Opren (Hansard, 20 July 1987)

§ Mr. Jack Ashley (Stoke-on-Trent, South)

Thalidomide was the drug disaster that devastated the lives of young children, shocked the public, and led to revolutionary changes in our approach to drug testing. Many people expressed the hope, "Never again".

Opren is another drug disaster, one that has mainly hit those at the other end of the age group—old people. Although their suffering has yet to capture the imagination of people, I believe that it will lead to an equally important revolution — this time about the methods of paying compensation for drug damage.

The battle for compensation for victims of the drug Opren highlights the cost and the strain involved in such struggles. I note the claim of Mr. Richard Bailey, the British managing director of Eli Lilly, that it is a caring, responsible pharmaceutical company which is concerned to do the right thing. I am not optimistic. This is a compay with an appalling record for integrity. The Amerian Food and Drug Adminstration, the drug watchdog, issued no fewer than 20 summonses against it, incuding one for not disclosing 26 deaths due to Opren. The company accepted fines rather than fight the charges and be publicly exposed. This is the company whose statiticians stressed that an unusually high incidence of adverse reactions among elderly people taking part in trials was not statistically significant. In fact, it was significant and, had this been recognised earlier, much suffering could have been avoided.

The Government also claim to be caring and responsible. I await action which shows their determination that British victims of Opren should get the same consideration as United States victims, who have now been paid. There are several reasons why the Government should intervene. The first is the scale and intensity of the suffering. It is doubtful that we shall ever learn the exact numbers of people who have suffered death, kidney or liver failure because of Opren. The Committee on Safety of Medicines had 332 adverses reaction reports including 77 deaths. It is generally accepted that adverse reactions to drugs are under-reported, so the actual figures will alomst certainly be higher.

Some idea of the suffering can be gleaned from this extract from a letter written to me by the son-in-law of a man who died: My father-in-law died in March of 1986 from the now proven symptoms created by the administration of Opren, the miracle drug for arthritis. Among the cocktail of problems he endured for 4–5 years were respiratory problems, lung and liver deteriroration, and photosensitivity to the skin. Really his death ensured relief from those years of suffering". Some people suffering photosensitivity cannot go out of their houses. They are prisoners in their own homes because they cannot be exposed to sunlight. They cannot cook or enjoy the warmth of a fire or even a warm bath. In tests on five healthy students, reported in the European Journal of Rheumatology and Inflammation 1982, two students who had taken Opren refused to continue with the planned exposure of a small patch of skin to 20 minutes in the sun because the burning pain was so intense. I hope 184 that, in addition to noting this information, the Government will ensure that urgent medical research into photosensitivity is carried out.

The Government are responsible for helping all sick and disabled people, but they have a particular responsibility for any drug-induced disability because it is Government procedures which determine the availability of particular medical drugs.

The relationship between the drug, consumer and manufacturer is unique. The product determines whether he or she lives or dies, is well or ill, yet the consumer swallows it with virtually no knowledge of it. He is guided by his general practitioner who is guided by the Committee on the Safety of Medicines.

Some Ministers, such as the right hon. and learned Member for Rushcliffe (Mr. Clarke), try to parody critics of damaging drugs, such as myself, and imply that we demand 100 per cent. safety. I realise that that is impossible. Nevertheless, there is a vital difference between unpredictable side effects which catch out all the world's experts, and side effects which damage patients in only one or two countries, while others with more vigilant drug regulation bodies stay unharmed.

The British Government, through the CSM, licensed Opren at a time when the United States watchdog, the Food and Drug Administration, was turning it down. Australia, Canada, New Zealand, Sweden and the Benelux countries all rejected Opren. Britain got it wrong—with terrible consequences. The Government have a clear moral responsibility to make amends.

The CSM accepted carcinogenicity tests that were rightly refused by the regulatory bodies in other countries. It licensed Opren on the basis of seriously flawed clinical trials which contained too few people taking the relevant dose and for too short a time. It accepted evidence from the company on sensitivity to the sun based on trials which took place in winter or on hospital patients not exposed to the sun. No doubt it is these issues among others which have led to the compensation settlements with United States claimants and to the approaches made to some selected British victims.

I realise that the Government cannot instruct the company on how it should pay compensation. But this horrendous affair has focused attention on the question of compensation. I have no doubt that reputable drug companies — and even the Association of British Pharmaceutical Industry—are concerned that Eli Lilly is not following the excellent example of ICI after the Eraldin disaster.

When there is a comprehensive drug disaster, there must be a comprehensive compensation scheme. A schedule of payments related to the degree of disability must be agreed.

Those damaged most should receive most, but no legitimate claimant should be overlooked. Once the schedule is agreed, it would be necessary for a claimant to argue that the damage was due to a particular drug. That is how the Eraldin scheme operated and, generally, it worked well.

This type of proposal was well on the way to being accepted by Eli Lilly in the spring of this year, but at the last moment there were instructions to call off the deal. No doubt the company calculated that the legal ruling on costs would lead to many claimants backing off. Its calculation was correct, but it had not counted on the remarkable generosity and public spirit of Mr. Bradman. I warmly 185 applaud his kindness and concern, and I pay warm tribute to the ability and persistence of Miss Kathleen Grasham, without whom this whole campaign could not have survived.

I want to ask the Minister if she accepts the need for meeting a comprehensive disaster with a comprehensive solution and, if so, whether she will encourage the company to offer the same compensation for British citizens as has been given to United States ones.

If the company rejects this approach, the Government should sponsor a boycott of all Eli Lilly's products where alternatives are available. They should refuse to use such products in the NHS and find sources elsewhere. In this way they would be showing that they were determined to defend the interests of British claimants and that they would not allow a powerful multinational company to use its muscle to deny justice.

§ The Parliamentary Under-Secretary of State for Health and Social Secur ity (Mrs. Edwina Currie)

May I first offer the right hon. Member for Stoke-on-Trent, South (Mr. Ashley) the usual courtesies on his success in the ballot.

This debate concerns the non-steroidal anti-inflammatory drug—NSAID for short —Opren. The last occasion that Opren was debated in the House was in January 1983. Hon. Members might find it helpful if I begin with a brief history of the drug to help place the current debate in perspective.

In 1974, the Secretary of State and the Ministers who comprise the licensing authority, sought the advice of the Committee on Safety of Medicines on an application by Lilly Industries Ltd. for a clinical trial certificate for Opren. This was to enable trials to take place on the drug as a treatment for rheumatoid arthritis. From 1974 onwards, an increasing number of clinical trials on the drug were authorised and in 1977 the company applied for a product licence to sell and supply the drug. The CSM considered all the evidence available at the time and called for more information on a number of side effects. On receipt of this further information, the CSM advised the licensing authority that a licence should be granted and a licence was accordingly granted in March 1980. The licence and its accompanying data sheet, which was to be made available to all medical and dental practitioners to see, included data on the product approved by the Committee covering contra-indications, warnings and precautions.

During its two years of marketing, Opren, like most NSAIDs, brought welcome relief to a large number of people who suffer from osteoarthritis and rheumatoid arthritis. However, all NSAIDs are quite toxic, which is why most are available only on prescription. The most notable exception is aspirin.

Continued monitoring of adverse reaction reports takes place to ensure that only drugs whose efficacy in relation to safety are considered to be acceptable by the CSM and licensing authority remain licensed. The CSM has a statutory duty to promote the collection and investigation of information relating to adverse reactions, known as the yellow card system. Following consideration of the evidence on adverse reactions by the CSM, the licensing authority suspended the licence for Opren in July 1982 and the company withdrew the product from the world market in August 1982 and surrendered its United Kingdom 186 licence. Opren was withdrawn because the benefit/risk ratio was considered unacceptable by the CSM and the licensing authority.

The decision to suspend the licence for Opren was controversial. Many doctors felt that it should not have been withdrawn as many patients derived benefit from it; on the other hand, others argued that it should have been withdrawn earlier.

In the debate in 1983, referred to by the right hon. Member for Stoke-on-Trent, South, my right hon. and learned Friend the Member for Rushcliffe (Mr. Clarke), then Minister for Health, expressed his sympathy for all those people who felt they had suffered after taking Opren and for the relatives of those who had died. I do, of course, repeat those sentiments, which the whole House will share. However, because of the current High Court actions, I am advised that it would be inappropriate for me, as a representative of the licensing authority, to go into any more detail at this stage about the effectiveness of the monitoring of the drug and the reasons behind the decision to withdraw it.

I turn now to the current litigation but must repeat that my legal advice is that it would be wrong for me, as a representative of the licensing authority joined in this action, to make any comments today which might prejudice the outcome of the case. Both the licensing authority, which consists of the Health and Agriculture Ministers, and the Committee on Safety of Medicines, which is one of a number of statutory committees established under the Medicines Act 1968 and advises the licensing authority on the safety, quality and efficacy of new medicinal products, have been joined with Lilly, the manufacturers of the drug, as defendants in an action for negligence. These actions have been brought by a large number of plaintiffs—our records show these to be in excess of 1,300—who alleged that they or their deceased relatives have been damaged as a result of Opren treatment. The Opren Action Committee is co-ordinating the litigation on behalf of a large number of the plaintiffs. It was decided by the court that, because of the large number of plaintiffs, lead actions should be agreed between the parties and the question of any liability in these should be decided first. The remaining cases would be stayed until the liability issue in the lead actions had been decided.

The actions allege negligence on the part of the Government defendants, and these allegations can be roughly divided into two groups. The first is that sufficient care had not been taken in the consideration of the applications for the clinical trial certificates and the product licences. The CSM should not have advised that Opren should be licensed; the licensing authority should not have acepted that advice.

The second is that action was not taken quickly enough to remove Opren from the market in 1982. It must be stressed that on the advice of Government lawyers and counsel, all claims of negligence are denied categorically. During the debate on Opren in January 1983, referred to earlier, the Government defended the action taken by the CSM and the licensing authority. At this point I must make it clear once again that, while the Government have sympathy with the plaintiffs who allege some adverse effect caused by Opren, as a defendant in the case it would be inappropriate for me to debate the issues involved. I am a defendant in this case. The right hon. Gentleman was a Minister of the Crown and is well aware of the difficulties 187 under which he places me on an issue which is sub judice. It is also not possible for me to speak now about any question of compensation and/or settlements relating to the Opren action, nor to comment on any settlements which may have occurred in the United States. It could be prejudicial to the proceedings if the licensing authority and the CSM, as co-defendants in this action, were to express a view on the reported activity of Lilly and the plaintiffs, or were seen to take sides or otherwise to get drawn into the current public debate. I offer my apologies but regret that I cannot be more forthcoming with the House on this occasion.

Before I close I should like to make one or two general remarks which should not be taken as applying to any particular or general aspects of the Opren case. It is most important that we should remember the enormous benefits that millions of people have gained, and continue to gain, from drug therapy. People suffering from all kinds of debilitating illnesses can now find relief thanks to treatment with medicinal products, and in many cases can be enabled to lead normal lives, which would not have 188 been possible only a comparatively short time ago. I am an asthmatic. Common ailments such as asthma, diabetes, high blood pressure and many others can be seriously disabling and life-threatening, but a range of medicinal products for treating these conditions has been developed in recent times by the pharmaceutical industry, not least by companies based in the United Kingdom. However, the public should be aware that any medicine which can be used as an effective treatment for an ailment cannot be regarded as totally without risk, particularly in the case of a medicine available only on prescription. The advice of doctors or pharmacists should be followed whenever appropriate.

Modern drug therapy has made an enormous contribution to improving the quality of life for many people. While we all have sympathy with those who may be adversely affected on the rare occasions when something goes wrong, we must also recognise the enormous contribution to a better life made by products developed by these great industries.