concerns have also been raised over the journal peer-review system, which largely relies on trust among researchers, and the role of journalists reporting on scientific theories that they "are hardly in a position to question and comprehend". Neil Cameron, a historian who specializes in the history of science, writing for The Montreal Gazette
labeled the controversy a "failure of journalism" that resulted in unnecessary deaths, saying that 1) The Lancet should not have published a study based on "statistically meaningless results" from only 12 cases; 2) the anti-vaccination crusade was continued by the satirical Private Eye magazine; and 3) a grapevine of worried parents and "nincompoop" celebrities fueled the widespread fears. The Gazette also reported that:
Scientific misconduct
Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in professional scientific research. A Lancet review on Handling of Scientific Misconduct in Scandinavian countries provides the following sample definitions: *Danish definition: "Intention or...
which triggered a health scare
Health scare
Health scare is a campaign to scare the public into avoiding a food or chemical on the grounds that it might cause them to contract an illness or have some other negative effect on their health...
. It followed the publication in 1998 of a paper in the medical journal The Lancet
The Lancet
The Lancet is a weekly peer-reviewed general medical journal. It is one of the world's best known, oldest, and most respected general medical journals...
which presented apparent evidence that autism spectrum disorders could be caused by the MMR vaccine
MMR vaccine
The MMR vaccine is an immunization shot against measles, mumps, and rubella . It was first developed by Maurice Hilleman while at Merck in the late 1960s....
, an immunization
Immunization
Immunization, or immunisation, is the process by which an individual's immune system becomes fortified against an agent ....
against measles
Measles
Measles, also known as rubeola or morbilli, is an infection of the respiratory system caused by a virus, specifically a paramyxovirus of the genus Morbillivirus. Morbilliviruses, like other paramyxoviruses, are enveloped, single-stranded, negative-sense RNA viruses...
, mumps
Mumps
Mumps is a viral disease of the human species, caused by the mumps virus. Before the development of vaccination and the introduction of a vaccine, it was a common childhood disease worldwide...
and rubella
Rubella
Rubella, commonly known as German measles, is a disease caused by the rubella virus. The name "rubella" is derived from the Latin, meaning little red. Rubella is also known as German measles because the disease was first described by German physicians in the mid-eighteenth century. This disease is...
.
Investigations by Sunday Times
The Sunday Times
The Sunday Times is a British Sunday newspaper.The Sunday Times may also refer to:*The Sunday Times *The Sunday Times *The Sunday Times *The Sunday Times...
journalist Brian Deer
Brian Deer
Brian Deer is a British investigative reporter, best known for inquiries into the drug industry, medicine and social issues for the Sunday Times of London.- Career :...
revealed that the lead author of the article, Andrew Wakefield
Andrew Wakefield
Andrew Wakefield is a British former surgeon and medical researcher, known as an advocate for the discredited claim that there is a link between the measles, mumps and rubella vaccine, autism and bowel disease, and for his fraudulent 1998 research paper in support of that claim.Four years after...
, had multiple undeclared conflicts of interest
Conflicts of Interest
"Conflicts of Interest" is an episode from the fourth season of the science fiction television series Babylon 5.-Arc significance:* Garibaldi begins to work for William Edgars. In the process Garibaldi is reintroduced to his ex-girlfriend, Lise, who is currently married to Edgars.* The "Voice of...
, had manipulated evidence, and had broken other ethical codes. The Lancet paper was partially retracted in 2004 and fully retracted in 2010, and Wakefield was found guilty by the General Medical Council
General Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...
of serious professional misconduct in May 2010 and was struck off the Medical Register, meaning he could no longer practice as a doctor. The research was declared fraudulent in 2011 by the BMJ
BMJ
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...
. The scientific consensus
Scientific consensus
Scientific consensus is the collective judgment, position, and opinion of the community of scientists in a particular field of study. Consensus implies general agreement, though not necessarily unanimity. Scientific consensus is not by itself a scientific argument, and it is not part of the...
is that no evidence
Scientific evidence
Scientific evidence has no universally accepted definition but generally refers to evidence which serves to either support or counter a scientific theory or hypothesis. Such evidence is generally expected to be empirical and properly documented in accordance with scientific method such as is...
links the vaccine to the development of autism, and that the vaccine's benefits greatly outweigh its risks.
Following the initial claims in 1998, multiple large epidemiological studies were undertaken. Reviews of the evidence by the Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
, the American Academy of Pediatrics
American Academy of Pediatrics
The American Academy of Pediatrics is the major professional association of pediatricians in the United States. The AAP was founded in 1930 by 35 pediatricians to address pediatric healthcare standards. It currently has 60,000 members in primary care and sub-specialist areas...
, the Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
of the US National Academy of Sciences
United States National Academy of Sciences
The National Academy of Sciences is a corporation in the United States whose members serve pro bono as "advisers to the nation on science, engineering, and medicine." As a national academy, new members of the organization are elected annually by current members, based on their distinguished and...
, the UK National Health Service
National Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...
, and the Cochrane Library
Cochrane Library
The Cochrane Library is a collection of databases in medicine and other healthcare specialties provided by the Cochrane Collaboration and other organisations. At its core is the collection of Cochrane Reviews, a database of systematic reviews and meta-analyses which summarize and interpret the...
all found no link between the vaccine and autism. While the Cochrane review expressed a need for improved design and reporting of safety outcomes in MMR vaccine studies, it concluded that the evidence of the safety and effectiveness of MMR in the prevention of diseases that still carry a heavy burden of morbidity and mortality
Mortality rate
Mortality rate is a measure of the number of deaths in a population, scaled to the size of that population, per unit time...
justifies its global use, and that the lack of confidence in the vaccine has damaged public health. A special court convened in the United States to review claims under the National Vaccine Injury Compensation Program rejected compensation claims from parents of autistic children.
The claims in Wakefield's 1998 The Lancet article were widely reported; vaccination rates in the UK and Ireland dropped sharply, which in turn led to greatly increased incidence of measles and mumps, resulting in deaths and severe and permanent injuries. Physicians, medical journals, and editors have made statements tying Wakefield's fraudulent actions to various epidemics and deaths.
Concerns about the Urabe strain
Before the autism-related controversy started in 1998, some concern had already arisen about the safety of the MMR vaccine due to side effects associated with the Urabe mumpsMumps
Mumps is a viral disease of the human species, caused by the mumps virus. Before the development of vaccination and the introduction of a vaccine, it was a common childhood disease worldwide...
strain including rare adverse events of aseptic meningitis
Aseptic meningitis
Aseptic meningitis, or sterile meningitis, is a condition in which the layers lining the brain, meninges, become inflamed and a pyogenic bacterial source is not to blame. Meningitis is diagnosed on a history of characteristic symptoms and certain examination findings...
, a transient mild form of viral meningitis. A late-1980s trial in Britain of a form of the MMR vaccine containing the Urabe mumps strain produced three cases of probably associated febrile convulsions per 1,000 vaccinations. Concerns about adverse reactions to the vaccine were raised by American and Canadian authorities based on reports from Japan linking Urabe MMR with meningoencephalitis
Meningoencephalitis
Meningoencephalitis is a medical condition that simultaneously resembles both meningitis, which is an infection or inflammation of the meninges, and encephalitis, which is an infection or inflammation of the brain.-Causes:...
. In early 1988, Canadian authorities suspended distribution of the Urabe-based MMR and eventually recalled the product.
The UK National Health Service
National Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...
introduced an MMR vaccine using the Urabe mumps strain in 1988, replacing it entirely with the Jeryl Lynn strain in September 1992 following the identification of an unacceptable risk of aseptic meningitis
Aseptic meningitis
Aseptic meningitis, or sterile meningitis, is a condition in which the layers lining the brain, meninges, become inflamed and a pyogenic bacterial source is not to blame. Meningitis is diagnosed on a history of characteristic symptoms and certain examination findings...
15–35 days after vaccination. Decisions taken by British authorities at this time were to be criticized later following documents delivered by FOIA. With no such risk seen in vaccines using the Jeryl Lynn
Jeryl Lynn
Jeryl Lynn are strains of mumps virus used in the Mumpsvax mumps vaccine made by Merck. The strains are named after Jeryl Lynn Hilleman. In 1963 Ms. Hilleman's father Dr. Maurice Hilleman, was leading efforts to produce a mumps vaccine for Merck...
mumps strain, the UK NHS withdrew two of the three MMR vaccine then available (Immravax, made by Merieux UK, and Pluserix, made by SmithKline Beecham
GlaxoSmithKline
GlaxoSmithKline plc is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom...
) in favor of Merck Sharp and Dohme's MMR II brand, based on the Jeryl Lynn strain. Although MMR administration did continue with MMR II, the MMR vaccination rate first began to fall after 1996, following claims by Wakefield that it was linked to the inflammatory bowel disease
Inflammatory bowel disease
In medicine, inflammatory bowel disease is a group of inflammatory conditions of the colon and small intestine. The major types of IBD are Crohn's disease and ulcerative colitis.-Classification:...
, Crohn's disease
Crohn's disease
Crohn's disease, also known as regional enteritis, is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus, causing a wide variety of symptoms...
.
The Urabe strain remains in use in a number of countries; MMR with the Urabe strain is much cheaper to manufacture than with the Jeryl Lynn
Jeryl Lynn
Jeryl Lynn are strains of mumps virus used in the Mumpsvax mumps vaccine made by Merck. The strains are named after Jeryl Lynn Hilleman. In 1963 Ms. Hilleman's father Dr. Maurice Hilleman, was leading efforts to produce a mumps vaccine for Merck...
strain, and a strain with higher efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
along with a somewhat higher rate of mild side effects may still have the advantage of reduced incidence of overall adverse events.
Revaccination campaign
In the wake of measles outbreaks which occurred in England in 1992, and on the basis of analyses of seroepidemiological data combined with mathematical modeling, British Health authorities predicted a major resurgence of measles in school age children. Two strategies were then examined: either to target vaccination at all children without a history of prior measles vaccination or to immunize all children irrespective of vaccination history. In November 1994, the latter option was chosen and a national measles and rubella vaccination campaign, described as "one of the most ambitious vaccination initiatives that Britain has undertaken" was commenced: within one month, 92% of the 7.1 million schoolchildren in England aged 5–16 years received measles and rubella (MR) vaccine.MMR litigation starts
In April 1994, Richard Barr, a solicitor, succeeded in winning legal aid for the pursuit of a class action against the manufacturers of MMR under the Consumer Protection Act 1987Consumer Protection Act 1987
The Consumer Protection Act 1987 is an Act of the Parliament of the United Kingdom that made important changes to the consumer law of the United Kingdom. Part 1 implemented European Community Directive 85/374/EEC, the product liability directive, by introducing a regime of strict liability for...
. The class action case was aimed at Aventis Pasteur, SmithKlineBeecham, and Merck
Merck & Co.
Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The Merck headquarters is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township...
, manufacturers respectively of Immravax, Pluserix-MMR and MMR II. This suit, based on a claim that MMR is a defective product and should not have been used, was the first big class action lawsuit funded by the Legal Aid Board (now the Legal Services Commission
Legal Services Commission
The Legal Services Commission is an executive non-departmental public body of the Ministry of Justice that is responsible for the operational administration of legal aid in England and Wales.-Overview:...
) after its formation in 1988. Noticing two publications from Andrew Wakefield that explored the role of measles virus in Crohn's disease
Crohn's disease
Crohn's disease, also known as regional enteritis, is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus, causing a wide variety of symptoms...
and inflammatory bowel disease
Inflammatory bowel disease
In medicine, inflammatory bowel disease is a group of inflammatory conditions of the colon and small intestine. The major types of IBD are Crohn's disease and ulcerative colitis.-Classification:...
, Barr contacted Wakefield for his expertise. According to Wakefield supporters, the two men first met on 6 January 1996. The Legal Services Commission halted proceedings in September 2003, citing a high probability of failure based on the medical evidence, bringing an end to the first case of research funding by the LSC.
1998 Lancet paper
In February 1998, a group led by Andrew WakefieldAndrew Wakefield
Andrew Wakefield is a British former surgeon and medical researcher, known as an advocate for the discredited claim that there is a link between the measles, mumps and rubella vaccine, autism and bowel disease, and for his fraudulent 1998 research paper in support of that claim.Four years after...
published a controversial paper in the respected British medical journal The Lancet
The Lancet
The Lancet is a weekly peer-reviewed general medical journal. It is one of the world's best known, oldest, and most respected general medical journals...
, supported by a press conference at the Royal Free Hospital
Royal Free Hospital
The Royal Free Hospital is a major teaching hospital in Hampstead, London, England and part of the Royal Free Hampstead NHS Trust....
in London. This paper reported on twelve children with developmental disorders referred to the Royal Free Hospital. The parents or physicians of eight of these children were said to have linked the start of behavioral symptoms to MMR vaccination. The paper described a collection of bowel symptoms, endoscopy
Endoscopy
Endoscopy means looking inside and typically refers to looking inside the body for medical reasons using an endoscope , an instrument used to examine the interior of a hollow organ or cavity of the body. Unlike most other medical imaging devices, endoscopes are inserted directly into the organ...
findings and biopsy
Biopsy
A biopsy is a medical test involving sampling of cells or tissues for examination. It is the medical removal of tissue from a living subject to determine the presence or extent of a disease. The tissue is generally examined under a microscope by a pathologist, and can also be analyzed chemically...
findings that were said to be evidence of a possible novel syndrome that Wakefield would later call autistic enterocolitis
Autistic enterocolitis
"Autistic enterocolitis" is a controversial term first used by discredited British gastroenterologist Andrew Wakefield to describe a number of common clinical symptoms and signs which he contends are distinctive to autism...
, and recommended further study into the possible link between the condition and the MMR vaccine. The paper suggested that the connection between autism and the gastrointestinal pathologies was real, but said it did not prove an association between the MMR vaccine and autism.
At the press conference before the paper's publication, later criticized as 'science by press conference
Science by press conference
The term science by press conference is a phrase referring to scientists who put an unusual focus on publicizing results of research in the media. The term is usually used disparagingly...
', Wakefield said that he thought it prudent to use single vaccines instead of the MMR triple vaccine until this could be ruled out as an environmental trigger; parents of eight of the twelve children studied were said to have blamed the MMR vaccine, saying that symptoms of autism had set in within days of vaccination at approximately 14 months. Wakefield said, "I can't support the continued use of these three vaccines given in combination until this issue has been resolved." In a video news release issued by the hospital to broadcasters in advance of the press conference, he called for MMR to be "suspended in favour of the single vaccines." In a BBC interview Wakefield's mentor Roy Pounder
Roy Pounder
Roy Pounder was Professor of Medicine at the Royal Free and University College Medical School in London and clinical Vice President of the Royal College of Physicians of London...
, who was not a coauthor, "admitted the study was controversial". He added: "In hindsight it may be a better solution to give the vaccinations separately,... When the vaccinations were given individually there was no problem." These suggestions were not supported by Wakefield's coauthors nor by any scientific evidence.
The limited initial press coverage of the story was reasonable for a small and not very significant study. The Guardian and the Independent reported it on their front pages, while the Daily Mail only gave the story a minor mention in the middle of the paper, and the Sun didn't cover it.
Wakefield Lancet paper controversy
The controversy began to gain momentum in 2001 and 2002, after Wakefield published papers which suggested that the immunisation programme was not safe. These were a review paper with no new evidence, published in a minor journal, and two papers on laboratory work which he claimed showed that measles virus had been found in tissue samples taken from children who had autism and bowel problems. There was wide media coverage including distressing anecdotal evidence from parents, and political coverage attacking the health service and government peaked with unmet demands that Prime ministerPrime minister
A prime minister is the most senior minister of cabinet in the executive branch of government in a parliamentary system. In many systems, the prime minister selects and may dismiss other members of the cabinet, and allocates posts to members within the government. In most systems, the prime...
Tony Blair
Tony Blair
Anthony Charles Lynton Blair is a former British Labour Party politician who served as the Prime Minister of the United Kingdom from 2 May 1997 to 27 June 2007. He was the Member of Parliament for Sedgefield from 1983 to 2007 and Leader of the Labour Party from 1994 to 2007...
reveal whether his infant son Leo had been given the vaccine. It was the biggest science story of 2002, with 1257 articles mostly written by non-expert commentators. In the period January to September 2002, 32% of the stories written about MMR mentioned Leo Blair, as opposed to only 25% which mentioned Wakefield. Less than a third of the stories mentioned the overwhelming evidence that MMR is safe. The paper, press conference and video sparked a major health
Health
Health is the level of functional or metabolic efficiency of a living being. In humans, it is the general condition of a person's mind, body and spirit, usually meaning to be free from illness, injury or pain...
scare in the United Kingdom. As a result of the scare, full confidence in MMR fell from 59% to 41% after publication of the Wakefield research. In 2001, 26% of family doctors felt the government had failed to prove there was no link between MMR and autism and bowel disease. In his book Bad Science
Bad Science (book)
Bad Science is a book by Ben Goldacre, criticising mainstream media reporting on health and science issues. Published by Fourth Estate in September 2008, the book contains extended and revised versions of many of his Guardian columns...
, Ben Goldacre
Ben Goldacre
Ben Michael Goldacre born 1974 is a British science writer, doctor and psychiatrist. He is the author of The Guardian newspaper's weekly Bad Science column and a book of the same title, published by Fourth Estate in September 2008....
describes the MMR vaccine scare as one of the "three all-time classic bogus science stories" by the British newspapers (the other two are the Arpad Pusztai affair
Pusztai affair
The Pusztai affair is a controversy that began in 1998 after protein scientist Arpad Pusztai went public with research he was conducting with genetically modified potatoes. In a short interview he reported that rats fed potatoes engineered to express a plant lectin had stunted growth and a...
about genetically modified crops, and Chris Malyszewicz and the MRSA hoax).
Confidence in the MMR vaccine increased as it became clearer that Wakefield's claims were unsupported by scientific evidence. A 2003 survey of 366 family doctors in the UK reported that 77% of them would advise giving the MMR vaccine to a child with a close family history of autism, and that 3% of them thought that autism could sometimes be caused by the MMR vaccine. A similar survey in 2004 found that these percentages changed to 82% and at most 2%, respectively, and that confidence in MMR had been increasing over the previous two years.
A factor in the controversy is that only the combined vaccine is available through the UK National Health Service. The importation license for the single measles vaccine was withdrawn in 1988, and as of 2010 there are no single vaccines for measles, mumps and rubella licensed for use in the UK. Prime minister Tony Blair gave support to the programme, and said that "the vaccine was safe enough for his young son, Leo", but refused on privacy grounds to state whether Leo had received the vaccine; in contrast, the subsequent Prime Minister, Gordon Brown
Gordon Brown
James Gordon Brown is a British Labour Party politician who was the Prime Minister of the United Kingdom and Leader of the Labour Party from 2007 until 2010. He previously served as Chancellor of the Exchequer in the Labour Government from 1997 to 2007...
, explicitly confirmed that his son has been immunised. The privacy concerns of the Blairs were later undermined when Cherie Blair
Cherie Blair
Cherie Blair , known professionally as Cherie Booth QC, is a British barrister working in the legal system of England and Wales. She is married to the former Prime Minister of the United Kingdom, Tony Blair; the couple have three sons and one daughter...
mentioned Leo's vaccination history when promoting her autobiography.
Administration of the combined vaccine instead of separate vaccines decreases the risk of children catching the disease while waiting for full immunisation coverage. The combined vaccine's two injections results in less pain and distress to the child than the six injections required by separate vaccines, and the extra clinic visits required by separate vaccinations increases the likelihood of some being delayed or missed altogether; vaccination uptake significantly increased in the UK when MMR was introduced in 1988. Health professionals have heavily criticized media coverage of the controversy for triggering a decline in vaccination rates. There is no scientific basis for preferring separate vaccines, or for using any particular interval between separate vaccines.
John Walker-Smith, a coauthor of Wakefield's report and a supporter of the MMR vaccine, wrote in 2002 that epidemiology has shown that MMR is safe in most children, but observed that epidemiology is a blunt tool and studies can miss at-risk groups that have a real link between MMR and autism. However, if a rare subtype of autism were reliably identified by clinical or pathological characteristics, epidemiological research could address the question whether MMR causes that autism subtype. There is no scientific evidence that MMR causes damage to the infant immune system, and there is much evidence to the contrary.
In 2001, Berelowitz, one of the co-authors of the paper, said "I am certainly not aware of any convincing evidence for the hypothesis of a link between MMR and autism". The Canadian Paediatric Society
Canadian Paediatric Society
The Canadian Paediatric Society is a national association of paediatricians, committed to working together to advance the health of children and youth by nurturing excellence in health care, advocacy, education, research and support of its membership....
, the Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
, the Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
of the National Academy of Sciences
United States National Academy of Sciences
The National Academy of Sciences is a corporation in the United States whose members serve pro bono as "advisers to the nation on science, engineering, and medicine." As a national academy, new members of the organization are elected annually by current members, based on their distinguished and...
, and the UK National Health Service
National Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...
have all concluded that there is no evidence of a link between the MMR vaccine and autism.
Conflict of interest allegations
In February 2004, after a four-month investigation, investigative reporter Brian DeerBrian Deer
Brian Deer is a British investigative reporter, best known for inquiries into the drug industry, medicine and social issues for the Sunday Times of London.- Career :...
wrote in The Sunday Times
The Sunday Times (UK)
The Sunday Times is a Sunday broadsheet newspaper, distributed in the United Kingdom. The Sunday Times is published by Times Newspapers Ltd, a subsidiary of News International, which is in turn owned by News Corporation. Times Newspapers also owns The Times, but the two papers were founded...
of London that Wakefield had received £
Pound sterling
The pound sterling , commonly called the pound, is the official currency of the United Kingdom, its Crown Dependencies and the British Overseas Territories of South Georgia and the South Sandwich Islands, British Antarctic Territory and Tristan da Cunha. It is subdivided into 100 pence...
55,000 funding from Legal Aid Board
Legal Services Commission
The Legal Services Commission is an executive non-departmental public body of the Ministry of Justice that is responsible for the operational administration of legal aid in England and Wales.-Overview:...
solicitors seeking evidence to use against vaccine manufacturers, that several of the parents quoted as saying that MMR had damaged their children were also litigants, and that Wakefield did not inform colleagues or medical authorities of the conflict of interest. When the editors of The Lancet learned about this, they said that based on Deer's evidence, Wakefield's paper should have never been published because its findings were "entirely flawed." Although Wakefield maintained that the legal aid funding was for a separate, unpublished study (a position later rejected by a panel of the UK General Medical Council
General Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...
), the editors of The Lancet judged that the funding source should have been disclosed to them. Richard Horton, the editor-in-chief, wrote, "It seems obvious now that had we appreciated the full context in which the work reported in the 1998 Lancet paper by Wakefield and colleagues was done, publication would not have taken place in the way that it did." Several of Dr. Wakefield's co-researchers also strongly criticized the lack of disclosure.
Deer continued his reporting in a BBC
BBC
The British Broadcasting Corporation is a British public service broadcaster. Its headquarters is at Broadcasting House in the City of Westminster, London. It is the largest broadcaster in the world, with about 23,000 staff...
Dispatches
Dispatches (TV series)
Dispatches is the British television current affairs documentary series on Channel 4, first transmitted in 1987. The programme covers issues about British society, politics, health, religion, international current affairs and the environment, usually featuring a mole in an organisation.-Awards:*...
television documentary, MMR: What They Didn't Tell You, broadcast on November 18, 2004. This documentary alleged that Wakefield had applied for patents on a vaccine that was a rival of the MMR vaccine, and that he knew of test results from his own laboratory at the Royal Free Hospital
Royal Free Hospital
The Royal Free Hospital is a major teaching hospital in Hampstead, London, England and part of the Royal Free Hampstead NHS Trust....
that contradicted his claims. Wakefield's patent application was also noted in the 2008 book Autism's False Prophets
Autism's False Prophets
Autism's False Prophets: Bad Science, Risky Medicine, and the Search for a Cure is a 2008 book by Paul Offit, a vaccine expert and chief of infectious diseases at Children's Hospital of Philadelphia...
by Paul Offit
Paul Offit
Paul A. Offit, M.D., is an American pediatrician specializing in infectious diseases and an expert on vaccines, immunology, and virology. He is the co-inventor of a rotavirus vaccine that has been credited with saving hundreds of lives every day. Offit is the Maurice R...
.
In January 2005, Wakefield sued Channel 4, 20/20 Productions, and the investigative reporter Brian Deer, who presented the Dispatches programme. However, after two years of litigation, and the revelation of more than £400,000 in undisclosed payments by lawyers to Wakefield, he discontinued his action and paid all the defendants' costs.
In 2006, Deer reported in The Sunday Times that Wakefield had been paid £435,643, plus expenses, by British trial lawyers attempting to prove that the vaccine was dangerous, with the undisclosed payments beginning two years before the Lancet paper's publication. This funding came from the UK legal aid fund, a fund intended to provide legal services to the poor.
Retraction of an interpretation
The Lancet and many other medical journals require papers to include the authors' conclusions about their research, known as the "interpretation". The summary of the 1998 Lancet paper ended as follows:
Interpretation We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.
In March 2004, immediately following the news of the conflict of interest allegations, ten of Wakefield's 12 coauthors retracted this interpretation, while insisting that the possibility of a distinctive gastrointestinal condition in children with autism merited further investigation. However, a separate study of children with gastrointestinal disturbances found no difference between those with ASD
Autism spectrum
The term "autism spectrum" is often used to describe disorders that are currently classified as pervasive developmental disorders. Pervasive developmental disorders include autism, Asperger syndrome, Childhood disintegrative disorder, Rett syndrome and Pervasive Developmental Disorder Not Otherwise...
and those without, with respect to the presence of measles virus RNA
RNA
Ribonucleic acid , or RNA, is one of the three major macromolecules that are essential for all known forms of life....
in the bowel; it also found that gastrointestinal symptoms and the onset of autism were unrelated in time to the administration of MMR vaccine.
Manipulation of data
On 8 February 2009, Brian Deer reported in The Sunday TimesThe Sunday Times
The Sunday Times is a British Sunday newspaper.The Sunday Times may also refer to:*The Sunday Times *The Sunday Times *The Sunday Times *The Sunday Times...
that Wakefield had "fixed" results and "manipulated" patient data in his 1998 paper, creating the appearance of a link with autism. Wakefield denied these allegations, and even filed a complaint with the Press Complaints Commission
Press Complaints Commission
The Press Complaints Commission is a voluntary regulatory body for British printed newspapers and magazines, consisting of representatives of the major publishers. The PCC is funded by the annual levy it charges newspapers and magazines...
(PCC) over this article on 13 March 2009. The complaint was expanded by a 20 March 2009 addendum by Wakefield's publicist. In July 2009, the PCC stated that it was staying any investigation regarding the Times article, pending the conclusion of the GMC investigation. In the event, Wakefield did not pursue his complaint, which Deer published with a statement that he and The Sunday Times rejected it as "false and disingenuous in all material respects", and that the action had been suspended by the PCC in February 2010.
General Medical Council investigation
The General Medical CouncilGeneral Medical Council
The General Medical Council registers and regulates doctors practising in the United Kingdom. It has the power to revoke or restrict a doctor's registration if it deems them unfit to practise...
(GMC), which is responsible for licensing doctors and supervising medical ethics in the UK, investigated the affair. The GMC brought the case itself, not citing any specific complaints, claiming that an investigation was in the public interest. The then-secretary of state for health, John Reid MP, called for a GMC investigation, an investigation Wakefield seems himself to have wished. During a debate in the House of Commons, on 15 Mar 2004, Dr. Evan Harris, a Liberal Democrat MP, called for a judicial inquiry into the ethical aspects of the case, even suggesting it might be conducted by the CPS
Crown Prosecution Service
The Crown Prosecution Service, or CPS, is a non-ministerial department of the Government of the United Kingdom responsible for public prosecutions of people charged with criminal offences in England and Wales. Its role is similar to that of the longer-established Crown Office in Scotland, and the...
. In June 2006 the GMC confirmed that they would hold a disciplinary hearing of Wakefield.
The GMC's Fitness to Practice Panel first met on 16 July 2007 to consider the cases of Dr. Wakefield, Professor John Angus Walker-Smith, and Professor Simon Harry Murch. All faced charges of serious professional misconduct. The GMC examined, among other ethical points, whether Wakefield and his colleagues obtained the required approvals for the tests they performed on the children; the data-manipulation charges reported in the Times, which surfaced after the case was prepared, were not at question in the hearings. The GMC stressed that it would not be assessing the validity of competing scientific theories on MMR and autism. The General Medical Council alleged that the trio acted unethically and dishonestly in preparing the research into the MMR vaccine. They denied the allegations. The case proceeded in front of a GMC fitness to practice panel of three medical and two lay members.
On 28 January 2010, the GMC panel gave its verdict on the facts of the case: Wakefield was found to have acted "dishonestly and irresponsibly" and to have acted with "callous disregard" for the children involved in his study, conducting unnecessary and invasive tests. The panel found that the trial was improperly conducted without the approval of an independent ethics committee
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
, and that Wakefield had multiple undeclared conflicts of interest
Conflict of interest
A conflict of interest occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other....
.
Full retraction and fraud allegations
In response to the GMC investigation and findings, the editors of The Lancet announced on 2 February 2010 that they "fully retract this paper from the published record."The Hansard
Hansard
Hansard is the name of the printed transcripts of parliamentary debates in the Westminster system of government. It is named after Thomas Curson Hansard, an early printer and publisher of these transcripts.-Origins:...
text for 16 March 2010 reported Lord McColl
Ian McColl, Baron McColl of Dulwich
Ian McColl, Baron McColl of Dulwich, CBE is a British surgeon, professor, politician and Conservative member of the House of Lords. McColl was made a Life Peer for his work for disabled people in the Queen's Birthday Honours in 1989. He was Parliamentary Private Secretary to Prime Minister John...
asking the Government whether it had plans to recover legal aid money paid to the experts in connection with the measles, mumps and rubella/measles and rubella vaccine litigation. Lord Bach, Ministry of Justice dismissed this possibility.
In an April 2010 report in the BMJ
BMJ
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...
, Deer expanded on laboratory aspects of his findings recounting how normal clinical histopathology
Histopathology
Histopathology refers to the microscopic examination of tissue in order to study the manifestations of disease...
results generated by the Royal Free Hospital
Royal Free Hospital
The Royal Free Hospital is a major teaching hospital in Hampstead, London, England and part of the Royal Free Hampstead NHS Trust....
were later changed in the medical school to abnormal results, published in The Lancet. Wakefield responded to these accusations in a press release. Deer wrote an article in the BMJ casting doubt on the "autistic enterocolitis" which Wakefield claimed to have discovered. In the same edition, Deirdre Kelly, President of the European Society of Pediatric Gastroenterology and Nutrition and the Editor of the Journal of Pediatric Gastroenterology and Nutrition expressed some concern about the BMJ publishing this article while the GMC proceedings were underway.
On 24 May 2010, the GMC panel announced the sentences in the case: Wakefield was found guilty of serious professional misconduct on four counts of dishonesty and 12 involving the abuse of developmentally challenged children, and was ordered to be struck off the medical register. John Walker-Smith was also found guilty of serious professional misconduct and struck off the medical register. Simon Murch was found not guilty, despite having previously been found to not have ethical approvals for the study.
On 5 January 2011, the BMJ published the first of a series of articles by Brian Deer, detailing how Wakefield and his colleagues had faked some of the data behind the 1998 Lancet article. By looking at the records and interviewing the parents, Deer found that for all 12 children in the Wakefield study, diagnoses had been tweaked or dates changed to fit the article's conclusion. Continuing the BMJ series on 11 January 2011, Deer said that based upon documents he obtained under Freedom of information legislation
Freedom of information legislation
Freedom of information legislation comprises laws that guarantee access to data held by the state. They establish a "right-to-know" legal process by which requests may be made for government-held information, to be received freely or at minimal cost, barring standard exceptions...
, Wakefield—in partnership with the father of one of the boys in the study—had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing". The Washington Post reported that Deer said that Wakefield predicted he "could make more than $43 million a year from diagnostic kits" for the new condition, autistic enterocolitis
Autistic enterocolitis
"Autistic enterocolitis" is a controversial term first used by discredited British gastroenterologist Andrew Wakefield to describe a number of common clinical symptoms and signs which he contends are distinctive to autism...
. WebMD
WebMD
WebMD is an American corporation which provides health information services. It was founded in 1996 by Jim Clark and Pavan Nigam as Healthscape, later Healtheon, and then acquired WebMD in 1999 to form Healtheon/WebMD...
reported on Deer's BMJ report, saying that the $43 million predicted yearly profits would come from marketing kits for "diagnosing patients with autism" and that "the initial market for the diagnostic will be litigation-driven testing of patients with AE [autistic enterocolitis, an unproven condition concocted by Wakefield] from both the UK and the USA". According to WebMD, the BMJ article also claimed that the venture would succeed in marketing products and developing a replacement vaccine if "public confidence in the MMR vaccine was damaged".
Litigation
Litigations are parts of the controversy in different ways. During the 1980s and 1990s, a number of lawsuits were brought in the United StatesUnited States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
against manufacturers of vaccines, alleging the vaccines had caused a variety of physical and mental disorders
Mental illness
A mental disorder or mental illness is a psychological or behavioral pattern generally associated with subjective distress or disability that occurs in an individual, and which is not a part of normal development or culture. Such a disorder may consist of a combination of affective, behavioural,...
in children. While these lawsuits were unsuccessful they did lead to a large jump in the costs of the MMR vaccine, and pharmaceutical companies sought legislative protections. In 1993, Merck KGaA
Merck KGaA
Merck KGaA is a German chemical and pharmaceutical company. Merck, also known as “German Merck” and “Merck Darmstadt”, was founded in Darmstadt, Germany, in 1668, making it the world's oldest operating chemical and pharmaceutical company. The company was privately owned until going public in 1995...
became the only company willing to sell MMR vaccines in the United States and the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
.
In the UK
Commenced before the Civil Procedure Rules were promulgated, The MMR Litigation had its status as group litigation achieved by the then Lord Chief Justice’s practice direction of 8 July 1999. On 8 June 2007, the High Court judge, Justice Keith, put an end to the group litigation because the withdrawal of legal aid by the legal services commission had made the pursuit of most of the claimants impossible. He ruled that all but two claims against various pharmaceutical companies must be discontinued. The judge stressed that his ruling did not amount to a rejection of any of the claims that MMR had seriously damaged the children concerned.A pressure group called JABS (Justice, Awareness, Basic Support) was established to represent families with children who, their parents said, were "vaccine-damaged". £15 million in public legal aid funding was spent on the litigation, of which £9.7 million went to solicitor
Solicitor
Solicitors are lawyers who traditionally deal with any legal matter including conducting proceedings in courts. In the United Kingdom, a few Australian states and the Republic of Ireland, the legal profession is split between solicitors and barristers , and a lawyer will usually only hold one title...
s and barrister
Barrister
A barrister is a member of one of the two classes of lawyer found in many common law jurisdictions with split legal professions. Barristers specialise in courtroom advocacy, drafting legal pleadings and giving expert legal opinions...
s, and £4.3 million to expert witnesses.
Several British cases where parents claimed that their children had died as a result of Urabe MMR had received compensation under the “vaccine damage payment” scheme.
In the US
The Omnibus Autism Proceeding (OAP) is a coordinated proceeding before the Office of Special Masters of the U.S Court of Federal Claims—commonly called the vaccine courtVaccine court
Vaccine court is the popular term which refers to the Office of Special Masters of the U.S. Court of Federal Claims, which administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but...
. It is structured to facilitate the handling of nearly 5000 vaccine petitions involving claims that children who have received certain vaccinations have developed autism. The Petitioners' Steering Committee have claimed that MMR vaccines can cause autism, possibly in combination with thiomersal-containing vaccines
Thiomersal controversy
The thiomersal controversy describes claims that vaccines containing the mercury-based preservative thiomersal contribute to the development of autism and other brain development disorders...
. In 2007 three individual test cases were presented to test the claims about the combination; these test cases failed. The vaccine court ruled against the plaintiffs in all three cases, stating that the evidence presented did not validate their claims that vaccinations caused autism in these specific patients, or in general.
In some cases, the plaintiffs' attorneys opted out of the Omnibus Autism Proceedings, which were concerned solely with autism, and also issues concerned with bowel disorders, and argue their cases in the regular vaccine court:
On 30 July 2007, the family of Bailey Banks, a child with pervasive developmental delay, won their case versus the Department of Health and Human Services. Special Master Richard Abell ruled that the Banks had successfully demonstrated that "the MMR vaccine at issue actually caused the conditions from which Bailey suffered and continues to suffer." In his conclusion, he ruled that he was satisfied that MMR had caused a brain inflammation called acute disseminated encephalomyelitis (ADEM).
In other cases, attorneys also did not claim that vaccines caused autism, but sought compensation for encephalopathy, encephalitis, or seizure disorders.
Japan
The Urabe strain, which was different from the strain used in UK, was introduced in 1989 and discontinued in 1993 due to causing a high incidence of aseptic meningitisAseptic meningitis
Aseptic meningitis, or sterile meningitis, is a condition in which the layers lining the brain, meninges, become inflamed and a pyogenic bacterial source is not to blame. Meningitis is diagnosed on a history of characteristic symptoms and certain examination findings...
and other low-level disorders, and it was replaced by the three different vaccines. The problems were caused by the anti-mumps component. The MMR scare caused a low percentage of mumps vaccination (less than 30%), which keeps causing outbreaks in Japan. Measles causes deaths in Japan while there are none in UK, but it's apparently due to Japan applying the vaccine at a later age; a spokesman for the Ministry of Health said that the discontinuation had no effect in measles, although also saying that there were more deaths by measles while MMR was being used. Forced by the 1993 MMR scare, the government had to drop in 1994 the vaccination requirement for measles and rubella. Japan is nowadays the only developed country with large measles epidemics, and it has been called a "measles exporter" by the US Centers for Disease Control and Prevention. As another consequence of the scare, in 2003, 7 million schoolchildren had not been vaccinated against rubella.
Autism rates continued to rise in Japan after the discontinuation of the MMR vaccine, which discards any large scale effect of vaccination, and means that the withdrawal of MMR on other countries is unlikely to cause a reduction in autism cases. The Japanese Government doesn't think that there is any link between MMR and autism and by 2003 it was still trying to find a combined vaccine to replace MMR.
It was later discovered that some of the vaccines were administered after their expiry date, and that the MMR compulsory vaccination was only retracted after the death of three children and more than 2000 reports of adverse effects. By 1993 the Japanese Government had paid $160,000 in compensation to the families of each of the three dead children. Other parents received no compensation because the government said that it was unproven that the MMR vaccine had been the cause, and they decided to sue the manufacturer instead of suing the government. The Osaka district court in Japan ruled on March 13, 2003 that the death of two children (among numerous other serious conditions) had been indeed caused by Japan's strain of Urabe MMR. In 2006, the Osaka High Court stated in another ruling that the state was responsible for failing to properly supervise a manufacturer of the measles-mumps-rubella vaccine, which caused severe side effects in children.
Research
The number of reported cases of autism increased dramatically in the 1990s and early 2000s. This increase is largely attributable to changes in diagnostic practices; it is not known how much, if any, growth came from real changes in autism's prevalencePrevalence
In epidemiology, the prevalence of a health-related state in a statistical population is defined as the total number of cases of the risk factor in the population at a given time, or the total number of cases in the population, divided by the number of individuals in the population...
, and no causal connection to the MMR vaccine has been demonstrated. The following were published after the 1998 Wakefield et al. paper:
- In October 2004, a meta review, financed by the European UnionEuropean UnionThe European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
, was published in the October 2004 edition of Vaccine that assessed the evidence given in 120 other studies and considered unintended effects of the MMR vaccine. The authors concluded that although the vaccine is associated with positive and negative side effects, a connection between MMR and autism was "unlikely".
- In February 2005, a study compared autism in Japan before and after the 1993 withdrawal of the MMR vaccine: the autism rates continued to increase, which means that the withdrawal of MMR on other countries is unlikely to cause a reduction in future autism cases.
- In October 2005, the Cochrane LibraryCochrane LibraryThe Cochrane Library is a collection of databases in medicine and other healthcare specialties provided by the Cochrane Collaboration and other organisations. At its core is the collection of Cochrane Reviews, a database of systematic reviews and meta-analyses which summarize and interpret the...
published a review of 31 scientific studies, which found no credible evidence of an involvement of MMR with either autism or Crohn's diseaseCrohn's diseaseCrohn's disease, also known as regional enteritis, is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus, causing a wide variety of symptoms...
. The review also stated "Measles, mumps and rubella are three very dangerous infectious diseases which cause a heavy disease, disability and death burden in the developing world ... [T]he impact of mass immunisation on the elimination of the diseases has been demonstrated worldwide." However the authors of the report also stated that "the design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate."
- A 2007 case study used the figure in Wakefield's 1999 letter to The Lancet alleging a temporal association between MMR vaccination and autism to illustrate how a graph can misrepresent its data, and gave advice to authors and publishers to avoid similar misrepresentations in the future.
- A 2007 review of independent studies performed after the publication of Wakefield et al.'s original report found that these studies provide compelling evidence against the hypothesis that MMR is associated with autism.
- A review of the work conducted in 2004 for UK court proceedings but not revealed until 2007 found that the polymerase chain reactionPolymerase chain reactionThe polymerase chain reaction is a scientific technique in molecular biology to amplify a single or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence....
analysis essential to the Wakefield et al. results was fatally flawed due to contamination, and that it could not have possibly detected the measles that it was supposed to have detected.
- A 2009 review of studies on links between vaccines and autism discusses the MMR vaccine controversyVaccine controversyA vaccine controversy is a dispute over the morality, ethics, effectiveness, or safety of vaccinations. Medical and scientific evidence surrounding vaccinations generally demonstrate that the benefits of preventing suffering and death from infectious diseases outweigh rare adverse effects of...
as one of three main hypotheses which epidemiological and biological studies fail to support.
Disease outbreaks
After the controversy began, the MMR vaccination compliance dropped sharply in the United Kingdom, from 92% in 1996 to 84% in 2002. In some parts of London, it was as low as 61% in 2003, far below the rate needed to avoid an epidemic of measles. By 2006 coverage for MMR in the UK at 24 months was 85%, lower than the about 94% coverage for other vaccines.After vaccination rates dropped, the incidence of two of the three diseases increased greatly in the UK. In 1998 there were 56 confirmed cases of measles in the UK; in 2006 there were 449 in the first five months of the year, with the first death since 1992; cases occurred in inadequately vaccinated children. Mumps cases began rising in 1999 after years of very few cases, and by 2005 the United Kingdom was in a mumps epidemic with almost 5000 notifications in the first month of 2005 alone. The age group affected was too old to have received the routine MMR immunisations around the time the paper by Wakefield et al. was published, and too young to have contracted natural mumps as a child, and thus to achieve a herd immunity
Herd immunity
Herd immunity describes a form of immunity that occurs when the vaccination of a significant portion of a population provides a measure of protection for individuals who have not developed immunity...
effect. With the decline in mumps that followed the introduction of the MMR vaccine, these individuals had not been exposed to the disease, but still had no immunity, either natural or vaccine induced. Therefore, as immunisation rates declined following the controversy and the disease re-emerged, they were susceptible to infection. Measles and mumps cases continued in 2006, at incidence rates 13 and 37 times greater than respective 1998 levels. Two children were severely and permanently injured by measles encephalitis
Encephalitis
Encephalitis is an acute inflammation of the brain. Encephalitis with meningitis is known as meningoencephalitis. Symptoms include headache, fever, confusion, drowsiness, and fatigue...
despite undergoing kidney transplantation
Kidney transplantation
Kidney transplantation or renal transplantation is the organ transplant of a kidney into a patient with end-stage renal disease. Kidney transplantation is typically classified as deceased-donor or living-donor transplantation depending on the source of the donor organ...
in London.
Disease outbreaks also caused casualties in nearby countries. Three deaths and 1,500 cases were reported in the Irish outbreak of 2000, which occurred as a direct result of decreased vaccination rates following the MMR scare.
In 2008, for the first time in 14 years, measles was declared endemic
Endemic (epidemiology)
In epidemiology, an infection is said to be endemic in a population when that infection is maintained in the population without the need for external inputs. For example, chickenpox is endemic in the UK, but malaria is not...
in the UK, meaning that the disease was sustained within the population; this was caused by the preceding decade's low MMR vaccination rates, which created a population of susceptible children who could spread the disease. MMR vaccination rates for English children were unchanged in 2007–08 from the year before, at too low a level to prevent serious measles outbreaks. In May 2008, a British 17-year-old with an underlying immunodeficiency
Immunodeficiency
Immunodeficiency is a state in which the immune system's ability to fight infectious disease is compromised or entirely absent. Immunodeficiency may also decrease cancer immunosurveillance. Most cases of immunodeficiency are acquired but some people are born with defects in their immune system,...
died of measles. In 2008 Europe also faced a measles epidemic, including large outbreaks in Austria, Italy, and Switzerland.
Following the January 2011 BMJ revelations of fraud by Wakefield, Paul Offit
Paul Offit
Paul A. Offit, M.D., is an American pediatrician specializing in infectious diseases and an expert on vaccines, immunology, and virology. He is the co-inventor of a rotavirus vaccine that has been credited with saving hundreds of lives every day. Offit is the Maurice R...
, a pediatrician at Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
The Children's Hospital of Philadelphia is one of the largest and oldest children's hospitals in the world. CHOP has been ranked as the best children's hospital in the United States by U.S. News & World Report and Parents Magazine in recent years. As of 2008, it was ranked #1 in the nation for...
and a "long-time critic of the dangers of the anti-vaccine movement", said, "that paper killed children",
and Michael Smith of the University of Louisville
University of Louisville
The University of Louisville is a public university in Louisville, Kentucky. When founded in 1798, it was the first city-owned public university in the United States and one of the first universities chartered west of the Allegheny Mountains. The university is mandated by the Kentucky General...
, an "infectious diseases expert who has studied the autism controversy's effect on immunization rates", who said "clearly, the results of this (Wakefield) study have had repercussions."
Impact on society
A New England Journal of MedicineNew England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
paper said that antivaccionationist activities resulted in a high cost to society, "including damage to individual and community well-being from outbreaks of previously controlled diseases, withdrawal of vaccine manufacturers from the market, compromising of national security (in the case of anthrax and smallpox vaccines), and lost productivity".
Costs to society from declining vaccination rates (in US dollars) were estimated by AOL's Daily Finance in 2011:
- A 2002–2003 outbreak of measles in Italy, "which led to the hospitalizations of more than 5,000 people, had a combined estimated cost between 17.6 million euros and 22.0 million euros".
- A 2004 outbreak of measles from "an unvaccinated student return[ing] from India in 2004 to Iowa was $142,452".
- A 2006 outbreak of mumps in Chicago, "caused by poorly immunized employees, cost the institution $262,788, or $29,199 per mumps case."
- A 2007 outbreak of mumps in Nova Scotia cost $3,511 per case.
- A 2008 outbreak of measles in San Diego, California cost $177,000, or $10,376 per case.
To offset increased insurance expenses, pediatrician
Pediatrics
Pediatrics or paediatrics is the branch of medicine that deals with the medical care of infants, children, and adolescents. A medical practitioner who specializes in this area is known as a pediatrician or paediatrician...
Rahul Parikh relates how he and a colleague have suggested how anti-vaccine parents should help to defray those expenses:
- "Refusing to vaccinate a child is dangerous not just for that child but for entire communities. It's precisely this point a colleague of mine was considering when he had the idea that parents who refuse to vaccinate their kids should pay substantially higher health insurance premiums. It makes sense. Insurance, after all, is just a pool of money into which we all pay."
He then related some of the human impact caused by the 2008 measles outbreak in San Diego, California mentioned above:
- "A child whose parents refused to vaccinate him traveled to Europe and brought home the measles. That family exposed 839 people, resulting in 11 additional cases of measles. One child too young to be vaccinated had to be hospitalized. Forty-eight children too young to be vaccinated had to be quarantined...."
Media role
Observers have criticized the involvement of mass mediaMass media
Mass media refers collectively to all media technologies which are intended to reach a large audience via mass communication. Broadcast media transmit their information electronically and comprise of television, film and radio, movies, CDs, DVDs and some other gadgets like cameras or video consoles...
in the controversy, what is known as 'science by press conference
Science by press conference
The term science by press conference is a phrase referring to scientists who put an unusual focus on publicizing results of research in the media. The term is usually used disparagingly...
', alleging that the media provided Wakefield's study with more credibility than it deserved. A March 2007 paper in BMC Public Health by Shona Hilton, Mark Petticrew, and Kate Hunt postulated that media reports on Wakefield's study had "created the misleading impression that the evidence for the link with autism was as substantial as the evidence against". Earlier papers in Communication in Medicine and British Medical Journal
British Medical Journal
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...
concluded that media reports provided a misleading picture of the level of support for Wakefield's theory.
A 2007 editorial in Australian Doctor complained that some journalists had continued to defend Wakefield's study even after Lancet had published the retraction by 10 of the study's 12 original authors, but noted that it was an investigative journalist, Brian Deer, who had played a leading role in exposing weaknesses in the study. PRWeek noted that after Wakefield was removed from the general medical register for misconduct in May 2010, 62% of respondents to a poll regarding the MMR controversy stated they did not feel that the media conducted responsible reporting on health issues.
A New England Journal of Medicine
New England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
article examining the history of antivaccinationists said that opposition to vaccines has existed since the 19th century, but "now the antivaccinationists' media of choice are typically television and the Internet, including its social media outlets, which are used to sway public opinion and distract attention from scientific evidence". The editorial characterized anti-vaccionationists as people who "tend toward complete mistrust of government and manufacturers, conspiratorial thinking, denialism, low cognitive complexity in thinking patterns, reasoning flaws, and a habit of substituting emotional anecdotes for data", including people who range from those "unable to understand and incorporate concepts of risk and probability into science-grounded decision making" and those "who use deliberate mistruths, intimidation, falsified data, and threats of violence".
In a January 2011 editorial in The American Spectator
The American Spectator
The American Spectator is a conservative U.S. monthly magazine covering news and politics, edited by R. Emmett Tyrrell Jr. and published by the non-profit American Spectator Foundation. From its founding in 1967 until the late 1980s, the small-circulation magazine featured the writings of authors...
, Robert M. Goldberg contended that evidence from the scientific community of issues with Wakefield's research " ... were undermined because the media allowed Wakefield and his followers to discredit the findings just by saying so".
Fiona Godlee
Fiona Godlee
Fiona Godlee has been editor in chief of the BMJ since 2005; she is the first female editor appointed in the journal's history.-Career:...
, editor of the BMJ said in January 2011:
- "The original paper has received so much media attention, with such potential to damage public health, that it is hard to find a parallel in the history of medical science. Many other medical frauds have been exposed but usually more quickly after publication and on less important health issues."
Concerns have also been raised over the journal peer-review system, which largely relies on trust among researchers, and the role of journalists reporting on scientific theories that they "are hardly in a position to question and comprehend". Neil Cameron, a historian who specializes in the history of science, writing for The Montreal Gazette
The Gazette (Montreal)
The Gazette, often called the Montreal Gazette to avoid ambiguity, is the only English-language daily newspaper published in Montreal, Quebec, Canada, with three other daily English newspapers all having shut down at different times during the second half of the 20th century.-History:In 1778,...
labeled the controversy a "failure of journalism" that resulted in unnecessary deaths, saying that 1) The Lancet should not have published a study based on "statistically meaningless results" from only 12 cases; 2) the anti-vaccination crusade was continued by the satirical Private Eye magazine; and 3) a grapevine of worried parents and "nincompoop" celebrities fueled the widespread fears. The Gazette also reported that:
- "There is no guarantee that debunking the original study is going to sway all parents. Medical experts are going to have to work hard to try to undo the damage inflicted by what is apparently a rogue medical researcher whose work was inadequately vetted by a top-ranked international journal."
Further reading
- "The Vaccine War", PBS FRONTLINE documentary, April 27, 2010
- WebMD FAQ
- MMR research timeline, BBC News