Category Archives: bioethics

Hamburg: Society needs to weigh in

Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader…

Share

Human germline engineering: The mom’s not in the picture

U.S. and British government agencies are moving toward enabling what would be the first clinical trials of what is, in effect, human germline engineering – genetic modifications that would be passed down through the generations. The modifications would not be…

Share

Don’t Call Them Generics!

When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The…

Share

DNA Donor Anonymity: for the Lucky Few?

Privacy concerns related to DNA sequencing got yet another airing today when a team from the Whitehead Institute reported in Science that using only publicly available information, they have been able to identify about 50 men who had anonymously donated…

Share

FDA’s Confusing Action Against Burzynski – What Does it Really Mean?

Last month the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to the Burzynski Research Institute Inc. and the Burzynski Clinic regarding claims made for its antineoplastons A10 and AS2-1 injections that violate the Federal Food, Drug,…

Share

Grappling with the Ethics

With science boldly taking us where we’ve never gone before, we’re exploring new worlds and stretching the boundaries of our universe. While these are exciting times for the adventurer in us, they can be discomfiting for our inner ethicist. From…

Share