Bioethicist quits job at controversial stem cell outfit

Posted under adult stem cells, bioethics, biotech jobs, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, stem cell, Universities, Videos by Ryan McBride

He came, he saw, he quit. Bioethicist Glenn McGee has resigned from his post at stem cell company Celltex Therapeutics after just three months on the job. He announced his departure from the company that has been accused of unethical use of stem cells on Tuesday, according to his Twitter account. Nature broke the news of McGee's resignation on Thursday.

"Enough. I resigned from #Celltex Therapeutics on & effective 2/28/2012. I am preparing timely, lengthy, pointed comments on the whole matter," he wrote on Twitter.

Houston-based Celltex had just announced McGee's joining the company as president of ethics and strategic initiatives on Feb. 13. As Nature reports, McGee, founder of The American Journal of Bioethics, took flak from his peers in the bioethics community over his taking the position at Celltex while still serving as an editor for the journal.

Celltex faced controversy of its own over accusations that the company, which says it provides adult stem cell banking and multiplication services, has peddled stem cells for illegal use in humans, Nature reported. McGee hasn't made public why he's leaving Celltex, but the "timely, lengthy, pointed" comments he's preparing should make for interesting reading.

- check out the Nature article

The Ethics of Global Clinical Trials

Posted under bioethics, Blog, clinical trial, Companies, Diagnostics, FDA, FDA approval, Food and Drug Administration, Funding, Health, Medical Devices, Medical Supply, Pharmaceuticals, regulation, Research and Development, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

By Dr. Russell Medford, Salutria Pharmaceuticals

Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world. Even prior to these reports, some have asserted that sponsors conduct clinical trials abroad to avoid red tape and avoid overly stringent and time consuming regulatory processes. However, research done by companies with the intent of seeking FDA approval and access to the U.S. market must still meet FDA standards regardless of where the research is conducted. FDA regulations require trial sponsors to undertake several quality assurance and audit activities, and failure to abide by these rules could delay or disqualify a product’s chances of getting marketing approval.  Companies develop numerous processes to ensure compliance and protect patient safety, including:

• Pharmacovigilance conducted by experts (oftentimes hundreds of individuals in one company) who collect, analyze, follow-up, and distribute safety-related information from new drug trials.
• Establishment of data and safety monitoring boards to impartially evaluate safety as studies progress.
• Regular sponsor monitoring of clinical trial sites to ensure quality, compliance, and safety of research participants.
• Quality assurance units that audit operations associated with clinical research to ensure adherence of company personnel to regulations, guidelines, and internal and external procedures, policies, and programs.

Unethical clinical trials, however rare, tarnish the reputation of all researchers and their work. BIO members are deeply concerned about any instance of unethical clinical research, and take seriously the ethical issues involved in conducting overseas clinical trials. BIO has long supported responsible and ethical testing, protection of individual privacy and genetic information, and regulatory systems that best serve humanity and advance research into new treatments for patients, regardless of where research is conducted. Toward that end, BIO supports appropriate oversight of clinical trials and medical research, whether conducted in the U.S. or elsewhere in the world. Performing important research and protecting research subjects are mutually attainable goals, and decisions regarding whether and how to use medical products and technologies must always be made with profound respect for the rights of patients. Appropriate regulation of biotech should be solidly rooted in values such as autonomy, privacy, beneficence, social justice, and intellectual freedom. Encouraging and enabling innovation through a timely and consistent regulatory process will ultimately result in medical treatments and cures for some of the most devastating and life-threatening diseases.