The statement noted that “the company continues to believe that [rosiglitazone] is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions ... GSK will voluntarily cease promotion of [rosiglitazone] in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.”
But other REMS programs – including the one that will be established for rosiglitazone – are much more restrictive, such as the one for the antiepileptic vigabatrin. That REMS requires not only a medication guide, but also a communication plan to ensure reporting of adverse events, elements to assure safe use, and a system to ensure that physicians, pharmacies, and patients who do not comply with the rules lose access to the drug.
Dr. Nissen has received research support from Takeda Pharmaceutical Co., AstraZeneca, Daiichi Sankyo Co., and several other pharmaceutical companies and has consulted for a many such companies without financial compensation. All payments from any for-profit entity are paid directly to charity. Dr. Rosen reports receiving a lecture fee from GlaxoSmithKline and grant support from Eli Lilly & Co., Merck & Co., and Novartis. Dr. Kaul has received research support from Hoffmann-La Roche and has been a consultant for that company as well as from Novo-Nordisk. Dr. Jellinger is on the speakers bureaus of Amylin Pharmaceuticals, Eli Lilly, Merck, Novo-Nordisk, Sanofi-Aventis, and Takeda.