Addressing Risks Derived From the Commodification of Substances of Human Origin: A European Proposal Applicable Worldwide.

In view of the public consultation recently launched by the World Health Organization on Regulatory Convergence of Cell and Gene Therapy Products and the Proposal for a Regulation on substances of human origin (SoHO) repealing the European Union Directives on Blood and on Tissues and Cells, an opportunity arises to define an ethical and transparent framework of collaboration between industry and authorities responsible for SoHO-derived products, comprising medicines, medical devices, transfusion, and transplantation. The commodification of SoHO-derived medicinal products and medical devices entails important risks to the sustainability of healthcare systems and threatens the equitable access of patients to innovative therapies. It may also jeopardize the principle of altruistic donation of SoHO that is required for the treatment and survival of thousands of patients every year. This article puts forward several proposals aimed at reconciling the ethical principles of voluntary and unpaid SoHO donation and the noncommercialization of the human body with obtaining a profit that allows business activities, while ensuring high quality, safety, and efficacy standards of tissues and cells for clinical use.

Platelet aggregation inhibition blocks C-reactive protein and interleukin-6 (IL-6) elevation after the coronary angioplasty: effect of the -174 G/C IL-6 gene polymorphism.

C-reactive protein (CRP), interleukin-6 (IL-6), and the -174 GC IL-6 gene polymorphism were analyzed after coronary angioplasty in 50 patients, 25 of whom were treated with the glycoprotein IIb/IIIa platelet receptor inhibitor eptifibatide for 24 hours. It was found that glycoprotein IIb/IIIa inhibition significantly blocked postangioplasty CRP increases in all patients but blocked IL-6 increases only in patients carrying the -174 GG genotype.