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The RMA - Ten Years On & Its Evolving RoleProfessor John Kearsley, RMA Member Paper prepared from edited transcripts of the RMA Forum The RMA - Ten Years On & 1998 Canberra Forum PublicationMy role, as the first RMA speaker, is really to set the scene for this conference, to offer an overview, to review our achievements and to review the limitations under which we also work as the Repatriation Medical Authority. I'd also like to provide a sense of the journey that has led us to these achievements. When the RMA was first created 10 years ago, the SOP concept was a largely foreign area. There was no template, there was no blueprint and there was no history that the fledging RMA could reflect upon. What we had was the Veterans' Entitlements Act and some very skilled people. At this point I would like to pay tribute to our Chairman, Professor Ken Donald, because I think he has been an amazing example of how to make an organisation forge ahead. Where there was nothing, there now is something substantial, and Professor Donald has been, in significant part, responsible for that achievement. One of the things Professor Donald has always implored to RMA members is that we need to act lawfully. It is important to understand the framework in which we've had to work. The first part of my talk is really an overview or a review of our achievements, and I will highlight seven achievements. The second part of my talk will be to review some of the limitations that really are, to a great extent, not in the RMA's direct control. It is important because sometimes individuals, and members of Ex-Service Organisations, do not agree with us or our views. It's important to understand that a lot of this tension is actually not our fault. We are often restricted by either the poor quality of the science, the poor quality of the published peer reviewed literature, or sometimes the legislation itself in respect of occasional unrealistic expectations. The first RMA achievement is the establishment and refinement of the SOP system. Back in 1994, we didn't really have a history and we didn't know what a SOP would look like. By the end of the year 2003, the RMA had produced nearly 1200 instruments, covering a total of 276 individual conditions and the percentage of conditions covered by SOPs at the primary level in 2003 was 93.2%. The RMA has covered the vast majority of the important SOPs. Initially, of course, the first priority was to determine as many SOPs as possible. We chose those SOPs for which we thought there were likely to be many claims and for which there was good and reliable peer-reviewed published evidence. In the first three years after the inception of the RMA, 229 conditions were covered, and 667 instruments were determined. The emphasis now has changed in that, while we are still creating SOPs, we now spend most our time reviewing SOPs because the nature of the peer reviewed literature is that it is always changing and being refined. In each investigation the evidence for all potential factors is reviewed. We have become very particular about how we write the factors because, as you will be aware, there are a large number of very sophisticated SOP users. These include the veteran community, Ex-Service Organisations, the courts, the AAT, the VRB, the SMRC and the wider community. The SOPs are now readily available on the RMA Website, and so there is a lot more scrutiny as to what we write and the factors that are created. I will come back to that issue of interpretation afterwards. Currently, of course, there's a steady and increasing flow of requests for investigations, or review. As I have said, new information accumulates rapidly, so that most requests require a review of the whole evidence and therefore an investigation is advertised. Requests for investigations can also be received from the SMRC. There is now an expanding role for SOPs for serving personnel because of the new MRC Act. I might just go back to this point about reviews and the thoroughness of the SOPs. The current review of Malignant Neoplasm of the Prostate gland for instance will take in excess of eight months to fully and properly re-examine. So these reviews do take time. We review the whole SOP and all the factors just to ensure that no new factor has emerged or existing factors have changed. Now, why do SOPs change? I want to clarify first of all that, in fact, existing SOPs do not of themselves change. If we want to change a SOP, the SOP needs to be revoked and then reissued. SOPs change for a number of reasons. One, as I've said, is that there is new sound medical-scientific evidence. Upon review a change may or may not be required, depending on the evolution of that information in peer reviewed journals. There may be administrative reasons for change- someone may have left out a semi-colon, there might be an alteration in the format, or at times there might be just too many amendments. Sometimes also, there are problems in interpreting the factors, or what we mean by a disease entity. I recall that there was great argument at one stage of what we meant by the "large intestine". Now, for most people the large intestine is the large intestine, but when we have to define it so carefully in SOPs we have to make sure that we know exactly where the ileo-caecal valve fits. Is it part of the large or small intestine? And does the recto-sigmoid include the large intestine? These are issues about clarity of disease definitions. Sometimes, we know what we think and what we meant, but other people think that we meant something different. The courts, ESOs and veterans are extremely helpful in helping to clarify factors, because sometimes what we write as a factor in terms of the exposure or the amount of the exposure is open to interpretation. We certainly thank the ESOs and other people who have pointed out variable interpretations of our factors to us. The RMA flowchart on Determination of SOPs shows the step by step process by which the RMA acts to produce a SOP (Appendix 1). When we receive a request from an ESO, the Repatriation Commission, other organisations, or veterans, the RMA goes through a process. The first step is; is the condition under consideration a disease? If it's not then we are unable, under the legislation, to create a SOP. The RMA has discussed the condition of hiatus hernia, and this is just provided as an illustration of how hard it is sometimes to know if an entity is a disease or not. Hiatus hernia is where part of the stomach slides up into the chest. We know from radiology studies that at least 60% of the normal population have a sliding hiatus hernia without symptoms, and sometimes it's an incidental finding. The problem for us sometimes is knowing whether a common condition can actually be considered a disease. What people come to the general practitioner with are symptoms, but if you have a sliding hiatus hernia you may have reflux, and that reflux may cause symptoms. However, there are some people who have a hiatus hernia, no reflux and no symptoms, and other people can have symptoms without reflux. Whether the "disease" is hiatus hernia, or whether the entity is "reflux", occupies our time in discussion. In a large number of cases the literature on particular entities is unhelpful and sometimes it's hard to separate in the published literature reflux and symptoms from hiatus hernia itself. The next step, after we have considered whether a condition is a disease under the Act, is to ask, "Is there published peer reviewed evidence?". If there is, we then collate a range of factors which can be potentially implicated in the causation of disease X with potential for military service exposure. This is a huge task and our Secretariat is involved heavily in this area. RMA members then view the evidence. Each RMA member brings with them their own experience on whether a factor identified can be considered "causative". We tend to use the option of clinical judgment if we are considering a relatively rare condition for which there is no peer reviewed published evidence on causation. One that I had personal experience with years ago is Merkel cell tumour of the skin. You will never, ever, ever see a published paper looking at causation in a strictly scientific fashion because the tumour is so rare. However, because I've had experience and seen patients with that condition, to me, it was fairly obvious that this particularly rare skin condition is highly related to sun exposure even though there is very little published evidence. You will see that in the skin cancer SOP, Merkel cell cancer therefore appears. Once we have assessed causation, we then apply the two standards of proof, either at the reasonable hypothesis level or at the balance of probabilities level. I will discuss those particular issues afterwards. The second major achievement is the development of an RMA website which contains an introduction to the RMA, a short history, profiles of the RMA members and a list of current investigations and reviews. The various RMA publications are published and there are useful links provided. The third achievement is a more efficient review process. Back in the year 2000 new powers were introduced in amendments to the VEA (section 196CA). The RMA is now allowed to decline a request for formal review if there is no new evidence provided. An investigation is a laborious process and it tends to tie up an enormous amount of RMA time. This amendment means that we don't need to look at reviewing SOPs if there is little in the way of new evidence. There is also the power to collate requests so that they can all be folded into the one investigation. In addition, we have had additional medical research officers appointed to the RMA because of the volume of work. The fourth achievement is independence from the Department of Veteran Affairs. That has been maintained, and we have separate legal advice and staff. The fifth achievement is that the expertise of the RMA membership has been maintained. We have always had an epidemiologist and most of us have epidemiology experience. The subject matter expertise of RMA members ranges across most diseases and we all have a broad experience, whether that be in public health, public administration, research and/or clinical practice. RMA members have varying periods of appointment to avoid all of us retiring at the same time and therefore a loss of corporate memory. It's very important that we calibrate with each other so that the mind of the RMA in five years is the same mind of the RMA as it currently is, assuming no change in the Veterans' Entitlements Act. The sixth achievement is our pro-active approach to communication between the RMA and the community of SOP users. There's never a sense that we have, in creating SOPs, tried to slip one in under cover. Any proposed change is always advertised. We always have that transparency so that people know what is happening with the factors. In fact, ESO representatives are always consulted if there is a potential to make a factor harder to meet in a Statement of Principle or in deed, if a factor is to be removed. There are regular mail outs and publication of annual reports and explanatory notes. Forums and conferences have been held and RMA members and the Secretariat attend relevant conferences and meetings. People also understand that when they ring the RMA they will get a good informal hearing by either the Registrar or by other members of the Secretariat. The seventh and final achievement relates to the RMA's other roles. The RMA is not always the RMA in that we have occasionally, as individuals, been appointed to various expert committees, and most of these expert committees or working parties have been followed by publications and proceedings. We have looked at spina bifida occurrence in children of Vietnam veterans; the health effects of depleted uranium; radiation exposure; and the health of SAS veterans. In the mid 90s there were big conference, on smoking and malignant neoplasm of the prostate gland; and stress and health. There are some negatives in that the expert groups and conferences do take up a lot of time for the RMA and the Secretariat. The second half of my talk is an attempt to illustrate some of the legislative and scientific limitations which affect the RMA processes. I think most people understand that the remit of the RMA is not to carry out research so I will not discuss that any further. We will consider these limitations under three headings. The first is: "What constitutes sound medical-scientific evidence (SMSE)?". The second limitation is, "How we define disease?". The third limitation is the standards of proof which apply to particular types of service. Section 5AB(2) of the VEA specifies what constitutes SMSE. SMSE is taken to be information that has been published in a medical or scientific publication and has been subjected to a peer review process. It can also be information which, in accordance with generally-accepted medical practice, would serve as a basis for diagnosis and management of a medical condition. Material on the Internet is often not peer-reviewed unless published by a reputable organisation, so generally we don't accept Internet material as SMSE. Expert opinions also don't usually count as SMSE, unless they are supported by published evidence. I should expand on the word "hypothesis", because there has always been some confusion about that word. In the Veterans' Entitlements Act, "hypothesis" is used in a legal sense, whereas scientists think of "hypothesis" more in a scientific sense. In the legal sense, "hypothesis" means that there is substantial evidence that points towards a causal association between a factor or an exposure and a disease. The linkage must not be fanciful, and it has sometimes been quantified by people outside the RMA as roughly a 1 in 20 probability that factor X is linked with disease Y. However, in the scientific sense a hypothesis is really a hunch and when scientists conduct experiments they have to state their hypothesis: "We think this is what happens. This is such and this is what we intend to prove". In the legal sense, for the purposes of the RMA, the evidence needs to be there first. I will now give some examples of the problems with expert opinions. It would be possible to pay an expert witness, I suspect, to show that cannon fire causes haemorrhoids. If you think about it, cannon fire is a shock that could increase straining or increase pelvic pressure, and if repeated over a time, could lead to haemorrhoids. That might have happened in the past, but if you look up the scientific literature, I doubt whether there will be any evidence of cannon fire as a causative agent in haemorrhoids in the legal sense that we work with. Another example of expert opinion is a letter which came from an eminent heart specialist. The issue at hand was whether smoking was related to thrombosis, or clotting in the veins, and the cardiologist said: "A specific cause for the thrombosis in this person was not found, but there is a well-established connection between cigarette smoking and venous thrombosis and it seems that cigarette smoking was a factor in its causation. In summary, then, this person has a history of femoral vein clotting and coronary artery disease. There is little doubt that cigarette smoking is causally related to both of these conditions." That opinion was sent in as a letter without any supporting evidence. A review of the literature between cigarette smoking and venous thrombus, showed that: ".. few controlled studies that dealt with venous clotting alone were found that supported a positive association with smoking, hence a smoking factor has not been suggested for the SOP on deep venous thrombosis." The RMA takes seriously the opinion of a medical colleague. We would look up the literature to see whether any literature had changed, but as people can see in this instance, the literature had not changed and there was still insufficient peer-reviewed published evidence to support that link. In the scientific literature it is part of the methodology of a study to clearly define exposures and outcomes, whereas the RMA is often asked to investigate chemicals or groups of exposures. We find out that veterans are concerned about aircraft exhaust, or petroleum fumes or smoke as being causative factors for disease or illness. Our understanding, as the RMA, is that we need to actually drill into what the chemical compounds are rather than just make a factor that says "exposed to smoke". It is our understanding that we need to know the chemicals that cause harm, rather than just a mixture of chemical substances. Similarly, it is neither legally nor scientifically correct to make factors for groups of veterans. In the past the RMA has made a factor for prisoners of war. That factor was made very early in the history of the RMA because it was almost impossible to tease out what the noxious exposure really was. There were very few prisoners of war and, of course, they were subject to appalling conditions. Since then we have tried to stay away from including groups of veterans in the SOP factors. We come now to the definition of "disease", which is defined in section 5D(1) of the legislation. I have already described the issue with hiatus hernia and tried to highlight the problems that the RMA faces in dealing with conditions that are common in apparently normal people. It is important to understand that a disease does not include a temporary departure from normal physiological state or the accepted ranges of physiological or biochemical measures that result from normal physiological stress. Another limitation related to 5D is the inability to make a SOP for a condition that is not recognised as a disease. For instance, studies of Gulf War veterans in Australia and overseas have found an excess of self-reported symptoms, but these are not able to be classified as a disease under the Act. Constellations of symptoms do not always cluster in a consistent way to enable a syndrome or disease to be defined. It is not clear sometimes when a risk factor becomes a disease. For many years within the RMA, we have debated whether conditions like obesity, hypertension or high serum cholesterol actually constitute a disease or whether they are simply a continuum of normal life. The issue with hypertension has cropped up over many years and people will understand that hypertension, obesity and hypercholesterolaemia are certainly risk factors for other diseases such as stroke. These are bad prognostic factors but whether the risk factors themselves actually constitute a disease is open to some debate. Of course, most of these risk factors are treated, and so if you go to your GP and you have high blood pressure or you are obese, or you have hypercholesterolaemia, you will almost certainly be treated. Take hypertension as an example. In the past, a blood pressure of 140 on 90 has been considered to be "normal", but if you have a blood pressure of 140 on 90, you can still suffer one of the side effects or one of the sequelae from hypertension. The lower your blood pressure is, it is claimed, the longer you will live, and blood pressure or hypertension is seen as a continuum rather than a fixed disease entity. The mind of the RMA in relation to this issue is still in a state of flux. However, as uou would be aware, we do in fact have SOPs for hypertension and morbid obesity. The next legislative issue relates to Sections 196B(2) and 196B(3) which specify the two standards of proof. The RMA must determine the Statement of Principles in respect of injuries, disease or death, setting out the factors that must, or must as a minimum, exist and which of those factors must be related to service. Our view is that any factor, or any circumstance, can be related to service, apart from genetic factors. The RMA is not able to include a factor unless the body of SMSE points to or supports a reasonable hypothesis of a causal association between the factor and the outcome. This standard of proof applies to injury, disease or death incurred on operational, hazardous or peacekeeping service. For the balance of probabilities standard, which applies to eligible war service and defence service, the SMSE has to show that it is more probable than not that the factor in question is causally related to the disease. For many diseases, despite extensive review of the literature and a very generous standard of proof, few or no causes can be identified. Sometimes factors related to service cannot be included due to lack of evidence. In looking at causation, the RMA starts with a particular disease rather than starting with a particular symptom or exposure. In general, the RMA is not required to examine risk factors or exposures and consider all their potential adverse health effects. The RMA is required to focus on particular kinds of injury, disease, or death, as they relate to service. The starting point is a disease rather than a risk factor or exposure. In addition, the RMA is not required to determine matters of fact concerning an individual veterans' service record and the link between his or her service and a factor. That is the role of DVA. Synergistic effects are not usually considered. Let us take cancers of the tongue as an example. If you smoke, then you are at risk of cancer of the tongue. If you drink alcohol, you are at risk of developing cancer of the tongue. If you both smoke and drink, then you are at a much greater risk of developing cancer of the tongue. The problem here is that the literature often is not of sufficient quality that we can tease out exactly how much of a contribution smoking and alcohol consumption may contribute to a given condition. Likewise, the RMA does not consider positive effects of exposures, only the negative effects. That is in accord with the legislation. Our remit is to consider exposures that are responsible for illness, not protective effects. In looking through factors causative for illness or disease we sometimes find protective factors, such as DDT in relation to breast cancer and alcohol in low doses in relation to heart attacks, but they do not enter into our consideration when we create factors for SOPs. We may however, consider inability to undertake protective actions, such as exercise or consumption of dietary fibre. The last issue is that of idiosyncratic factors in disease causation. These are largely genetic factors which we don't take into consideration. One example is UV light exposure and skin cancer. It is obvious that a person's skin has an impact on whether they are predisposed to developing skin cancer. Some people have fairer skin than others, but this is again not a consideration that we take into account. In concluding my talk, I hope that I have been able to set the scene for speakers who will follow. I have attempted to provide an overview of the journey that the RMA has taken over these 10 years, and also to point out to you our achievements over that period of time. As the RMA we will continue to act appropriately, carefully and, most of all, lawfully. We will continue to seek sound medical-scientific evidence for causation and we will continue to be open to surprises in our work. Thank you.
This page last updated 22 March 2005. |
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