Comments on: What Negative Data? Paxil & Selective Reporting http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/ News, Comment and Conversation Fri, 10 Feb 2012 22:23:55 +0000 http://wordpress.org/?v=2.6.2 By: Matthew Holford http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-328566 Matthew Holford Thu, 01 May 2008 23:12:18 +0000 http://www.pharmalot.com/?p=13378#comment-328566 I'd still like to know who McCafferty and Oakes reported to, within SKB/GSK. Matt I’d still like to know who McCafferty and Oakes reported to, within SKB/GSK.

Matt

]]> By: Laurie http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-327677 Laurie Thu, 01 May 2008 18:01:54 +0000 http://www.pharmalot.com/?p=13378#comment-327677 Nathan, the fact that Paxil didn't recieved FDA approval for Paxil for children should throw up the big red flag. The current prescribing of paxil for children is being done on a "word of mouth" by psychiatrists, which always begs the question, why are ancedotal positive effects used to prescribe, yet negative anecdotal effects dismissed? In 329 we have documentation of those negative effects(even with very short use time), yet we battle every day for clear warnings for parents to make informed decisions. GSK fought hard with the FDA to water down the black box warning and succeeded in getting "causal role" removed...well, here is a study that confirms that causal role. How is a parent supposed to know the truth if the label is so misleading? Nathan, the fact that Paxil didn’t recieved FDA approval for Paxil for children should throw up the big red flag.

The current prescribing of paxil for children is being done on a “word of mouth” by psychiatrists, which always begs the question, why are ancedotal positive effects used to prescribe, yet negative anecdotal effects dismissed?

In 329 we have documentation of those negative effects(even with very short use time), yet we battle every day for clear warnings for parents to make informed decisions. GSK fought hard with the FDA to water down the black box warning and succeeded in getting “causal role” removed…well, here is a study that confirms that causal role. How is a parent supposed to know the truth if the label is so misleading?

]]> By: Nathan http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-327236 Nathan Thu, 01 May 2008 15:38:15 +0000 http://www.pharmalot.com/?p=13378#comment-327236 It's hard to know how to deal with papers like '329. Someone relatively new in the field who is looking for some background references would stumble across the '329 study and assume it is positive. How would they know otherwise? Maybe in cases like this, there should be some sort of perminent "addendum" to the paper to warn people of the misleading information that it contains. This is a problem with the entire scientific literature system - not just this paper. It’s hard to know how to deal with papers like ‘329. Someone relatively new in the field who is looking for some background references would stumble across the ‘329 study and assume it is positive. How would they know otherwise? Maybe in cases like this, there should be some sort of perminent “addendum” to the paper to warn people of the misleading information that it contains. This is a problem with the entire scientific literature system - not just this paper.

]]> By: Anon http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-326988 Anon Thu, 01 May 2008 14:11:08 +0000 http://www.pharmalot.com/?p=13378#comment-326988 Are the "days of the 329 study" over yet? I don't think so. Peer reviewers may be experts in their field, but if they are not quite up to the job of interpreting complicated statistics, what is to stop sponsors publishing unjustifiably positive spin they have massaged out of the numbers, even if those numbers are available? How many clinicians actually check for results on clinicaltrials.gov or on companies websites? How many can understand the stats themselves? Once the genie is out of the bottle, it's very hard to get it back in. According to Jureidini, in 2008 "study 329" is still being reported unequivocally in some papers as positive. Are the “days of the 329 study” over yet? I don’t think so.

Peer reviewers may be experts in their field, but if they are not quite up to the job of interpreting complicated statistics, what is to stop sponsors publishing unjustifiably positive spin they have massaged out of the numbers, even if those numbers are available? How many clinicians actually check for results on clinicaltrials.gov or on companies websites? How many can understand the stats themselves?

Once the genie is out of the bottle, it’s very hard to get it back in. According to Jureidini, in 2008 “study 329″ is still being reported unequivocally in some papers as positive.

]]> By: Jack2 http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-326721 Jack2 Thu, 01 May 2008 12:39:20 +0000 http://www.pharmalot.com/?p=13378#comment-326721 Posting something on clinicaltrials.gov before the trial and some results after the trial will become FDA required during 2008. For serious/life threatening diseases it phases in earlier (I think this spring, so maybe already), and for other diseases it happens later this year. My understanding is: 1. this only affects new trials 2. the 1 yr deadline for posting results of the trial runs from last patient out. 3. this will actually change practice minimally, since almost everyone already did it, because they wanted to publish in a top journal. My company already put its trials on the website. The journals really set the standard because they already insisted the sponser (industry or otherwise) post the trial at inception on the website. 4. when posting results, the guidelines, the last time I saw them, were vague. I seriously doubt you will see the whole database on the website. I don't think you will see as much as you would if the trial was published as a 5-10 page summary in a journal, let alone a 3,000 page CSR. I think it will just be a few paragraphs - but I confess I don't really know. 5. Some journals will view posting on clinicaltrials.gov as publication of the data, which will disqualify you from submitting to that journal. Sometimes a manufacturer doesn't publish a study because they overshoot about which journal will accept the study, and the review/revision/rejection process can take over a year. Maybe they submit to JAMA when they only had a small shot of getting into JAMA - but months go by as they get reviewed, revised and rejected. Then they miss the deadline. This is different from the Enhance trial delays, and would affect the myriad of important, but lower profile trials. 6. Small, early trials are exempt (example: a phase I PK study), since they could require companies to release secret information (example: the molecular structure). Posting something on clinicaltrials.gov before the trial and some results after the trial will become FDA required during 2008. For serious/life threatening diseases it phases in earlier (I think this spring, so maybe already), and for other diseases it happens later this year. My understanding is:
1. this only affects new trials
2. the 1 yr deadline for posting results of the trial runs from last patient out.
3. this will actually change practice minimally, since almost everyone already did it, because they wanted to publish in a top journal. My company already put its trials on the website. The journals really set the standard because they already insisted the sponser (industry or otherwise) post the trial at inception on the website.
4. when posting results, the guidelines, the last time I saw them, were vague. I seriously doubt you will see the whole database on the website. I don’t think you will see as much as you would if the trial was published as a 5-10 page summary in a journal, let alone a 3,000 page CSR. I think it will just be a few paragraphs - but I confess I don’t really know.
5. Some journals will view posting on clinicaltrials.gov as publication of the data, which will disqualify you from submitting to that journal. Sometimes a manufacturer doesn’t publish a study because they overshoot about which journal will accept the study, and the review/revision/rejection process can take over a year. Maybe they submit to JAMA when they only had a small shot of getting into JAMA - but months go by as they get reviewed, revised and rejected. Then they miss the deadline. This is different from the Enhance trial delays, and would affect the myriad of important, but lower profile trials.
6. Small, early trials are exempt (example: a phase I PK study), since they could require companies to release secret information (example: the molecular structure).

]]> By: Nathan http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-326708 Nathan Thu, 01 May 2008 12:35:56 +0000 http://www.pharmalot.com/?p=13378#comment-326708 Jack2 - thanks for your comments. It sounds like the system has improved a lot from the days of the "329 Study" and hopefully something like that won't happen again. I went to th lead author's website yesterday -- he's still a professor at Brown and sits on countless advisory boards. It's ashame that such blatent abuse of his position didn't cost him his career. Jack2 - thanks for your comments. It sounds like the system has improved a lot from the days of the “329 Study” and hopefully something like that won’t happen again.

I went to th lead author’s website yesterday — he’s still a professor at Brown and sits on countless advisory boards. It’s ashame that such blatent abuse of his position didn’t cost him his career.

]]> By: Janet http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-326568 Janet Thu, 01 May 2008 11:36:59 +0000 http://www.pharmalot.com/?p=13378#comment-326568 Lisa - I think we are using different terminology. When I referred to 'raw data', it was after coding was already done and the data was in a database. Lisa -
I think we are using different terminology. When I referred to ‘raw data’, it was after coding was already done and the data was in a database.

]]> By: "Selective Reporting of Study 329" | Womenhealth http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-325971 "Selective Reporting of Study 329" | Womenhealth Thu, 01 May 2008 07:36:29 +0000 http://www.pharmalot.com/?p=13378#comment-325971 [...] For the background, let me take the easy way out, and quote Ed Silverman from PharmaLot: [...] [...] For the background, let me take the easy way out, and quote Ed Silverman from PharmaLot: [...]

]]> By: Lisa Van S http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-325341 Lisa Van S Thu, 01 May 2008 01:56:29 +0000 http://www.pharmalot.com/?p=13378#comment-325341 Jack2, I actually disagree w/Janet.. Access to Raw Data,.. "WOULD HELP".. with coding issues!!!!!!!!!!!!!!!!!!!!!! Janet, "Care to challenge me"?,,,, Maybe a colonoscopy is needed here,.. to get rid of the bullshit! Jack2,

I actually disagree w/Janet.. Access to Raw Data,.. “WOULD HELP”.. with coding issues!!!!!!!!!!!!!!!!!!!!!!

Janet, “Care to challenge me”?,,,,

Maybe a colonoscopy is needed here,.. to get rid of the bullshit!

]]> By: Janet http://www.pharmalot.com/2008/04/what-negative-data-paxil-selective-reporting/#comment-325201 Janet Thu, 01 May 2008 00:58:31 +0000 http://www.pharmalot.com/?p=13378#comment-325201 Jack2 - It is my understanding that posting on clinicaltrials.gov is a voluntary effort outside of federally funded agencies (eg. NIH, etc.), and is not mandatory for pharma companies, although some pharma companies have made it their stated policy to post all their trials. (Drugs studied for efficacy under an IND that are for the treatment of Serious or Life-Threatening Diseases or conditions are also required to be posted. Post-marketing studies though would not fall in this category) I believe that (at least some) top journals do make posting on clinicaltrials.gov a requirement for publication. Access to 'Raw data' would still not help you with coding issues. Jack2 -
It is my understanding that posting on clinicaltrials.gov is a voluntary effort outside of federally funded agencies (eg. NIH, etc.), and is not mandatory for pharma companies, although some pharma companies have made it their stated policy to post all their trials. (Drugs studied for efficacy under an IND that are for the treatment of Serious or Life-Threatening Diseases or conditions are also required to be posted. Post-marketing studies though would not fall in this category)

I believe that (at least some) top journals do make posting on clinicaltrials.gov a requirement for publication.

Access to ‘Raw data’ would still not help you with coding issues.

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