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UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE
- Clifford G. Miller (12 March 2004)
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Presenting ignorance as "evidence."
- Lawrence J. O'Brien, Arlington, Virginia 22209 USA (12 March 2004)
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The "Public" Understand Science
- Saadedine Tebbal (16 March 2004)
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Re: The "Public" Understand Science
- MC Feliciello (17 March 2004)
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Re: UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE
- F. Edward Yazbak (17 March 2004)
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When will this pantomime end?
- John Daniel Stone (18 March 2004)
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Re: When will this pantomime end?
- John Daniel Stone (19 March 2004)
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Evidence based medicine
- Alan J Mulcahy (23 March 2004)
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Re: Evidence based medicine
- John Daniel Stone (23 March 2004)
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Re: UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE
- Viera Scheibner (26 March 2004)
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Re: UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE - THE WRONG REACTION
- John Stone (23 November 2004)
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Re: Re: UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE - THE WRONG REACTION
- John Stone (26 November 2004)
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Re: UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE - THE WRONG REACTION
- Raymond Gallup (26 November 2004)
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Re: Re: Unreliability of scientific papers as evidence
- Richard P Carruthers (27 November 2004)
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Clifford G. Miller, Solicitor & graduate physicist BR3 3LA
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Dear Sirs, UNRELIABILITY OF SCIENTIFIC PAPERS AS EVIDENCE The MMR and similar issues serve to illustrate the limited utility of scientific papers outside of the scientific arena and makes the kind of debate in this BMJ article a sterile and inconsequential one for many other purposes. Unless changes are made to the manner in which medical science treats and accepts evidence, then medical scientific evidence needs to be treated with great circumspection when used outside the scientific context. There are clear and specific reasons for this. The main reason medical science is potentially to be considered flawed, such as in the legal arena is because, it intentionally, necessarily (for its own purposes) and systemically fails to take account of evidence which is fundamental to the deliberations of a court. Reliable evidence is that which is authentic, accurate and complete. In short, scientific evidence is incomplete if used for purposes outside the strict confines of science because it fails to take account of evidence of lay witnesses of the facts and is hence only applicable to the narrow and specific confines of scientific enquiry and not the broader ones found in other fields of human endeavour. Examples in point include the parental evidence of symptoms in the MMR cases or that of Gulf War veterans about their symptoms. A court (or the Legal Services Commission in the case of MMR) in contrast, ought to take that oral evidence into account for the very reasons science dismisses it. The point, unfortunately is not as well taken by our legal system as it might be. We have seen this recently with the Legal Services Commission in the MMR cases and in the cases of Gulf War veterans. Science treats evidence of lay witnesses of fact as inadmissible (as ‘anecdotal’ only) for reasons which are inapplicable in Court, but science does so for two main reasons. The higher scientific standard of proof (in effect, irrefutability) only admits evidence which can be tested scientifically for reliability. Oral witness evidence is discounted by medical science because medical scientific method does not currently have or recognise a mechanism for testing oral evidence to the scientific standard and so, for the sake of rigour, excludes it. Neither of these propositions apply in Court. Evidence of the direct witness of the fact, whether oral, or more frequently now, by way of written statement, is always admissible and is, in fact, the keystone of the trial system of evidence and the primary source of information a court uses to make decisions of fact. The Court has and applies its own mechanisms for testing witness evidence (eg. cross-examination). Further, the Court applies a far lower standard of proof, namely a balance of probability and not the unnecessarily high one of irrefutability applied by science. Hence, the evidence of 1000 plus sets of parents in the MMR cases backed by before and after video, photographs and medical records, ought to be considered by a court in preference to the science. However, it seems that is not happening as it should. Whilst scientific opinion evidence ought to play second fiddle to the oral witness evidence, it takes pride of place and forces the oral witness evidence into the shadows. This is despite scientific opinion evidence getting into court by the back door as one of the exceptions to the rule that only oral witness evidence is admissible and opinion evidence is normally inadmissible. Scientific opinion is allowed because the Court is often not in a position to assess complex science without expert opinion. However, in the case of oral witness evidence, the Court is perfectly well able to assess direct oral evidence of witnesses, perhaps with some scientific aid if need be. Perhaps our courts may yet develop further the degree of sophistication presently required in their approach to the assessment of 'expert' opinion evidence. Governments also take advantage of the confusion and often use the term ‘evidence’ interchangeably with ‘proof’ when dismissing evidence they choose not to agree with or set unreasonably high standards of proof for the kind of decision required. The press and public alike are continually hoodwinked by this approach. In law ‘evidence’ is nothing more than information. It is information which one party proposes in support of, or to undermine, a disputed proposition. ‘Proof’, however, depends upon the decision-making process concerned. For the public interest, the standard of proof is sometimes based on risk and sometimes on other factors. In civil courts it is ‘balance of probability’. In criminal it is ‘beyond reasonable doubt’. And science requires irrefutable proof: a remarkably high standard. It is a fundamental error to apply the wrong standard of proof to the decision making process concerned and yet it seems to happen regularly. For issues of public safety, such as medicines like MMR or vaccines in the Gulf War, or the BSE crisis, the risk standard ought to be applied. However, instead, we, the public, are told frequently by officials in government there is no scientific evidence of a causal link between one thing and another. Whereas, often evidence to the contrary does in fact exist, it is not evidence that the officaldom concerned may either choose to or sometimes be at liberty to accept as proof of the issue. This is much the same for the BSE crisis with the government as it was for the Courts in relation to Gulf War syndrome or the Legal Services Commission for MMR. Whereas in the case of courts, the court has to rely on the expert evidence presented, in the case of public health officials like the Chief Medical Officer, he is in a position to assess the reliability himself, with the aid of his own experts if necessary. However, in the latter case, the risk standard of proof ought to be applied to decision making in the public interest rather than the scientific standard, which is only applicable to proof in science. In the scientific context, the only answer to a scientific issue that scientific journals should involve themselves in is a scientific one and they should only trouble themselves with the scientific standard of proof. If MMR did not cause autism, or vaccines in the Gulf War did not cause other problems, then it is for scientific journals to publish irrefutable scientific proof of what ails the 1000 or so children and the numerous afflicted Gulf War veterans. The current political debates about these kinds of issues are ones science could answer, if only the scientists got on with it and stopped playing politics. It is, for example, no answer to Wakefield to claim there is no scientific evidence of a link between MMR and autism. That just shows science has not found one that it can accept as proven to its very high standard of proof. It does not prove there are none, nor that there is no proof to other more realistic and practical standards for day-to-day decision making. It also leaves the public confused and distrustful of science. Buried in the MMR debate and little known to the general public is formal confirmation of a link between immunisation and the so-called allergy epidemics in the developed world. According to the US National Academies' Institute of Medicine (IoM) Immunization Safety Review Committee (1), for at least two years it has been known that current vaccination programmes can expose children to risk of various problems ranging from allergy to infection. The IoM have also confirmed (2) that reasonable theories exist to explain how too many immunizations can overwhelm an infant's immune system. A clear indication of the possibility of the existence of a causal connection between vaccination and the emergence of the various allergy and other issues over the last 20 years is the contemporaneous substantial increase in vaccinations as reported by the IoM (3). This shows an increase from 4 vaccinations per child in 1980 to up to 20 now. Whilst the IoM considered (4), as regards asthma in particular, and allergies in general, it had inadequate evidence to accept or reject a causal relationship, it accepted there is cause to consider that there might be a connection. Effectively, all the IoM statement amounts to is an admission by the most authoritative governmental authority in the US that they will not accept any evidence unless it provides the answer to a scientific standard of proof, and until someone produces that proof, they will not apply a risk standard, such that it is immunization as usual for children. The IoM's conclusion is also not a reliable one for government to apply to the risk standard of proof because the IoM rely upon the scientific standard of proof and that is the wrong standard to apply for a decision based on risk. Irrefutability is too high a hurdle. Similarly, parents taking practical day-to-day decisions risk their child’s health if they wait for scientific proof, because proof to such a standard also takes too long to be produced. When looking for a cause of the world wide epidemic in allergies, immunization is a likely suspect, being one uniform common intercontinental factor. It would be foolhardy for anyone to dismiss such an obvious candidate as immunization from consideration as the prime suspect. In the causation debate, immunization applies across diverse populations and continents in the developed world. It affects all concerned in all walks of life, regardless of social standing or any other factor. The absence of any explanation for other more probable causes, coupled with a singular failure of any governmental authority to establish any cause and the admissions from US authorities that immunization may be a possible cause, the case for review becomes compelling. MMR might be a pointer in the right direction in that it also provides us with evidence, albeit in a different but related immunization context (and albeit not taken into account by medical science in its present state of development), of parents who have direct oral, photographic, video and witness evidence of a rapid deterioration following from MMR vaccination. A study of Cambridgeshire schools by Cambridge University (5) indicates 1 in 50 boys has an autism spectrum disorder (ASD) in some areas. That this is not a local issue to Cambridge is supported by data from the State of California and US Federal Government sources. These show autism affecting approximately one in every 160 US school aged children. The most recent California data record a doubling in the past four years. However, from a boy's perspective the figures are higher, approximately 1 in 80 boys has autism nation wide in the US. All this means is that science itself is the very reason why parents cannot wait for scientists to stop their dithering. Science requires repeatable and reproducible results, taking proof to a level beyond question or fallibility of human judgement. Until that has been done it means multiple immunizations are not just a possible cause of the allergy, autism and other epidemics we are seeing, but the only realistic suspect. Just because some scientists argue that the evidence establishing a causal connection to the scientific standard has not yet been produced does not mean immunization is not the cause. Applying the same scientific standard of proof, no one can be sure there is no causal connection until that is generally established to that standard. Parents have to ask themselves, can they risk the matter whilst the scientists, other experts and governments dither in disarray, battling between themselves? Regrettably, the scientific standard of proof can also be used inappropriately by vested interests in political debates. In such debate, the politics and economics overwhelm the ordinary person. Immunization is a multi-billion dollar issue, covering all continents and with all the forces hard cash brings to support it, along with conflicts of interest and the intricate relationships of professionals and public officials. Ordinary folk just cannot compete with that, having nothing like the same kind of resources. At the time of writing, it is being claimed by a US Board Certified Paediatrician (6) that the IoM and US Courts accept as proof of causation evidence showing a double reaction, first to the initial MMR inoculation and again followed by a reaction to the booster. Whilst references are awaited by this author, it seems a logical and possible premise for a court to follow on a balance of probability in the absence of any other cogent and persuasive proof of causation. If that is the case, then this debate was over long ago and that also means it may have been prolonged unnecessarily by whatever interests there are that have been using science in a manner in which it is not intended. This may well have again have caused damage to the reputation of science in the public mind, when it can be such a powerful tool for good. In that regard, it is instructive to note that US Judges are admonished (7) that it is a myth to believe scientists are people of uncompromising honesty and integrity and that they, instead, are ordinary mortals like all other ordinary mortals. The writer is a practising English lawyer, graduate in physics and a sometime examining lecturer on law, standards and ethics (particularly, the law of evidence) to Masters student technologists at the Imperial College of Science Technology and Medicine. He also declares a personal interest, with a close relative with a life threatening food allergy. REFERENCES: (1) IoM, Feb 20, 2002 Multiple Immunizations and Immune Dysfunction (2) Ibid (3) Ibid. By two years of age, healthy infants in the United States can receive up to 20 vaccinations to protect against 11 diseases. In 1980, infants were vaccinated against only four diseases. (4) IoM, Feb 20, 2002 Multiple Immunizations and Immune Dysfunction (5) In press Autism: International Journal of Research and Practice, Brief Report: Prevalence of Autism Spectrum Conditions in Children Aged 5 -11 Years in Cambridgeshire, UK. Fiona J. Scott, Simon Baron-Cohen, Patrick Bolton, and Carol Brayne. Autism Research Centre, University of Cambridge, Departments of Psychiatry and Experimental Psychology. (6) ‘Some parents have also reported that their children, after improving on special diets, supplements and behavioral therapy, regressed a second time around the age of 5 years shortly after receiving their MMR booster. Such double-hit situation (challenge-rechallenge) has been accepted in courts and by a committee of the Institute of Medicine (IOM) as proof of causation.’ REGRESSIVE AUTISM AND MMR VACCINATION, F. Edward Yazbak, MD, FAAP, TL Autism Research, http://www.redflagsweekly.com/yazbak/2003_nov01_1.html, (7) p79 Reference Manual on Scientific Evidence, Second Edition, US Federal Judicial Center. An electronic version of the Reference Manual can be downloaded from the Federal Judicial Center’s site on the World Wide Web. Go to http://air.fjc.gov/public/fjcweb.nsf/pages/16 For the Center’s overall home page on the Web, go to http://www.fjc.gov. Competing interests: A close relative with a life threatening food allergy. |
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Lawrence J. O'Brien, author/consultant 1200 N. Nash Street - Ste. 535, Arlington, Virginia 22209 USA
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Clifford Miller's letter is excellent, however I believe that it touches too lightly on the fact that an inherent logical fallacy is being given a pass in this discussion of the safety of MMR vaccinations. Traditional Western logic treats an assertion that "no evidence of harm has been shown" as a fundamental fallacy of human thinking. The proof of its falsity is self-contained, being that the statement is in its essence an argument from ignorance, constituting a logical fallacy of the highest order. As applied to the MMR controversy, in the terms of classical logic such statements merely assert that the maker of the statement is completely ignorant of any harmful effect being caused by the medical intervention in question. It ought to be evident to reasonable minds that guarantees issued by physicians or pharmaceutical investigators that they are entirely ignorant of potential harm being caused to patients is the diametrical opposite of providing quantitative, objective evidence that it has been completely determined that no harm will ever result to a patient from the specific medical intervention under consideration. Ignorance of potentially harmful outcomes for patients being vaccinated with MMR cannot stand as either a valid excuse or a legitimate defense for medical experimenters. Recall the 2500-year-old Greek dictum which every medical professional is committed to live by: "This above all, I shall do no harm." Although ignorance of harm being caused and scientific proof that no harm will be caused are completely contradictory things, few contemporary physicians would even be aware that the logical basis for their own arguments from ignorance has been well-recognized in the annals of Western intellectual history as being false, misleading, and fundamentally invalid. Ignorance of this history begets ignorance of harm being done. In his testimony last year before an inquiry by the US Congress into injury to children resulting from MMR injections containing the preservative thimerosol, Walter Spitzer, MD, an epidemiologist on the faculty of McGill University in Canada, observed that the hallmarks of the scientific method are replication, verification, and corroboration. In noting that a fundamental tenet of the scientific method is that one study proves nothing, Spitzer added: “Or even two.” Certainly, those who hotly defend the safety of MMR vaccines have no studies -- not even one -- to offer that prove the MMR vaccine to be safe. Their own personal ignorance of the harm that is clearly being done to children all over the world by the excessive stimulation of immature immune systems during the period of "brain growth spurt" is all that they have to offer to parents who are overwhelmed with the daily "anecdotal" evidence of this harm. Of course, these people who dismiss such evidence as anecdotal are not scientists, but are self-interested individuals driven by their commercial point of view, individuals bent on confusing public opinion by presenting their personal beliefs as if they were matters of established scientific fact. Public opinion needs to catch on, and fast. Lawrence J. O'Brien Competing interests: None declared |
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Saadedine Tebbal, None Texas, 77477
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It is time for the medical establishment and health officials to understand once for all that the public can and do understand what science is. We are not in the Middle Age anymore, we are in the Information Age. So anybody being afraid of alarming the public is talking non-sense. What the public understand is that there is a good chance that MMR causes Autism according to an experimental (as opposed to epidemiologic) study. They are asking for single doses. Give them single doses until it is scientifically proven with an experimental study (which should have been done years ago) that MMR is safe. Just stop staling or using epidemiological studies to negate science. The "big" MMR epidemiological study that is being referenced again and again by the MMR proponents as a proof that MMR is safe, was funded by the manufacturer of the MMR vaccine and was made in Denmark amongst all developped countries. Why? Because Denmark was the only developed country who stopped using the mercury derivative Thimerosal for all the vaccines since 1991. This is without taking into account all the flaws found in the study. With all due respect, MD's are not Scientists. They are Clinicians. They do not do any research to get their medical degree, they learn how to match symptoms to diseases. So please leave science to scientists. Saadedine Tebbal, Ph.D. Competing interests: Kid With Autism |
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MC Feliciello, n/a Leeds
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I really wish I did understand science and what it attempts to be, the ideals that are reputedly enshrined in this field of human endeavour are hard to spot sometimes. I remain bewildered in the face of conflicts of evidence that purports to be legal proof (1)and conflicts of interest in or lack of clinical research in this area of vaccination policy, whether pro or anti. I don't think I'm entirely alone. This press release was forwarded on to me this morning, tell me, what should I and other parents make of this? http://www.universityofhealth.net/PR/3304PRUSNOMHearing.htm What do you, as Doctors, make of this? MCF (1)http://bmj.bmjjournals.com/cgi/eletters/328/7440/602-c#52948 Competing interests: Parent of child diagnosed ASD |
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F. Edward Yazbak, Pediatrician, Director, TL Autism Research, Falmouth, Massachusetts 02540
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The Tragic Second Hit. As quoted by Mr. Clifford G. Miller, my statement was ‘Some parents have also reported that their children, after improving on special diets, supplements and behavioral therapy, regressed a second time around the age of 5 years shortly after receiving their MMR booster. Such double-hit situation (challenge-rechallenge) has been accepted in courts and by a committee of the Institute of Medicine (IOM) as proof of causation’. (1) Mr. Miller has interpreted the above as implying that the IOM and US Courts accept evidence showing a double reaction, first to the initial MMR inoculation and again to the MMR booster, as proof of causation. When Mr. Miller contacted me, I informed him that my reference to the IOM was about another vaccine and that the Court litigations involved certain medications and not the MMR vaccine. His legal interpretation of the situation is nevertheless still valid, and on target, when he states “… it seems a logical and possible premise for a court to follow on a balance of probability in the absence of any other cogent and persuasive proof of causation. If that is the case, then this debate was over long ago and that also means it may have been prolonged unnecessarily by whatever interests there are that have been using science in a manner in which it is not intended. This may well have again have caused damage to the reputation of science in the public mind, when it can be such a powerful tool for good.” My reference to the IOM is based on two documents. The first is a 1991 IOM report entitled “Adverse Effects of Pertussis and Rubella Vaccines” and edited by Howson, Howe and Fineberg. On page 48 the editors stated: "In the case of hemolytic anemia, a single striking case was sufficient to suggest biologic relevance” and under Summary on page 159: “… the case described by Coulter and Fisher (1985) is suggestive of a causal relation because hemolytic anemia was detected 6 days after DPT immunization on two separate occasions”. The second IOM report “Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality”: was published in 1994 and was edited by Stratton, Howe and Johnston. On page 24, the editors listed several criteria including …6. Dechallenge: Did the adverse event diminish as would be expected if the vaccine caused the event ... 7. Rechallenge: Was the vaccine redministered? If so, did the adverse event recur? On page 26 they added "Rechallenge is unusual, because physicians are unlikely to readminister a vaccine previously associated with an adverse event. When rechallenge does occur, however, the recurrence or non recurrence of the adverse event will often have a major impact on the causality assessment”. The above references should be available from the IOM. (2) As mentioned, the principle of Challenge and Re-Challenge has also been cited, in several Court proceedings involving Selective Serotonin Reuptake Inhibitor (SSRI) litigation. Interested attorneys can obtain those transcripts by simple Lexus-Nexus and Google searches. As for physicians, the following three documents may be more informative. The first is a comprehensive Power Point presentation on “Clinical Analysis of Adverse Drug Reactions” by K. A. Calis, Pharm.D., MPH, of the National Institutes of Health. (3) Under “Causality Assessment” on slide 38, Dr. Calis lists De-Challenge and Re-Challenge after temporal relationship and before dose-response relationship. On slide 45, under “Component of an ADR (Adverse Drug Reaction) Report”, Dr. Calis once more lists “De-Challenge and Re-Challenge information”. The second article is by Ms. Vera Hassner Sharav, President of The Alliance for Human Research Protection (AHRP) in New York. It is entitled “Where is the Scientific Evidence to Justify Exposing Children to the Risks of Antidepressant Drugs?” (4) and was submitted to the FDA Psychopharmacological Drugs Advisory Committee. The author states:“The case is particularly significant in demonstrating a causal effect of the drug because: It occurred within the context of a controlled clinical trial; Violent symptoms developed with start of “Drug” (challenge); The symptoms ceased when the drug was stopped (dechalllenge); Suicidal symptoms returned when the drug was restarted (rechallenge); Suicidal symptoms cleared a second time when the drug was again stopped”. The last reference, “Suicide and Neuropsychiatric Adverse Effects of SSRI Medications: Methodological Issues” by Ronald Wm. Maris, PH.D, Professor Emeritus, University of South Carolina, was read at a symposium in Philadelphia on October 4, 2002. (5) Dr. Maris stated: “Challenge/Dechallenge/Rechallenge studies are a useful and reliable methodology in suggesting drug or SSRI drug causation. In a challenge/dechallenge/rechallenge study patients or subjects are given specific ADs /SSRIs (See Rothchild & Locke, 1991; King, Riddle, Chappell et al., 1991; Beasley rechallenge protocol for Lilly, 1991). If an adverse reaction occurs, the drug may then be discontinued. The adverse side-effect may also stop. Finally, the AD drug may then be readministered and the adverse side-effect may reoccur. Other things being equal, it is scientifically sound to posit in such circumstances that this drug was a proximate cause of the adverse side-effect (See Grounds et al., 1995; Teicher et al., 1990; Mann, 2000: 100).” Many families, including our own, have seen and documented regressions after the first MMR vaccination and then again after the booster. Even if the parents were lured into believing that the initial regression was “just a coincidence”, no one can convince them or for that matter convince a Judge or Jury, that a profound second regression, after a period of improvement, is still yet another coincidence. The tragedy of this situation is that 92 to 95% of children develop immunity to all three diseases after receiving their initial MMR. References 1. Regressive Autism and MMR Vaccination F. Edward Yazbak, MD, FAAP, TL Autism Research. http://www.redflagsweekly.com/yazbak/2003_nov01_1.html 2. The Institute of Medicine of The National Academies 500 Fifth Street NW, Washington DC 20001 E-Mail: iomwww@nas.edu. Website: www.iom.edu Tel: 202.334.2352 .Fax: 202.334.1412 3. http://www.cc.nih.gov/ccc/principles/CALIS%20SLIDES%202002- 2003.ppt 4. ttp://www.researchprotection.org/risks/SSRI0204/AHRP.html 5. http://www.oism.info/teoria_prassi/2002_03_gb.htm Competing interests: Grandfather of a boy with two documented regressions, autistic enterocolitis and evidence of Measles Genomic RNA. |
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John Daniel Stone, None 34 Outram Road, London N22 7AF
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Defending herself against a claim of "conflict of interest" in Private Eye (19 March 2004) Prof. Elizabeth Miller, Head of the Immunisation Division of the UK Health Protection Agency states: "Firstly, there can be no conflict of interest when acting as an expert witness for the courts, because the duty to the courts overrides any other obligation, including to the person from whom the expert receives instruction or by whom they are paid". If this is the case what was basis for the events of four weeks ago when leading scientists, clinicians, journalists and politicians (including the Chief Medical Officer and the Prime Minister) queued up to publicly condemn Dr Wakefield on precisely this same basis? If we can no longer have ordinary decency in our public life, we have to ask why? Competing interests: Parent of an autistic child |
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John Daniel Stone, None 34 Outram Road, London N22 7AF
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Irrespective of who is scientifically correct and who is wrong, I would like to pose the question why it is that we cannot have a tolerant and open professional debate on this issue? Dr Wakefield's professional isolation is often cited in the media, but it is by no means absolute on international basis and could not even be supported with reference to the Rapid Response columns of the BMJ. On the other hand the near 100% unanimity of the profession in this country is sustained by the extraordinary professional consequences that are likely to ensue from open dissent. In pure academic terms this unanimity is for this reason all but meaningless. Equally, the reporting of it in the media has been largelynaieve, to the point of incompetence. Equally puzzling has been the selective and one sided reporting of this affair. It emerged on 27 Febuary (seven days after the present paroxysm began) in The Independnt that Andrew Wakefield had written to The Lancet as long ago as 2 May 1998 to declare his involvement in prosecution case, the letter was published and no one at the time had thought any further about it. However, this has not been reported by the BBC, Times Newspapers, The Lancet or The BMJ, although it is a matter of simple public record and of material value. You wonder at this stage whether anybody ever professionally believed that a serious charge was being brought against Dr Wakefield. Indeed, to have declared this matter as "an interest" might have been considered highly irregular and exceptional. However, it has obviously been greatly exploited for its effect on public opinion. Finally, we must also look with concern at the political dimension. Irrespective of whether Dr Wakefield is right or wrong no one can really look back at the events of four weeks ago and say that this was a wholesome model for dealing with differences of scientific opinion. People who thought that Dr Wakefield was scientifically wrong ought to have been shocked by this extraordinary parade of people ready to condemn him ahead of any hearing. Some newspapers broke ranks to some extent from the official lines of recent months (The Daily Telegraph, The Independent), but not one of our 659 MPs stood up and declared their reservations (although I am sure many had them). The question is, how can we trust a scientific or political community that deals with dissent in this way? Competing interests: Parent of an autistic child |
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Alan J Mulcahy, Management Consultant Dublin, IReland
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Dr Wakefield raised a serious question about a small subset of autism cases. It is important as the first piece of apparent evidence of a link. However in the wider question of vaccine safety, it does not claim to give an opinion. Other studies appear to show that there are problems with vaccinations. These are simply ignored by the authorities, who seem to believe in dogma based medicine, rather than evidence based medicine. There is no study showing that a population of vaccinated children is healthier than a population of never vaccinated children. The Danish study is the closest we have to this. However as the previous use of the DPT for the autistic population was not considered, the study seemed inconclusive to me. If the Danish data really does show no relationship those who have been vaccinated with MMR or DPT and autism, then the finger will probably still point to Mercury poisoning from vaccines. Until there is a cause found for the autism that is prevalent today, then the vaccines remain the prime suspect (I assume that the Autism associated with systems thinking is natural). Competing interests: None declared |
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John Daniel Stone, none 34 Outram Road, London N22 7AF
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Interesting that Alan Mulcahy declares no interest. It is not my experience that there are many parents of autistic children who are anti- vaccine, only some who have become a little more than sceptical as to whether the present policy is as safe as it should be. It would obviously be rash not to administer the DPT (but also rash, perhaps, to administer a big and unnecessary dose of mercury in the cocktail). Confronted by serial charities such as 'Sense', 'Sense about Science' and now, believe it or not 'Inject Sense' it is as well to point out that many of those who have doubts about the safety of MMR or thiomersal/thimerosal are deeply sensible people, with a perfectly legitimate and completely unanswered concern. The patronising tone of these organisations is a cheap and repulsive shot - bearing in mind what these children and their families have to endure. It would, of course, be folly to abandon an immunisation programme altogether, and entertaining it as an intellectual possibility purely whimsical. Competing interests: Parent of an autistic child |
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Viera Scheibner, Principle Research Scientist (Retired) Blackheath, NSW 2785
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C.G. Miller correctly writes in his letter that according to the rule of evidence in law, parents’ videoed observations of their children’s reactions to the administered vaccines are superior to “scientific” evidence. According to Miller the standard of scientific evidence is much higher than the standard of evidence in law because “the scientific standard of proof is the highest known requiring irrefutability, which is too high a hurdle when decision-making in the public interest is concerned”. As a scientist I feel compelled to comment on four aspects in the consideration of scientific evidence relating to medicine: 1. The basic method of scientific inquiry is observation. What is observed with the eyes and other senses is fundamental and material to scientific evidence, in the age of technology observation with the senses is augmented by laboratory tests and instrumentation. The case history is the alpha and omega particularly in medical research. Patients themselves are best equipped to describe their symptoms and, in the case of small children, their parents or other carers. 2. Orthodox medicine is toxic and harmful. It seems accepted that all medications have side (undesirable) effects. However, this is only relevant to orthodox medications. Correctly administered, homoeopathic remedies and natural remedies have no side effects. One has to elaborate here that there could be uncomfortable feelings after homoeopathics but they are desirable effects. Elevated temperature, rashes and vomiting are signs of detoxification and of a desired change of a chronic condition into an acute illness leading to healing. 3. Orthodox medicine with its pharmaceutical industry has become a huge money spinner and as such has become vulnerable to political interference. Vaccination is the best example. To make a lot of money, vaccinators want to vaccinate every child. The more children are vaccinated, the more obvious are the serious side (undesirable) effects including brain damage and death. Politically motivated medicine denies or plays down undesirable effects. The word “obvious” has been banished even though it is considered prudent medical practice that when a medication or a procedure is administered and symptoms appear afterwards, then that medication and/or procedure must be considered as the cause of the observed symptoms. Temporal relationship is the number one condition to satisfy when endeavouring to establish causality, but pro-vaccinators delegate temporal relationship to coincidence despite tens of thousands of cases in which the same symptoms have occurred repeatedly after vaccination. 4. The observed and measured symptoms are the facts and not the conclusions of the researchers which often do not reflect the described facts. A classic example is the observation of polio outbreaks occurring after vaccination programmes: In their paper on the polio epidemic in Taiwan, Kim-Farley et al. (1984) wrote “Taiwan had been free of major poliomyelitis outbreaks since 1975, but from May 29 to October 26 1982, 1031 cases of type 1 paralytic poliomyelitis were reported to the Taiwan health authorities. Before the outbreak approximately 80% of infants had received at least two doses of trivalent oral polio vaccine (OPV) before their first birthday… Vaccinations received in the 28 days before onset of illness were not counted because they might have been given after exposure”. The facts of the matter are that the majority of vaccine-caused poliomyelitis cases occur after the first and second doses (Strebel et al. 1992) while the statement “…they might have been given after the exposure” is not a fact but only an unproven assumption since there had been no major outbreaks of polio since 1975 (for 8 years) and there was no reason to expect an epidemic. Sutter et al. (1991) described the poliomyelitis outbreak in Oman. “From January 1988 to March 1989, a widespread outbreak (118) cases of poliomyelitis type 1 occurred in Oman. Incidence of paralytic disease was highest in children younger than 2 years (87/100 000) despite an immunisation programme that recently had raised coverage with 3 doses of oral poliovirus vaccine (OPV) among 12-month old children from 67% to 87%.” Despite? Moreover, “There was no correlation between vaccination coverage and attack rates by region; the region with the highest attack rate (Batinah. 117/100 000) had one of the highest coverage rates (88%), whereas the region with the lowest coverage had a low attack rate.” No correlation? There was actually a perfect correlation between the coverage rates and a number of cases, demonstrating that vaccine was actually causing poliomyelitis in its recipients (and their contacts). The fact of the vaccine causing poliomyelitis is further supported by the events in Namibia. Van Niekerk et al. (1994) wrote “The last confirmed case of poliomyelitis in Namibia had been reported in 1988. However, between Nov 8, 1993, and Jan 7, 1994, 27 cases of paralytic poliomyelitis were confirmed in the country. The outbreak had been limited to the south health region; at least 80% of infants in this region had received four doses of oral poliovaccine (OPV) by the age of 1 year… Of the 26 patients whose vaccine status was known, 14 had received four doses of OPV, 6 had one or two doses, and 6 no vaccine.” Hardly a great vaccination success! Importantly, there was no vaccination programme in the north health region and no epidemic. Despite such obvious facts to the contrary, the authors wrote that vaccine efficacy for three or more doses of polio vaccine was calculated to be about 80%. Since most vaccine-caused poliomyelitis occurs after the first and second doses, then the “calculated 80% efficacy for three or more doses” simply demonstrated that most of the cases in Namibia occurred after the first and second doses. Just like in Taiwan, mass vaccination in Oman was not only an abysmal failure, but the vaccine actually caused the observed poliomyelitis outbreak. Polio outbreaks closely following mass vaccination programmes also occurred in Gambia, Albania, Romania and Brazil to mention just a few of many examples. Since 1996 I have been asked and written some 80 reports on shaken baby syndrome, vaccine compensation and other vaccine related problem cases in the USA, UK, Australia and Iceland. The ubiquitous pathological findings in SBS cases are: 1. Central nervous system (brain and spinal cord) subdural and subarachnoid and parenchymal haemorrhages and retinal haemorrhages separately or together with brain oedema. 2. Diabetes insipidus accompanied by metabolic acidosis (low pH values) polyuria, polydipsia and hyperglycaemia and in some cases by bizarre rib and other bone fractures known to be characteristic of acute scurvy and bizarre haemorrhages such as around the base of the scalp hair. 3. Lack of signs of external injury. 4. Blood clotting derangements (hypo- or hyper-coagulability) including acquired von Willebrand Syndrome. Medical “evidence” claims in unison that such injuries can only be caused by shaking. The truth is that there are dozens of research articles published in refereed medical journals which link the above pathology to vaccines (Scheibner 2001). In many of my reports I now write that the accused parents are not perpetrators of the observed injuries, in reality they are eye witnesses to medical misadventure or iatrogenesis. Medicine treats case histories as invalid and “only anecdotal” and the word anecdotal has become a sort of dirty word in medicine. Medicine tends to rely on diagnostic value of tests and instruments. In the SBS cases, however, even though these tests themselves show clearly that the observed injuries are a result of immunological injury rather than trauma, they are ignored and the SBS diagnosis is made before any tests are done. What about MMR causing autism? Even those researchers who found the measles vaccine virus in the diseased gut of the autistic children denied that their research represents the evidence of causality without defining what they would consider the evidence of causality. When the wild and, later on, vaccine measles viruses were found in the diseased brains of SSPE sufferers, the causal link to these viruses was accepted without dispute (Payne et al. 1969). Many medical doctors have an alarming lack of understanding of laboratory tests and particularly of x-.rays, one of the best examples being mistaking typical bone changes (including bizarre “fractures”) known to occur in scurvy, as traumatic fractures caused by the carers. This devaluation of observation and instrument and laboratory tests as diagnostic tools in SBS started with Caffey in 1946 when he published his paper “Multiple fractures in the long bones of infants suffering from chronic subdural hematoma”. In 1965 Caffey admitted that he was not a formally trained radiologist: sadly, these days the formally trained radiologists blindly follow the misinterpretations started by Caffey. The result is a mess which will take years to rectify. In my Letter to the Editor of “Vaccine” (Scheibner 2003) I wrote that I do not delve into conspiracies, I rather talk about ignorance and stupidity. Most mainstream journalists have little to contribute. I conclude that medicine has to an alarming extent become a system which is neither based on case histories nor on science. As one lawyer put it, medicine is devaluing the rule of evidence in law and, may I add, also the rule of evidence in medicine and science. Quo vadis, medicine? Viera Scheibner, PhD. References: Kim-Farley RJ, Lichfield P. Orenstein WA, Bart KJ et al. 1984. Outbreak of paralytic poliomyelitis, Taiwan. Lancet (December 8): 1322- 1324. Strebel PM, Sutter RW, Cochi SL, Biellik, RJ et al. 1991. Epidemiology of poliomyelitis in the United States one decade after the last reported case of indigenous wild virus-associated disease. Clinical infect Diseases; 14: 568-579. Sutter RW, Patriarca PA, Brogan S, Malankar PG, et al. 1991. Outbreak of paralytic poliomyelitis in Oman: evidence for widespread transmission among fully vaccinated children. Lancet; 338: 715-720. Scheibner V. 2001. Shaken Baby Syndrome Diagnosis On Shaky Ground. J Australasian College of Nutritional and environmental Medicine (ACNEM); 20(2): 5-8 &15. Payne FE, Baublis JV, and Hidedo H. Itabashi. 1969. Isolation of measles virus from cell cultures of brain from a patient with subacute sclerosing panencephalitis. New Engl J Med; 281(11): 585-589. Caffey J, 1946. Multiple fractures in the long bones of infants suffering from chronic subdural hematoma. AM J Roentgenol & Radiation Therapy; 56(2): 163-173. Caffey J, 1965. Significance of history in the diagnosis of traumatic injury to children. J Pediatrics; 67(5) part 2: 1008-1014. Scheibner V. 2003. Response to Leask and McIntyre’s attack on myself as a public opponent of vaccination. Vaccine 22: vi-ix. Competing interests: None declared |
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John Stone, none London N22
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Many months on from Clifford Miller's original post we find that still people will not address the key point, which is the almost utter irrelevance of what has taken place in the past nearly seven years. What was the reaction by health official to parents on learning that their children had suffered serious adverse effects from the application of a pharmaceutical product (namely MMR)? Was it to express concern? Was it to change or modify the policy? Was it to launch an investigation? NO: THE FIRST RESPONSE WAS TO DENY EVERYTHING. I think it is worth pointing out that this attitude is neither responsible, trustworthy or even decently human. From then on everything they did deserved to be treated with extreme scepticism, derision and contempt. Competing interests: Parent of an autistic child |
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John Stone, none London N22
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Since I submitted my previous post two days ago the following relevant documents have been published: 1) F Edward Yazbak, 'Vioxx and vaccines: Vive la difference', at http://www.redflagsweekly.com/conferences/vaccines/2004_nov22.html 2) Harold Buttram, 'Vaccine safety testings: what are they, and why do them? (As related to the current epidemics of childhood autism, learning disabilities, and other medical-legal issues)at http://www.sarnet.org/lib/VaxTest.htm 3) PR Newswire Nov 22: 'Safe-minds' report shows CDC ignored autism- mercury data: documents show agency discovered elevated autism risks and witheld from public/Congress' at http://biz.yahoo.com/prnews/041122/nem030_1.html Competing interests: Parent of an autistic child |
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Raymond Gallup, Founder of The Autism Autoimmunity Project 45 Iroquois Avenue, Lake Hiawatha, NJ 07034, USA
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I agree with John Stone's response below: "Many months on from Clifford Miller's original post we find that still people will not address the key point, which is the almost utter irrelevance of what has taken place in the past nearly seven years. What was the reaction by health official to parents on learning that their children had suffered serious adverse effects from the application of a pharmaceutical product (namely MMR)? Was it to express concern? Was it to change or modify the policy? Was it to launch an investigation? NO: THE FIRST RESPONSE WAS TO DENY EVERYTHING. I think it is worth pointing out that this attitude is neither responsible, trustworthy or even decently human. From then on everything they did deserved to be treated with extreme scepticism, derision and contempt." A recent article by F. Edward Yazbak, MD titled "VIOXX and Vaccines: Vive La Difference" points out that prescription drugs that have adverse reactions are treated different than vaccines. (1) Also, in the movie, "A Civil Action" (2), the John Travolta character named Jan Schlichtmann, based on a true story, says that white males with earning potential are usually people that win lawsuits and not children. So too, it seems that adults that die or are injured by a prescription drug matter much more than babies or children that die or are injured by a vaccine. References: 1.http://www.redflagsweekly.com/conferences/vaccines/2004_nov22.html 2.http://us.imdb.com/title/tt0120633/ Competing interests: Founder of The Autism Autoimmunity Project and father to Eric Gallup, who was born normal and regressed into autism after receiving the MMR vaccine |
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Richard P Carruthers, Carer Brantwood, 8 Pomona Road, Shanklin, Isle of Wight, PO37 6PF
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Dear all, I write to support Viera Scheibner's contribution, 26 March 2004, http://bmj.bmjjournals.com/cgi/eletters/328/7440/602-c#54389 She writes: "C.G. Miller correctly writes in his letter that according to the rule of evidence in law, parents’ videoed observations of their children’s reactions to the administered vaccines are superior to “scientific” evidence. According to Miller the standard of scientific evidence is much higher than the standard of evidence in law because “the scientific standard of proof is the highest known requiring irrefutability, which is too high a hurdle when decision-making in the public interest is concerned". Concerning the scientific standard of proof being the highest known and requiring "IRREFUTABILITY" or "CONCLUSIVE PROOF". This really seems to be to high a standard to be practical even in a scientific context. To illustrate this particular point I refer to the work of Dr. Barry Trower, from his (at one time) confidential report on TETRA (Terrestrial Trunked Radio) for the police federation of England and Wales, 2000. http://www.planningsanity.co.uk/reports/trower.htm Dr. Trower's comments also highlight other problems encountered when asking "authority" - Please look at ALL the evidence and do so in a truly scientific manner and see what has been under your noses for years, i.e. Vaccine Damaged Children. "THE CONCLUSIVE PROOF ARGUMENT The Government's scientists will often ask for conclusive proof when they are challenged. It is a word often used when you wish to win your side of the argument. Scientifically conclusive proof is impossible to obtain – let me explain. I was at a legal hearing in Torquay representing a community and the barrister representing the communications industry said "there is no conclusive proof that these microwaves will cause damage". I argued: if somebody stood up and shot me in this courtroom there would be three levels of proof. You would have everybody as a witness and that would be accepted in a Court of Law. A pathologist could perform a post mortem, decide that the bullet killed me and that would be a second level of proof. If, however you wanted conclusive proof that the bullet killed me, you would have to argue that at the split second the bullet went into my body every system in my body was working perfectly because there are thousands of reasons why I could drop dead on the spot before the bullet went in and you would have to prove conclusively that all of these systems were working perfectly before the bullet went in. Clearly, this is scientifically impossible; there is no such thing as conclusive proof, yet it is what is demanded by government scientists when challenging their decisions. Conclusive proof has been demanded by scientists defending their decisions after they have said the following are safe: Thalidomide; Asbestos; BSE; Smoking; Sheep dip; Gulf War Syndrome; GM Foods; and Vitamin B6. With the above list it will be recognised that evidence of damage from these comes only from counting the people who are injured. I am arguing scientifically that there is a blanket denial by some scientists and the only way to show them wrong is to present them with a certain number of bodies. When commercial interests are at stake there seems to be a denial of relevant scientific data. The problem with the microwave communications industry is that they do not have to prove it is safe; you have to prove it is not, and that is an entirely different ball game. As a scientist, if I develop a new pill I have to run a 5 or 10 year clinical trial and convince a Board of my peers that it is safe before I have permission to release the pill onto the market. With the telecommunications industry the tables are completely turned around. They do not have to show these instruments are safe; you have to show they are not." Competing interests: Parent of two Autistic children. No MMR Vaccinations but other medicines may have triggered their mental conditions. |
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