Thursday, March 1, 2012

Pathological science Arsenic CKDU  and Pesticides



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Dr. Anura Wiejsekara

Registrar of Pesticides

Pathological Science

A few days ago (on 21st of February) an important regulation under the Control of Pesticide act No. 33 of 1980 was discussed and passed by the Parliament of Sri Lanka. Although both government and opposition members of the parliament were supportive of the regulation all were very critical of pesticides. The issue of Arsenic in pesticides was the favorite subject of discussion during the debate. While listening to our honorable members of the parliament for over four hours I was reminded of Pathological Science.

The term Pathological Science was coined by the Nobel laureate Chemist Irving Langmuir in 1953. He defined pathological science as an area of research that do not go away long after it was given up as false by the majority of scientists in the field. In other words it is the science of things that are not so. N-Rays described by the physicist Prosper-René Blondlot in 1903, Polywater of the Physicist Nikolai Fedyakin in 1960s and Cold Fusion by electrochemists Stanley Pons and Martin Fleischmann in 1989 are often cited as examples of pathological science. Probably it is too early to decide, whether recently revealed faster than speed of light particle and Arsenic based life forms in the United States are also cases of pathological science. However, the Arsenic scare that is being advertised by various activists in Sri Lanka at present certainly has characteristics of Pathological Science.

Medical Doctor Henry I. Miller, physician and fellow at Stanford University has published an article titled ‘Activism, Mendacity, and Pathological Science’ in Genetic Engineering and Biotechnology News (Vol. 29, No. 15 -2009). In this article he states that "Consumers are increasingly being exposed to pathological science. It is the specialty of self-styled public interest groups, whose agenda too often is not protection of public health or the environment, but intractable opposition to whatever research, product, or technology they happen to dislike. This is not a harmless diversion: When their machinations give rise to overregulation—or even bans—of safe and useful products or processes, all of society is the poorer for it".

Arsenic

What transpired in the parliament debate mentioned above was the depth of the Arsenic scare that has been created by a group of activists through media. The word ‘Arsenic’ has become synonymous with poison among the general public although there are more deadlier poisons in the world probably due to horror stories of deliberate poisoning by use of Arsenic. Yet it is largely unknown that Arsenic is the 20th most abundant element in the World. Scientists consider Arsenic as a trace element but not a rear earth element. Being the 20th most abundant element it is present in the environment in varying amounts. It is naturally found in the air, water, soil, plants and animals including humans. Arsenic occurs in above average amounts naturally in some areas of the world. Human activities have sometimes lead to the accumulation of Arsenic in excessive amounts in certain areas. It is estimated that fossil fuel burning alone add 80,000 tons of Arsenic to the world environment annually. In nature, Arsenic as many other elements cycle in the environment. Animals including humans have evolved mechanisms of excreting Arsenic when it is consumed in normal amounts. However, long term consumption of relatively higher amounts of Arsenic leads to accumulation of Arsenic in various body tissues and to Chronic Arsenic Poisoning.

CKDU

From what I have read Chronic Kidney Disease (CKD) or gradual deterioration of kidneys is not an uncommon ailment around the world. There seems to be many different causes for CKD like diabetes, high blood pressure, genetics, snake poisons etc. In addition to CKD with known causes doctors have found CKD that cannot be explained with known causes. This form of chronic kidney disease with unknown cause is called Chronic Kidney Disease of Unknown etiology (CKDU). There is CKDU in Balkan countries for the last 50 years and doctors are still trying to find the cause of this disease. Similarly the workers of sugar cane fields in Central American countries are also suffering from a form of CKDU. Unfortunately increasing incidence of CKDU has been reported from very specific geographic areas of Sri Lanka too. Many scientists in the country have been studying the disease trying find out the causal factor or factors of this disease. Few hypotheses have been put forward and many experiments have been conducted trying to prove these hypothesis. Yet the published results indicate that that there is no consensus among the scientists on cause of CKDU in Sri Lanka.

The most recent hypothecs put forward is that the causal agent of CKDU in Sri Lanka is Arsenic. This probably is a worthwhile hypothesis to test. But unfortunately proponents of the hypothesis have shown exact characteristics of pathological science making it very difficult for fellow scientist to accept their results. The following paragraph from Dr. Millers article is exactly true for the Arsenic scare that has been dumped upon our society by proponents of above hypothesis. Dr. Miller says "activist-funded research is commonly held to a lower standard or none at all. Activists’ claims are typically promoted by alarmist press releases and reported by the media (their dual mottos: "If it bleeds, it leads," and "Never let facts get in the way of a good story"), but seldom are they independently peer-reviewed and published in scientific journals. Sadly, after its claims are repeated again and again, policy-makers, the media, and the public come to accept this pathological science as credible—or even proven".

Pesticides

The proponents of the CKDU due to Arsenic first claimed that excessive amounts of Arsenic in CKDU endemic areas come from pesticides and most of this Arsenic accumulates in water and rice. Later they withdrew the claim of Arsenic in rice apparently due to political pressure. They also have implied that certain multinational companies add Arsenic deliberately to increase the effectiveness of pesticides. How true the words of Dr. Miller when he wrote "Activists who disapprove of certain kinds of R&D or marketed products often try to stigmatize them via guilt by association with corporate interests". The Arsenic found in certain pesticides is in parts per billion levels. They are nothing but unavoidable impurities that come from the production process. If companies add such low amounts of Arsenic to increase the efficiency of their pesticides as the proponents claim the companies are wasting their time. Such low levels of Arsenic will not kill any pest and pest control cannot depend on chronic effects of pesticides.

The proponents of ‘Arsenic from pesticides’ also claim that there is no Arsenic in bed rock of Sri Lanka and therefore, our soil cannot contain Arsenic in it as soil is form by the withering of rocks. Yet there is published literature to show that Arsenic is present in bed rocks of this country!

As the Registrar of Pesticides I have a responsibility to investigate the claims made on pesticides. As I have already explained to the public (article published in The Island on 17th June 2011) Arsenic was found in few pesticides in minuscule amounts as impurities. The duty of fifteen members of the Pesticide Technical and Advisory Committee formed according to the provisions of the Control of Pesticides Act was to decide whether the amounts of Arsenic found in certain pesticides would cause Arsenic accumulation in the environment due to repetitive use of pesticides over long period of time. They listened to the views of leading geologist in the country who have studied Arsenic in our environment. They studied the published scientific information relevant to the issue and the committee decided that there is no evidence at all to support the idea that pesticides cause Arsenic accumulation in the environment, agricultural or natural. By contrast we found enough scientific evidence from published literature to falsify the claims of Arsenic hypothesis proponents.

There is an interesting study done by a local group of scientists to find out why elephants eat soil (geophagy) from certain areas in the jungle but not from other areas. They have analyzed soils from Udawalawa sanctuary for this purpose. One of the chemicals they analyzed happened to be Arsenic. The relevance here is that this study shows that soil from Udawalawa has more Arsenic (9-33 ppm) than what has been found in pesticides of CKDU endemic areas (maximum 2.6 ppm). Such findings do not support the claims of Arsenic hypothesis proponents.

Proponents of Arsenic hypothesis have blamed the Registrar of Pesticides (ROP) for not banning the pesticides with Arsenic. On the contrary it is the ROP that has banned importation of any pesticide to Sri Lanka with Arsenic as an active ingredient. This piece of regulation under the Control of Pesticides Act has been misinterpreted by the proponents in support of their cause. In addition they claim that ROP has stated that eating small amounts of Arsenic is not a problem. This again is a misinterpretation of my attempts to educate the public on the natural occurrence of arsenic as a trace element.

Dr. Miller states that "Frequently decision makers give up the difficult task of finding out where the weight of scientific opinion lies, and instead attach equal value to each side in an effort to approximate fairness. In this way extraordinary opinions are promoted to a form of respectability that approaches equal status. This kind of undeserved moral equivalence frequently compromises governmental decision making and has given rise to unscientific and inconsistent regulation of many other products and technologies as well, including pesticides and other chemicals".

It is true that some of the regulatory decisions that we have taken have been induced by the Arsenic fiasco. Yet I have made it certain not to give way to unscientific and inconsistent regulation of pesticides in Sri Lanka. As Dr. Miller points out "No one should mistake activists’ misdemeanors and mischief for naive exuberance or excessive zeal in a good cause. In case after case, their motives are self-serving and their tactics callous".

The present Dean of the Faculty of Science, University of Peradeniya once told me that there are four types of people according to Buddhism. Later, I found this explained in Valahaka Sutta of Anguttara Nikaya. Four types of people are; those who know that they know, those who know that they don’t know, those who don’t know that they know and those who don’t know that they don’t know. There are many parties involved in the Arsenic fiasco in Sri Lanka; proponent of the Arsenic hypothesis, scientist, journalists, politicians, religious leaders, registrar of pesticides and so on. I will let you decide to which type the parties involved in the Arsenic fiasco belongs to.

Discussion on university crisis

, The Island.

A panel discussion entitled ‘University crisis’, organised by Transparency International Sri Lanka, is to be held at the auditorium of the Organization of Professional Associations, Stanley Wijesundera Mawatha, Colombo 7, today at 4p.m.

The panelists would be the former Vice Chancellor of the Sri Jayewardenepura University, Dr. Jagath Wickremasinghe, Dr Nirmal Ranjith Dewasiri from the Colombo University and Convener of the Inter University Students’ Federation, Sanjeewa Bandara. Dr. Mahim Mendis of the Open University, will be the moderator, a TISL spokesman said.

Private Medical Schools:
An Educationist’s Perspective

, The Island.

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Raja C. Bandaranayake

[The text of the Inaugural Lecture of the Forum for Sri Lankan Medical Educationists, delivered on 9 January 2012, at the Postgraduate Institute of Medicine]

Continued from yesterday

The relationship between the private medical school and the teaching hospital may take one of several different forms:

1. The private medical school has its own teaching hospital. This is the model used by most established schools.

2. The private medical school shares a teaching hospital with a public medical school. This model usually affects both schools adversely.

3. The private medical school pays a fee to a public hospital for using it as a teaching hospital. Usually the fee is very high fee, eroding the school’s income.

4. The private medical school uses one or more existing private hospitals for clinical teaching.

 The most suitable model is the first one, as the school can develop its own identity and become a useful resource to the community, without being an encumbrance to any other training institution. However, private patients are generally averse to allowing medical students to learn from their illnesses. Thus many private medical schools utilize public hospitals for a significant part or all of their clinical training. I am of the firm opinion that, if a hospital, public or private, is designated a teaching hospital, carrying with it all the benefits of a teaching hospital, a condition of patient admission to that hospital should be their consent to be used for teaching purposes.

Another potential disadvantage is the laxity of student admission policy adopted by some private medical schools. Often admission is dependent on paying capacity than on academic merit, sometimes even at the expense of ignoring minimum standards. Some schools insist on minimum standards but these are often below those required for admission to state schools. This would naturally compromise the quality of the product.

Private medical schools sometimes pose a threat to public medical schools by attracting academic staff from the latter with higher salaries and/or better working conditions. Another strategy is for faculty to work part-time in each institution. I have seen both these practices occur, often to the detriment of an already established public school.

Private medical schools, because they are expensive, result in a diminution in socio-economic diversity in their student populations. Combined with the fact that patients admitted to private hospitals usually lack that diversity, such bias will affect the graduates’ ability to deal with lower socio-economic patient groups and minority groups.

Unless rural medicine is a stated goal, private medical schools tend to be established in urban areas, in order to attract the wealthier sectors of the community. Rather than correct the mal-distribution of doctors, such schools tend to contribute to it. In some countries permission is granted to open new schools only if they are located in under-served areas.

Guidelines for the establishment of private medical schools

The key to ensuring that any private medical school contributes effectively to healthcare in the community in which its graduates serve is to enforce a system of monitoring which guarantees that minimum standards are met.  In order to meet these standards prerequisite resources must be in place before the school is permitted to admit students. It is not enough if the school is allowed to open its doors on promises that it will meet these requirements in the future. Schools often may agree to "put facilities in place", particularly for the conduct of clinical training, but often find themselves in difficulty to do so effectively when students are due to enter the clinical training phase. They then have to resort to interim measures until suitable facilities are available. Irrespective of whether the school intends to have its own teaching hospital, or to use the facilities already available in the public or private sector, the facilities must be available and/or agreement must be reached before students are admitted. If clinical skills are to be taught in the early phases of the curriculum the facility of a clinical skills laboratory must be available before students are admitted. The nature of the curriculum plan will determine the resource requirements for the school to implement the different phases of the curriculum.

Even more important are human resource requirements. No school should be allowed to open its doors to students if it is to depend on academic staff of an existing school for the implementation of the teaching program. As pointed out above, this could lead to lower standards in both schools.

Minimum academic requirements should be insisted upon in the system of student admission to the new school, commensurate with existing requirements in the country. Allowances should not be made based on socio-economic status, influence or paying capacity of the candidate.

The task of ensuring that the minimum criteria for a medical school are met is the responsibility of the independent body granting licensure to the graduates of the school to practise in the society which the school is to serve. In most instances this is a medical council (such as the Medical Council of India, the General Medical Council in the UK or the Australian Medical Council in Australia), or other specially appointed body (such as the Liaison Committee for Medical Education in the US) which is not affiliated to any particular medical school or university in the country. It must be recognised that certification of competence, manifested by the granting of the degree, is an internal matter, which is the responsibility of the training institution, while licensure to practise in a given country or society is an external matter, which is the responsibility of the independent licensing body. These are clearly distinct functions. For example, a school may deem its products competent based on internal assessment, but the licensing body may not find the assessment procedures used meet minimum standards for safe practice. On the other hand, the curriculum may be deemed appropriate for practice in one country but not in another. These are issues which have to be dealt with by the licensing body, which in Sri Lanka is the Sri Lanka Medical Council (SLMC).

What then can the SLMC do in this regard? The practice of undertaking pre-accreditation visits by a responsible and entrusted body, such as the SLMC, can go a long way to ensuring that adequate facilities are in place in any proposed medical school, public or private, before it is allowed to admit students. I would suggest that SLMC develops its own set of guidelines for such pre-accreditation, as well a set of standards representing the minimum essential requirements before a new school can commence training. These guidelines and standards can take into account the socio-economic realities in Sri Lanka better than standards developed elsewhere by other bodies. If such a set of guidelines and standards are in place now, before new schools are ready to commence, then the SLMC can be entrusted with the task of appointing an accreditation committee which can judge each proposed school’s plans and resources against the standards before approval is granted. In doing so, the Council must judge the resources available in relation to the intended curriculum plan.

If a private school is opened jointly with an existing school in another country, SLMC must ensure that the standards of the latter are at least on par with the minimum standards expected of a medical school in Sri Lanka before such a joint venture is accredited for licensure in Sri Lanka.

The Council should be particularly wary of prestigious schools using their prestige to encourage sub-standard schools to be opened in Sri Lanka, and ensure that adequate standards are met before such schools are allowed to admit students.

Conclusion

 I have attempted to take a dispassionate and educational view of the vexed question of privatisation of medical education. The history of the trend of privatisation and the forces which contributed to its development point to important lessons for Sri Lanka as it grapples with this issue. The advantages and disadvantages of privatisation must be considered carefully and steps taken to enhance the former while minimising the latter. I see any venture which contributes to the development of healthcare in the community as a positive one. However it could be fraught with dangers if adequate safeguards are not taken to maintain the high standards of healthcare which this country is noted for. I have outlined some steps which could be taken by an independent body, such as the SLMC, to avert these dangers. We must be constantly vigilant to prevent the "trade school mentality" of the pre-Flexnerian era from permeating our medical schools, which until now have been held in high esteem internationally.