Sir Peter J Lachmann FRS FMedSci Emeritus Sheila Joan Smith Professor of Immunology | Department of Veterinary Medicine CB3 0ES Telephone: 01223 766242 | |
Secretary: 01223 766242 Fax: 01223 766244 e-mail: pjl1000@cam.ac.uk |
8 November 2010
Rt Hon Andrew Lansley CBE MP,
Department of Health
79 Whitehall
Dear Andrew (if I may),
Thank you very much for your detailed and constructive response to my letter to you. I have read the various points you raised with considerable interest and I am delighted to see that the Department is taking the issues raised seriously.
I fully appreciate that if drugs are to be introduced at the end of Phase 2 - as I suggested, initially on a voluntary basis and subject to the patients giving indemnity - this may well require Phase 2 trials to be modified in order to provide satisfactory evidence of efficacy and lack of common adverse effects. However most clinical trials on the optimal use of drugs already take place after drugs have been licensed and the ethical problems of using a placebo when a drug with some efficacy is already available applies equally to pre-registration and post-registration trials.
I am much encouraged by your telling me that MHRA is developing a scheme to make some promising new drugs available earlier. I was also pleased to see a report that MHRA are to propose changes to the regulation of Biosimilars. The requirement that a new therapeutic antibody of the same class and subclass and with the identical specificity as an existing licensed antibody still has to go through a full programme of clinical trials before registration has always seemed quite excessive and certainly contributes to the high cost that even antibodies that have been used on many tens of thousands of patients (such as anti-TNF antibodies) still command. A third encouraging development is the issue by the FDA of a call for robust surrogate markers for use in place of outcome measures in pre-licensing trials.
However I would like to remind your colleagues in the Department of Health of Francis Cornford’s famous aphorism from the Microcosmographia Academica: “there is only one reason for doing something the others are all reasons for doing nothing”.
Getting drugs into use much more rapidly and much more cheaply is a categorical imperative if health services for the whole population are to survive at all. Among the responses I have received to the letter I wrote to you is one from a colleague with a close connection to a large pharmaceutical company who tells me that the most recent estimate of the cost of taking a new drug to market is around $1.5 billion. It is also vitally important that drugs can be brought into use by companies other than big pharma and that drugs can profitably be developed for diseases that are neither rare enough to come under the orphan drug regulations or common enough for the drugs to be blockbusters. The reasons for doing nothing all pale into insignificance by comparison.
Closely associated problems arise from the litigation culture - suing drug companies and, for that matter, hospitals and primary care trusts, when any adverse effect occurs, whether or not there has been negligence or malfeasance; and I will copy, as you suggest, this correspondence to the Ministry of Justice in the hope that Kenneth Clarke, whom I still remember as Health Secretary many years ago, will be sympathetic to the arguments that something really does need to be done about it if drug development, and indeed the running of the Health Service as a whole, is to work in the real interest of patients. There is no doubt that to an increasing degree medical practice is dominated by the fear of litigation and the resulting defensive practices are clearly enough not usually in the best interests of the patient. This also applies strongly to the issues surrounding invasive therapies at the end of life.
I imagine that it would be extremely difficult for any individual NHS organisation to decide to go over to providing far more services on a 24 hours a day, seven day a week basis. This would require the consent of the Health Service unions to work more unsocial hours. It would involve changing the British implementation of the European Working Time Directive by applying derogation for health staff. There would be longer term implications for the number of doctors required to be trained in the acute specialities. I would agree that it would be an excellent idea to trial such a project in one region; and to measure quality of care outcomes to see what effects such a change would have on survival rates in various diseases or following various operations. I would predict that if such an experiment were done, the attractions for doing this on a national scale would rapidly become apparent.
I am most interested in what you have to say about end of life care and what you say is unexceptionable. It does not, however, address one of the main problems I was trying to raise which is that large amounts of undignified, painful, and probably useless, intervention is carried out in the last months or weeks of life, not because it is in the best interests of the patient or the patient’s wish, but for a variety of complex reasons in which fear of prosecution by the GMC and fear of litigation play a role.
Allowing doctors to take an active role in assisting patients at the end of life is a criminal offence while withholding treatment and/or nutrition is allowed. The categorical distinction that the law makes between these two courses of action is not shared by many of the medical profession to whom inaction is just one option among many. What can be done to improve this situation is highly controversial, but things should not be allowed to continue just as they are at the moment.
Yours sincerely,
Peter
