PRESCRIBED DRUGS (REGULATION OF PROMOTION) (Hansard, 21 June 1978)

§ Mr. Mike Thomas (Newcastle upon Tyne, East)
I beg to move, That leave be given to bring in a Bill to regulate the promotion and advertisement of prescribed drugs; to remove prescription charges in respect of certain classes of prescribed drugs; and for purposes connected therewith. I am grateful to my right hon. Friend the Minister of State for taking the trouble to be with us today.
My Bill proposes to do two things: first, to abolish prescription charges on a wide range of drugs, which, as many right hon. and hon. Members know, is an important component of Labour Party policy; secondly, to put an end to bogus trials of drugs, in which both general practitioners and patients are 468 misled as to the real purposes of the drug companies in advocating the trials.
I want to make it clear at the outset that I have no prejudice against the pharmaceutical industry. I believe that the benefits of a vigorous, inventive and productive pharmaceutical industry to the National Health Service and to the economy as a whole are clear, and I have no wish to damage that industry.
However, there are two marketing practices in which the industry is now engaging in which the State should take a hand and which Parliament should take powers to control. They are, first, an old practice, that of branding drugs, which frankly has no merit for the patient, no merit for the doctor and no merit for the NHS. Its only merit is one for the drug companies, in that it enables them to promote the sales of their drugs after the patent life has been used up. They promote sales to doctors through branding in much the same way as soap powder manufacturers seek to promote the sales of their own products to the consumer.
The other practice that I wish to regulate is a new one and is in some ways much more sinister. It is the practice of bogus clinical trials, in which large numbers of patients are induced, through their doctors, to transfer to a drug, not because they may get any benefit from so doing, not because doctors, the medical profession or academia at large will learn anything from the rudimentary study that is made of the transfer of the patient to that drug, but simply because it will promote the drug company's market share in sales of that preparation. I regard those trials, which have been widely criticised in the Press and elsewhere, as reprehensible, and I hope to say a little more about that as I make my speech.
First, I turn to the question of branding. As I said, it is designed for one purpose only and that is to prolong the sales life of a product, and it leads to almost all the bad practices in which drug companies indulge. It is branding that leads to extensive advertising and to representatives expensively calling upon doctors and bothering and cajoling them about the use of their company's drugs.
I do not object to the drug companies, in common with others, being given the protection of the patent laws. Indeed, 469 in this Parliament we propose—I am not sure whether the Bill has become law yet—to extend patent life from 16 to 20 years, and that will give companies substantial benefits which may well be deserved. But to prolong the benefit beyond the patent life by having got the doctor indoctrinated into using a brand name rather than the chemical, the generic or the official name in the pharmacopoeia is in my view, a quite unjustified practice.
I should make clear that it is also a practice that results in great cost to the National Health Service. For example —if I may just give one—the drug tetracycline is available in dozens of varieties, all chemically identical, and those who say that I am advocating that patients should be given an inferior or different drug are wrong, because the Pharmacopoeia Commission lays down that drugs must be formulated in an identical way for them to be able to take the chemical name. As I have said, there are dozens of varieties of tetracycline and some, while several times more expensive than others, in their effect on the patient are identical.
There is a simple way to stop that, and I propose it in my Bill. I have to say that it is not my own idea but the idea of a magazine published by the Consumers Association, entitled the Drug and Therapeutics Bulletin. It says, and I believe it to be right, that a practical means of dealing with this problem would be to mark on all prescription forms "Please dispense non-proprietary equivalent", which the doctor could cross out or leave. That would be at the bottom of every prescription form, and if the doctor did not delete those words, thereby leaving the chemist free to dispense the cheapest drug of that kind, I propose in my Bill that no prescription charge would be made.
The purpose of that is to provide a small incentive to doctors and to patients to give some thought to the massive drug bill which they impose on the NHS, which now extends to £400 million or £500 million. To those who say that that could not work, I say that it is already working, and that it works for large numbers of my constituents, because in all of the hospitals of the Newcastle Area Health Authority that is already the case. No matter what the doctor writes on the pres- 470 cription form in hospital, the patient is dispensed the cheapest equivalent.
Let me give just one example. If the doctor writes "aldomet", which is the Merck, Sharpe and Dohme variety of the drug methyldopa, the patient is given methyldopa in the cheapest form that is available. There is no question of that being inferior or different. It is the same drug and the only difference is a saving to the NHS. On a slightly different basis, in Australia, New Zealand and a number of other countries precisely that arrangement is pursued with general practitioners.
I want to put in one reserve caveat because I am well aware of the remuneration problem of retail pharmacists. The formula for rewarding chemists would need to be adjusted so that they did not suffer because of the lower turnover that would result from the cheapest drugs being prescribed. I also propose that as well as getting a formula to make sure that their rewards stayed broadly the same they would get a more interesting job, for the simple reason that they would be relieved of the boring process of taking a drug from a shelf and putting it in a bottle. They would have to give some thought to which brand of the drug was to be provided in response to the prescription. They would not, of course, decide which type of drug; that would he decided by the doctor.
I come now to the question of bogus clinical trials. These are reprehensible in the extreme. There is an increasing public and professional concern about them, and it has been expressed by clinical pharmacologists, by the Drug and Therapeutics Bulletin and by a number of other people, including the British Pharmacological Society.
The basis on which the trials are operated is as follows. A pseudo trial is designed by a pharmaceutical company, often by its marketing division with little or no guidance from its medical department. The trial protocols, the rules by which it is run, usually have characteristic features. They generally aim to recruit enormous numbers of patients. A total of 20,000 to 30,000 is common, and one study hoped to recruit 100,000.
Either the drug has been introduced recently and is competing with a lot of other drugs designed for the same purpose, or sometimes it is a drug whose patent life is about to run out and the 471 company hopes to get the patient transferred to a drug which still has a long patent life. The disease being treated is frequently one where drugs may have to be taken for a considerable period of time.
The methods for assessing the benefits of the trial are usually crude, the duration of observation is minimal, and the methods for recognising adverse drug reactions are very much over-simplified. Usually, the doctors concerned are provided with some small pecuniary reward, although it must be made clear that in my view in the vast majority of cases general practitioners are well motivated in participating in these trials and often are misled by the drug companies concerned as to their value.
The trial is analysed by the company's own personnel. The results are published in some obscure scientific or pseudoscientific journal in which often the rule of economy is reversed. The contributors are not paid. The drug companies which wish to have articles placed in the journals actually pay the journals. According to The Sunday Times earlier this year, as much as £85 per page is paid by the drug companies to get the results written up.
The real aims of the trials are threefold. They make sure that large numbers of patients go on to the drugs, and the sponsoring companies hope that they will stay on the drugs after the trials have ended. They are a means of drawing attention—

§ Mr. Speaker
Order. The hon. Member will come to a conclusion, will he not? He has had a Welsh 10 minutes already.

§ Mr. Thomas
Forgive me, Mr. Speaker. As I began my speech, I noticed the time. It was 3.32 precisely. I have still a minute to go.

§ Mr. Speaker
No. It was 3.31 when the hon. Member began.

§ Mr. Thomas
I shall get my spectacles adjusted, perhaps by consulting your optician Mr. Speaker.
I shall bring my remarks to a rapid conclusion. The purpose of the trials is as I have described them. No British-based research company indulges in these trials. They are indulged in entirely by multinationals.
In conclusion, I quote from the evidence by the British Pharmacological Society to the Royal Commission on the National Health Service, which spells out the matter very clearly. It said: Most of these studies are at best useless from a scientific point of view, and at worst they amount to little more than buying of prescriptions. I believe that by involving the Medicines Commission and the ethical committee of the area health authority concerned, which my Bill proposes, we could control these trials.
The object of my Bill is very simple. It will not affect research. It will not affect exports. It will not affect the freedom of doctors to prescribe what they wish. However, it will abolish charges on most prescriptions at no cost to the National Health Service. It will stop wasteful expenditure on promotion. It will make the best use of doctors' and chemists' talents.