Comments on: Massachusetts To Track Meds Given Kids http://www.pharmalot.com/2007/10/9693/ News, Comment and Conversation Sun, 21 Mar 2010 16:52:33 +0000 http://wordpress.org/?v=2.6.2 By: http proxy report message http://www.pharmalot.com/2007/10/9693/#comment-24600 http proxy report message Tue, 06 Nov 2007 03:01:17 +0000 http://www.pharmalot.com/2007/10/9693/#comment-24600 <strong>http proxy report message...</strong> See Online Stream Videos At www.Bestvideosclip.com... http proxy report message…

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]]> By: Lisa Van S http://www.pharmalot.com/2007/10/9693/#comment-21634 Lisa Van S Mon, 08 Oct 2007 23:04:17 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21634 Reality, I agree with you 100%. Reality,

I agree with you 100%.

]]> By: Reality http://www.pharmalot.com/2007/10/9693/#comment-21632 Reality Mon, 08 Oct 2007 22:28:14 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21632 Lisa, When you say you are most interested in unpublished studies, I think what you are implying is that pharma is trying to hide negative results. While this may be the case in some instances, I'd like to take the opportunity to say that journals and their editors are at least as culpable in the publication bias (of unpublished negative studies). Generally speaking, unless they're dealing with a huge, major, paradigm-shifting study, journals are not interested in publishing negative results, and those that will publish those results are not exactly NEJM or JAMA. The sanctimonious editors at those and other top-tier journals who criticize pharma for allegedly not publishing negative results are the same who reject negative trials on first-pass. By the time authors find a journal for those results, 2 years may have passed since the study ended. Lisa,

When you say you are most interested in unpublished studies, I think what you are implying is that pharma is trying to hide negative results. While this may be the case in some instances, I’d like to take the opportunity to say that journals and their editors are at least as culpable in the publication bias (of unpublished negative studies).

Generally speaking, unless they’re dealing with a huge, major, paradigm-shifting study, journals are not interested in publishing negative results, and those that will publish those results are not exactly NEJM or JAMA. The sanctimonious editors at those and other top-tier journals who criticize pharma for allegedly not publishing negative results are the same who reject negative trials on first-pass. By the time authors find a journal for those results, 2 years may have passed since the study ended.

]]> By: Lisa Van S http://www.pharmalot.com/2007/10/9693/#comment-21624 Lisa Van S Mon, 08 Oct 2007 20:15:51 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21624 Todd, (PREA)!!! Todd,

(PREA)!!!

]]> By: todd http://www.pharmalot.com/2007/10/9693/#comment-21619 todd Mon, 08 Oct 2007 19:00:59 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21619 Also, Stephany commented that she took Lamictal, I am assuming she is over 18 Also, Stephany commented that she took Lamictal, I am assuming she is over 18

]]> By: todd http://www.pharmalot.com/2007/10/9693/#comment-21618 todd Mon, 08 Oct 2007 18:59:32 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21618 LVS, How many meds are written off-label in peds? Well over 50%. And when they do put the time and energy into research, as the post on acid suppression in peds shows, then people blame pharma for marketing to kids by providing data. Ask any pediatrician, there is a lack of information for peds. They have to use their professional judgement and experience. If you wait for the manufacturer to get it approved through the FDA it may never happen. It is now a large financial committment to get increased labeling. So if the data is out there, and financially it doesn't make sense, most companies chose not to pursue formal indications. LVS,

How many meds are written off-label in peds? Well over 50%. And when they do put the time and energy into research, as the post on acid suppression in peds shows, then people blame pharma for marketing to kids by providing data.

Ask any pediatrician, there is a lack of information for peds. They have to use their professional judgement and experience. If you wait for the manufacturer to get it approved through the FDA it may never happen. It is now a large financial committment to get increased labeling. So if the data is out there, and financially it doesn’t make sense, most companies chose not to pursue formal indications.

]]> By: Reality http://www.pharmalot.com/2007/10/9693/#comment-21610 Reality Mon, 08 Oct 2007 17:31:52 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21610 Lisa, Also, a quick, top-level search of pubmed (pubmed.gov) shows at least 1 trial (albeit open-label) of lamotrigine in adolescents with bipolar. Note, I am not commenting on the trial itself, the design, its weaknesses, the results, conflicts of interests, etc. This is simply to let users know that there are a lot of resources out there, so use them! Lisa,

Also, a quick, top-level search of pubmed (pubmed.gov) shows at least 1 trial (albeit open-label) of lamotrigine in adolescents with bipolar.

Note, I am not commenting on the trial itself, the design, its weaknesses, the results, conflicts of interests, etc. This is simply to let users know that there are a lot of resources out there, so use them!

]]> By: Lisa Van S http://www.pharmalot.com/2007/10/9693/#comment-21609 Lisa Van S Mon, 08 Oct 2007 17:27:49 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21609 Reality, Im always more interested in the ones that arent published, For obvious reasons of course. Reality,
Im always more interested in the ones that arent published,
For obvious reasons of course.

]]> By: Reality http://www.pharmalot.com/2007/10/9693/#comment-21607 Reality Mon, 08 Oct 2007 17:14:31 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21607 Lisa (and others), there are resources out there to check on these things: If you search clinicaltrials.gov, you'll see there are trials currently recruiting for pediatric bipolar disorder. You may also want to search clinicalstudyresults.org to see if there are unpublished results. Lisa (and others), there are resources out there to check on these things:

If you search clinicaltrials.gov, you’ll see there are trials currently recruiting for pediatric bipolar disorder. You may also want to search clinicalstudyresults.org to see if there are unpublished results.

]]> By: Stephany http://www.pharmalot.com/2007/10/9693/#comment-21601 Stephany Mon, 08 Oct 2007 15:38:53 +0000 http://www.pharmalot.com/2007/10/9693/#comment-21601 Furious Seasons is on the sidebar blog roll on this site as well. The bottom line is most medications were not approved for use in kids under age 18, and dx were based on adult criteria. As far as being tested in kids--some were. I've linked quite a few abstracts for reading re: this topic in my 1999-2007 evolution of a dx series. Or, Google scholar Beiderman or Nemeroff and start reading their published work. Then read the fine print most were funded by the same Pharma company that the drug trial was being tested---and then take it further for instance w/ Nemeroff and see how he is a paid speaker for CME classes, paid by Pharma company...there's much to the complex puzzle that came down to an innocent child dying on psych meds approved for adult use, and who had a bipolar dx at age 2-3 based on adult criteria. It's unbelievable. Furious Seasons is on the sidebar blog roll on this site as well. The bottom line is most medications were not approved for use in kids under age 18, and dx were based on adult criteria. As far as being tested in kids–some were. I’ve linked quite a few abstracts for reading re: this topic in my 1999-2007 evolution of a dx series. Or, Google scholar Beiderman or Nemeroff and start reading their published work. Then read the fine print most were funded by the same Pharma company that the drug trial was being tested—and then take it further for instance w/ Nemeroff and see how he is a paid speaker for CME classes, paid by Pharma company…there’s much to the complex puzzle that came down to an innocent child dying on psych meds approved for adult use, and who had a bipolar dx at age 2-3 based on adult criteria. It’s unbelievable.

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