WRITTEN QUESTION E-1614/00

by Cristiana Muscardini (UEN) to the Commission

(29 May 2000)

Subject: Use of somatostatin in the treatment of osteosarcomas

Six months ago, the National Cancer Institute financed a study at five major US cancer research centres into the use of somatostatin in the treatment of osteosarcomas, one of the most malignant forms of tumour. The study was to receive further financing for one year if it proved successful (halting or reducing tumours without toxic effects). However, an NCI document shows that, as a result of the positive findings, the study has received further funding in all five centres, confirming the efficacy of the product which is the basis of the method used by Dr Di Bella. Further confirmation of the effectiveness of this treatment is provided by the decisions by more than 40 Italian courts requiring local health care units to offer this treatment on the basis of reports by cancer specialists.

The Commission:

1. Is it aware of the decision taken by the National Cancer Institute?

2. Does it know of any similar studies conducted in Europe and their findings?

3. Why not include a study of this kind in its four-year research programme?

4. Is somatostatin included in any of the Member States' pharmaceutical tables as a tumoricidal drug and, if so, in which ones?

Answer given by Mr Byrne on behalf of the Commission

(19 September 2000)

1. The Commission is not aware of any decisions taken by the National cancer institute (NCI). It has identified the listing by the NCI of a recent clinical phase I study of a somatostatin analogue, of which the outcome will become known in about three years time. However, this study does not use the Di Bella method(1).

2. The Commission is not aware of any similar studies carried out in Europe. Such trials are subject to national controls and information may be available from the national agencies. More information may also be available from the European Osteosarcoma Intergroup (Chairman: Antonie Taminiau, e-mail: A.H.M.taminiau@lumc.nl)

3. The Commission does not finance clinical studies. This is usually the sole remit of the pharmaceutical company, which would like to obtain the market authorisation following a set of established regulations, directives and procedures guaranteeing a high level of safety, quality and efficacy of any drug before entering the market. Nevertheless, any European research institution is free to participate in the research programmes of the Community, if the eligibility criteria are met, following a peer review by independent experts and depending on the available budget.

4. Somatostatin or its long-acting analogues octreotide and lanreotide are not licensed through the European centralised or mutual recognition procedures. The Commission is not aware of the nationally authorised indications in all Member States. It appears, however, from the information in Martindale, The Complete Drug Reference, 32nd edition published 1999, that somatostatin and its analogues are not indicated as tumouricidal drugs in the Member States.

(1) Phase I Study of Octreotide Pamoate With or Without Tamoxifen in Patients With Osteosarcoma (Summary Last Modified 07/2000), Protocol Ids: NCI-95 C-0119I, NCI-T96-0047N.