Lessons for World CTs from European Medical Device Failings
By PETER ODONNELL | Applied Clinical Trials Online – Published: FEBRUARY 10, 2012:
At first sight, the deficiencies of European controls on breast implants might seem to have little to offer in the way of guidance for effective clinical trials on medicines.
But once again, European regulators are under the harsh glare of scrutiny, and—once again, as in the recent Mediator case, when questions were raised over patient injury from Servier’s anti-diabetic medicine, it is a French company that is the focus of the criticisms.
To be fair, Poly Implant Prothèse, the company under the spotlight now, for supplying non medical grade silicone in breast implants, received its product authorization from Germany. But the essential issues are the same—questionable business practice, and insufficiently stringent control by health authorities.
In mid-February, the European Commissioner for health, John Dalli, announced a new crackdown on the devices industry in Europe. It is necessary, he said, to tighten controls and increase surveillance, so as to protect citizens and to restore confidence in the regulatory system.
“Patients’ health is the priority in this situation”, he intoned—rather obviously—as he made his announcement. But although obvious, it needed saying. And he admitted that the case had exposed “major loopholes” in the legislation. Equally obvious, but equally important as a starting point for reform. Read Full Article