IJF, the classic personal "would you take it" when a drug is being evaluated is completely irrelevant for the evaluation of effectiveness and/or investment.
I would take Erbitux as part of a ramdomized, placebo control study, then I would have the chance of benefit myself and/or help with the creation of knowledge.
The outside of trial compassionate care use is appropriate in certain cases. I would probably consider a drug out of desperation, like any other terminally ill subject, that says nothing about the drug, it says a lot about human condition.
For the record, I have not objected to any of the compassionate use of Erbitux cases presented here or in the media. I do argue that they are very much irrelevant, as the oppinion of the clinicians involved, except for propaganda in this case.
Go and check Allp web site (I am heavily invested on it, have made good money on it in the past) they have a cute girl birthday photos. She was part of the "matched" patients in the Liquivent study published in the NEJM on premature newborns, read the study, very impressive, 7 "close to death" ventilatory failure babies survived, the other 6 matched control babies died. Impressive 100% vs 0% results. Later a pII in adults gave mediocre results, the definitive pIII in adults was very good but just that placebo was better.
Well, there is no development for cute little babies, and tens of thousands sick like the Allp birthday girl and more premature and weighing a lot less are being saved every year in the USA. At the time, I did not understand the big controversy about the lack of a prospective concurrent placebo control group very well, now it is very clear: It distorts the view and evaluation of drugs and creates more problems than solved. The birthday girl is PROPAGANDA (I own tons of the stock).
I mentioned few posts before the problems of steroids in brochopulmonary dysplasia of premature newborns and recent Pediatrics journal position of US and Canada Pediatric Societies: no more use unless on ramdomized studies, they leave open an "Inform Consent" treatment for the severely ill close to death compassionate use URGING to be very strict in criteria to use. |
