Pharmaceuticals Policy and Law - Volume 11, issue 4

Authors: Koski, Carol Lee

Article Type: Research Article

DOI: 10.3233/PPL-2009-0240

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 307-315, 2009

Authors: Chatzimarkakis, Jorgo

Article Type: Other

DOI: 10.3233/PPL-2009-0247

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 319-321, 2009

Authors: Chatzimarkakis, Jorgo | Mikolasik, Miroslav

Article Type: Other

DOI: 10.3233/PPL-2009-0248

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 323-324, 2009

Authors: Prevot, Johan | Waller, Charles

Article Type: Other

DOI: 10.3233/PPL-2009-0245

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 325-332, 2009

Authors: Budde, Willi

Article Type: Other

DOI: 10.3233/PPL-2009-0227

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 335-341, 2009

Authors: Farrugia, Albert

Article Type: Research Article

Abstract: The application of evidence-based medicine to the indications addressed by plasma protein therapies is problematic. So-called Level 1 evidence in the form of randomized clinical trials using classical designs to demonstrate efficacy is seldom possible, because the small numbers of patients denies the appropriate level of power from being built in the trial design. In addition, patient accrual is difficult because of understandable patient resistance and "fatigue" at the number of trials. Efforts to address this …by regulating agencies over the past years have yielded promising policies in some areas, which recognize the inherent problems and outline practical solutions. The use of patient registries to accrue safety and efficacy data, while rapidly becoming accepting an accepted component as a basis for pre-market review and approval, is also promising as a basis for the incorporation of post-market data, through Phase 4 surveys, of approved therapies. As such, innovative thinking to address the problem of rare disorders may also lead to desirable reform in all aspects of regulation, with a shift from pre- to post-market review. Show more

DOI: 10.3233/PPL-2009-0230

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 345-352, 2009

Authors: Naylor, Gordon

Article Type: Other

DOI: 10.3233/PPL-2009-0249

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 353-357, 2009

Authors: Robert, Patrick

Article Type: Other

DOI: 10.3233/PPL-2009-0250

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 359-367, 2009

Authors: Wallner, Jürgen

Article Type: Research Article

Abstract: Background: Blood and plasma (b&p) are crucial but scarce resources for medical therapies. Collecting b&p poses technical and ethical challenges, as can be observed when it comes to regulation. Objective: To provide ethical orientation for organizing and regulating the donation and collection of b&p. Method: Analysis of ethical theories in regard to their potentials to reach the objective. Results: The ongoing ethical debate between paid vs. unpaid b&p donation is …shaped by a 'simple b&p ethics' approach that focuses on the individual donor and the existence or non-existence of one motivation: altruism. Utilitarian and deontological ethics come to different conclusions but basically apply the same simple approach. In contrast, forms of 'complex b&p ethics' acknowledge the ambiguity of altruism, try to find a common framework for the plurality of motives to give b&p (contractualism), or point out that giving b&p is part of a good life (virtue ethics). Complex b&p ethics furthermore widens the perspective from the individual donor to the collecting organization and the donation/collection regime and critically assesses them. Conclusion: Neither 'gift fetishism' nor total commodification seem to be ethically sound ways of enabling people to live good lives. Those engaged in b&p collection will be well advised to acknowledge the complex plurality of motives while simultaneously upholding the caring nature of b&p donation, collection, and distribution. Show more

Keywords: Blood donors, plasma, ethics, altruism, gift giving

DOI: 10.3233/PPL-2009-0246

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 371-384, 2009

Authors: Kerr, Jacqueline

Article Type: Other

DOI: 10.3233/PPL-2009-0239

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 387-395, 2009

Authors: Weinstein, Mark | Jain, Nisha

Article Type: Research Article

Abstract: FDA encourages the development of products that demonstrate promise for the treatment of rare plasma protein disorders. This is accomplished through a program of regulatory provisions, financial incentives, clinical trials designed to address small patient populations, and measures to increase the number of patients under study.

Keywords: Orphan drug act, rare plasma protein disorders

DOI: 10.3233/PPL-2009-0241

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 397-402, 2009

Article Type: Other

DOI: 10.3233/PPL-2009-0226

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 405-409, 2009

Article Type: Other

DOI: 10.3233/PPL-2009-0234

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 411-499, 2009

Article Type: Other

DOI: 10.3233/PPL-2009-0233

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 501-503, 2009

Article Type: Other

DOI: 10.3233/PPL-2009-0235

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 505-522, 2009

Article Type: Other

DOI: 10.3233/PPL-2009-0236

Citation: Pharmaceuticals, Policy and Law, vol. 11, no. 4, pp. 523-557, 2009