For the second time in a month, a journal is publishing data that were already used by the FDA — in non-peer-reviewed form — to decide the fate of two new drugs/indications.
The other day, The Lancet ran this study on monthly naltrexone (Vivitrol) for opioid addiction. However, that indication had been approved back in October — largely based on this lone study that hadn’t yet been subject to the scrutiny of scientific peers.
Daniel Wolfe, PhD, of the Open Society Institute in New York, and colleagues pointed this out in an accompanying editorial: “The FDA’s assessment … was based on then-unpublished evidence from this trial,” they wrote.
Granted, the monthly shot has been approved since 2006 for alcohol addiction treatment. Still, Wolfe and colleagues were concerned that the data were severely flawed. For one, the treatment wasn’t compared against other standards such as methadone or buprenorphine. Nor did it look at post-treatment opioid overdose, a major concern with naltrexone.
Something similar occurred earlier this month with the investigational weight loss combination of phentermine and topiramate (Qnexa). The Lancet just published data that the FDA had already relied on to make a decision about the drug six months earlier.
Though an advisory committee recommended against approval, it still made that decision based on unpublished data.
Perhaps it could be taken that advisory committee review is a form of peer review in its own right. In fact, that’s the position put forward by the agency when asked for comment on the issue, in this emailed statement:
“The Agency often reviews data that have not been published and our review is much more extensive than what happens during the peer review process. We have access to the original protocol and all amendments, we have access to the original statistical analysis plan and all revisions, and most importantly, we have access to all the data and can do all our own analyses to confirm what is reported by the sponsor and also to explore the data and any concerns raised by them in great detail.”
Still, monthly naltrexone was okayed for opioid dependence despite the flaws noted in the Wolfe editorial.
The only thing this after-the-fact publication seems to generate is more media attention for the compound — and perhaps for those approved, a boost in sales, as well as in the company’s stock.
This blog was originally posted on MedPageToday.com.
Tags: addiction, drug approval, FDA, Qnexa, Vivitrol, weight loss
