§ Ms CorstonTo ask the Secretary of State for Health what research trials for the licensing of the drug Lariam were carried out on(a) women, other than service personnel, and (b) tourists going to countries subject to malaria, before the licensing of the drug in 1990; and what trials have been conducted subsequently, indicating the dates. [15195]
§ Mr. MaloneAs for other medicines, information from research trials of Lariam (mefloquine) held by the Licensing Authority is confidential. Section 118 of the Medicines Act 1971 precludes the disclosure of confidential information received in pursuance of the Act.
§ Ms CorstonTo ask the Secretary of State for Health what factors underlie the delay in publication of the Malaria Advisory Committee's new guidelines for the use of Lariam; what is the revised date of publication; and if he will make a statement. [15196]
§ Mr. HoramThe United Kingdom malaria guidelines are prepared by an informal group of experts. This group has no statutory status. We have been advised that this group of experts is preparing new guidelines. The consultation process is taking longer than anticipated. Publication will take place as soon as possible following finalisation of the consultation process.
§ Ms CorstonTo ask the Secretary of State for Health what evidence his Department has evaluated concerning the number and proportion of patients prescribed Lariam who visit overseas countries where malaria is prevalent and subsequently(a) contract malaria and (b) incur (i) severe and (ii) non-severe side-effects of the drug. [15192]
§ Mr. HoramThe number of cases of falciparum malaria reported in the United Kingdom since 1987 are given in the table. The table is subdivided to give the chemoprophylactic regimen stated in each case but information on compliance with this regimen is not available, nor is information on the number of people taking each different malaria prophylactic regimen.
Cases of falciparum malaria—excluding mixed infections—by stated chemoprophylactic regimen, reported in the United Kingdom to the Malaria Reference Laboratory: 285W
Mefloquine Proguanil and Chloroquine Other None Unknown Total 1991 1 265 186 529 287 1,268 1992 4 168 102 422 239 935 1993 3 180 129 474 262 1,048 1994 16 114 109 541 398 1,178 1995 28 96 97 492 399 1,112 19961 35 136 119 514 464 1,268 1 1996 data are provisional. There are several possible reasons for the changes in the number of cases of malaria occurring with the different prophylaxis regimens. The number of cases may rise either because of increasing resistance by the malaria parasites or because more of the drug is being used and they may fall because of better compliance or because the drug is used by fewer people.
As for any licensed medicine, the Medicines Control Agency evaluates reports of suspected adverse drug reactions associated with Lariam (mefloquine) from the yellow card reporting scheme. However, often full details of the degree of the severity of side effects are not reported. In addition, worldwide information on adverse drug reactions from published literature, post-marketing studies and safety reports provided by the manufacturer are also evaluated, in order to ensure that the benefits of mefloquine in treating and preventing malaria outweigh the risks of developing an adverse drug reaction.
§ Ms CorstonTo ask the Secretary of State for Health if he will list(a) the scientific reports, with dates of publication, which provided the basis for granting a licence for the sale of Lariam in 1990 and (b) the scientific reports published since 1990 which are relevant to that licence. [15194]
§ Mr. MaloneThe decision to grant a licence for Lariam was based on all the available evidence, published or unpublished and whether or not favourable to the application. The data submitted by the company was assessed by the Medicines Control Agency, which sought the advice of the Committee on Safety of Medicines, the Government's independent safety experts. The CSM were satisfied as to the safety, quality and efficacy of the product, the sole criteria under the Medicines Act 1968.
A large number of scientific reports are published relating to authorised medicines. As for all medicines, the Medicines Control Agency continuously reviews the published scientific reports in conjunction with other evidence that becomes available to ensure that the benefits of use outweigh the risk of developing adverse reactions.