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Volume 11: Scientists after Southwood
5. Challenges to the Government's approach
Dr Harash Narang
The urine test for CJD
Discussion

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The urine test for CJD

5.263 During 1995, Dr Narang worked on the development of a urine test which he described in his statement to us:

. . . a simple method to concentrate the agent from CJD patients' urine and I have by EM [electron microscopy] demonstrated the presence of both NVF [nemavirus fibrils] and SAF [scrapie-associated fibrils] similar to those seen in brain samples of CJD victims. 1

5.264 He carried out his first urine test on a live patient with suspect CJD in 1995, and continued with 'a number of live subjects who have subsequently died and were confirmed to have had CJD by the Surveillance Unit in Edinburgh'. 2

5.265 At the 22nd meeting of SEAC on 23 November 1995, under the item, 'Any other business', Professor Pattison asked Dr Wight to write to Dr Narang for details of his CJD test. 3 On 4 December, Mr G M Robb from DH wrote to Dr Narang on behalf of the SEAC secretariat. He said:

The SEAC has seen reports in the media of a potential diagnostic test for CJD which you are reported to have developed. Any such test, if clinically robust, would be valuable, and the Committee have therefore asked if you would be willing to send them details of this test, and, if possible, also of its use so far. Moreover, they would be interested to know whether you have yet submitted any papers on the test for publication, and if you have, whether you would be prepared to let them see copies.
The Committee will next meet early in January 1996, and it would, if possible, be very useful to have an initial response from you by the end of the year. 4

5.266 It would appear that Mr Robb did not receive a reply from Dr Narang. However, on 9 December, Dr Narang wrote to Douglas Hogg noting that he had heard Mr Hogg's statement 'on Channel 4 News on 6 December 1995 to the effect that you would like to try the brain test which I have developed for BSE.' 5 He went on to give a brief outline of his touch test and urine test for BSE.

5.267 On 18 December 1995 Dr Render wrote to Mr K Taylor, attaching Dr Narang's letter to Mr Hogg. He stated that, in relation to the urine test:

The second test, the 'urine test', is, I presume, the one recently described in newspaper articles. DH have written to Dr Narang to ask for further details of this to put to SEAC. If Dr Narang responds to that request I hope it will be in considerably more detail than here, to allow for proper scientific analysis. 6

5.268 Dr Render subsequently drafted the reply to Dr Narang, which was sent by Mr Hogg's Private Secretary, Marcus Nisbet, on 21 December 1995. He thanked Dr Narang for his approach and the offer on the tests. He continued:

As a scientist you will appreciate that all claims need to be rigorously tested and receive sound experimental support. This is, of course, usually seen to be achieved by publication of papers in independently refereed scientific journals. We are not aware that details of your tests have been published in this way and so would be grateful if you could provide more detailed information of a standard which can be properly assessed.
. . .
I understand that the Secretariat of the Spongiform Encephalopathy Advisory Committee has already written to you to ask that you provide the Committee with full details of your 'urine test'. The Minister has asked me to urge you to provide them with full details to enable them to evaluate the tests to see if it could prove clinically reliable and robust. 7
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Dr Narang continues to press his case with Mr Hogg and Mr Dorrell

5.269 Dr Narang wrote again to Mr Hogg on 27 December 1995, having received the reply from Mr Nisbet. 8 He said:

I would ask you, since MAFF have spent millions on this research, I do not see another instance where such claims were tested before grants were awarded. With all the effort so far no real progress has been made.

5.270 He noted that a company had recently been given a contract to develop a live test, 'as far as I am aware this firm has not developed a test yet or even done any work in relation to spongiform encephalopathy research'. He continued:

The Spongiform Encephalopathy Advisory Committee has asked for my experimental details of the live test. I need facilities so that I can make it available to farmers, I do not want some one else to exploit my test while I take a back seat and suffer. 9

5.271 Two days later, Dr Narang wrote again to Mr Hogg, claiming that he had successfully used his urine test for CJD on a young patient who was suspected of having CJD. He invited Mr Hogg and Stephen Dorrell, the Secretary of State for Heath, to visit this young patient. Dr Narang considered that the visit would press home the importance of developing a rapid diagnostic test for CJD. He commented:

It is strange that a number of patients under the age of 40 have contracted this disease in the past few years in the UK and therefore it is important to realise that this is a new phenomenon which suggests that there is a different source of infection in these patients. 10

5.272 Mr Nisbet replied to this latest letter on 5 January 1996, advising Dr Narang that CJD was a matter for the Secretary of State for Health. 11 Accordingly Dr Narang wrote to Mr Dorrell on 8 January, enclosing a copy of the letter he had sent to Mr Hogg. 12

5.273 Mr Dorrell's Private Secretary, Shaun Gallagher, replied to Dr Narang on 19 January, turning down Dr Narang's invitation to meet the young patient with suspect CJD. Mr Gallagher continued:

The Government appreciates fully the seriousness of CJD. It is a rare disease, and, if a validated test were to become available, it would overcome current diagnostic difficulties. I understand the Spongiform Encephalopathy Advisory Committee (SEAC) wrote to you on 4 December seeking details of your urine test. The Committee still wishes to give the Government an independent assessment of its clinical robustness and would welcome receiving the details necessary for this. 13
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Mr Hogg replies to Dr Narang's letters of 27 December and 5 January

5.274 On 21 February 1996, Mr Hogg replied to Dr Narang's letters of 27 December and 5 January. 14 He had sought 'expert advice on the highly technical issues' Dr Narang had raised, and enclosed a copy of this advice with his reply. Mr Hogg's reply focused on the various points Dr Narang had made about MAFF's long-established mechanisms for funding research. Among other things he said:

I certainly agree that fairness is one criterion for awarding research funds but of equal or greater importance are the need for the work, the skill of the team, the resources required and available, the design of the study, its costs and priority in relation to other studies. Work with TSE is necessarily long term and usually demands a team approach in a centre of excellence though new groups have been encouraged to initiate work and some have creditable results.
I understand that any proposals from yourself have been examined in the same way as those from other individuals and institutes. If they have not been funded this is because they lacked sufficient merit or were not of sufficient priority. 15

5.275 Mr Hogg went on to respond to Dr Narang's suggestion that a particular company had been given a contract to develop a live test without previously having experience in TSE research. Mr Hogg informed him that the company did have experience, particularly on working with blood and cerebrospinal fluid from patients with CJD. Mr Hogg continued:

It is clear to me from reading the papers that this Department and the BBSRC have gone to considerable lengths to try to confirm some of the experiments which you claim underpin your theories about the agents causing BSE and scrapie. I have to say that, despite the expenditure of considerable sums of taxpayers' money, the results remain disappointing and I see no justification and none of my scientific advisers have proposed that we should spend more money to develop tests based on theories which are not accepted by the majority of workers in the field and which are not substantiated by research findings. I know that this will be a disappointment to you and I am prepared to ask my scientific advisers to look again at the matter if you can give us sufficient technical background for a proper research proposal. However, I am not prepared to ask them to depart from the normal procedures and to underwrite work which has only been reported in very general terms in the national press and not in sufficient detail in the peer reviewed scientific press and which you have subsequently refused to explain both to Departments and to the independent advisory committee, SEAC. 16
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SEAC considers Dr Narang's test

5.276 SEAC discussed Dr Narang's urine test at their 24th meeting on 1 February 1996. 17 Dr Will said that Dr Narang had allegedly diagnosed several CJD cases with his urine test based on the detection of either the nemavirus or single stranded DNA. The minutes record:

SEAC was told that Dr Narang has as yet been unwilling to give the Government details of his test. Mr Bradley expressed concern at possible safety risks involved in Dr Narang's work, as we understand that he has no laboratory of his own and uses shared equipment. The Committee noted the major programme underway to develop diagnostic techniques, particularly for BSE, and felt that new avenues should be explored if they looked promising. This may well come about as a benefit from further basic research. 18

5.277 Dr Will wrote to Dr Narang on 16 February 1996 proposing that the CJD Surveillance Unit should attempt to replicate his urine test. 19 He said:

I note from recent press reports that you have had some apparent success in using the urine test for diagnostic purposes in CJD. As I am sure you will recall from our previous discussions, it would seem to me that such a test is exceedingly unlikely to be helpful in CJD because of the wealth of evidence that suggests that conventional viruses are not involved in the pathogenesis of the TSEs. However clearly if there was any suggestion that there is a test that is of positive predictive value in the diagnosis of CJD this is something we must seriously consider here at the CJD Surveillance Unit. Accordingly, I do think it would be sensible for us to attempt here to replicate your test on samples of urine from patients with CJD.
I am sure you will agree that with any diagnostic test or development it is very important that results are replicated in other laboratories in order to achieve independent validation of any diagnostic procedure. What I am therefore writing to ask you is whether you would give us details of your protocol which I understand at least in part involves PCR of urine in order that we can test your interesting findings on an independent basis. 20

5.278 Dr Will suggested that they meet to discuss this proposal further. Dr Narang replied on 21 February agreeing to a meeting, stating that:

I note from your many public statements that you do not believe that BSE can be passed to humans. You also say in your fax that the urine test would be 'exceedingly unlikely' to be helpful in CJD cases. Given your clear beliefs in this regard, and your own department's lack of experience in dealing with the Nemavirus, I think the best way forward would be for you and I to meet, with a view to discussing terms and conditions for having my test validated. 21

5.279 Dr Will and Dr Narang met on 13 March in Newcastle. They agreed to proceed with the validation of the urine test. Dr Narang wrote to Dr Will on 19 March to confirm that four points were agreed at the meeting. 22 He said:

    1. You would supply frozen urine specimens from confirmed cases of CJD to find out if frozen nature of the specimens does not interfere with the test result.
    2. That you cannot provide funding for this research. Mr Ken Bell of Ken Bell International has agreed that he would provide immediate financial needs.
    3. That you have no influence in securing lab facilities. Therefore, in order to arrange for lab space, I will write to individuals who may be able to help.
    4. If everything goes well, we could then arrange a blind study by coding specimens from suspect CJD cases mixed with normal specimens.

5.280 Dr Will replied on 10 April, advising that he would arrange the delivery of some frozen urine samples from confirmed cases of CJD. 23 He sent a number of other faxes before he received a reply from Dr Narang on 7 June. 24 Dr Narang stated that he had not been able to secure a laboratory space as yet, but was trying to negotiate with Newcastle University.

5.281 It would appear that the validation work proposed by Dr Will did not proceed. Dr Narang told us that it was not until 1997 that the 'MRC funded a project at Leeds University to verify the urine test'. 25 However, there were many problems with this project and at the end of the 18-month evaluation, no firm conclusions had been reached. 26

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Discussion

5.282 Dr Narang's experiences mirror those of many medical scientists who fail to attract research grant support from either the Research Councils or from the Medical Charities. The main grounds for refusal of peer-reviewed grant applications include lack of scientific merit and low priority in relation to other applications. Where an application is declined, reasons are normally given and the applicant is at liberty to reapply to the same or a different funding body. The system has stood the test of time and is considered by most scientists as being fair, and the best way of distributing limited funds so that the most deserving projects are supported.

5.283 Dr Narang only made one formal application to MAFF for research funding. This was the proposal submitted on 16 November 1989 under MAFF's open contracting scheme. We are satisfied that this proposal received fair consideration in competition with the other applications for research funding from this source.

5.284 We wish to recognise Mr Ken Bell's generosity in funding privately the development of Dr Narang's touch test. The results of this were viewed differently by Dr Narang and by MAFF. Of the ten samples, five were positive and five negative. Initially Dr Narang's test only identified two of the positive samples, although he subsequently identified a third. He described this result as a positive identification of the presence or absence of BSE in eight out of ten cattle brains. MAFF officials considered that the test had only had a 40 per cent success rate, in making an initial diagnosis of two positive cases out of five. This was not considered sufficiently reliable to give the test any practical value.

5.285 Dr Narang gave evidence to us. We found him a sympathetic and moderate witness, devoted to his science and concerned that he had been unable to make the contribution to addressing the challenge of BSE and CJD of which he believed he was capable. The contemporary documents indicate, however, that he had difficulty in his relationships with some of his professional colleagues. More particularly, he appears to have irritated scientists at the CVL during his visit to the laboratory in 1989 which left the CVL scientists not merely sceptical of his technique, but reluctant to invite him back.

5.286 While Dr Narang's touch test had not been a complete success, it was far from a total failure. Had he established a better working relationship with the CVL scientists, we cannot help feeling that there might have been scope for profitable collaboration between them. As it was we do not feel that MAFF officials can be criticised for insisting that Dr Narang should justify requests for further assistance by submitting the work that he had done to date for peer review and publication.

5.287 MAFF officials demonstrated that they were not turning their face against Dr Narang's work when they agreed to join in funding Professor Oxford's application to validate Dr Narang's work using his experimental protocols. By October 1994 it was reported that Professor Oxford's group had been unable to repeat Dr Narang's results and that the claims made for the live test were unsupported. An independent study at the Staten Island Laboratory in the United States came to the same conclusion.

5.288 Dr Narang was involved in developing a third diagnostic test, this time for CJD using urine samples. EM studies on concentrated urine were claimed to be able to identify scrapie-associated fibrils and nemavirus fluids. He reported the success of this test on a young patient suspected of having CJD to Mr Douglas Hogg and Mr Stephen Dorrell by letter in December 1995. SEAC sought details of the test from Dr Narang who had not published on it and was unwilling to provide the method until he had completed his investigation on CJD patients and BSE affected animals. Dr Will offered to attempt to replicate the test at the CJDSU. But this did not happen, and it was not until 1997 that MRC funded a project on the urine test at Leeds University. This has not had a successful outcome.

5.289 We have concluded, for the reasons given above, that Dr Narang's work received fair consideration by MAFF scientists. While we would pay tribute to Dr Narang's dedication to research into TSEs, we feel that he had a fair opportunity to demonstrate the validity of his work but did not succeed in doing so.

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1 S113 Narang para. 1.11

2 S113 Narang para. 1.11

3 YB95/11.23/1.1

4 YB95/12.4/6.1

5 YB95/12.9/2.1

6 YB95/12.18/13.1

7 YB95/12.20/11.3

8 YB95/12.27/2.1

9 YB95/12.27/2.1

10 YB95/12.29/1.1

11 YB96/1.5/6.1

12 YB96/1.8/5.1

13 YB96/1.19/12.1

14 YB96/2.21/4.1-4.14

15 YB96/2.21/4.2

16 YB96/2.21/4.2-4.3

17 SEAC24

18 M71 tab 24 p.13

19 M37 tab 12 /96/2.16/1.11

20 M37 tab 12 /96/2.16/1.11

21 YB96/2.21/5.2

22 M37 tab 12 /96/3.19/1.1

23 M37 tab 12 /96/4.10/1.1

24 M37 tab 12 /96/6.7/1.1

25 S113 Narang para. 1.11

26 YB97/09.03/1.1, YB 97/10.31/2.1, YB97/10.31/3.1

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