Email Clifford G. Miller
 

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