---

Organophosphates

8.54 p.m.

{**/st**}{**qn**}{**sp**}

The Countess of Mar: rose to ask Her Majesty's Government how members of their advisory committees concerned with the licensing and use of organophosphate products are selected for appointment, and whether they are satisfied that the advice they receive is, in every respect, impartial.

The noble Countess said: My Lords, may I say from the start that, by asking this Question, I cast no aspersions on individuals. It is the system with which I am concerned.

There are three main committees which advise the Government on pesticide matters. About 90 per cent. of pesticides are regulated by the Pesticides Safety Directorate, with the remainder being regulated by the Health and Safety Executive. The Veterinary Products Committee, under the Veterinary Medicines Directorate, advises, among other matters, on veterinary medicines which have organophosphates as an active ingredient. The Advisory Committee on Pesticides advises on agricultural pesticides and the Health and Safety Executive advises on non-agricultural pesticides. As far as I can ascertain, it is only the Health and Safety Committee which includes industry and trades unions on its committees.

As well as the main committees there are specialist sub-committees to advise the main committee on safety and licensing aspects. The main committees then report to Ministers with their recommendations. The lead department is the Ministry of Agriculture, Fisheries and Food. I am delighted that the Government are now trying to resolve the conflicting interests within MAFF, where the ministry is expected to promote agricultural production and the interests of farmers and growers while it has a duty to promote consumer and worker health and safety and to protect the environment. There is also an urgent need to review the system of regulation, monitoring and enforcement of pesticide licensing and use.

The advisory committees are all described as "independent", the dictionary definition of which is:

"not dependent or relying on anybody".

I do believe that these committees are independent of government, but I am not so certain that they are independent of the industry which they were set up to regulate. The Veterinary Medicines Directorate and the Pesticides Safety Directorate are both government agencies, dependent for much of their income upon the fees they charge the chemical companies for licensing new products. They rely upon those same companies to carry out safety assessments and to

24 Jun 1997 : Column 1556

submit authentic data. There is no independent cross-check of that data, as I have established from Answers to parliamentary Questions. The committees need trained and experienced staff. In many cases these people will have come from the chemical companies and, as so many are now on short-term contracts, some will want to return to the industry. The industry is also expected to report to the regulators any adverse reactions in humans, animals or the environment. Does the noble Lord the Minister find this dependence acceptable?

Members of the advisory committees tend to be distinguished academics with backgrounds in research, administration and teaching. With the exception of the Health and Safety Executive committees, there are no lay members and, perhaps surprisingly, no women on the main committees. Are there no distinguished women working in the fields from which the advisers are drawn? Appointments are made by MAFF and members must sign a declaration of their interests in chemical companies. We do not know how the appointment process operates, but there must be an element of personal recommendation. There is nothing wrong with this, as long as it is not the only means by which members are selected. There seems to be a nucleus of about 25 individuals who advise on a number of committees.

The scientific community is very close-knit and because the numbers of individuals in specialties is small, they will all know one another. They are dependent upon one another for support, guidance, praise and recognition. If they wish to succeed, they must run with the prevailing ethos of their group, department or specialism. History is littered with stories of the establishment refusing to accept new scientific discoveries and of the ostracism of the discoverers. The first I can think of is Galileo. There may be a number of reasons why scientists tend to take this stance. Their prestige, and therefore their position in the scientific hierarchy, depends upon the authority which is accorded to their work by their peers and by the wider public. They may therefore resist any challengers to their established doctrine for fear of losing face. There may be subtle pressures put upon them by the larger chemical companies to the extent that any dissent from current thinking and practice might lead to a loss of financial or other support to themselves or to their university department. The influence may be as crude as a threat to move to a country where the regulatory regime is more amenable.

What were the influences which precipitated the unfortunate circumstances under which Dr. Jamal, a member of the scientific panel of the Veterinary Products Committee, was forced to tender his resignation? He has said publicly that his experience with large numbers of farmers and others who are suffering nervous system damage led him to believe that continued use of OPs should be suspended, and he made his opinion known to the chairman of the Veterinary Products Committee before he was ever appointed to the panel.

24 Jun 1997 : Column 1557

Those who believe their health has been damaged by OPs and others who are working with them have the distinct impression that the establishment is demonstrating an unwillingness to accept the evidence of hundreds of published scientific papers and thousands of individuals who are ill after using OP pesticides.

Members of the advisory committees may not have any direct interest in the chemical companies, but they will have earned the status which has got them on to the committees after working for the industry either directly or through research on behalf of their universities. Unless they have retired, they will still be involved with colleagues who are dependent on chemical company research funds for the continuation of their departments, and those who are administrators may even be involved in obtaining industry funding. Is it unreasonable to suggest that, no matter how they try to avoid it, these people may be influenced by the pressures placed upon them by the need to ensure the viability of their faculties? Are there not pressures put upon them from outside by implied threats of relocation and the loss of valuable income to the nation?

Are Her Majesty's Government satisfied that the advice they receive is in every respect impartial? "Impartial" means "not favouring one more than another". Impartial advisers will hear and see all the available evidence, test its validity and weigh it in the balance without fear or favour. If there is a lack of evidence to support one side or the other, no balanced conclusion can be drawn. Remember Toyber's dictum: absence of evidence is not evidence of absence.

The Veterinary Products Committee in its report on the Suspected Adverse Reaction Scheme has consistently stated that evidence on the health effects of exposure to OP sheep dips is "inconclusive", without seeking further field or clinical evidence. It has based its advice that OP sheep dips should continue to be used upon that lack of evidence of adverse health effects. It continues to assert that, provided the recommended protective clothing is worn, those involved in sheep dipping will be safe. This is in spite of evidence from the Institute of Occupational Medicine that metabolites from OPs were found in the urine of dippers, whether or not they were wearing protective clothing, indicating that the chemicals had been absorbed. It has also asserted that the inhalation of vapour and spray is not a problem, despite evidence from sufferers. The argument is that no measurable quantities have been found in field tests, while it admits that the equipment used is not able to measure minute doses.

The authorisation procedure relies on the "predictive model". This means that a standard is set based upon the expected effect of a dose of a chemical which is extrapolated from laboratory experiments and conformity with which is deemed to satisfy the safety requirements. Humans are not large rats; even less are they the hens which are used to predict chronic neurological damage. Humans do not all come from the same mould either. It is very apparent that some

24 Jun 1997 : Column 1558

can tolerate much higher levels of exposure than others. The underlying ethos is that no drug, chemical or medicine can be absolutely safe and that no test method can be devised to ensure that all possible dangers are identified. Against this, unless a very good reason can be given, there is the general imperative that a product must be approved for sale. If the assessment is made on risk/benefit principles, I ask the Minister how many people--men, women and, worst of all, children--must be made ill before a product is seen to constitute a risk?

The existence of a regulatory system has lulled the public into the belief that all products which are licensed as pesticides or medicines have been subjected to rigorous testing and are safe to use provided the recommended safety precautions are heeded. In reality, there are huge gaps in the safety data, particularly for OPs. The public is now beginning to doubt that the system is reliable. Once a licence has been granted for a product it is contrary to human nature to expect that either the licensing authorities or the manufacturers will willingly admit that they have failed to detect effects which subsequently come to light, for to do so is likely to result in huge compensation claims, particularly where the advisers have recommended to government the use of a particular product in order that compulsory treatment or prevention be carried out--for example, the dipping of sheep to control scab or dressing cattle to prevent warble fly infestation. Manufacturers who were forced to withdraw products by the licensing authority without very strong evidence of undesirable effects would not hesitate to sue. This point was made very clear to the all-party group of MPs and me when we met the then Minister, Mr. John Gummer, to ask for a moratorium on OP dips in 1993. Do not these factors have a bearing on the decision-making process of the Government's advisers?

There is no mechanism for an impartial challenge to be made to the fundamental bases upon which the evaluation of a pesticide is conducted. While the regulating authority may take a neutral view, accepting and proposing authorisation criteria, it does not appear to question whether the criteria are adequate. The view that the authority takes may be neutral, but it is not impartial. The developer puts his case but there is no one to put the case against and it does not call for any contrary evidence.

As many have found to their cost, there is a fundamental imbalance between the evidence required prior to the licensing of a product and that required post-release. If damage is alleged to have occurred it must be proven to a very rigorous scientific level, while the scientific evidence required by the regulators need not. Compared with the energy and resources generated prior to licence authorisation, the manpower and funding provided to investigate events which have led to claims of ill-health or environmental damage is minuscule. This results in a procedure which cannot be impartial because the system in which it operates lacks balance.

These expert committees are often required to make decisions upon incomplete evidence, so the only verdict they can give is that of "not proven". This

24 Jun 1997 : Column 1559

cannot be an impartial response if the resources allocated to field and clinical investigations are inadequate and the evaluators do not qualify their findings accordingly. They rely upon what may be called "constructive ignorance" by being content to rule on the evidence which is before them and avoid a search for information that may lead them to a different decision. That is not being impartial.

Of course, there is also an inherent bias in that human nature decrees that arbiters tend to favour their own judgment and resist the opposite view. The Cairns Committee in its review of the authority which both licensed aircraft as airworthy and was responsible for investigating aircraft accidents coined the phrase "intellectual corruption". Is there not room for intellectual corruption in the deliberations of these committees?

A short while ago I came upon the following quotation from A Pride of Tigers by Sybil Marshall:

"I fell to wondering why it is that 'experts' so often get things wrong. Once they become experts they know all the answers, so they don't ask questions. They simply reach out and take the most likely ready-made explanation from the peg and use it, whether it fits the case in point or not".

OP victims are tired of, and distressed by, a medical profession which tells them that they should see a psychologist, or that conventional medicine can do nothing for them, simply because the medical profession is confounded by the multitude of symptoms with which their patients present, and there is no easy explanation in the medical literature and no clear lead from the Department of Health.

I ask the Minister whether he will ask his right honourable friend in another place to review the means by which appointments to the Government advisory committees are made; whether he will consider creating a pool of suitable candidates from which he can draw by a method similar to that used for jury service; that these candidates should include young scientists, PhD students for example, as well as senior members of the profession; women, and lay people with field experience in using products similar to those to be licensed. Will he look into ways of reducing the dependence of university departments and other research facilities on the chemical industry for funding of research into their particular field? Will he consider the exercise of the precautionary principle rather than risk analysis as the basis for the issue of a licence for a product, especially when there is a lack of toxicity data available? Will he work towards the separation of licensing procedures from procedures to investigate harm caused to humans, animals and the environment by licensed products? Finally, will he make all these procedures open to scrutiny? Is he aware that I have obtained most of the information I have on OPs not from the UK but from the United States under their Freedom of Information Act?

9.9 p.m.

Baroness Park of Monmouth: My Lords, I propose to intervene briefly in the debate to support the noble Countess in yet another aspect of the long

24 Jun 1997 : Column 1560

battle to establish the truth about the Gulf War syndrome and the role of OPs and to raise a related concern.

On the first point, much of what the noble Countess had to say about possible constructive ignorance and intellectual corruption, and above all about the need to make procedures open to scrutiny, including the way in which committees are appointed, is equally applicable to some of the committees appointed by the European Commission. On a number of issues, ranging from the quality of bathing water to the protection of birds, I have been struck by the lack of transparency which characterises the agenda, the reporting and even the membership of the committees responsible. It is often difficult, if not impossible, to establish what scientific and technical advice has been given, and only too often legitimate requests for information are refused.

It is all the more important therefore that we should ensure the most open proceedings possible on the issue at a national level, especially when the issue is one of public confidence and morale. The public is much more ready to accept bad news than to encounter all the doubts and anxieties that arise from obfuscation. We have good scientists and conscientious public servants. Let us ensure that they are seen to be open to accept even the most inconvenient facts.

My other concern, though somewhat alleviated by the statement yesterday of the noble Lord, Lord Gilbert, that research into OPs is being funded jointly by the Department of Health, MAFF and the HSE, is that the Ministry of Defence should be fully seized of all scientific evidence available to the three main committees listed by the noble Countess and should, in its turn, submit to them whatever scientific, medical or other relevant information on the issue of the effect of OPs may emerge from the inquiry being conducted by the Ministry of Defence in response to the Defence Committee in another place.

An independent co-ordinator, someone who is neither a civil servant in the ministries concerned (the MoD and MAFF) nor a member of any of the existing committees, should be appointed to review all relevant information. Such a co-ordinator should be free to hear evidence given under the equivalent of parliamentary immunity from any present or indeed former member of those ministries who possesses relevant information.

If mistakes were made or information was not considered relevant or sufficiently substantial and was therefore not brought forward, or even suppressed, now is the time to remedy that. That may offer the chance to set the record straight and to ensure that there are no more time-bombs of undisclosed knowledge ticking away. An independent co-ordinator could help to ensure that ministries do not decide that partial evidence is no evidence and therefore take no action. Sufferers from the effects of OPs have been left in limbo for too long. That is not right, and something must be done.

24 Jun 1997 : Column 1561

---