As some predicted...the joint advisory committee decided to recommend against using Ketek for sinus infections and bronchitis but leave it available for pneumonia. That's a distinction with some clinical difference but not always since at what point do you being antibiotic treatment to prevent pneumonia once you know the source of the community acquire strain of the infection? Do you simply withhold a Ketek type drug in stanching other types of infections leading up to pneumonia that are resistant to other drugs? So my guess is that there will be some retooling on the label....
As for non-inferiority trials...shame on those who call it a lower standard of approval..it is not..it is a different way of obtaining information on effectiveness and it has emerged in recognition of the existence of many new therapies that affect survival or serious morbidity, and that therefore cannot be denied patients by dumping some folks into a placebo group. So that means some people get the standard treatment and others get the new drug...isn't that what Waxman and others who are screaming about non inferiority trials with Ketek have been bitching they want more of? Or am I confused? Or are these pols so hopelessly hypocritically and twisted in knots in order to posture fot the media they don't care or is that they don't even know what an inferiority trial is or consists of? Oh, and it is not a test tube test as one ex-FDAer derided it... And let's not forget it is the basis by which many HIV and cancer drugs are approved...OK? This is what having the David Grahams of the world embedded in CDER review teams -- as the IOM in their finite wisdom has proposed -- would get us....the elimination of active controls;single well controlled trials with confirmatory evidece; creeping Grassleyism at time when personalized medicine should be bustling right along....
As Peter as noted, this is an example of the FDA just not doing a good enough job explaining what they do and how they do and the media letting blowhards like Graham distort science.... Note to Grassley...an epidemiologist does NOT conduct clinical trials or review them or know anything about infectious disease or see patients, particularl if that epidemiologist is David Graham. Rather, he just plays with his large database until he gets attention.
As for non-inferiority trials...shame on those who call it a lower standard of approval..it is not..it is a different way of obtaining information on effectiveness and it has emerged in recognition of the existence of many new therapies that affect survival or serious morbidity, and that therefore cannot be denied patients by dumping some folks into a placebo group. So that means some people get the standard treatment and others get the new drug...isn't that what Waxman and others who are screaming about non inferiority trials with Ketek have been bitching they want more of? Or am I confused? Or are these pols so hopelessly hypocritically and twisted in knots in order to posture fot the media they don't care or is that they don't even know what an inferiority trial is or consists of? Oh, and it is not a test tube test as one ex-FDAer derided it... And let's not forget it is the basis by which many HIV and cancer drugs are approved...OK? This is what having the David Grahams of the world embedded in CDER review teams -- as the IOM in their finite wisdom has proposed -- would get us....the elimination of active controls;single well controlled trials with confirmatory evidece; creeping Grassleyism at time when personalized medicine should be bustling right along....
As Peter as noted, this is an example of the FDA just not doing a good enough job explaining what they do and how they do and the media letting blowhards like Graham distort science.... Note to Grassley...an epidemiologist does NOT conduct clinical trials or review them or know anything about infectious disease or see patients, particularl if that epidemiologist is David Graham. Rather, he just plays with his large database until he gets attention.
