MMR vaccine controversy

The MMR vaccine controversy started with the 1998 publication of a fraudulent research paper in the medical journal The Lancet that lent support to the later discredited claim that colitis and autism spectrum disorders are linked to the combined measles, mumps, and rubella (MMR) vaccine. Aspects of the media coverage were criticized for naïve reporting and lending undue credibility to the architect of the fraud, Andrew Wakefield. Investigations by Sunday Times journalist Brian Deer reported that Andrew Wakefield, the author of the original research paper, 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, when The Lancet's editor-in-chief Richard Horton described it as "utterly false" and said that the journal had been "deceived." 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 in the UK. In 2011, Deer provided further information on Wakefield's improper research practices to the British medical journal, BMJ, which in a signed editorial described the original paper as fraudulent. The scientific consensus is the MMR vaccine has no link to the development of autism, and that this 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 MMR 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 justified its global use, and that the lack of confidence in the vaccine had 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 was followed by significantly increased incidence of measles and mumps, resulting in deaths and severe and permanent injuries. Physicians, medical journals, and editors have described Wakefield's actions as fraudulent and tied them to epidemics and deaths, and a 2011 journal article described the vaccine–autism connection as "perhaps the most damaging medical hoax of the last 100 years". 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 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 solicitors and barristers, 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. United States: 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 court. 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 test cases were presented to test the claims about the combination; these 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 issues concerned with bowel disorders; they argued their cases in the regular vaccine court. On 30 July 2007, the family of Bailey Banks, a child with pervasive developmental delay, won its case versus the Department of Health and Human Services. In a case listed as relating to 'non-autistic developmental delay', Special Master Richard B. 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). He reached this conclusion because of two vaccine cases in 1994 and 2001, which had concluded that "ADEM can be caused by natural measles, mumps, and rubella infections, as well as by measles, mumps, and rubella vaccines." In other cases, attorneys did not claim that vaccines caused autism; they sought compensation for encephalopathy, encephalitis, or seizure disorders. 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 prevalence, and no causal connection to the MMR vaccine has been demonstrated. In 2004, a meta review financed by the European Union assessed the evidence given in 120 other studies and considered unintended effects of the MMR vaccine, concluding that although the vaccine is associated with positive and negative side effects, a connection between MMR and autism was "unlikely". Also in 2004, a review article was published which concluded that "The evidence now is convincing that the measles–mumps–rubella vaccine does not cause autism or any particular subtypes of autistic spectrum disorder." A 2006 review of the literature regarding vaccines and autism found that "the bulk of the evidence suggests no causal relationship between the MMR vaccine and autism." 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 the studies provided 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 reaction 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 discussed the MMR vaccine controversy as one of three main hypotheses which epidemiological and biological studies failed to support. In 2012, the Cochrane Library published a review of dozens of scientific studies involving about 14,700,000 children, which found no credible evidence of an involvement of MMR with either autism or Crohn's disease. The authors stated that "the design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate". A June 2014 meta-analysis involving more than 1.25 million children found that "vaccinations are not associated with the development of autism or autism spectrum disorder. Furthermore, the components of the vaccines (thimerosal or mercury) or multiple vaccines (MMR) are not associated with the development of autism or autism spectrum disorder." In July 2014, a systematic review found "strong evidence that MMR vaccine is not associated with autism". 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 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 statements about Wakefield's fraud, 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", said "clearly, the results of this (Wakefield) study have had repercussions." In 2014, Laurie Garrett, senior fellow at the Council on Foreign Relations, blamed "Wakefieldism" for an increase in the number of unvaccinated children in countries such as Australia and New Zealand, saying, "Our data suggests that where Wakefield's message has caught on, measles follows." Impact on society: The New England Journal of Medicine said that antivaccinationist 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 returning 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. In the United States, Jenny McCarthy blamed vaccinations for her son Evan's disorders and leveraged her celebrity status to warn parents of a link between vaccines and autism. Evan's disorder began with seizures and his improvement occurred after the seizures were treated, symptoms experts have noted are more consistent with Landau–Kleffner syndrome, often misdiagnosed as autism. After the Lancet article was discredited, McCarthy continued to defend Wakefield. An article in Salon.com called McCarthy "a menace" for her continued position that vaccines are dangerous.