Safe drug with no proven effectiveness is waste of time, resources, and adding complexity to treatment is in itself harmful, ask the nurses and doctors who has to monitor complex ICU patients.
Your moral point is almost right, My and the FDA is RIGHT.
Face it: Your xoma investment interest is FIRST!.
I have no problem with it.
It Is so easy, Just ask your baxoma to spend the money the right way, more trials on as many indications as possible, as soon as possible.
Yor are fully bias pro bpi as good, including monetary bias.
There are many ethical standards and committes and wachtdog organizations.
But baxoma are balking from 2000 to 2001 to ....
Plus, bpi is not the only drug in town, the Fda knows of many candidates that will address sepsis shock and amputations in DIC: Zovant will be out in 2001 (sooner than bpi), pafase in 2002, tifacogin in 2002 to 2003.
For amputations in DIC, all of the above and TPA (trial ongoing, already use off label) reopro, corr's intgrillin, and many more on the way.
If xoma likes off label uses and unproven drugs for indication why did their trial did not allowed for Tpa, very well know to decrease clots and amputations (definite trials for this indication ongoing) simple, it is ethically Right to design away from off label uses, especially if not proven in control respected trials. xoma was right on designing away from tpa (and xoma likes the idea of getting tpa out of the way from the market in this disorder).
Keep your moral objective toward your problem: xoma! |
