Efficacy, safety, and cost of new anticancer drugs

Italian pharmacologists at Mario Negri Institute for Pharmacological Research noted that the new anticancer drugs reaching the European market, offered few or no substantial advantages over existing preparations. In spite of not improving survival, quality of life, or safety, these new drugs cost much more than the standard treatments, in one case, 350 times as much. They identified 12 anticancer drugs and collected information on the new drugs from several documents including the European public assessment report, which describe the steps, reasons, and commitments for the approval of a given drug, and the summaries of product characteristics, the technical documents that report indications and adverse reactions for each drug. They calculated the costs of treatments on the basis of cost per cycle of therapy and compared costs with those of reference drugs. An analysis revealed that few attempts are made to establish the value of the new drugs in relation to the reference drugs. Most drugs caused the usual signs of cytotoxicity, including neutropenia, fever, infections, and gastrointestinal toxicity. In no instance did comparisons show a clear-cut advantage, in terms of adverse reactions, over the reference drugs. The approval of new drugs that offer no substantial advantages had put further burden on national health services, insurers, and patients. The costs of the new preparations were several times higher than those of existing drugs. None of the 12 drugs included in the list offered any significant improvement in activity. From these results there is little to justify some of the promises made to the public. It is widely expected that the general population of cancer patients not involved in clinical trials will gain no benefit from new anticancer drugs. It is to be hoped, however, that some new anticancer drugs will soon undergo adequate clinical testing and show substantial benefits over current therapies.