§ Mr. Ashleyasked the Secretary of State for Social Services (1) what steps he is taking to discover the total number of people who have been disabled by Eraldin (Practolol);
(2) whether he has been advised that adverse effects from the drug Eraldin (Practolol) can begin after treatment of the drug has ended; and what was his reaction to this advice;
214W(3) what is his estimate of the number of people who have suffered from serious adverse reaction to Eraldin (Practolol);
(4) what is his estimate of the number of people who have died as a result of adverse reaction to the drug Eraldin (Practolol).
§ Dr. VaughanThe Committee on Safety of Medicines' reporting system is designed to identify adverse drug reactions. By May 1979, the Committee on Safety of Medicines had received from doctors approximately 2,300 reports of patients who had developed suspected adverse reactions to Eraldin, of which 36 referred to deaths. Most of these suspected reactions occurred before or during 1974 when a possible association with Eraldin was first recognised.
There is evidence that adverse reactions to Eraldin have developed after treatment with the drug has been stopped. A proportion of the reports no doubt relate to events which would have occurred independently or which were due to concurrently administered drugs and bear only a coincidental relation to treatment with Eraldin. At the same time, there may be some cases where adverse reactions to Eraldin have not been reported.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) what steps he proposes to take to establish why the Committee on Safety of Medicines issued its yellow warning, after a delay of months following th reports of adverse effects, of Eraldin (Practolol);
(2) why the Committee on Safety of Medicines took no action to warn doctors when Imperial Chemical Industries first informed doctors of the possibility of adverse reactions to the drug Eraldin (Practolol);
(3) if he will now institute an independent inquiry into the circumstances in which the drug Eraldin (Practolol) was marketed, promoted, and adverse reactions reported; and if he will make a statement.
§ Dr. VaughanWhen Eraldin complications were first recognised, the Committee on Safety of Medicines agreed that Imperial Chemical Industries Ltd, should advise doctors of the possibility of 215W adverse reactions. Subsequently, however, when the reports of adverse reactions to the drug increased in both severity and number, the committee decided to issue its own warning to doctors.
The implications of the Eraldin incident have been examined by the Medicines Commission and the Committee on Safety of Medicines, both of which are independent advisory bodies, and I am satisfied that there is no need for an additional inquiry at the moment.
§ Mr. Ashleyasked the Secretary of State for Social Services how many community health councils have sought the people who were damaged by the drug Eraldin (Practolol); what proportion this was of the total numbers of community health councils; and what steps he proposes to take to encourage the rest to seek the people so damaged who are as yet unaware of the reason for their disability.
§ Dr. VaughanI do not have the information. The identification and reporting of a suspected adverse reaction is primarily a matter for the patient's doctor, and I do not think that community health councils should take over this function.
§ Mr. Ashleyasked the Secretary of State for Social Services (1) how many people who suffered from adverse reactions to Eraldin (Practolol) have received any payment; what discussions his department have had with the people who made the payment; and what was the maximum, minimum and average payment made;
(2) how many people who claim to have suffered from adverse reactions to the drug Eraldin (Practolol) have been awarded any payment; how many claims have been rejected; and how many claims are being considered;
(3) what discussions he has had with Imperial Chemical Industries about the adverse effects of the drug Eraldin (Practolol); what subjects were discussed; and what conclusions were reached.
§ Dr. VaughanThe secretariat of the Committee on Safety of Medicines is in continuous contact with the pharmaceutical industry over medical aspects of possible adverse reactions to drugs. In the case of Eraldin, discussions with ICI Ltd. covered a wide range of subjects relating to the investigation of reports of suspected adverse reactions.
216WCompensation for adverse reactions to specific drugs is a matter for the parties concerned. I understand that ICI Ltd., the manufacturer of Eraldin (Practolol), has voluntarily established a compensation scheme but this is not an issue for discussion with my Department.