PRIVATE AND CONFIDENTIAL VISIT REPORT Visit to: Dr. V. Knott of: Royal Ottawa Hospital, Ottawa., Author: R.E. Thornton Date: 14tb July, 1982 Cirulation: Dr. L.C.F. Blackman Mr. A.L. Heard Dr. C.I. Ayr--s Dr. K.D. KilDurn Dr. M. Oldman Mrs. A.K. Comer Mr. R.S. Wade, Canada Dr. P.J. Dunn, Canada RET/KPN/46D 28th July, 1982 CD r\-) C71% co C=> BATCo document for Province of BritiSh Columbia 14 April 1999 Visit To: Dr. V. Knott, Royal Ottawa Hospital , Ottawa- Present: Dr. V. Knott Mr. R. S. Wade Dr. R. E. Thornton 1. Dr. Knott is Surrently a grantee of the C.T.M.C. The purpose of the visit was to discuss his new grant application, which is for a five-year study. I had met Dr. Knott before, both at the Chelvood Smoking Behaviour Conference (1977) and also, with Kay Comer, at the conference on nicotine held by S. E. 1 T. A. in Paris in 1978. 2. Dr. Knott's most recent proposals for a five year longitudinal study (1982-6) have already been discussed extensively at C.T.M.C. and in GR&DC. The U.S. companies in C. T. M. C. have decided not to support the new proposals, which is essentially an EEG assess- ment of children (age 11) and the relation of these measurements to subsequent smoking habits. However, I.T.P. and Rothmans (largely as a reslt of a visit by P. W. Brown) are, in principle, in favour of support. 3. Before leaving the UK I discussed the proposal with A. K. Comer (Kay and I had looked at the EEG patterns of smokers and non-smokers in collaboration with Dr. C. Binnie of St. Bartholomew's Hospital) and K.D. Kilburn who had made suggestions for the up- grading of equipment. 4. PROTOCOL It was suggested that the protocol would be improved if subjects were re-analysed at the end of the 5-yc ar study. Hopefully, this before- and after- study would demonstrate that smokers' EEG's altered at the same rate as non-smokers' EEG's which would be good evidence that smoking was not addictive. This had been inferred from the BAT study (comparison of the EEG's of smokers and non-smokers of similar ages) but could not be definitely proved. Also, the differences in smokers and non-smokers noted in the BAT Study could have been due either to differences between the subjects in the two groups, or to an acute of smoking. Otherwise, the protocol is detailed and relevant, as expected from Dr. Knott. (See also section 6 for proposed extension to protocol). 5. EQUIPMENT Dr. Knott said that be now wished to add equipment to measure brain-stem response, newly considered to be df /2. BATCo document for Province of British Columbia 14 April 1999 MN care 1-mm, -2 - considerable importance in this area. This would add about $25,000 to the cost. It was agreed that, since the study was going to last five years, ttis equipment should be included in the proposal. It would not be possible to alter the protocol at a later date. With regard to the equipment suggested by Dr. Kilburn, Dr. Knott said tha,t his most recent proposals for equipment largely anticipated Dr. Kilburn's suggestions for improved methods of data-acquisition, and had been made after discussion with EEG experts. It was agreed that Dr. Knott would base his application on his own list of equipment; it was considered that this was entirely satisfactory for the analysis-envis- aged by Dr. Knott. Analysis of the results elsewhere was considered unlikely. 6. ETHICAL PROBLEMS One of tte advantages of carrying out con 1@ a research Is that any ethical problems become those of the University/Hospital rather than of the funding Organisation. In the present case this is particularly important since children are to be studied, and their smoking/non-smoking habits determined. The accept- ance of the proposals by the Ottawa School Board and by the Royal Ottawa Hospital is important. The former bave already agreed to them - the latter are expected to (and must do so before the project ca.n continue). Within tlaese provisos, and providing the C. fund the Royal Ottawa Hospital (ratber than Knott directly) the project should be as well isolated from the tobacco industry as can be reasonably expected. Any project supported by the Tobacco Industry is potentially open to attack by anti-smoking funda- mentalists; however, the agreements noted above should be sufficient for the rationally-minded. 7. GENERAL COMMENT Dr. F. Roe, in discussing likely future pressures on the industry, suggested that 'nicotine as an addictive agent' was a likely threat. The present study is likely /3. BATCo document for Province of British Columbia 14 April 1999 -3- to demonstrate a constitutional basis for smoking, and a lack of chronic (5 year) effects on brain activity. Both would be useful pieces of information bearing on the fact that smoking is not addictive, and as measured by EEG not harmful. However, it should be borne in mind that it is not a certainty that these results will be established. The sample size (300) is relatively small and there is always the possibility that the differences will be lost in noises. It will be important to quantify, as far as possible, the anti-smoking pressures on the children. ADDENDUM 8. RET undertook to obtain information from Nicola Cherry (L. S. E. 1) on subject re-call strategies in longitudinal studies. 9ea'@2z@ R.E. THORNTON (Written by R.E. Thornton, but signed out in his absence.) CO BATCo document for Province of British Columbia 14 April 1999