The FDA is broken. How can it be fixed?
In a recent NY Times article, reporter Barry Meier discussed Medtronic’s acknowledgment that some 13 deaths have been attributed to malfunctions of a device it manufactured –a small cable, known as the Sprint Fidelis, that connects an implanted defibrillator to the patient’s heart. Apparently, Medtronic knew the device was failing shortly after it reached the market in 2004, according to the [...]
More Transparency, Fewer Kickbacks for Doctors
In today’s NY Times, Gardiner Harris reports on renewed interest by federal prosecutors in going after doctors who accept illegal kickbacks from drug and device manufacturers in return for using their products. The Department of Health and Human Services is concerned about “marketing tactics that enrich doctors but increase health care costs and sometimes endanger [...]
Outsourcing of Drug Trials Raises Concerns
Today’s NY Times discusses the good and the potentially bad when it comes to conducting trials of new drugs outside of the United States. Subjects in developing countries may be rushing to sign up and disregarding their own safety. Populations in some other countries may be so physically different from Americans that results of testing may [...]