Withdrawn Drugs

HC Deb 20 February 1984 vol 54 cc565-9 3.32 pm

Mr. Michael Meacher (Oldham, West)

(by private notice) asked the Secretary of State for Social Services if he will make a statement about the circumstances in which withdrawn drugs can still be prescribed.

The Minister for Health (Mr. Kenneth Clarke)

The circumstances in which the four drugs mentioned in recent press reports have been withdrawn are varied. In some cases the drugs have been withdrawn by the manufacturers, even though their product licences have not yet been withdrawn. In other cases product licences have been withdrawn on the advice of the Committee on Safety of Medicines.

In all cases, however, action has been taken to prevent further uninformed or unintentional prescribing of the drugs. Letters were sent to every doctor and pharmacist informing them of the withdrawal, and in each case the manufacturing company withdrew its stocks from wholesalers and retail pharmacists, reimbursing them for the cost of stocks reclaimed. However, a few pharmacists have retained stocks.

Doctors are free to prescribe whatever treatment they think necessary in the interests of their patients, even where a drug does not have a product licence. It is an important part of the exercise of doctors' clinical judgment that they should be free to decide whether the benefits resulting from the use of a particular product for a given patient outweigh the risks involved.

The Government's first responsibility is to ensure that the professional people concerned are fully informed of the position and that the drugs are not freely available. I am, however, concerned about the position revealed by reports in the Daily Mail. I propose to investigate further whether existing arrangements are operating satisfactorily and shall seek the advice of the Medicines Commission on those provisions of the Medicines Act 1968 which exempt doctors and pharmacists from the controls imposed on products by the Act.

Mr. Meacher

Is it not an extremely serious failure of Government regulations that four drugs linked with 29 deaths are still being prescribed several months—in one case 11 months—after they were withdrawn? Will the Minister ensure that the inquiry that he is undertaking will find out precisely how widespread is the breakdown in controls, whether the present voluntary arrangements need to be replaced by regular use of the prohibition powers under the 1968 Act and why the Government monitoring system failed to pick up the need for the use of those powers in the four cases?

Is it not a serious anomaly that it is not illegal for either a doctor to prescribe or a pharmacist to dispense drugs whose withdrawal has been called for by the Committee on Safety of Medicines? Will the right hon. and learned Gentleman undertake to amend the law as necessary to ensure that death in those circumstances will never be allowed to happen again?

Mr. Clarke

It would not be right to make it absolutely illegal ever to prescribe or dispense drugs that have lost their product licence. After the withdrawal of the licence from the drug Opren, a doctor at University hospital in my constituency approached me, anxious to get supplies of that drug for patients suffering from psoriasis, who were visibly deteriorating before her eyes because they were unable to get the only drug to which they responded. The doctor believed that the clinical risk was worth taking to restore those patients to fit and healthy life.

In this case, the doctor who prescribed the drugs did so in the public interest as a test case and knew that he was prescribing drugs that had been withdrawn from the market. The majority of the pharmacists who were approached were puzzled by the prescription and asked the patient to return to the doctor and consult him about the prescription. In only three out of 30 cases was the drug, with reluctance, dispensed. 'That was legal. However, I agree that it is worrying that this is happening on slightly more than rare occasions. Therefore, the Government are considering the evidence supplied by the Daily Mail and we are asking the Medicines Commission to examine the operation of that part of the Act.

Mrs. Jill Knight (Birmingham, Edgbaston)

I assure my right hon. and learned Friend that there will be much satisfaction over the fact that he has at once announced that he is setting up an inquiry into the matter. Does he not think it ludicrous that a committee of 20 highly paid and extremely expert people spend their time under a chairman deciding which drugs are safe and which are not—even to the extent of producing or refusing a product licence—yet doctors are free to prescribe the drugs which those experts have said should not be prescribed?

Mr. Clarke

In this case the doctor obviously knew what he was doing. It was a test case in the public interest, but he knew exactly what the problem was with those drugs. Each and every pharmacist had also been written to and told why the drugs were being withdrawn from the market. They were offered reimbursement in full for the stocks that they returned to the manufacturing company. For the reasons that I gave, small stocks might legitimately be held by some pharmacists.

As I explained to the hon. Member for Oldham, West (Mr. Meacher), I am describing rare and exceptional circumstances, where doctors and pharmacists should be free to prescribe a drug to a patient. What this evidence shows is that there were more stocks of the drugs about and that they were more available than would have been expected. I agree with my hon. Friend that we should look into that.

Mr. Michael Meadowcroft (Leeds, West)

There will be general satisfaction at the Minister's statement that there is to be an inquiry into the evidence. Does he accept that section 62 of the Act exists precisely to cope with the circumstances outlined in the report? Will he therefore accept that there is a need for action to be taken in view of the existence of that section?

Mr. Clarke

I assure the hon. Gentleman that the Government would not hesitate to use section 62 in a proper case, just as we have not hesitated in the case of any of the four drugs either to withdraw the licence or to ensure that the product is withdrawn from the usual market. Section 62 is appropriate where, to take an extreme example, one has a batch of a drug contaminated with cyanide, which would not be safe in any circumstances. Under section 62 we would call in Me drugs and ensure that no pharmacist could legally dispense them.

That would be too draconian in the present case, where the occasional doctor may wish to prescribe one of the drugs because his patient, who is suffering acute pain, will not respond to any other drug. In the present case, therefore, section 62 is not appropriate. However, an urgent inquiry into the position on these four drugs is appropriate, and that is what we are undertaking.

Dr. Brian Mawhinney (Peterborough)

The quick action of my right hon. and learned Friend is much appreciated. Will he confirm that a patient who, without his knowledge or agreement, is prescribed a product whose licence has been withdrawn for safety reasons is free to take legal action against the manufacturer, doctor or pharmacist if he subsequently develops the symptoms and difficulties which were originally suggested might follow from the administration of that drug?

Mr. Clarke

It would be open to the patient to take legal action only if the doctor had been negligent in prescribing the drug, or the pharmacist negligent in dispensing it. If a doctor makes the clinical judgment that the benefits to the patient outweigh the risks to him, he is free to prescribe the drug. It is a matter for the doctor how far he advises the patient about the calculated risk that he is taking.

To return to negligence, I emphasise that in this case 27 out of 30 pharmacists approached would not dispense the drug and sensibly told the patients to return to the doctor, presumably so that the doctor would have the opportunity to think twice about whether this drug was the one that he intended to prescribe. The legal position is as I have described it.

Mr. Laurie Pavitt (Brent, South)

When did the Minister last examine the mechanism of procedures for informing general practitioners about pharmaceuticals, not only in this sort of case but on the whole question of values? Is the procedure now computerised? Is the Minister satisfied that the procedures, apart from the law, for the Committee on Safety of Medicines are satisfactory? Is he aware that, outside this provision, sweeteners have recently been shown to be injurious to health? They are not medicines, but what powers can he take to protect those who take damaging sweeteners?

Mr. Clarke

We are always revising our procedures and ensuring that we inform professional people of the risks of drugs, and we act promptly when we discover that there are unacceptable dangers associated with some drugs. We intend to computerise the system by which doctors notify the Committee on Safety of Medicines of adverse reactions to drugs. We inform doctors of problems by writing to them individually when a product loses its licence or is withdrawn from the market. They are told what has happened and why it has happened. In the case of all drugs that are freely available, many of which have adverse side effects for some patients, data sheets are readily available and should be consulted by every doctor.

Sweeteners are a separate issue, and I should be happy to discuss the evidence with the hon. Gentleman on another occasion.

Mr. Robert McCrindle (Brentwood and Ongar)

Have we not stumbled almost accidentally on a rather worrying grey area, in that until now most members of the public will have assumed that medicines which are effectively banned by the Committee on Safety of Medicines are not permitted, in any circumstances, to remain in circulation? Will my right hon. and learned Friend take this opportunity to clarify what powers the committee possesses and, in the process, help those members of the public who may be worried to get the matter into perspective?

Mr. Clarke

I agree with my hon. Friend that all of us assume that once a product is withdrawn, and especially when its licence is suspended, it vanishes from the market and is no longer prescribed or dispensed by anyone. As I said, in some cases that can be an error, because there are rare exceptions to the rule. Nevertheless, I and those who advise me were surprised by the extent of the evidence produced by the Daily Mail showing that these drugs are being dispensed to a number of patients. We shall examine the matter and will go to the Medicines Commission, which is the best qualified body in this area of the law, to give us urgent advice.

Mr. D. N. Campbell-Savours (Workington)

Now that it has been proved that Professor Turner, the chairman of the Government's toxicology sub-committee which approved aspartame and its use, had a commercial interest in Searles of the United States, the manufacturer, through the Synthelabo Foundation—an organisation that funds its own research—does that not place a major question mark over the use of aspartame? Should not the decision that was taken last October be reviewed, and can that product be withdrawn from the market pending further investigation by the Government?

Mr. Clarke

This is not the occasion on which to examine the evidence for and against the safety of aspartame. There are clear rules about the declaration of interests by those involved in advising us. In the first place, the Government must go to leading experts in any area to get the best possible advice for the public on the safety of drugs. Inevitably, a number of those whom we approach are involved with manufacturers and pharmaceutical companies. However, the rules are clear: they declare their interests and keep out of decisions on matters where they have a direct interest. We ensure that we take the best objective advice on the products involved.

Sir Dudley Smith (Warwick and Leamington)

The hon. Member for Oldham, West (Mr. Meacher) gave a figure, but can my right hon. and learned Friend say definitely how many deaths due to adverse reactions to the drugs have been reported to his Department?

Mr. Clarke

I regret to say that, off the cuff, I cannot give the total number of deaths due to adverse reactions to the four drugs. I have a feeling that the figure given by the hon. Member for Oldham, West was more or less correct.

Mr. David Crouch (Canterbury)

The House will appreciate the concern that my right hon. and learned Friend has shown and the care with which he has answered questions on this worrying matter. Where a drug has had its licence withdrawn on the advice of the Committee on Safety of Medicines, is it not unlikely that a pharmacy in a hospital would issue such a drug to any consultant or doctor in that hospital seeking to prescribe that drug? Does that not show that in hospitals at least there is tight control once a drug has had its licence withdrawn, and is that not different from the looser application of the regulations that appears to operate in general practice?

Mr. Clarke

We are all anxious that dispensing should be tightly controlled both in the hospital service and in general practice. I agree with my hon. Friend that when we acted as promptly as we did to suspend the product licence for Flosint, our expectation was that supplies would rapidly go back to the manufacturers and no more patients would receive it, and that if any patient received Flosint again it would only when a doctor had made a considered judgment about an individual patient whom he found reacted to that and nothing else and who suffered serious symptoms which would not otherwise be alleviated. I accept that, on the face of it, the Daily Mail report shows a rather looser approach than that being adopted by a few pharmacists. We shall look into that to see whether the law needs tightening.

Later—

Mr. Campbell-Savours

On a point of order, Mr. Speaker. In reply to my question about an interest of the chairman of the DHSS toxicology sub-committee, the Minister for Health replied that sometimes there are medical links between research foundations and individual members working—

Mr. Speaker

Order. I am not certain that this is a matter on which I can rule. I hope that the House will understand that we are getting rather too many points of order concerning unsatisfactory answers. If we allow that sort of thing to happen we shall not get very far with our business.

Mr. Campbell-Savours

To abbreviate the point, Mr. Speaker, may I lay it on the record that the Government, in a reply to me—

Mr. Speaker

Order. That is just what I feared. It is not a matter for me.

Mr. Campbell-Savours

rose—

Mr. Speaker

Order. I think that the hon. Gentleman has shot his bolt for today.