This is one of those stories that I find very difficult to write. My anger is great and clouds my mind. Yet if I do not, there may be some kind of eruption – tears, shouts, or pounding on the wall.
The headline in the Philadelphia Inquirer read, “4 ex-pharma execs face possible jail time.”
“Possible” jail time? This is murder.
In brief:
Synthes received FDA approval bone cement for use only to fill bony voids or defects in some parts of the body, but not in the spine.
In 2003 and 2004, the company is accused of having its representative train surgeons to use this cement for the very thing they were forbidden by the government to do.
For those who don’t know, many surgeries are performed by people who aren’t technically allowed to practice medicine. A lot of times, people who didn’t complete medical school or people who have had their medical licenses taken away for various disciplinary reasons can get employment with a manufacturer of pharmaceuticals or medical appliances (like replacement hip joints) and will train doctors on how to utilize these new products.
This isn’t widely discussed and is shady, at best. It’s probably criminal, but that’s another column.
Synthes executives are charged with conducting illegal clinical trials in which 200 patients were treated for ways not approved by the FDA.
Of those 200, three died.
Filed under big pharma by on Nov 22nd, 2011. Comment. 
When I was a very junior neurosurgical resident in France, I always thanked my lucky stars I had not overused coffee. Mme. M., who ran the cafe below my apartment throughout the first part of my studies, which were mostly classroom, had an Italian espresso machine and little demitasses (half-cups) of potent brew — so potent that I could not consume more than one in the morning. Arabica, fragrant, and aromatic, it was a true joy.
After I moved closer to the hospital center, I heard for the first time the expression “pump yourself full of coffee.” (se pomper pleine de cafe) It was foul tasting stuff, consumed in an infinity of Styrofoam cups, and strong — really strong. There were rumors that it came from the same “common market supplier” as the wine, which was supposed to also be from a a mixture of common market (it had not yet become the European Union) countries. All the food was free, as we were government employees.
Nobody ever figured out where the coffee had come from.
There was an open bar 24/7, about as well outfitted as Mme. M’s. I was afraid to be in the same room with it. I am delighted to report that I never saw anyone use it on an on-call night.
This is the place I could access a small bed — iron tubes for headboard and rails, mattress probably stiffened with starch. The joke, which may well have been true, was that it was Napoleonic non-issue, meant for a barracks.
After the first night I lay upon it sleepless, answering a beeper that whenever it rang told me to call the operator and they would tell me who to call, my then-young back was killing me and I was fighting tears. Read more on Save Lives — Let Doctors Sleep!…
Filed under medical errors by on Aug 26th, 2011. Comment.
I wrote not long ago about the problem with sleep-deprived doctors. Now I feel I must tell you that the person you are relying upon to perform delicate surgery may be so depressed that he’s contemplating suicide.
Why surgeons? I used to be one and maybe I can shed some light.
Of course you can’t prove causality. Maybe just the fact that a person is a surgeon doesn’t mean he is at risk. The same statement about “we can’t tell if there is something causing this or if this is an epiphenomenon” can be a criticism of almost any study, the way those invited to critique this study have spoken.
There is a problem, and this only hints at it.
Filed under Doctors by on Mar 11th, 2011. Comment.