Drugs & Medication

The vaccine controversy encompasses many issues over the benefits and risks of vaccines.

Vaccines are widely credited with reducing the prevalence and consequences of many diseases. National and international public health organizations have made vaccination a central part of their strategies. The consensus of health organizations and medical doctors is that mass vaccination campaigns have been an essential and effective component of eradication or control of several deadly diseases via individual and herd immunity.

Critics question the claimed efficacy and safety of such programs, often citing lack of research on the adverse effects as the cause. The medical community, however, overwhelmingly supports vaccination as an effective and safe means of preventing the spread and reducing the impact of infectious illnesses. The majority of public health advocates holds the opinion that the benefit to the public justifies mandatory programs.

Research continues into both the development of new vaccines for a broadening array of diseases and the efficacy and safety of vaccines already in common use.

Contents 1 The case for widespread vaccines 2 Criticism of widespread vaccine policy 3 The MMR controversy 3.1 Dr. Andrew Wakefield's report 3.1.1 1998 Lancet paper 3.1.2 Controversy following publication of report 3.1.3 Conflict of interest allegations 3.1.4 Retraction of an interpretation of the Lancet paper 3.1.5 General Medical Council Investigation 3.2 Recent studies 4 Vaccination supporters 4.1 Organizations 5 Vaccination critics 5.1 Organizations 6 References 7 External links 7.1 Vaccine promotion sites, little or no anti-vaccination viewpoint 7.2 Sites or articles supportive of vaccines 7.3 Sites or articles critical of vaccines 7.4 Sites decidedly or apparently totally against vaccination 7.5 Links related to controversy and specific to MMR

The case for widespread vaccines

Public health officials, the medical community and public opinion overwhelmingly agree that children should routinely be vaccinated against a range of diseases, such as measles, polio, diphtheria, rubella, tetanus, pertussis, hepatitis B, and others. Some vulnerable groups are also advised to be vaccinated against influenza. Supporters of widespread vaccination policies contend that:

• Vaccines have saved more lives than any other form of medical intervention. Among the most striking successes are the worldwide destruction of smallpox and the near eradication of polio.

• Vaccines are a cost-effective way of ensuring health, compared to treatment of a manifest disease. Routine childhood immunization saves about $40 billion in overall healthcare and social costs per birth year cohort vaccinated. [2]

• Vaccines prevent epidemics in vulnerable areas. When vaccination against polio was recently halted in Nigeria, for instance, the number of cases significantly rose [3]. A recent measles outbreak in 2005 in Indiana was attributed to lack of vaccination among children whose parents refused vaccination [4].

• Critics of vaccination often lack relevant qualifications.

• Other critics of vaccination, such as Robert F. Kennedy, Jr. and Andrew Wakefield, are part of a plaintiffs' lawyers' campaign to generate contingent fees from litigation against vaccine manufacturers using junk science.[5]

• Physicians almost uniformly support polyvalent (more than one antigen) vaccines, such as DPT and MMR, as being in the best interests of the child. The reasons given are that it reduces the unprotected exposure to all but one of the components over that of spaced immunization with single components, one injection is less uncomfortable than several, and it is more cost-effective for parents.

• If individual or multiple vaccinations were to "weaken the immune system", then they would be expected to increase hospitalization for other infections following immunization. Epidemiological surveys give a probability below one in a thousand that this happens. The statistical power of the study —given the Cohort size— is too small to reduce uncertainty further.[6].

Criticism of widespread vaccine policy

The practice of vaccination has been opposed by some since its inception in the late 18th century [7], but criticism has become more visible in the US and some other developed countries in recent years, roughly paralleling the widespread availability of online information. While positions vary from outright rejection of the practice to calls for more selective and cautious use of vaccination, one or several of the following arguments are typically invoked:

• Critics claim that the public health benefits of vaccinations are exaggerated. They further claim that the mortality rates of some illnesses were already dramatically reduced before vaccines were introduced, and claim that further reductions cannot immediately be attributed to vaccines.

• Secondary and long-term effects on the immune system from introducing immunogens and adjuvants directly into the body are not fully understood. Some autoimmune diseases like Acute disseminated encephalomyelitis, Guillain-Barré syndrome, Transverse myelitis and multiple sclerosis are known to be connected to vaccines, which suggests other autoimmune disorders might also be vaccine-related ^{[1] [2]}

• The recommended vaccination schedule does not consider the cumulative effect of being exposed to multiple immunogens at the same time and at a young age.

• At least some vaccine studies did not include such young children (e.g., 5 week old infants, 2 month old infants), yet vaccination schedules start with newborns[8]. There can be a vast difference between the weight and all around development of a newborn baby versus a toddler, yet this is not accounted for.

• Opponents of current vaccination policy question whether vaccinations actually create immunity against the targeted diseases, since some people who have been vaccinated still contracted the illness.

• By not exposing children to common childhood illnesses, they may be more susceptible to diseases at a point when their immune system is weakened, e.g., at an old age or when sick for other reasons.

• As is true with any medication, adverse events to the vaccine (even when rare) may be worse than the disease itself, and there are isolated reports of serious health damage and even death, within hours or a few days of vaccination. Although there are now various national databases where reported reactions can be recorded, anti-vacinationists claim that serious adverse events are grossly under-reported.

• There are a number of possible conflicts of interest that may affect the research design, findings, and opinions about vaccines, including financial interests of companies, the self-regulatory mechanism of medical doctors, and fear of the consequences should vaccines be found to be dangerous (see 2000 Simpsonwood CDC conference for example of such fears). But there are also concerns that opponents of vaccines may be seeking to enrich themselves through litigation or the sale of alternatives, by spreading fear and misjudgment among the public.

• Religious objections, by certain churches and by Christian Scientists to all forms of medical intervention.

• In many studies, adverse effects of vaccines are actively monitored only for a short time, e.g. 14 days.

• In many studies, the vaccine efficacy and safety research is not done by comparing to a group not receiving the vaccine, but to a group receiving a different vaccine for a different disease or a coctail of vaccine additives (e.g. aluminum adjuvants) - thus the research is not designed to show and can not show real vaccine efficacy or safety

The MMR controversy

Controversy has arisen regarding the safety of the MMR vaccine, because a handful of scientists and parents argue that the vaccine is the cause of the increased incidence of autism noted in western countries and Japan, and bowel disorders such as Crohn's disease. A theory advanced by proponents of the link is that the MMR vaccine overwhelms an immune system they assert is already struggling from the effect of thimerosal contained in previous vaccines. They assert that live measles virus in the formulation of the MMR is detrimental to susceptible individuals in a fashion in which wild measles never was.

During the 1980s and 1990s, a number of lawsuits were brought in the United States against manufacturers of vaccines, alleging the vaccines had caused a variety of physical and mental disorders in children. While these were inconclusive, they did lead to a massive jump in the costs of the MMR vaccine, as pharmaceutical companies sought to cover potential liabilities by lobbying for legislative protection. By 1993, Merck KGaA had become the only company willing to sell MMR vaccines in the United States and the United Kingdom. Two other MMR vaccines were withdrawn in the UK in 1992 on safety grounds arising from the strain of mumps component.

In September 1995, the Legal Aid Board in the UK granted a number of families financial assistance to pursue legal claims against the state health authorities and the vaccine's manufacturers, claiming that their children were killed or seriously injured by the MMR vaccine. A pressure group called JABS (Justice, Awareness, Basic Support) was established to represent families with children who, their parents said, were "vaccine-damaged."

In 1996, in New Zealand claims by an academic from Melbourne University that MMR contained a human blood product, serum albumin, and could therefore spread Creutzfeldt-Jakob disease caused anxiety. This did not last, since serum albumin was not an ingredient of the MMR vaccine.

Dr. Andrew Wakefield's report

1998 Lancet paper

In February 1998, a group led by Dr. Andrew Wakefield wrote a paper (on which almost all the other authors later issued a retraction of an interepretation; see below), Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children published in the respected medical journal The Lancet. The report analysed the cases of twelve children with developmental disorders admitted to the Royal Free Hospital in north London in 1996-1997, described a collection of bowel symptoms, which Wakefield asserted was evidence of a possible novel syndrome, which he would later call autistic enterocolitis, and recommended further study into the possible link between the condition and environmental triggers, i.e., the MMR vaccine. The paper proposed links between gastrointestinal symptoms and developmental disorders in twelve children that were alleged to be associated in time with MMR vaccination. No conclusions about causal links, such as that MMR could lead to autism, were reached. However, at a press conference before the paper's publication, Dr 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, given that 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. He declared, "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." [9]

Controversy following publication of report

The paper, press conference and video sparked a major health scare in the United Kingdom. The subsequent debate became polarised. Wakefield's research was misused by parties from both sides of the argument. The controversy was seized upon by some UK newspapers, which argued that separate vaccines ought to be available on the National Health Service (NHS) (It can be argued that these newspapers may have been serving their own interest by promoting this "health scare story" up the news agenda). Wakefield became subject to attacks, his critics questioning the validity and the ethics of the research. The UK government and medical authorities, such as the NHS, stressed extensive epidemiological evidence that failed to show any connection between MMR and developmental disorders. These denials were disbelieved by some parents, not least because previous government pronouncements on safety had been faulty, such as in the 'Mad Cow' (BSE) affair. The government was also alleged to be unwilling to support the use of separate vaccines because the NHS could not afford them. As a result, the takeup of MMR dropped sharply, from 92% in 1996 to 84% in 2002. In some parts of London, it was said to be as low as 60% - far below the rate thought to be needed to avoid an epidemic of measles. Although an epidemic has not yet occurred, measles rates have risen and doctors have warned of the likelihood of a future epidemic, because of the failure of the protection offered by herd immunity.

A factor in the controversy is that only the combined vaccine is available through the UK National Health Service; those who do not wish to have it given to their children must either have the separate vaccines given privately, or not vaccinate their children at all. The Prime Minister, Tony Blair, has refused to state whether his son Leo has received the MMR vaccine, but has strongly supported the vaccine in public. The Chancellor, Gordon Brown, has confirmed his son has been immunised^[3].

The great majority of doctors prefer to administer the combined vaccine rather than the separate ones, as it is less distressing to the child, and parents are more likely to attend for one vaccination than for three.

Epidemiologic research on hundreds of thousands of children in numerous studies continues to show no link between MMR and autism. Critics of these epidemiology studies, such as retired British clinician John Walker-Smith, although a supporter of the triple vaccine, have pointed out that epidemiology is a 'blunt tool' and may miss causal relationships. [10] For example, it can be difficult to find two populations of sufficient size which differ only in whether they were vaccinated.

Dr. Wakefield left his job at the Royal Free Hospital in 2001. His continued research includes involvement in scientific collaborations in the U.S and Europe, and a report on possible immunologic, metabolic, and pathologic changes occurring in what Wakefield has called "autistic enterocolitis", links between intestinal disease and neurologic disorders in children, and the potential relationship of these disorders to environmental causes, such as vaccines. [11]

Conflict of interest allegations

In February 2004, it emerged that when Wakefield had published The Lancet report, £55,000 funding was received by the Royal Free Hospital from lawyers seeking evidence of any link between autism and the MMR vaccine [12]. According to a Sunday Times investigation, several of the parents quoted as saying that MMR had damaged their children were also litigants. Although Wakefield maintains the funding was properly disclosed from the outset, allegations have been made that the funding was not revealed to either The Lancet or Wakefield's co-researchers. On February 20, 2005, The Lancet said it should have never published Wakefield's study, which was "flawed" because Dr Wakefield had "a fatal conflict of interest." Several of Dr. Wakefield's co-researchers also strongly criticised the lack of disclosure. [13]

Retraction of an interpretation of the Lancet paper

The investigation which led to 10 of the 13 authors of the 1998 Lancet paper formally retracting [14] the interpretation that the article claimed a link between MMR and autism was carried out by Brian Deer for The Sunday Times of London. [15] Deer continued his investigation in a British 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. [16]

General Medical Council Investigation

The General Medical Council, which is responsible for licensing doctors and Supervising Medical Ethics in the UK were reported to be investigating the affair [17], and in June 2006 was reported to be prepared to accuse Wakefield of four charges: "that he published inadequately founded research, failed to obtain ethical committee approval for the work, obtained funding for it improperly, and subjected children to "unnecessary and invasive investigations." [18] This could result in him being struck off the Medical Register in the UK.

Recent studies

Epidemiological research continues to show a dramatic increase in the incidence of autism, but whether the increase is real, rather than an artifact of changes in diagnosis and reporting, is unknown, and no causal connection has been demonstrated to the MMR vaccine. Since Wakefield's paper, there has been substantial clinical research investigating his claim to have found measles virus located in the gut of proportion of children, much of which has been financed by litigation, with the results not reported on legal grounds.

• In October 2004, the Journal of American Physicians and Surgeons, formerly the Medical Sentinel, magazine of the conservative Association of American Physicians and Surgeons, published a paper by Wakefield supporters and concluded that "Developing safer vaccination strategies and supporting further investigation of the hypothesized link between the MMR vaccine and autism should have a high priority." It also noted that in Denmark Thimerosal is eliminated as a factor in any relationship between MMR and autism. [19]
• Also in October 2004, a review, financed by the European Union, was published in the October 2004 edition of Vaccine^[4] that assessed the evidence given in 120 other studies and considered unintended effects of the MMR vaccine. The authors concluded that
  • the vaccine is associated with some positive and negative side effects,
  • it was "unlikely" that there was a connection between MMR and autism, and
  • "The design and reporting of safety outcomes in MMR vaccine studies ... are largely inadequate".
• In January 2005, intensive research in a single county in Minnesota reported an eightfold increase in the incidence of autism over a period beginning in the early eighties and ending in the late nineties but found no evidence of a link with MMR. The authors of the research suggested that the increase in autism was due to an increased awareness of the disorder, a growth in services, and changing definitions. [20]

• Japan provided a natural experiment on the subject: combined MMR vaccine was introduced in 1989, but the programme was terminated in 1993 and only single vaccines used thereafter.[21] In March 2005 a study of over 30,000 children (278 cases) born in one district of Yokohama concluded "The incidence of all autistic spectrum disorders (ASD), and of autism, continued to rise after MMR vaccine was discontinued. The incidence of autism was higher in children born after 1992 who were not vaccinated with MMR than in children born before 1992 who were vaccinated. The incidence of autism associated with regression was the same during the use of MMR and after it was discontinued." Autism rose (from 46-86 cases per 10,000 children, to 97-161/10,000). The authors concluded: "The significance of this finding is that MMR vaccination is most unlikely to be a main cause of ASD, that it cannot explain the rise over time in the incidence of ASD, and that withdrawal of MMR in countries where it is still being used cannot be expected to lead to a reduction in the incidence of ASD."^[5] This study did not question whether or not both MMR and separate vaccines were capable of contributing to ASD, Crohns and other disorders; with separate vaccines, rather than MMR, being responsible for a more severe effect.

• Dr. Wakefield contends the pattern of autism rates revealed by the data support his hypothesis[22] . His views, however, have found little support.^[6]

• In October 2005, the Cochrane Library published a review of 31 scientific studies, and concluded that "there was no credible evidence behind claims of harm from the MMR vaccination" and "MMR is an important vaccine that has prevented diseases that still carry a heavy burden of death ....."[23] 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."[7] Cochrane, based in Oxford, England, is widely regarded by scientists as the most authoritative independent reviewer of medical literature, and the custodian of evidence-based medicine.

• A Journalist for UPI, Dan Olmsted, has conducted a journalistic investigation reported in his "Age of Autism" column [24] and did not find many never-vaccinated children with autism. Olmsted looked for autistic children among unvaccinated Amish; in a subset of homeschooled children who are not vaccinated for religious reasons; and in a pediatric practice in Chicago with several thousand never-vaccinated children. Partly as a result of this, a U.S. Congresswoman has produced a draft Autism Bill [25]

• In 2006 a study is underway, led by Arthur Krigsman of New York University School of Medicine, involving 275 children. Serious intestinal inflammations have been found in some of the autistic children and biopsies of gut tissue have been performed on 82 of them. Of these, 70 are said to have shown evidence of the measles virus. The study is yet to be completed or peer reviewed.^[8]

Vaccination supporters

Supporters of vaccination, which includes most medical organizations:

Vaccination critics

References

1. ^ http://us.gsk.com/products/assets/us_engerixb.pdf
2. ^ Acute disseminated encephalomyelitis
3. ^ Nic Fleming My son has had MMR jab, says Brown (in dig at Blair) Telegraph 07 February 2006
4. ^ Jefferson T, Price D, Demicheli V, Bianco E (2003). "Unintended events following immunization with MMR: a systematic review". Vaccine 21 (25-26): 3954-60. PMID 12922131.
5. ^ Hideo Honda, Yasuo Shimizu and Michael Rutter (June 2005). "No effect of MMR withdrawal on the incidence of autism: a total population study". Journal of Child Psychology and Psychiatry 46 (6): 572. DOI:10.1111/j.1469-7610.2005.01425.x. Cited in New Scientist[1], reviewed in Bandolier with graph of main results.
6. ^ Ian Sample. "Lingering fears of MMR-autism link dispelled", The Guardian, March 3, 2005.
7. ^ V Demicheli, T Jefferson, A Rivetti, D Price (2005). "Vaccines for measles, mumps and rubella in children". The Cochrane Database of Systematic Reviews (4). DOI:10.1002/14651858.CD004407.pub2.
8. ^ Sam Lister US study supports claims of MMR link to autism The Times 29 May 29 2006

• "Anti-vaccinationists Past and Present" BMJ 2002;325:430-432
  • Supplementary boxes - arguments from 1850 etc
• "MMR: Science and Fiction. Exploring the Vaccine Crisis; MMR and Autism: What Parents Need to Know", Rapid Responses to book review, British Medical Journal 2004

• "Content and Design Attributes of Antivaccination Web Sites" Robert M. Wolfe, MD; Lisa K. Sharp, PhD; Martin S. Lipsky, MD Journal of the American Medical Association JAMA. 2002;287:3245-3248  : Systematically examined antivaccination Web site attributes and delineated specific claims and concerns of antivaccination groups. 22 sites.
• Miller, C.L. Deaths from Measles in England and Wales. 1970-83.], Epidemiological Research Laboratory, Public Health Laboratory Service, London; measles mortality statistics published in the British Medical Journal, Vol 290, February 9, 1985

External links

Vaccine promotion sites, little or no anti-vaccination viewpoint

• Immunize.org - Immunization Action Coalition' (nonprofit working to increase immunization rates)
• MMRtheFacts.nhs.uk - 'MMR the Facts', UK National Health Service
• WHO.int - 'Immunizations, Vaccines and Biologicals: Towards a World Free of Vaccine Preventable Diseases', World Health Organization (WHO's global vaccination campaign website)

Sites or articles supportive of vaccines

• CDC.gov - "National Immunization Program: Leading the Way to Healthy Lives", US Centers for Disease Control (CDC information on vaccinations)

• CDC.gov - "Mercury and Vaccines (Thimerosal)", US Centers for Disease Control

• NYTimes.com - "On Autism's Cause, It's Parents vs. Research", Gardiner Harris, Anahad O'Connor, New York Times (front page; June 25, 2005)
• OpinionJournal.com - "Autism and Vaccines: Activists Wage a Nasty Campaign to Silence Scientists" (editorial), Wall Street Journal (February 16, 2004)
• SNHS.com - "Anti-vaccine Activists get Jabbed", Michael Fumento (March 11, 2004)
• ZyNet.co.uk - "Polio Virus, Vaccine and Eradication", Lincolnshire Post-Polio Network (UK)
• iVillage ParentsPlace Vaccine Support Message Board

Sites or articles critical of vaccines

• About.com - 'Killing the Messenger: Dr. Andrew Wakefield Fired', Floyd Tilton (December 5, 2001)
• Doctors' Group Votes to Oppose Vaccine Mandates.. Association of American Physicians and Surgeons, Inc.. Archived from the original on 2000-11-02. Retrieved on 2006-07-01.
• GenerationRescue.org - 'Thousands of Parents, Hundreds of Doctors and Scientists and Several Congressmen Agree. The Cause of Autism - and its Cure- has been Found.', Generation Rescue
• InformedParent.co.uk - 'MMR Manufacturers Keep Up Legal Pressure on MMR Children', Informed Parent
• NewMediaExplorer.org - 'S 1873: Pandemic Vaccine Bill to Put Drug Firms Beyond Reach of Law', Sepp Hasslberger, Health Supreme (October 26, 2005)
• NVIC.org - National Vaccine Information Center
• RollingStone.com - 'Kennedy Report Sparks Controversy: Intense Reaction from Medical Establishment and Leading News Organizations' (editorial), Rolling Stone (July 14, 2005)
• ThinkTwice.com - Think Twice Global Vaccine Institute
• Vaccination - The Hidden Truth (1998) - 1 1/2 hour video document with many vaccine critics (including medical doctors) interviewed

Sites decidedly or apparently totally against vaccination

• AVN.org.au - The Australian Vaccination Network (AVN)
• Educate-Yourself.org - 'The Vaccine Industry vs Robert F. Kennedy, Jr.', Mark Sircus Ac, OMD (June 22, 2005)
• VaccinationDebate.com - 'Vaccination Debate', Ian Sinclair
• VacLib.org - 'Free Your Mind...From the Vaccination Paradigm', Vaccination Liberation
• VRAN.org - 'Vaccine Risk Awareness Network: Your Source for Vaccination Information' (Canada)

Links related to controversy and specific to MMR

• BBC.co.uk - 'Does the MMR Jab Cause Autism?' (TV programme transcript), BBC (May 29, 2005)
• Susan Mayor (March 13, 2004). "Authors Reject Interpretation Linking Autism and MMR Vaccine". British Medical Journal 328: 602. DOI:10.1136/bmj.328.7440.602-c.
• Abi Berger (13 September 2003). "The Third Degree. MMR: Can You Decide?". British Medical Journal 327: 628. DOI:10.1136/bmj.327.7415.628.
• BrianDeer.com - "The Lancet Scandal (Investigation of MMR Affair), Brian Deer
• "At Last - the End of the MMR Myth: Dr Simon Atkins on Why it's Safe to Give Jabs", The Guardian, October 20, 2005.
• Jabs.org.uk - 'The Support Group for Vaccine-Damaged Children' (UK advocacy group)
• MedicalNewsToday.com - "Cochrane Library Publishes the Most Thorough Survey of MMR Vaccination Data", Medical News Today
• Medinfo.co.uk - "Medical Information for Patients: MMR Vaccination"
• MMRTheFacts.NHS.uk - "MMR the Facts", United Kingdom National Health Service (government website)
• MMRTheQuestions.com - "MMR: The Questions" (includes response from Andrew Wakefield to Brian Deer's investigation)
• RedFlagsDaily.com - "Alive and Well: The MMR-Autism Connection", F. Edward Yazbak, MD, FAAP, Red Flags (October 29, 2005)
• SpikedOnline.com - "How Did the Doctor Get Away With it? Brian Deer's Investigative Documentary on MMR went Some Way Towards Redeeming the Reputation of the Media", Dr. Michael Fitzpatrick (November 19, 2004)