Showing papers by "Tufts Center for the Study of Drug Development published in 2005"
TL;DR: The roles that pharmaceutical firms, healthcare organisations, and government regulatory agencies played in three recent switches that have fuelled global debate are illustrated: simvastatin in theUnited Kingdom, omeprazole in Sweden, and loratadine in the United States are illustrated.
Abstract: Appropriate self treatment is an important aspect of both the European and American healthcare systems, but what is really driving increased over the counter availability?
Increased numbers of prescription drugs are being made available over the counter worldwide. Recent high profile switches have included drugs in classes previously not eligible, such as omeprazole in Sweden and simvastatin in the United Kingdom. Switches are motivated mainly by three factors: pharmaceutical firms' desire to extend the viability of brand names; attempts by healthcare funders to contain costs; and the self care movement. Making drugs available over the counter affects a large number of stakeholders, including patients, pharmaceutical firms, physicians, pharmacists, drug regulatory agencies, and private and public health funding organisations. In this article, we illustrate the roles that pharmaceutical firms, healthcare organisations, and government regulatory agencies played in three recent switches that have fuelled global debate: simvastatin in the United Kingdom, omeprazole in Sweden, and loratadine in the United States.
Generally, a prescription drug becomes a candidate for over the counter availability if it is used for a non-chronic condition that is relatively easy to self diagnose and has low potential for harm from abuse under conditions of widespread availability. Statins do not fit this description. Much has been said about the UK Medicines and Healthcare Products Regulatory Agency's controversial decision in May 2004 to reclassify simvastatin 10 mg as an over the counter medicine. In a best case scenario, the switch will increase use of simvastatin by people at moderate risk of developing coronary heart disease, resulting in reduced risk. However, there have been no clinical trials of over the counter statins for primary prevention of heart disease.
Concern has been raised that the main motive behind the government's decision to allow simvastatin to be sold directly to the public is …
64 citations
TL;DR: In Light and Warburton’s (2005b) rejoinder to the authors' reply, the authors reiterate some erroneous assertions made in their original comment and add unsubstantiated insinuations of bias on the part of the now defunct US Congressional Office of Technology Assessment (OTA).
29 citations
Journal Article•
TL;DR: The versatile nature of mAbs and the need for innovative medicines for infectious diseases, especially for those caused by newly emerging pathogens, should cause both the public and private sector to reconsider mAbs as anti-infective agents.
Abstract: Extract: Monoclonal antibodies (mAbs) are a thriving class of therapeutics with more than 150 products currently in clinical studies. Like antibodies made naturally in the human body, mAbs bind only to specific targets and can recruit elements of the immune system to destroy the targets. However, since the products are genetically engineered, mAbs can be designed to have characteristics suitable for a variety of medical needs. Since the products first entered clinical studies in the 1980s, commercial interest has focused on cancer and immunological disease treatments. Relatively few companies have used mAbs to target pathogens. The versatile nature of mAbs and the need for innovative medicines for infectious diseases, especially for those caused by newly emerging pathogens, should cause both the public and private sector to reconsider mAbs as anti-infective agents.
3 citations