They have a tough job, those government doctors, scientists, and bureaucrats who are charged with assessing the safety and effectiveness of proposed new medical products. As you know, they rely largely on studies presented by the applicants.
The Food and Drug Administration (FDA) has the power to not approve a new drug or product or even pull it off the market. Right now it is considering limiting or pulling GlaxoSmithKline’s (GSK) diabetes drug, Avandia, because of newly discovered data that it may have caused heart attack in some patients –- data mysteriously not shown in GSK’s own studies. If the drug is pulled it will cost GSK billions of dollars in lost revenue but, from the FDA’s point-of-view, it will be protecting the public. And, after all, there are safer diabetes drugs on the market as alternatives. Read more »
*This blog post was originally published at Andrew's Blog*
“…I have always depended on the kindness of strangers.” — Blanche DuBois in Tennessee Williams’ play A Streetcar Named Desire
Years ago when I began my medical training, I recall enrolling patients for clinical research. In cardiology, there were a myriad of questions that needed to be answered, especially in the area of defining which medications were best to limit the damage caused by a heart attack.
Patients routinely participated in large, multi-center prospective randomized trials to answer these questions. It was routine for them not to charged for participating in the trial — the drug(s) and additional testing would be funded by the company whose drug was being studied. Patients enrolled willingly, eager to help advance science and perhaps, in some small way, their fellow man. It never dawned on me in those early days why hospitals and research centers were so eager to promote research. Read more »
*This blog post was originally published at Dr. Wes*