Tag: tools

kaytee:

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

[…]In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

Unfortunately, this is not shocking at all to me. In college, one of my profs was married to a scientist that was part of FDA studies on NutraSweet. Said spouse told my prof that in those studies, not one single colleague signed off on this toxic chemical compund that had, at that time, been found to cause brain tumors in rats (this was covered up).

Of course, NutraSweet hit the markets. By the time all the big legal shit hit the fan, the company was dissolved and the people behind all of this were very wealthy.

I later worked for a company that sponsored a QA lab and frequently ate lunch with the food scientist there. He occasionally mentioned (with only barely repressed disgust) how the people selling (my company) would dictate the desired outcome. Tests can be set up to produce any result. It’s just a matter of fixing the data, right?

As I’ve written here before, that’s how the world we live in has always worked. Can we change it? I think we should. In fact, I think we have to change or die!