Select Committee on Science and Technology Minutes of Evidence


Examination of Witness (Questions 400 - 419)

TUESDAY 28 JULY 1998

DR PETER LEWIS

  400. So that was the nature of the misdemeanour, if misdemeanour it was, that Dr Millar had committed, that he had risked aborting the whole trial in the eyes of the FDA?
  (Dr Lewis) Certainly, and I just could not believe he had done it to be honest. That was why I wrote in that letter to Andy I really did not believe he had done it, I thought there had been a mistake and it was a misunderstanding. It was only when the company circular came out when they actually documented they had followed this up and had an audit and what not that I had to accept he actually had done it.

  401. Following up Dr Jones' question, it cannot have been so exceptional to do this because the FDA did give him permission at one point and then the law refused him permission to use it.
  (Dr Lewis) Well, I do not know what that FDA thing was. I have read that. I do not know any details about it. I think he went to the FDA much later, long after I had left the company, and sort of retrospectively asked for permission to unblind the study and I do not know what the FDA said. I am very surprised that they said, "Well, that's fine". Normally they do not do that. However, it must be said that if you want to unblind a study for reasons other than the ones that are in the protocol, safety and so on, the only way to do that would be to go to the competent regulatory authority and ask them for permission to do it.

Dr Turner

  402. You clearly had a great difference of opinion with Dr McCullagh over the strategy the company should be following.
  (Dr Lewis) Yes.

  403. When did that really begin to emerge and to what extent was it a question of your assessment of the commercial possibilities, prospects of the trials on the products that were in process versus the expectations of Dr McCullagh?
  (Dr Lewis) Well, as far as the timing was concerned, I always felt that he was rather optimistic and gung-ho on everything, but I accepted that because he was an optimistic sort of chap. When we really began to fall out about these matters of strategy was really immediately after the rights issue which was in June or July of 1996. Both the Finance Director and I, who saw eye to eye on these matters, felt that once he had got the money in, he was now going to an expansionary phase and there was no holding him, and that in fact proved to be the case, I think. He became much more expansionary and he determined that he would hire a lot of people for the commercial side, for example, and that was the one thing I put my finger on, that he went out and he hired a director of commercialisation and that person hired more people and we were spending a lot of money on commercialisation and that was really the thing when I finally said, "That's it. I don't want to go on with this".

  404. Did this come back on you as pressure to stretch the results of trials beyond what they would actually substantiate?
  (Dr Lewis) No, it was not quite like that. I felt under terrific pressure because I knew that the results of the trials were what was driving us and had to pay for all this and if any of the trials were late or they did not work, then it was a disaster waiting to happen. I really felt it was unnecessary to do all this, and I would have preferred some more conservative measures, licensing out the first products, doing some more alliances, potentially not buying all our own commercial people, but merging with a company that perhaps had a few products and which had a commercial network and so on. I have to say that Dr McCullagh's policy, he made it crystal clear to all the investors and everybody else that that was what he wanted to do, and I just felt that it was over-ambitious, but he convinced everybody else that it was right, he convinced the Board that it was right, and I felt, "Well, the guy is the founder. He may be right. I just don't feel happy with it", so I started to disengage myself and said I wanted to leave.

  405. He was clearly counting on something approaching 100 per cent chance of success, whereas you were not?
  (Dr Lewis) Well, quite. We had had six compounds going to the clinic already. Four of them had failed and two of them were still ongoing and yet he still felt that there was going to be 100 per cent success on the other two. Well, probability theory is not like that.

  406. Whereas your assessment would have been of the order of what?
  (Dr Lewis) Well, I thought differently about the two different compounds. I thought Marimastat was going to be a winner and I still do actually. I think it is probably going to be a long haul because it is such a revolutionary type of compound, but that is a real gem, but, and I think Andy said something like this, it needs a lot of time and money to get a compound like that through, but I thought it is just the sort of thing that you need a partner for. In fact they were knocking on our door. My former company, or I should not say this, but another major pharma company was calling me quite frequently saying that this is just the sort of compound they would like to get involved with, and at one point we had another partnership lined up for a very, very large sum of money to partner Marimastat and he just would not countenance it. He said that it was giving away the upside of the company. Well, I saw it the other way around and I thought it was reducing the risk of the company.

Dr Gibson

  407. Why did you write this supportive letter? What guided you to do that?
  (Dr Lewis) Well, it was a very foolish thing to do in retrospect—

  408. Why do you say "foolish"?
  (Dr Lewis) I felt and I have been told it was very foolish and I felt foolish when it was given to The Times and published and that it made me look extremely foolish. Why I wrote it was that I heard that Andy was going through a rough time and that the company was being very tough on him and they had thrown him out without any compensation. I read his letter in the Financial Times in which he attacked the sort of policies of the company which was this strategy issue about hiring commercial people too early and so on, and I thoroughly agreed with that and I felt that that was just right. Then I sat down and I watched him on TV on The Money Programme and he looked absolutely awful, he was haggard and he looked like he had lost about two stones in weight, and I just felt sympathy for him. I thought, "Well, it's a bit rotten that I left the company over these issues and I am not saying anything about it", so I wrote a hand-written letter quite quickly and I sent it off. As I put it in the letter box, I thought, "Is this the right thing to do?" but I thought, "Well, I've known the guy for years. It'll be fine. He'll probably call me and we'll have a chat about this". That did not happen and I read the newspaper and the excerpts of my letter in The Times a couple of days later.

  409. Did you express this view to anybody else in the company that you were—mind you, you were still part of the company at the time, so it did not prejudice your chances of getting a settlement with the company?
  (Dr Lewis) Well, this was ongoing. I wrote this letter when I was already very much a part-time consultant to British Biotech and, as I say, I regarded that purely as a way of receiving in settlement the sum that I was due, but I did not discuss this letter with anybody before I sent it, no, I just sent it off.

Chairman

  410. So although you might have thought that it was a foolish letter to send with hindsight because it has been made public, the fact remains that at the time you wrote it, you certainly thought that Dr Millar had some justice for saying the things he was saying.
  (Dr Lewis) Yes, I did.

Dr Jones

  411. Why did you say, "I got you into this and I feel responsible for some of it"? What did you mean by that?
  (Dr Lewis) Well, I meant that I had always been his mentor and I persuaded him to join British Biotech in the first place and in fact on a couple of occasions he resigned because he did not like things about the company and I kept him on and said, "Look, it's going to be fine. You are doing a good job", so I felt that I had kept him there for longer than he probably should have been there and that was really the reason.

Dr Turner

  412. How do you respond to Dr Millar's suggestion that you acted treacherously and that you are denying knowledge of his actions because of your own share dealings in April 1997?
  (Dr Lewis) Well, I was very hurt when I heard him say that. I saw him on the video saying it and I just felt that that was just awful. I felt awful about it. He also said that he did not like me. This is a guy I have known for 15 years and I got him two jobs at least and I thought I was on very good terms with him. I thought he was headstrong and difficult, but I simply did not bear him any malice and I was very upset when he said those things about me.

Chairman

  413. Staying on that very point that Dr Turner has just asked you, we have thought on this Committee that it is always possible that if there are people who are less careful than we expect them to be, there could be a conflict between money and drug trial results. Now, Dr Turner has just asked you about Dr Millar's suggestion that you acted treacherously in denying that there was anything wrong with the trials so that the share price held up, and held up at about £2.80 instead of crashing to 30 pence as it did later. Do you think it is possible that people could come up rather optimistically with trial results to help the shares that they are holding in very large number in their own portfolio?
  (Dr Lewis) I think it is possible. I do not think it happened on this particular occasion. It certainly was not my motivation, Chairman. Obviously that is possible, but to go back to what actually happened around that period of time, there actually was not any bad news around. We were in purdah, as it were, and there was nothing going on. There were a couple of large clinical trials going on which had been blinded, but we were in a period in the beginning part of 1997 when there were not any clinical results. We had just submitted the Zacutex marketing authorisation and there was not an awful lot going on as far as results of clinical trials were concerned. There was a big clinical trial going on but there were not any results coming out.

  414. Neither good nor bad at that time?
  (Dr Lewis) No, there was nothing happening. That was part of our problem, we had nothing to talk to the analysts about, it was just ongoing.

Mr Beard

  415. Dr Lewis, could I take you back to your letter to Dr Millar of 17 May in which you say: "When I finally realised that Keith" that is Dr McCullagh, "was not going to accept any soft landing by merging the company or out-licensing products to lay off the risks then I knew I had to leave. The central problem at British Biotech is Keith's ridiculous arrogant optimism". Do you still stand by those words?
  (Dr Lewis) Yes.

Mr Jones

  416. I wanted to pursue what are your relations with Dr Millar now after what you have been through? You have employed him twice, would you employ him again?
  (Dr Lewis) Certainly not. I think he has behaved despicably. What he did with my letter was pretty awful. He sat here and said he did not like me and I had done wrong, which I utterly reject. I think he has become obsessed with a sort of vendetta. A lot of the things he said in terms of strategy I agreed with and that was why I wrote the letter, but when he went into all these individual accusations about share sales and the Batimastat matter and so on and so forth, I totally part company with him. As I said in my submission I pretty largely agreed with everything that was in British Biotech's circular to shareholders[1] on these matters.

Dr Williams

  417. I put a completely different construction on things and there are four or five things I would like to put to you. The first is in terms of your working relationship with Dr Millar you were his immediate superior, his boss?
  (Dr Lewis) Yes.

  418. So you were seeing him every week, maybe even every day?
  (Dr Lewis) Yes.

  419. From November 1996 to May 1997, the last six months of your employment, he was unblinding these trials?
  (Dr Lewis) Yes, so it appears.


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