In contrast to the well-known stories of the embryotoxic drug, thalidomide, in countries where it was responsible for large numbers of birth defects, there is limited information on its history in India. Its presence before 2002, when the country issued the first marketing licence for a thalidomide-containing preparation, is assumed to be negligible. This article challenges this view by showing that the drug entered the Indian subcontinent through the former Portuguese territory of Goa around 1960. We examine the subsequent development of its distribution, use and regulation in India from the mid-1960s up to the present situation. Colonial legacies are a crucial explanation for the early appearance of thalidomide on the Indian subcontinent. They also influenced its re-emergence as drug for treating leprosy reactions in India after 1965. We identify key actors in this process: the original German producer that delivered thalidomide free of charge, European doctors who worked for international non-governmental organizations, the World Health Organization (WHO), which supported clinical trials and later discouraged the use of the drug, and finally the Indian state institutions that limited its distribution and later quickly opened the way for the private sector to produce and market thalidomide and its analogues. Finally, we discuss the risk of thalidomide-induced birth defects by casting a critical look on the present state of regulatory provisions and the monitoring of birth defects in India.

Multiple myeloma is a neoplastic proliferation of a plasma cell clone that produces a monoclonal immunoglobulin. It is one of the most common haematological malignancies and the incidence increases with age, with a median age at diagnosis of 65–70 years. The diagnosis of multiple myeloma requires the presence of ≥10% plasma cells in the bone marrow and an M-protein in serum and/or urine. Cytogenetic status, serum β2-microglobulin and response to therapy are the key prognostic factors. Treatment is necessary for the patient diagnosed with symptomatic multiple myeloma, with organ damage. Patients older than 65 years are ineligible for autologous transplantation. The introduction of novel agents, such as thalidomide, bortezomib and lenalidomide, have changed the management of myeloma and extended overall survival. However, in older patients the results are not as satisfactory and treatment strategies have to be individualized to improve tolerability and optimize efficacy.

Objectives: To compare cost effectiveness models for the first-line treatment of multiple myeloma, and explore the differences between the models’ structure, parameters, assumptions and results.

Methods: Three cost effectiveness models for the treatment of multiple myeloma, were compared that had been developed to inform resource allocation in the UK for the chemotherapy regimens bortezomib, melphalan and prednisolone (BMP); and melphalan, prednisolone and thalidomide (MPT) versus melphalan and prednisolone (MP). The models used alternative approaches and assumptions to estimate the overall survival and progression-free survival for each of the interventions. Through the use of sensitivity analyses, the most influential parameters and assumptions of each of the models were identified.

Results: The models developed by the manufacturers gave conflicting results, with each manufacturer favouring their drug. The differences between the model results were determined by two parameters: the hazard ratio for overall survival for MPT vs. MP and the cost of bortezomib.

Conclusions: Using models developed for assessing treatments for multiple myeloma we demonstrated that it was feasible to compare models, which then aided decision makers in making reimbursement decisions.

Among 93 cases of thalidomide embryopathy ascertained in Brazil, one pair of female dizygotic twins was found. One of them presented complete paraxial hemimelia in the right arm while the other showed a triphalangeal thumb at the left hand and had duodenal stenosis. Of the eight dizygotic twin pairs exposed to thalidomide in utero described thus far, only four were concordant for the type of malformation.