Keep The Old Antidepressant Med Guides: Poll
6 CommentsBy Ed Silverman // October 24th, 2007 // 10:50 am
Last week, we wrote that a flap has emerged over the Medication Guide that drugmakers are required to have distributed with their antidepressants. The guide issued in 2005, shortly after the FDA first required Black Box warnings on the pills, was filled with tips and suggestions for parents and guardians - behavior that can be interpreted as worrisome; a reference to clinical study results, and specific info on when a doctor visit is a good idea. The words ‘child’ and ‘children’ are mentioned a total of 31 times.
Now, a revised version is circulating and, while similar to the 2005 guide, the language is different. The new two-page guide offers a more generalized alert for children, teenagers and young adults - the populations for which Black Box warnings were issued. Some of the specifics found in the earlier guide are missing or condensed, and the emphasis that was initially placed on children is no longer there. This is the old guide and this is the new guide. So we asked you to take a look and tell us your preference. Caveat - this is not a scientific poll, but the outcome suggests more info is deemed to be better.
Which Med Guide should be distributed?
Old Med Guide - 265 votes, or 96 percent;
New Med Gide - 10 votes, or 4 percent.
peagee
Perhaps we should ask the children?
http://www.youtube.com/watch?v=1XHNJyti1gE
peagee
We could ask drug companies like PFIZER too. Is there a risk? What about homicidality? Did, for instance, 12 year old Christopher Pittman suffer from side effects from Zoloft? Did you find homicidality, even in adults, appear in clinical trials? Did you tell anyone? Do children get a future in prison because you didn’t?
What does this ‘internal document’ show on Page 2, is young Christopher paying for something that Pfizer knew, but omitted, from clinical trials?:
http://www.ssri-uksupport.com/PfizerZoloft1983.pdf
peagee
Perhaps we could also ask drug makers like GlaxoSmithKline.
Why is the agitation that causes so much trouble in withdrawal/”discontinuation” so funny to you that you’d send internal memos around the firm while denying to the world that any such problem exists?
Why didn’t you let physicians and people taking those drugs know that there was one big problem, and yet put INTERNAL confidential memos around the company as if it was funny? Such as this one:
http://www.ssri-uksupport.com/files/GSKwheresmypaxil.pdf
And what kind of ‘law’ and ‘justice’ allows material such as that to be ‘protected’ ?
peagee
As far as GSK is concerned, THIS internal memo says exactly why silence about withdrawal/discontinuation problems (which include severe agitation sometimes so severe that suicidal and homicidal ideation are created) MATTERED to GSK - in just one clear internal cartoon:
http://www.ssri-uksupport.com/files/GSKmoneybagmemo.pdf
Again, what kind of ‘justice’ allows a protective order to be put on something that can cost lives?
peagee
When did non-disclosure of life threatening drug effects become SCIENCE? And what type of professionals, be it judges putting protective orders on information that could save lives, or industry ’scientists’ with financial conflicts of interest, or FDA members ignoring the evidence they receive, would protect the drug makers knowing that such scientific misconduct will kill a proportion of people taking those drugs?
What type of people are calling for the warnings to be lifted?
What type of people care so much about their own future that they willingly sacrifice the lives of others?
Lauren
I wonder what the NEXT version of the antidepressant Medguide will say? ” Nice pills that make you feel better”? Why does Pharma have so much control over an agency that is supposed to, but does not, protect human life?
And why is there no medguide at all, lousy or not, for the lethal Zyprexa - and the less lethal other atypicals? The FDA knows full well there are none. Actually, if one reviews all the existing medguides, their quality, quantity, and effectiveness are totally uneven. We are talking about drugs that kill people.