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.
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.
Tags: back surgery, blood pressure, bone cement, clinical trials, cover-upmurder, criminal, doctors, Drug Companies, FDA, Frankenstein, informed consent, Johnson & Johnson, lapsus, lobbyists, Love and Other Drugs, malpractice, medical appliance, patient advocate, Penn State, pharmaceutical companies, pharmaceutical executives, pharmaceutical sales rep, risk management, surgeons, Synthes.