This debate is about Britain's greatest drug disaster. It is about the scandal of a huge United States pharmaceutical company coming to Britain and boasting of Opren, a new wonder drug to treat arthritis — with tragic results. It left a terrible trail of human destruction — adverse reactions were officially reported for 3,963 people, of whom 83 died. The true extent of human suffering is undoubtedly far higher. More than 7,000 people sought help from the Opren action group.
The agony, disfigurements and deaths are akin to a battlefield. They have been cynically and systematically played down by the company, yet some of them are horrific. They include rashes which blister and bleed, ulceration and haemorrhages of the stomach, bladder incontinence, liver jaundice, kidney damage, acute eye sensitivity, detached finger nails and toe nails, and skin photosensitivity. The widow of one man who died wrote:
The drug caused his hair to fall out, his kidneys became infected, dried his toe nails and finger nails on both hands and feet, burst two toes on the left foot which never stopped discharging till his death … he couldn't even bear the weight of a sheet on his feet. It is only those of us who have witnessed the sufferings from this drug who can tell of the agonies it produces on the human body".
To the 1,300 British people who are claiming compensation for Opren suffering, the company has offered a derisory £2·75 million—an average of £1,800 per person. This breathtaking contempt for victims, insulting attitude and brass-necked insolence can be understood only by appreciating the background of the company and its development of the drug. I hope that every Member of the House of Commons and House of Lords—and every Minister—will take careful note of the following facts.
The company is distorting the truth. Honest reporting of adverse reactions is essential for drug safety, but Eli Lilly failed to report 26 United Kingdom deaths from Opren to the United States drug watchdog, the Food and Drug Administration, when it was seeking the American licence. It was lucky to get away with a fine of $25,000 for this serious offence.
The clincial trials, conducted before marketing, were hopelessly inadequate according to some experts. They were too small, conducted for too short a period, the participants were given too low a dose, and there were too few old people. The company also failed to act immediately when the potential dangers of the drug for old people were pointed out. It offered jobs — salary unspecified — to experts whose work revealing the dangers of Opren for old people had been ignored. Eli Lilly knew that their testimony would be damaging in court, as indeed it was. One of those experts, Dr. Hamdy, said in the television programme "World in Action" that even after he warned of the dangers for old people the company continued to recommend the original dosage. He said in "Panorama" that they refused to change because it was "commercially non-viable".
Putting profits before lives, inadequate research, cheating the record, misleading the people—this is the unacceptable face of the pharmaceutical industry, one which is damaging the good name of responsible and reputable firms and makes a mockery of Ministers who run a mile to avoid involvement.
British victims approached the company for compensation when the full and horrible effects of this drug were known. They were aware of ICI's fair-minded response after the Eraldin disaster, when that company set up a proper compensation scheme. They found out that Eli Lilly had paid £27 million to 103 United States victims. They were hoping for a fair deal, but they were disastrously disappointed. The derisory offer of some £2·275 million to 1,350 British sufferers shocked them, especially when compared with the United States payment. Many of them had not appreciated that we have an archaic legal system which imposes crippling shackles on any drug-damaged litigant who is not a millionaire.
The company exploited this system to the full. It imposed unbelievably harsh conditions on disabled people, many of them too old, bewildered and poor to fight. It bludgeoned them into submission—using the euphemism "acceptable" settlements—by the threat of court battles which the individuals could not afford but which this wealthy multinational could. The imposed settlement bound these disabled people with strict legal conditions, gagged them for life, and denied their solicitors freedom to act for other sufferers.
The reasons why the company got away with this were partly our antiquated legal system, but mainly the financial power of a selfish and rapacious company. It has behaved like a cruel tiger, toying with helpless people, knowing that they lacked the health and the money to fight. It has created an enormous well of frustration and bitterness in Britain by adding this financial insult to the original injury.
Fortunately, the victims had their champions. The main one has been the admirable Kathleen Grasham, whose mother died from Opren in tragic circumstances. She has been a skilful and persistent leader of the action group for more than five years. David Mason has added his considerable weight, intelligence and energy to the battle. I do not share the political views of the Daily Mail, but it has fought a vigorous, well-directed and sustained campaign on behalf of the victims. I pay my tribute to these campaigners for their distinguised efforts.
The question I want to put to the House tonight is: where do we go from here? This is the third parliamentary debate on Opren which I have initiated. I have been pressing the issue with debates, parliamentary questions and deputations to Ministers for more than five years. "Panorama" and "World in Action" have done splendid programmes. There has been vast press coverage. The damage to Eli Lilly is incalculable, especially from the television programmes. Yet when over 100 Members of this House, and the House of Lords, last week put a reasoned and moderate proposal to the United States chairman urging the setting up of a trust fund, it was turned down flat.
That contemptuous dismissal of a reasonable settlement, which would have avoided further legal wrangling, does not mean that Eli Lilly has won. The fight will certainly continue. New cases are being prepared, new initiatives are being launched, and the company must expect a renewed onslaught.
Even at this moment, the Department of Health and Social Security is investigating allegations against Eli Lilly of non-reporting of serious adverse reactions made by the telvision programme "World in Action". I might add, in parenthesis, that when the Under-Secretary of State for Health gave me this news, she said that she could give me no undertaking to let me know the outcome. If she thinks she can keep this kind of thing secret, and treat the House of Commons with contempt, she had better think again.
An international boycott of Eli Lilly's products has already been launched by Ralph Nader. The British Government have declined to act on this, but, in view of the company's rejection of the suggested trust fund, I would ask the Government to consider what helpful action they can take. They cannot simply wash their hands of the whole affair while British citizens are being discriminated against, especially as Opren was distributed by the NHS. I do not believe that they should sanction the provision of non-essential Eli Lilly drugs, knowing that if any new disaster should occur the British victims would almost certainly face the same harrowing ordeal as the Opren victims. Surely, other things being equal, an ICI drug is better than a Lilly one.
I know that, as a representative of the licensing authority, the Minister will claim to be part of the legal action. Nevertheless, Ministers wear many hats and there is no reason why Ministers should not act.
The Association of the British Phamaceutical Industry should also take a hand in this tragedy. It is being seriously damaged by the affair and ought to step in with some constructive suggestions.
Community health councils should put Opren on their agendas, and work with the Opren action group. There is always the risk of adverse reactions with every drug, and it is surely unwise to add the danger of inadequate compensation from using a Lilly drug if others are available.
Trade unions should also consider the very serious disadvantage to their members of using Eli Lilly drugs, and should ask for alternatives when available. In particular, those trade unions working in Lilly companies, which include Dista Products, should consider what action they can take.
The sooner Eli Lilly recognises that this issue will not go away, the better for all concerned. Drug accidents can happen to anyone while millions of prescriptions are given every year. The top priority is to avoid them, but, when they happen, people in Britain expect fair play. They will not tolerate unscrupulous disregard for people suffering so terribly as a result of Opren. As their collective concern and anger grow, so the prospects of fairness will improve. It is in the interests of the company, no less than of the victims, that even at this late hour a fair and honourable settlement is reached and a trust fund set up. The next step lies with the company, and, after that, with all of us.
First, I congratulate and support the right hon. Member for Stoke-on-Trent, South (Mr.
Ashley) on the speech that he has just made and on bringing to the attention of the House the important and deeply tragic situation facing Opren sufferers.
Secondly, I should like to ask my hon. Friend one question relating to the principle that the right hon. Gentleman has enunciated. It is a fact that many people become the victims of drug-related medical accidents, especially in the early years of a drug's introduction. I suggest that it is time that the Department of Health and Social Security brought the major drug companies together to create an effective, equitable and properly managed compensation scheme.
May I begin by extending to the right hon. Member for Stoke-on-Trent, South (Mr. Ashley) the usual courtesies on his success in the ballot. I am sure that he would agree that neither he nor I would ever treat this House, nor indeed each other, with contempt.
I also listened to the comments of my hon. Friend the Member for Newbury (Mr. McNair-Wilson). I refer him to a written question from the right hon. Member for Stoke-on-Trent, South to which my right hon. Friend the Minister for Health replied. The right hon. Gentleman asked
the Secretary of State for Social Services if he will initiate discussions with the Association of British Pharmaceutical Industries regarding the establishment of a no-fault drug compensation scheme.
My right hon. Friend replied by saying:
It must be for the pharmaceutical industry to decide whether it wishes to set up its own no-fault drug compensation scheme"—[Official Report, 8 March 1988; Vol. 129, c. 172.]
However, I have no doubt that the industry will have taken note of my hon. Friend's remarks.
This debate concerns the non-steroidal anti-inflammation drug benoxaprofen, Opren, and the settlement recently negotiated between the manufacturers of the drug Eli Lilly and the plaintiffs concerned in the current litigation. It follows, as the right hon. Gentleman said, an earlier Adjournment debate on Opren just eight months ago on 20 July 1987, to which I replied.
On that occasion, I outlined for the House a brief history of the drug to help place the subject of that particular debate in perspective. The history that I related then is clearly still relevant to today's debate but, in view of the comparatively short period since we last debated Opren, I will not prolong matters unnecessarily by repeating the bulk of what I said then. I will, however, repeat that both the Licensing Authority—that is, the United Kingdom Health Ministers—and the Committee on Safety of Medicines are co-defendants in the action with the manufacturers of the drug. In the light of all the evidence held and the advice of the Government lawyers and leading counsel, all claims of negligence against the Government defendants are and have been denied categorically. I said on that occasion that Ministers felt considerable sympathy for those who feel that they have suffered and for their relatives and I am content to repeat that now. The right hon. Gentleman and my hon. Friend the Member for Newbury will know that I mean it.
As I said towards the end of the previous debate on this subject, the right hon. Gentleman places me in a difficult position in answering this debate. My up-to-date legal advice is that it is still inappropriate for Ministers as co-defendants in this case to debate any of the issues involved, including the privately agreed settlement. Although in many cases the plaintiffs have, I understand, accepted the offer made by Lilly, there still remain cases before the courts in which members of the Licensing Authority—that is, Ministers—and the CSM are defendants.
The previous debate was conducted in the early hours of a Tuesday morning in July 1987 and the Hansard report of it was published on the morning of Wednesday 22 July. On that day, Mr. Justice Hirst gave a strong public warning about the propriety of a publicity campaign and called for due restraint. The right hon. Gentleman will know exactly what the judge said on that occasion as it was widely reported and I see no reaason to repeat it here. However, on 9 December 1987, the judge was able to announce details of a proposed settlement between Lilly and the plaintiffs. During that judgment he said:
It may be that certain individuals will be disappointed with the way the proposals affect their own claim. In coming to a conclusion, they will all I am sure, with the benefit of legal advice, balance their prospects of success in pursuing a claim outside the settlement proposals against the risks involved in proceeding individually if unsuccessful at the end of the day.
Fairness and justice demand that each individual one of these plaintiffs should have the opportunity to consider the offer calmly on its merits, without being subjected to outside pressure of any kind, whether through national publicity or from private groups or individuals.
Last July I had occasion to give a warning as to the propriety of a campaign which was then afoot. Happily that campaign immediately died down, and this I am sure contributed to the successful progress of the settlement negotiations. I wish to stress that the case is still sub-judice, and so my July warning still applies. The success of negotiations of this kind greatly depends on continued confidentiality." Subsequently, on 3 February 1988, Mr. Justice Hirst stated that approximately 1,104 Opren plaintiffs at that date had accepted the offer unconditionally; approximately 125 had accepted subject to arbitration, only a handful of those being non-qualifying plaintiffs; 43 had refused the offer; and approximately 72 had still not replied. There has been no official announcement since in court, but I understand that all but a handful have now replied. I also understand that arbitration is not yet complete.
I must stress that the settlement is the result of private negotiations between representatives of the plaintiffs concerned and the manufacturers of the drug. The Government defendants have not been involved in any way in those private discussions, nor in the negotiations on the terms of the settlement.
My right hon. Friend the Minister for Health met the right hon. Member for Stoke-on-Trent, South and a small group whom he led on 15 February 1988. Subsequently, my right hon. Friend the Minister for Health wrote to the right hon. Member for Stoke-on-Trent. South on 18 February and pointed out once again that it would be
for the Government
to intervene in the settlement freely negotiated by solicitors representing the Plaintiffs.
I fully recognise the right hon. Gentleman's concern, and that of other hon. Members, but it remains wholly inappropriate for the Government to intervene.
The right hon. Gentleman has the right to call the debate and, Mr. Deputy Speaker, on two occasions recently, you have agreed that the subject should be debated. As always, the right hon. Gentleman has expressed his views with vigour and sincerity. As a former Minister, he knows exactly in what difficulty he places me in attempting to answer him tonight. I hope that he will understand and accept the points that I have made.
Let me finish by quoting once more from Mr. Justice Hirst's statement of 19 December. Perhaps this will also be a sufficient response to the point made by my hon. Friend the Member for Newbury. The judge said:
once the Opren litigation is finally disposed of, those who have worked so hard on it will have, I feel sure, a great contribution to make in the future in finding solutions to the problems which have come to light in the handling and financing of litigation of this kind and on this scale under our present legal system".
On that basis, I wish to conclude my remarks.
I am glad to have the opportunity to say a few further words. I have raised some important issues in the debate and the Minister, according to the notes that I have received, has made little effort to answer some of the profoundly important points that I have made—profoundly important to severely disabled people damaged by this ruthless company. It is wrong that she should come here and read a brief without making one essential point when thousands of British people are suffering. That was a disgraceful response to the debate.
I put to the Minister a clear and specific point that I raised which she either did not hear or follow. If she wants to listen, I repeat it. Can the Minister confirm that she wrote a letter to me on 1 February 1988 in which she said:
Officials are currently investigating the allegations made in the recent 'World in Action' programme against Eli Lilly and will take account of documents sent with your letter. Once the investigation is complete the facts will be considered and, if warranted, appropriate action will be taken. I can give no undertakings to let you know the outcome".
I contend that is deeply insulting to the House of Commons. For a Minister to conduct an investigation into a matter of profound importance to hon. Members and then to tell the Member of Parliament who raised it that the House of Commons will not be told the outcome of those investigations is deeply insulting.
This is not a secret society; this is a democracy. The Minister is not playing fair with the victims of Opren by keeping secret this information. I will give her five minutes to respond to those points. The debate does not finish until 10.30 pm, so she has five minutes if she wants. I could speak for an hour, but I rushed my speech to give the Minister an opportunity to reply. The hon. Member for Newbury (Mr. McNair-Wilson) wanted to intervene, but I gabbled my speech so that we could get a decent answer. But what did we get? We got absolute rubbish from the Minister.
The problem is very grave and people are suffering appallingly. They need someone to fight for them. They should not have to rely on a voluntary group, a few Members of Parliament and a few campaigners to fight for their rights from the Government. The Government ought to step in and fight Eli Lilly, and say: "Be as fair to British citizens as you have been to American citizens." Why is there a vast discrepancy between the treatment of one lot of victims and another? It is outrageous that the British Government should turn away and do nothing, while the American Government made damn sure that their people were looked after. No wonder we are becoming a second-rate country, with Ministers such as this one. The Minister now has five minutes to respond. Let us hear her answer.