Select Committee on Science and Technology Minutes of Evidence


Examination of Witness (Questions 420 - 439)

TUESDAY 28 JULY 1998

DR PETER LEWIS

  420. And it turns out now that he was quite alarmed at that time by his findings.
  (Dr Lewis) He did not convey that to me and in fact there is plenty of documentary evidence that he was not alarmed or pessimistic. In fact, I included a couple of bits of evidence on that on the Marimastat front. There was a meeting with an outside consultant in February when he was very bullish on the whole thing and he did not indicate in any way that he was worried about Marimastat.

  421. I saw that letter. He told us in his evidence on several occasions that he did communicate his pessimism to yourself in the full expectation that would then go on to McCullagh and the directors.
  (Dr Lewis) I know he said that and really I cannot corroborate that. He was not pessimistic. He was very upbeat on both Zacutex and Marimastat. If anything I was the one who was calming him down and saying "Yes, but we cannot extrapolate from phase two to phase three, one never knows", etc. I think I was the voice of reason. I am generally known to be somewhat pessimistic and downbeat about these things, I always tried to restrain Dr McCullagh's optimism on things. Really it does not tally. I think he is rationalising backwards to something which did not happen.

  422. The line that he gave us three or four weeks ago when he gave evidence was to the effect that he became very concerned by what he had found in unblinding, that he conveyed these in verbal form at least to yourself expecting that message to be passed on and it was not passed on. We asked Dr Millar why not, why did he think this would not have been passed on, and he made reference to the fact that you had share options, quite large share options, and in his evidence to us he told us that you sold a large amount of shares in March or April 1997 while in receipt of this information. Is it true that you did sell a large amount of shares during that period, March/April 1997?
  (Dr Lewis) In March, just before the beginning of the new financial year, I exercised half the options I had available and I sold 250,000 shares, but I retained as a result of the exercise all the profits from that exercise as British Biotech shares. I acquired only shares as a result of that exercise. Although I sold shares I did not receive any money, I ploughed all the money back into shares. I became a shareholder of 400,000 British Biotech shares.

  423. Were you involved in the January 1995 inquiry by the Stock Exchange?
  (Dr Lewis) No. I bought shares on that occasion.

  424. Can you see that there is another construction here that Dr Millar put to us of him having unblinded the trials, having told you about these results in broad terms, expecting that message to be passed on, finding that it was not and coincidentally at this very time you were involved in share dealings within the company?
  (Dr Lewis) Yes, I understand the construction; it is just that he did not do this. He did not pass this on. He was not pessimistic; he was actually optimistic. I mentioned he was optimistic on the Marimastat front, he was also very optimistic on the Zacutex front. He fought like mad with the Commercial Director in order to have control over post-marketing medical direction, for example, showing that he was actually very optimistic about the situation with Zacutex. Really it does not hang together. The reason why I exercised those share options in March was nothing to do with that; and in fact I acquired shares at what subsequently turned out to be an absolute top price for them, £2.48 every share I bought. If I was worried about the fact that everything was going to go wrong and the shares were going to plummet I would hardly have acquired 400,000 shares at that price.

Mr Beard

  425. I find it difficult to square that answer, Dr Lewis, with the answer you have just given me which was a somewhat damning observation on the company's strategy which you summarised as "ridiculous arrogant optimism".
  (Dr Lewis) Remember when I wrote that letter it was a year later. One of the things that I thought was an example of Keith's ridiculous arrogant optimism was the way he chucked Dr Millar out of the company. He thought that he could do anything. I think I went on in the letter to say "...it is another example that he just pushed you out of the company without thinking through the consequences". He dismissed Dr Millar without any sort of compensation and then he was surprised when Andy turned on him and went to the press and so on and so forth.

  426. That is mentioned but it is also mentioned that that phrase occurs in the context of not out-licensing and not taking partners on. In the context of your own answer earlier this afternoon you said "we had six drugs in line, four failed and two were still going on and there was an assumption that both of them would go through unscathed". That is the context of the optimism and yet in answer to my colleague, Dr Williams, you are saying you saw no reason why you should not have high expectations, and indeed in the statement you have given us this afternoon you said "Certainly during my time at British Biotech the company was extremely scrupulous in its handling of investor relations. There was extensive consultation on press releases and professional advice was frequently sought". I find it very difficult to see how that phrase squares with the view that you expressed privately that the company ought to be following a quite radically different strategy and without following it the risks were too great to tolerate so you were going to resign.
  (Dr Lewis) It was over a period of time. I felt Keith was optimistic. I regret the way I said he was arrogant, he was just very sure of himself, and I felt he was taking the company down this route which was unnecessarily risky. I thought, in fact, we were going to win through. I thought we had some very, very good products. Indeed, when I acquired those shares in March everything was going well, we had just filed our first marketing application. As I say, Andy was optimistic as well on Marimastat and Zacutex. I was uneasy that everything was going too well and I did not want to stick around in case it did not go too well. I suppose that is the honest way of putting it. It sounds paradoxical when you put it like that, Mr Beard. Really that was my feeling about it. I was not immediately worried about anything in particular. Things were going well. As I say, we were in a sort of black hole as far as clinical trial results were concerned, one did not know what was happening, but recruitment was going on reasonably well in both of the studies and we had our first marketing authorisation going through EMEA. It was quite a good time. I was taking my time over leaving the company. I told Keith and Mr Raisman earlier on that I wanted to leave. I wrote a letter of resignation in April, which I fished out of the records and I have in fact given to you. It gives those reasons why I wanted to leave and that is a contemporaneous record. It says I was not happy with this strategy.

Chairman

  427. Can I take you back to a comment you made just now. In criticising Dr McCullagh on two points; firstly, you criticised him on the grounds that he treated Dr Millar badly as a result of which Dr Millar went to the press, but the facts are that Dr Millar went to the press first and it was Dr Millar going to the press that irritated Dr McCullagh and caused Dr McCullagh to see Dr Millar which resulted in Dr Millar's dismissal. The second point I would like to make to you is that you have criticised Dr McCullagh for firing Dr Millar, but you yourself said a few moments ago that you would certainly not employ Dr Millar again because he had far too many faults and you would never employ him again. Is it not possible that Dr McCullagh had a little more foresight than you did?
  (Dr Lewis) Yes, I accept those criticisms. What I really meant was that the way in which Keith dealt with this and dealt with Andy, I read an account saying that Andy had asked to leave the company and he wanted to get redundancy and wanted to leave when he was passed over for the job of Development Director, and Keith had refused him and eventually he fired him. I think actually, according to one account I read, Andy did not go to the press until he had actually been fired.

  428. That is not the evidence we have.
  (Dr Lewis) Well, I thought that was what the point was.

Dr Gibson

  429. Is Keith a man who would get his way with commercial bankers, individual employees, a board of non-executive directors? Did he always get his way and did he cut corners sometimes in getting that, in your opinion?
  (Dr Lewis) No, he persuaded people that this was the right thing to do. He persuaded me for four and a half years that this was the right policy and he is a very persuasive man and a man of great ability. He did not cut corners and I do not want to imply in any way when I am criticising Keith that he did anything wrong and, I repeat, the investors knew exactly what he was doing.

Mr Beard

  430. You say, Dr Lewis, that he was very persuasive, but you have a strong scientific background in statistics as well as in bioscience and medicine and you yourself have mentioned this afternoon that you ended up with two drugs which the company strategy was almost presuming would be certainly successful and it sounds as though the probability of your succeeding was probably about 40 per cent each. Is that a reasonable thing to assume?
  (Dr Lewis) Yes.

  431. So the company was dependent on two drugs with a 40 per cent chance of success each, according to normal statistics, which meant that there was a strong one-third chance that neither of them would succeed, so the company's future was based on two drugs with a one-in-three chance of failing, both of them failing, and huge amounts of money were being raised against this, and press releases were being put out in a very up-beat way. I go back to your original judgment as that seems nearer the line than the later judgments in that case. How can you explain why you were persuaded by Dr McCullagh in these contexts? As the chief adviser on scientific and clinical matters to the Board, how were you persuaded to overcome those very, very salient facts?
  (Dr Lewis) Well, in the first place, you are correct in saying that if a drug is in Phase III, it does not have a 100 per cent chance of success, the argument being, "What is the chance of success?" When a drug actually, however, has been submitted as a marketing authorisation through a regulatory authority, one is entitled to think that there is probably a 90 per cent chance of it getting through and that is what the case was with Zacutex and it actually had been filed with the European regulatory authority.

Dr Gibson

  432. Was that for acute pancreatitis or severe acute pancreatitis?
  (Dr Lewis) For acute pancreatitis.

  433. The word "severe" appears in the shareholders' report.
  (Dr Lewis) Well, what we did was we applied for the widest possible indications to start with. When I was with the company, and I was there for three months after the thing had been filed, we applied initially for acute pancreatitis, knowing that during the course of a negotiation, one usually gets toned down to a more precise, more restricted indication. It was one of the tactics in fact I referred to in one of my memos, which I think you may have, that possibly, if there were objections or difficulties, we would tone it back to severe acute pancreatitis. That in fact means that there are fewer patients, but in fact you can charge a higher price, so it is not a disaster. So that is the answer.

  434. So the answer is that there was zero chance with acute, but 15 per cent or 30 per cent or something with severe acute? You changed the parameters of the drug, from the shareholders' report?
  (Dr Lewis) Well, I did not write the shareholders' report and I am not familiar—

  435. I am talking about the company.
  (Dr Lewis) Well, that is a potential issue which I have not examined. I knew that at some point it was likely that we were going to get restricted to severe acute pancreatitis. As I say, that is about 30 per cent of acute pancreatitis and it does not make much difference commercially because if you have fewer patients, then the chances are that you will get a higher price around Europe.

Dr Kumar

  436. In your submission to this Committee, you said that "it is clear that he", that is Dr Millar, "engineered my early departure from British Biotech".
  (Dr Lewis) Yes.

  437. What evidence do you have to support that view?
  (Dr Lewis) Well, I did not know what had happened and it was purely Dr Millar's evidence to this Committee. He talked about things I did not know about. My experience of directly what happened was that I had been negotiating with Dr McCullagh to leave the company for three or four months and it had all been very amicable, et cetera, et cetera. I came back from a conference I had been at in early May and I was called in to Dr McCullagh and he said, "I've changed my mind. I don't want you to stay on. I am not happy about the way research is being run, so I want you to leave immediately. I in fact have told your reports that you are leaving and they are going to report directly to me". Only a week previously he had given me a bonus and said that he could not have achieved what he had done without me, so something had happened and I did not know what it was. It was only later, in fact precisely when I saw the videotape of what Andy, Dr Millar, had said to this Committee that I realised that he had been in there and made accusations about me and in fact that was the net result.

  438. Did you have any suspicion at that time that he had engineered it?
  (Dr Lewis) No, I had none at all. In fact I found it a bit odd that I did not speak to Andy around this time, but I was bounced out of the company so quickly that I did not really have much chance to talk to anybody. I did not understand what had happened and in fact as I wanted to leave anyway, I did not really make any objections to it and I was relieved that finally I was going to be doing something different, but I was upset about it, very much so.

Dr Gibson

  439. Why were you bounced, Dr Lewis?
  (Dr Lewis) Why was I bounced? Well, because I was asked to leave immediately.


 
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