PROFESSOR VERNON COLEMAN

tUESDAY 12 FEBRUARY 2002

  1300. If thalidomide was new and introduced today under your system then it would be expected that the only way you would discover its effects would be when it started having those effects on human.
  (Professor Coleman) Yes, which is exactly what happened under the old system.

  1301. And we would take that risk and we would understand that risk.
  (Professor Coleman) Which is exactly the risk we took before but we were not enough aware of the risk. Under my system, were some strange god to come down and say "Vernon, you can now rule the world as far as drug testing is concerned", we must not roll out one drug all around the world and let millions, or in the case of thalidomide many thousands of women, take that drug before we have done a proper epidemiological testing, a proper testing on people. That is one of the great scandals—another scandal—that the present system allows a drug company to get a drug through the animal testing procedure and then through the quite small human testing procedure and then, bam, they can sell it all around the world for three, four, five years, and then and only then do people start to realise "oh my God, this is thalidomide" or "oh my God it is one of the 60 drugs a year or whatever it is that have to be pulled because they prove to be dangerous".

  1302. Can I ask you a couple of questions, Dr Coleman. The first question is for clarification. Attached to one of your documents is a list of products I think from one of your books which are shown, according to the data sheet, to have involved findings of carcinogenicity and tumours and so on in animals. Is it part of your case that with all of these 50 products, three of which are in major and general use, the manufacturers and the regulatory system have put them on the market and exposed human beings to carcinogenic risk?
  (Professor Coleman) No, because animals are different from people. My case is that the drugs have been put on the market despite the fact that they cause cancer in animals because the drug companies and the regulatory authorities argue that it does not matter because animals are different from people.

  1303. That clarifies the point. The second point is we have been taking evidence for many months, it has been published up to, I understand, the end of November or thereabouts, have you read any of the evidence?
  (Professor Coleman) I have not, I am afraid, no.

  1304. None of it?
  (Professor Coleman) No.

  1305. Lastly, I would not want you to leave this Committee with any side, you or us, having any false illusions about what went on. You made a comment a few minutes ago about how many committees are biased and wrongly influenced. Are you making such a suggestion about this Committee?
  (Professor Coleman) Not in the slightest, no. No, I was not, I was making a comment about the sort of committees which compose professionals.

  1306. May I ask, Dr Coleman, there are two drugs, ACE inhibitors such as captopril which treats heart disease and tamoxifen which treats breast cancer. Fundamental research identifies the causes of the disease, e.g. the hormone angiotension 2 was found to cause heart disease, and this was discovered as a result of animal experimentation. The development of the drug work on rates in the 1970s led to the discovery of inhibitors which stopped the hormones being released. These could then be targeted at the hormone causing heart disease. Beyond that there is the standard toxicology testing to make sure the drugs are safe before they go on to the market. Are you saying that knowledge would have been found without that test?

  A. Yes.[2]

  1307. You are saying it could have been found anyway?
  (Professor Coleman) Yes. You could find it other ways.

  1308. Ah.
  (Professor Coleman) There are an enormous number of different ways.

  1309. How? How would you have discovered it? You say it can be done, I am the seeker after knowledge, I have an open mind. I would like you to tell me how it could be found?
  (Professor Coleman) You can do tests. You can do tests in laboratories, you can do tests on people, you can do tests these days on very sophisticated computer models which tell us everything we possibly want to know about hormones and all other human parts.

  1310. Can I just explore a little your comment, if I understand it correctly, that instead of doing the testing on animals, say, for thalidomide, let us say we have a new thalidomide, you would not want it tested on animals, you would do the epidemiological survey of it.
  (Professor Coleman) No, what I would do, I would do the tests which are normally done on computers, on human models, on cell tissue and so on. That would probably not have shown the problem with thalidomide, the phocomelia problem with thalidomide which was not shown by the animal experiment—

  1311. No, well it was not tested to show that. It was only after.
  (Professor Coleman) That is right. Even afterwards the problem with thalidomide was that it was rolled out to vast numbers of people before anyone had a chance to find out what it did. I would slow down the rolling out of new drugs until we had a chance to check to see whether they were safe or not.

  1312. You used the word "epidemiological studies", to my mind that means lots of people, big populations.
  (Professor Coleman) Sure.

  1313. Am I correct in saying that you would want to test a new compound which may be was something like thalidomide, we do not know the effects of it, say it was an anxiety suppressant drug for example, you would test it on large numbers of people, different cohorts of drug dose and all the rest of it, and if it was like thalidomide you would then have a substantial number of people, women, giving birth to deformed children. Is that an acceptable way?
  (Professor Coleman) No, that is not what I said. That was exactly what happened. When a drug goes on to the market, whether you tested it on animals or not, you are still experimenting because you do not know what will happen with people.

  1314. These are clinical trials we are talking about.
  (Professor Coleman) Yes. Clinical trials are often quite small. They are often relatively small. If a drug causes a serious problem in, say, a thousand patients and you only test it on 100 patients, you are quite likely not to find that there is a problem. If it causes, say, one in a thousand, I do not know what the figures are for phocomelia, thalidomide, if it causes, say, one in a thousand after two years or after a woman has been pregnant, you have to lodge when you prescribe new drugs for patients, you have to watch that drug with a small cohort of patients and not allow that drug to be given to a large number of people. If my system had been in use when thalidomide was introduced, thalidomide would have only been prescribed for a relatively small number of women and then it would have been gradually rolled out to a slightly bigger group of women. That way you would be able to find whether or not the drug was going to cause problems before you suddenly end up with vast numbers of women who have got problems.

  1315. Okay. I understand. You would do this with every potential new drug for human use?
  (Professor Coleman) Yes, because most new drugs are only what are called in the business "me too", they are just variations on themes. There are not very many new drugs.

  1316. That is a lot of drugs.
  (Professor Coleman) A lot of drug testing.

  1317. Well, a lot of drugs so a lot of testing.
  (Professor Coleman) It does not need a lot of testing because all you have to do is you have to get GPs and consultants around the world to co-ordinate a little bit. In fact if you look at the history of thalidomide you will see that the evidence about thalidomide causing problems was available long before it was published, sadly, unfortunately it was not collated. There were people in, different parts of the world, Australia was one of them and, I think, Germany, the drug came from Germany in the first place. The research was done in bits around the world with fairly small numbers of people and if those small numbers of people had known about all the other people we would have had a far smaller problem in the end. What I am saying is we take away the animal experiments which are useless. We spend the money which was wasted on animal experiments on basically doing some good epidemiological research whenever a new drug is produced.

  1318. I find it difficult to find justifications for you saying you can test it on humans, and all sorts of horrible results may result from animals, and yet that is satisfactory.
  (Professor Coleman) But we do that anyway. When you give a drug to human beings after it has been tested on animals you are still testing it.

  1319. That depends whether you believe animal testing is useless or not.
  (Professor Coleman) You still have not been able to answer my question why animal experiments—

  1320. I ask the questions.
  (Professor Coleman) All right.

  Chairman: Dr Coleman, we could go on. Thank you very much indeed for coming to see us. If we have not stuck strictly to your questions they were unfolding and you were answering them as we went along, thank you very much for that. If when you possibly look at some of the evidence that has been coming before this Committee you have any further comments to make we would be very grateful if you would write to us. Thank you very much.