§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will hold an immediate inquiry into the pharmaceutical firm Sterling-Winthrop in respect of its activities relating to the medical drug Amrinone;
(2) if he will publish the evidence received in the course of his inquiries into the activities of the pharmaceutical company Sterling-Winthrop regarding its activities with the medical drug Amrinone; and if he will make a statement;
(3) on how many occasions Dr. Wilmshurst requested his Department to investigate the pharmaceutical company Sterling-Winthrop under the Medicines Act 1968, for its actions on Amrinone; what replies he sent; and if he will make a statement.
§ Mr. Tony NewtonDr. Wilmshurst requested an investigation of Sterling-Winthrop for its actions on Amrinone on three occasions, January 1983, October 1984 and February 1985, and communicated with the Department on detailed points at various other times. The Department mounted two full investigations one in 1983 and one in 1985 to determine whether Sterling-Winthrop Group Ltd was in breach of the Medicines Act 1968 and its subordinate legislation, or of any other provisions of the criminal law.
The Department took legal advice on the reports of these investigations but was advised that there was 698W insufficient evidence to undertake a criminal prosecution. It was however clear that there had been confusion and misunderstanding between the company and the doctors at St. Thomas' about the basis of the clinical trials at the hospital. The company was given strict instructions regarding the improvements of these procedures in such trials, including the need for adequate communication with medical investigators, involved in a clinical trial, to ensure that they understand fully the situation. The company has undertaken to comply fully in future with all legal requirements.
Dr. Wilmshurst was advised in general terms of the outcome of both investigations, in October 1984 and in August 1985 respectively. Dr. Wilmshurst wrote again to my right hon. Friend on 30 August 1985 seeking a further investigation into his allegations. The text of the reply dated 4 November 1985 is as follows. A further letter from Dr. Wilmshurst dated 4 November 1986 has been received and is being studied.
It is not correct to suggest, as some have done, that the Department is unable to act against any pharmaceutical company which threatened doctors or acted fraudulently.
Where the evidence justifies it, we would not hesitate to use all available powers either under the Medicines Act or the general criminal law.
Dear Dr. Wilmshurst,Norman Fowler has passed me your letter to him of 30 August and asked me to look into the matters you raised. You wrote about the activities of Sterling Winthrop Group Ltd. in relation to clinical trials, with specific reference to clinical trials of oral amrinone, and asked that the earlier investigations into Sterling Winthrop's behaviour be reopened.In the light of your letter, Ministers initiated a thorough review of the whole matter. On the basis of that review I must advise you now at the outset, that I am satisfied that there is no basis for me to take the matter further.I am advised that following your earlier complaints in January 1983 and the subsequent ones in October 1984 and February 1985, the Department mounted two full investigations to determine whether Sterling Winthrop Group Ltd, were in breach of the Medicines Act 1968 and its subordinate legislation, or of any other provisions of the criminal law. Medical researchers at all centres involved in the clinical trials of amrinone were seen by an experienced investigating officer who was accompanied, when necessary, by a doctor from the Department. A different investigating officer was used for each investigation and, among others, they saw both you and Dr. Webb-Peploe—who was the person who had dealt most directly with Sterling Winthrop—about the matter you raised.The reports of these investigations were carefully studied by the Department. These reports, like those of prosecuting authorities in general, must remain confidential. But the clear conclusion reached was that the evidence available was not such as to enable the Department to undertake a criminal prosecution. The Department was, however, concerned about the lack of understanding by all participants in these cases about the responsibilities of those involved with clinical trials. The Department's Medicines Division has recently brought to the attention of all licence holders the need to ensure that all relevant evidence is submitted, and is considering whether any further action is needed.I can assure you that the Department always conducts vigorous investigations into matters of this nature and is concerned to improve the understanding and effectiveness of the Medicines Act whenever there appears a need to do so.Sincerely,Ray Whitney
§ Mr. Ashleyasked the Secretary of State for Social Services (1) what adverse reactions from the medical drug 699W Amrinone were reported to his Department; and if he will investigate the interpretation of the data provided by Sterling-Winthrop;
(2) what requests his Department received about a clinical trials certificate with oral Amrinone; what reply was sent; and if he will make a statement;
(3) what trials have been conducted in National Health Service hospitals with the medical drug Amrinone; how many patients suffered serious side effects; and if he will make a statement;
(4) what requests were made to his Department about licensing the medical drug Amrinone: what replies he sent; and if he will make a statement.
§ Mr. NewtonSeparate applications for product licences for Amrinone capsules and Amrinone injection from Sterling Winthrop were withdrawn by the company in, respectively, January 1984 and September 1985 before final decisions on them by the licensing authority. An application for an exemption from a clinical trail certificate for a clinical study of Amrinone capsules by one named doctor was approved by the licensing authority in November 1981; approval for further studies using the original protocol was given for two more named doctors in, respectively, December 1981 and January 1982. Two further applications for studies of Amrinone capsules by named doctors using new protocols were approved in, respectively, November 1981 and July 1982.
All the above clinical trial exemptions were terminated in August 1982 when other similar applications from the Company, received in July 1982, were also refused. In September 1982, Sterling Winthrop applied for clinical trials certificates for studies of Amrinone capsules by various doctors, but the company withdrew these applications in January 1984 before the licensing authority had reached final decisions on them.
A clinical trials certificate for studies of Amrinone injection at St. Thomas' hospital was issued in January 1980 but no application for a certificate or exemption to cover studies of Amrinone capsules at St. Thomas' was received by the licensing authority. Clinical trials of Amrinone injection were conducted at St. Thomas' and some patients received Amrinone capsules.
Clinical trials of Amrinone for which certificates or exemption were granted by the licensing authority were also conducted at Kings College hospital (capsules) and Freeman road hospital Newcastle-upon-Tyne (capsules and injection). Clinical trials involving Amrinone were also conducted by doctors on a named-patient basis at Hillingdon hospital (capsules and injection) and Leeds general infirmary (injection). Both the doctors at St. Thomas' hospital and Sterling Winthrop made procedural errors and there was a breakdown of trust between the two parties. However it is clear that the procedural irregularities did not expose these severely ill patients to additional risks.
A further examination of the interpretation of the data provided by Sterling Winthrop is not appropriate at present as a thorough examination was carried out of all the adverse reaction data when the product licence application was assessed in the Department and by the Committee on Safety of Medicines. A product licence has never been issued for Amrinone; nor is an application for such a licence currently with the Department. Under these circumstances, I do not consider any further investigation is warranted.
700WSterling Winthrop has waived its right in this regard to commercial confidentiality of relevant information held by the Department on clinical investigations of Amrinone sponsored by the company.