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Free access to NEJM article here:
http://content.nejm.org/cgi/content/full/356/16/1601
The aspect of this that I was mostly unaware, is the fact that the effectiveness of the medication was also in question.
(excerpt from artcle):
"Against this backdrop of concerns about both safety and fraud, critical questions also arose about the efficacy of Ketek, which had been examined only in noninferiority trials. Such trials are not designed to demonstrate directly a new intervention's superiority to an active control or a placebo but instead involve the selection of a maximum margin by which the new intervention may be less effective than older interventions but still be considered better than placebo.3 Throughout the 1990s, noninferiority trials had been standard procedure in the development of antimicrobial agents for the outpatient treatment of self-resolving respiratory tract infections. But by 2004, FDA workshops and advisory committee meetings on this topic had concluded that the use of noninferiority trials in this setting was not justifiable, since there is no evidence of a substantial treatment effect of antimicrobial drugs in self-resolving respiratory tract infections such as acute bacterial sinusitis and acute exacerbation of chronic bronchitis the diseases for which clinicians most frequently prescribe antimicrobials, for which the market is largest, and for which treatment with Ketek was proposed."
"Nevertheless, the FDA approved Ketek entirely on the basis of noninferiority trials. The reason given for the agency's continued acceptance of such trials in the study of antibiotics for self-resolving respiratory tract infections was the need to stand by prior agreements with industry sponsors regarding adequate trial designs the Ketek trials, after all, had been designed and largely conducted before the adequacy of noninferiority trials had been called into question. Once it had been established that such trials could not demonstrate efficacy, however, it might reasonably have been argued that the welfare of prospective patients ought to outweigh any promise to manufacturers. Yet the FDA accepted the trials without discussion of either the patients who might be exposed to a drug that had serious toxic effects and for which there was no evidence of effectiveness or the failure of the trials to meet the FDA's own standards at the time of approval."
(end of article excerpt)
So here we have a medication, with many red flags raised in regards to safety, outright fraudulent safety trials (the FDA knew this, it seems!), and questionable efficacy, yet it still clears the FDA approval process. WTF?
This doesn't seem to have received a whole lot of media attention. I'm pretty sure the drug is still available. I've seen local ENT docs prescribe the drug as recently as early february.
I post the article because I think these issues should be publicized a little more. The media does a horrible job covering public health issues. Also, I'd prefer to pile on the FDA and pharmaceutical industry now, while I still can, without having to distance myself from Michael Moore and his latest propagandist film coming out this summer relating to big pharm and the FDA.
http://content.nejm.org/cgi/content/full/356/16/1601
The aspect of this that I was mostly unaware, is the fact that the effectiveness of the medication was also in question.
(excerpt from artcle):
"Against this backdrop of concerns about both safety and fraud, critical questions also arose about the efficacy of Ketek, which had been examined only in noninferiority trials. Such trials are not designed to demonstrate directly a new intervention's superiority to an active control or a placebo but instead involve the selection of a maximum margin by which the new intervention may be less effective than older interventions but still be considered better than placebo.3 Throughout the 1990s, noninferiority trials had been standard procedure in the development of antimicrobial agents for the outpatient treatment of self-resolving respiratory tract infections. But by 2004, FDA workshops and advisory committee meetings on this topic had concluded that the use of noninferiority trials in this setting was not justifiable, since there is no evidence of a substantial treatment effect of antimicrobial drugs in self-resolving respiratory tract infections such as acute bacterial sinusitis and acute exacerbation of chronic bronchitis the diseases for which clinicians most frequently prescribe antimicrobials, for which the market is largest, and for which treatment with Ketek was proposed."
"Nevertheless, the FDA approved Ketek entirely on the basis of noninferiority trials. The reason given for the agency's continued acceptance of such trials in the study of antibiotics for self-resolving respiratory tract infections was the need to stand by prior agreements with industry sponsors regarding adequate trial designs the Ketek trials, after all, had been designed and largely conducted before the adequacy of noninferiority trials had been called into question. Once it had been established that such trials could not demonstrate efficacy, however, it might reasonably have been argued that the welfare of prospective patients ought to outweigh any promise to manufacturers. Yet the FDA accepted the trials without discussion of either the patients who might be exposed to a drug that had serious toxic effects and for which there was no evidence of effectiveness or the failure of the trials to meet the FDA's own standards at the time of approval."
(end of article excerpt)
So here we have a medication, with many red flags raised in regards to safety, outright fraudulent safety trials (the FDA knew this, it seems!), and questionable efficacy, yet it still clears the FDA approval process. WTF?
This doesn't seem to have received a whole lot of media attention. I'm pretty sure the drug is still available. I've seen local ENT docs prescribe the drug as recently as early february.
I post the article because I think these issues should be publicized a little more. The media does a horrible job covering public health issues. Also, I'd prefer to pile on the FDA and pharmaceutical industry now, while I still can, without having to distance myself from Michael Moore and his latest propagandist film coming out this summer relating to big pharm and the FDA.
