http://groups.yahoo.com/group/uksurvivors/msearch?AT=tuesday&AM=contains&ST=fiddaman&SM=contains&pos=0&cnt=10
http://groups.yahoo.com/group/uksurvivors/msearch?AT=tuesday&AM=contains&ST=fiddaman&SM=contains&pos=10&cnt=10
Friday, 31 October 2008
Posts by Bob Fiddaman on UKsurvivors - why did he leave this support group mental health user/survivors in the UK ?
http://groups.yahoo.com/group/uksurvivors/msearch?AT=bob_fid2000&AM=contains&pos=0&cnt=10
http://groups.yahoo.com/group/uksurvivors/msearch?AT=bob_fid2000&AM=contains&pos=10&cnt=10
http://groups.yahoo.com/group/uksurvivors/msearch?AT=bob_fid2000&AM=contains&pos=20&cnt=10
http://groups.yahoo.com/group/uksurvivors/msearch?AT=bob_fid2000&AM=contains&pos=30&cnt=10
http://groups.yahoo.com/group/uksurvivors/msearch?AT=bob_fid2000&AM=contains&pos=10&cnt=10
http://groups.yahoo.com/group/uksurvivors/msearch?AT=bob_fid2000&AM=contains&pos=20&cnt=10
http://groups.yahoo.com/group/uksurvivors/msearch?AT=bob_fid2000&AM=contains&pos=30&cnt=10
Thursday, 30 October 2008
so Fiddaman claims he was discriminated against by his trade union
It is with regret that I have to inform you that I have received treatment of a discriminatory manner during the past two years by Rover/Ford management, T&G Union officials, Rover board of Trustees and the Occupational Health based at Solihull.
http://www.labournet.net/ukunion/0109/rover1.html
http://www.labournet.net/ukunion/0109/rover1.html
"failed in an attempt at suicide because of the way Rover/Ford have treated " (him)
My wife has had a complete nervous breakdown, my three children have suffered and I failed in an attempt at suicide because of the way Rover/Ford have treated me.
http://www.labournet.net/ukunion/0109/rover1.html
http://www.labournet.net/ukunion/0109/rover1.html
Wednesday, 29 October 2008
Dr David Healy is pro ECT - is this the kind of help Fiddaman invisiged when asking the MHRA to involve him ?
SEROXAT SUFFERERS - STAND UP AND BE COUNTED: MHRA - A Good Sign
http://fiddaman.blogspot.com/2008/10/mhra-good-sign.html
It seems the wheels are in motion regarding the MHRA meeting with SSRi expert David Healy to discuss the withdrawal issues regarding SSRi's. I firmly believe this is a step in the right direction, otherwise I would not have suggested it to Kent Woods when I met with him a few months back.
Strides are also being made to change the advice given for SSRi's in the BNF
I'll post more about this matter as it unfolds.
Fid
Posted by Fiddy at 4:16 PM
http://fiddaman.blogspot.com/2008/10/mhra-good-sign.html
It seems the wheels are in motion regarding the MHRA meeting with SSRi expert David Healy to discuss the withdrawal issues regarding SSRi's. I firmly believe this is a step in the right direction, otherwise I would not have suggested it to Kent Woods when I met with him a few months back.
Strides are also being made to change the advice given for SSRi's in the BNF
I'll post more about this matter as it unfolds.
Fid
Posted by Fiddy at 4:16 PM
Shock Therapy: A History of ... book reader
Shock Therapy: A History of ... - Google Book Search
http://books.google.co.uk/books?hl=en&id=RvXzXnskJB4C&dq=david+healy+electroconvulsive&printsec=frontcover&source=web&ots=bT97_7hPLC&sig=Au1U5-_-BXyTH0AlX_A9aXzGqrw&sa=X&oi=book_result&resnum=1&ct=result
http://books.google.co.uk/books?hl=en&id=RvXzXnskJB4C&dq=david+healy+electroconvulsive&printsec=frontcover&source=web&ots=bT97_7hPLC&sig=Au1U5-_-BXyTH0AlX_A9aXzGqrw&sa=X&oi=book_result&resnum=1&ct=result
Shock Therapy: A History of Electroconvulsive Treatment in Mental Illness (2007) by Edward Shorter and David Healy
Shock Therapy: A History of Electroconvulsive Treatment in Mental Illness (2007)
by Edward Shorter and David Healy
Synopsis
"Shock therapy is making a comeback today in the treatment of serious mental illness. Despite its reemergence as a safe and effective psychiatric tool, however, it continues to be shrouded by a longstanding negative public image, not least due to films such as the classic "One Flew over the Cuckoo's Nest", where the inmate of a psychiatric clinic (played by Jack Nicholson) is subjected to electroshock to curb his rebellious behavior. Beyond its vilification in popular culture, the stereotype of convulsive therapy as a dangerous and inhumane practice is fuelled by professional posturing and public misinformation. Electroconvulsive therapy, or ECT, has in the last thirty years been considered a method of last resort in the treatment of debilitating depression, suicidal ideation, and other forms of mental illness. Yet, ironically, its effectiveness in treating these patients would suggest it as a frontline therapy, bringing relief from acute symptoms and saving lives. In this book, Edward Shorter and David Healy trace the controversial history of ECT and other "shock" therapies.
Drawing on case studies, public debates, extensive interviews, and archival research, the authors expose the myths about ECT that have proliferated over the years. By showing ECT's often life-saving results, Shorter and Healy endorse a point of view that is hotly contested in professional circles and in public debates, but for the nearly half of all clinically depressed patients who do not respond to drugs this book brings much needed hope."
http://biopsychiatry.com/ect/index.html
Why did the MHRA meet with Fiddaman when Duloxetine kills 9.65 times more per thousand scripts than Seroxat
1/17,500 devide by 1/169,000
same as 1/17.5 devide by 1/169
same as .05714 / .005917
= 9.65 !!
http://www.network54.com/Forum/281849/message/1225269667/Death+per+thousand+prescripion+%21+comparison+of+brands+Seroxat+Efexor+%26amp%3B+Duloxetine
Using UK National Statistic total prescription figures 1998 to 2007 for Seroxat and Efexor, the UK National Statistic total prescription figures 2004 to 2007 for Duloxetine and the ADR total deaths figures quoted by Mr Fiddamen ( http://fiddaman.blogspot.com/2008/10/seroxat-for-sale-despite-serious.html ) equates to: -
166 fatal ADR reports for 27,712,400 Seroxat prescriptions = 1 in 166.9 thousand prescriptions
145 fatal ADR reports for 19,020,000 Efexor prescriptions = 1 in 131.1 thousand prescriptions
38 fatal ADR reports for 666,100 Duloxetine prescriptions = 1 in 17.5 thousand prescriptions
same as 1/17.5 devide by 1/169
same as .05714 / .005917
= 9.65 !!
http://www.network54.com/Forum/281849/message/1225269667/Death+per+thousand+prescripion+%21+comparison+of+brands+Seroxat+Efexor+%26amp%3B+Duloxetine
Using UK National Statistic total prescription figures 1998 to 2007 for Seroxat and Efexor, the UK National Statistic total prescription figures 2004 to 2007 for Duloxetine and the ADR total deaths figures quoted by Mr Fiddamen ( http://fiddaman.blogspot.com/2008/10/seroxat-for-sale-despite-serious.html ) equates to: -
166 fatal ADR reports for 27,712,400 Seroxat prescriptions = 1 in 166.9 thousand prescriptions
145 fatal ADR reports for 19,020,000 Efexor prescriptions = 1 in 131.1 thousand prescriptions
38 fatal ADR reports for 666,100 Duloxetine prescriptions = 1 in 17.5 thousand prescriptions
Seroxat kills 1 in 166.9 thousand scripts - Efexor kills 1 in 131.1 thousand scripts - Duloxetine kills 1 in 17.5 thousand prescriptions
Using UK National Statistic total prescription figures 1998 to 2007 for Seroxat and Efexor, the UK National Statistic total prescription figures 2004 to 2007 for Duloxetine and the ADR total deaths figures quoted by Mr Fiddamen ( http://fiddaman.blogspot.com/2008/10/seroxat-for-sale-despite-serious.html ) equates to: -
166 fatal ADR reports for 27,712,400 Seroxat prescriptions = 1 in 166.9 thousand prescriptions
145 fatal ADR reports for 19,020,000 Efexor prescriptions = 1 in 131.1 thousand prescriptions
38 fatal ADR reports for 666,100 Duloxetine prescriptions = 1 in 17.5 thousand prescriptions
166 fatal ADR reports for 27,712,400 Seroxat prescriptions = 1 in 166.9 thousand prescriptions
145 fatal ADR reports for 19,020,000 Efexor prescriptions = 1 in 131.1 thousand prescriptions
38 fatal ADR reports for 666,100 Duloxetine prescriptions = 1 in 17.5 thousand prescriptions
uksurvivors message 37839 : Drug Analysis - antidepressant fatal drug reaction per brand
uksurvivors : Message: Drug Analysis - antidepressant fatal drug reaction per brand
http://groups.yahoo.com/group/uksurvivors/message/37839
http://groups.yahoo.com/group/uksurvivors/message/37839
Agneta would like to see number of deaths on Seroxat & other brands.
#links
I would still like to know the number of reported adverse reactions and deaths for Seroxat and the other drugs mentioned related to the number of prescribed doses.
http://fiddaman.blogspot.com/2008/10/seroxat-for-sale-despite-serious.html#links
I would still like to know the number of reported adverse reactions and deaths for Seroxat and the other drugs mentioned related to the number of prescribed doses.
http://fiddaman.blogspot.com/2008/10/seroxat-for-sale-despite-serious.html#links
Tuesday, 28 October 2008
However if you are getting into an unseemly power play about which SSRI kills most (according to MHRA statistics) - better check out Prozac !!
SSRI DISCUSSION FORUM: MHRA Drug Analysis Print Drug name: VENLAFAXINE - 145 fatal ADR's
http://www.network54.com/Forum/281849/message/1225215834/MHRA+Drug+Analysis+Print+Drug+name-+VENLAFAXINE+-+145+fatal+ADR%27s
http://www.network54.com/Forum/281849/message/1225215834/MHRA+Drug+Analysis+Print+Drug+name-+VENLAFAXINE+-+145+fatal+ADR%27s
Fiddaman would like to claim Seroxat is worst SSRI & has the greatest number of Fatal Adverse Reactions. - Next he'll tell us 5 + 5 = 9 !!
SEROXAT SUFFERERS - STAND UP AND BE COUNTED: SEROXAT FOR SALE DESPITE SERIOUS ADVERSE REACTION REPORTS
http://fiddaman.blogspot.com/2008/10/seroxat-for-sale-despite-serious.html
In fact both Acomplia and Dutonin have less ADR reports than Efexor [Venlafaxine] another antidepressant with 5,064 ADR reports and a total of 145 fatal ADR reports!
145 fatal ADR reports for Efexor, 166 for Seroxat!
Something is drastically wrong here. It's akin to pulling Walkers Crisps from the market when in fact it is Golden Wonder Crisps that has the problem!
http://fiddaman.blogspot.com/2008/10/seroxat-for-sale-despite-serious.html
In fact both Acomplia and Dutonin have less ADR reports than Efexor [Venlafaxine] another antidepressant with 5,064 ADR reports and a total of 145 fatal ADR reports!
145 fatal ADR reports for Efexor, 166 for Seroxat!
Something is drastically wrong here. It's akin to pulling Walkers Crisps from the market when in fact it is Golden Wonder Crisps that has the problem!
Bob Fiddaman by: Deborah Russell @ Post Poems who learnt (his) "arthritis is controlled by painkillers and at best it is only mild"
PostPoems - Bob Fiddaman by: Deborah Russell
D: But isn't that difficult for you to have your fingers crossed? Legs too, for that matter...isn't osteoarthritis very difficult to live with? Making everyday tasks difficult and sometimes impossible to accomplish?
Bob: You learn to live with pain - my arthritis is controlled by painkillers and at best it is only mild.
http://www.postpoems.com/cgi-bin/displaypoem.cgi?pid=18979
D: But isn't that difficult for you to have your fingers crossed? Legs too, for that matter...isn't osteoarthritis very difficult to live with? Making everyday tasks difficult and sometimes impossible to accomplish?
Bob: You learn to live with pain - my arthritis is controlled by painkillers and at best it is only mild.
http://www.postpoems.com/cgi-bin/displaypoem.cgi?pid=18979
Monday, 27 October 2008
& to round off we show Seroxat guru Derek Scott stating - Prozac withdrawal worse than Seroxat
That article made me angry as well, condescending bastards, and coming just days after members of this group met with MP’s inclusive of Paul Flynn MP mentioned in that article. Be careful of Prozac Katie, it was on the third and 4th week that I started experiencing Prozac withdrawal because of the longer half life. If you feel suicidal, or agitated it’s the withdrawal of the drug that has made you feel that way. But I do agree with you in that you do find that you have much more energy, get your appetite back and generally feel… alive again once successfully weaned off Seroxat/Prozac. Unlike you however I have found myself suffering intense anxiety, suicidal thoughts and continued Seroxat withdrawal symptoms months later despite not being on any antidepressant medications whatsoever. I did suffer such symptoms on Seroxat but they became much much worse on Prozac and even after successful withdrawal are still present. No amount of Lorazepam seems able to shift it. I never suffered suicidal thoughts before being prescribed Seroxat in October 2000, therefore clearly that drug has damaged my brain/body, something GlaxoSmithKline and the mendacious MHRA knew full well could occur (in a proportion of patients prescribed it) from the outset yet the drug was provided with a license! Licensed and we (adults and children alike) are the ones suffering as a direct result of that and yet the Government and her ministers who sanctioned the prescribing of that dangerous/addictive antidepressant medicine (and medicine class) could not care less. At the meeting before MP’s last week I brought up the issue of a Government compensation scheme for patients damaged by licensed prescription medications, I was not listened to the proposal fell on deaf ears. I don’t know why I bother.
Derek.
Derek.
We met with Fiddaman because he makes lots of noise - not we met because he has something useful to say !
It has been a very high profile issue, and our response to the requests is mindful of that.
source -
http://groups.yahoo.com/group/uksurvivors/message/35858
From: Watkins, John
Date: 11/04/2008 16:19:57
To: Jeremy Bryce
Subject: RE: Meeting Janice Simmons & others re antidepressants
Dear Jeremy
We treat each request for a meeting on its own merits. With respect to Seroxat we recently had two requests, and the issue is one that has exercised both ourselves and media, conventional or web, for quite some time. It has been a very high profile issue, and our response to the requests is mindful of that.You will note that I have not promised a meeting with Robert Fiddaman, though I have not ruled it out either. Whatever the Seroxat lobby might or might not gain, we will note and weigh what they may say to us in any meeting and only take action that we think is in the best interests of society as a whole.
Regards,
John Watkins
source -
http://groups.yahoo.com/group/uksurvivors/message/35858
From: Watkins, John
Date: 11/04/2008 16:19:57
To: Jeremy Bryce
Subject: RE: Meeting Janice Simmons & others re antidepressants
Dear Jeremy
We treat each request for a meeting on its own merits. With respect to Seroxat we recently had two requests, and the issue is one that has exercised both ourselves and media, conventional or web, for quite some time. It has been a very high profile issue, and our response to the requests is mindful of that.You will note that I have not promised a meeting with Robert Fiddaman, though I have not ruled it out either. Whatever the Seroxat lobby might or might not gain, we will note and weigh what they may say to us in any meeting and only take action that we think is in the best interests of society as a whole.
Regards,
John Watkins
Period to date shows the Effexor petition has19160 Signatures
http://www.petitiononline.com/mod_perl/signed.cgi?effexor&1
19160 Total Signatures
19160 Total Signatures
Paxil/Seroxat petition has 9994 Signatures period to date
http://www.petitiononline.com/mod_perl/signed.cgi?oky71
Is Seroxat the most complained about antidepressant?
#links
Sunday, October 26, 2008
Obesity drug withdrawn over depression link
Source: The Guardian
Sales and prescriptions of a weight-loss drug were suspended yesterday after European health authorities said the benefits no longer outweighed the risks.
The European Medicines Agency said obese people taking Acomplia were roughly twice as likely to develop psychiatric disorders, such as depression, anxiety and aggression, than those taking a placebo. US authorities have refused to allow Acomplia to be marketed in America.
The Medicines and Healthcare products Regulatory Agency (MHRA), which oversees drugs in the UK, said that as a result of the ruling, healthcare professionals would be told not to give any new prescriptions for Acomplia. Patients taking the drug have been told to consult their doctor.
FULL STORY
Yet Seroxat and other SSRi's remain on the market despite the thousands of adverse reactions reported to the MHRA.
This file from the MHRA website recieved no publicity, they released it on the 13th October 2008 - SSRI anti-depressants - withdrawal and side effects (08/319)
There have been 1,425 'reported' reactions of Seroxat, only 156 of these have been reported by patients under the age of 24 which leaves 1,370 reports from patients over the age of 24. Yet the MHRA have banned the use of Seroxat in patients where there are less adverse reactions. How absurd is this?
Remember these are just the 'reported' reactions to Seroxat, there are literally thousands of others that haven't been reported to the MHRA. One only has to visit Paxil Progress to see how many people are suffering at the hands of Seroxat.
I've been accused by members of a mental health forum for concentrating too much on Seroxat, the latest release by the MHRA shows why I write what I do about it. These same people accuse me of having a vested interest in Seroxat because I am part of the Seroxat litigation here in the UK. This blog was created long before I knew I was part of the litigation.
Other 'reports' of SSRi withdrawal from the recent MHRA file are:
Citalopram [Cipramil] - TOTAL 170
Duloxetine [Cymbalta] - TOTAL 55
Escitalopram [Cipralex] - TOTAL 53
Fluvoxamine [Luvox] - TOTAL 161
Fluoxetine [Prozac] - TOTAL 680
Sertraline [Zoloft] - TOTAL 162
Venlafaxine [Efexor] - TOTAL 318
I am 100% certain that these figures for all SSRi drugs are vastly underplayed. However, it seems that Seroxat with 1,425 'reported' adverse reactions more than doubles that of any other SSRi on the market. And people wonder why myself and others create awareness about the dangers of it!
Fid
Posted by Fiddy at 4:41 AM 0 comments Links to this post
Labels: GSK - Brushed Under The Carpet, MHRA Correspondence,
Sunday, October 26, 2008
Obesity drug withdrawn over depression link
Source: The Guardian
Sales and prescriptions of a weight-loss drug were suspended yesterday after European health authorities said the benefits no longer outweighed the risks.
The European Medicines Agency said obese people taking Acomplia were roughly twice as likely to develop psychiatric disorders, such as depression, anxiety and aggression, than those taking a placebo. US authorities have refused to allow Acomplia to be marketed in America.
The Medicines and Healthcare products Regulatory Agency (MHRA), which oversees drugs in the UK, said that as a result of the ruling, healthcare professionals would be told not to give any new prescriptions for Acomplia. Patients taking the drug have been told to consult their doctor.
FULL STORY
Yet Seroxat and other SSRi's remain on the market despite the thousands of adverse reactions reported to the MHRA.
This file from the MHRA website recieved no publicity, they released it on the 13th October 2008 - SSRI anti-depressants - withdrawal and side effects (08/319)
There have been 1,425 'reported' reactions of Seroxat, only 156 of these have been reported by patients under the age of 24 which leaves 1,370 reports from patients over the age of 24. Yet the MHRA have banned the use of Seroxat in patients where there are less adverse reactions. How absurd is this?
Remember these are just the 'reported' reactions to Seroxat, there are literally thousands of others that haven't been reported to the MHRA. One only has to visit Paxil Progress to see how many people are suffering at the hands of Seroxat.
I've been accused by members of a mental health forum for concentrating too much on Seroxat, the latest release by the MHRA shows why I write what I do about it. These same people accuse me of having a vested interest in Seroxat because I am part of the Seroxat litigation here in the UK. This blog was created long before I knew I was part of the litigation.
Other 'reports' of SSRi withdrawal from the recent MHRA file are:
Citalopram [Cipramil] - TOTAL 170
Duloxetine [Cymbalta] - TOTAL 55
Escitalopram [Cipralex] - TOTAL 53
Fluvoxamine [Luvox] - TOTAL 161
Fluoxetine [Prozac] - TOTAL 680
Sertraline [Zoloft] - TOTAL 162
Venlafaxine [Efexor] - TOTAL 318
I am 100% certain that these figures for all SSRi drugs are vastly underplayed. However, it seems that Seroxat with 1,425 'reported' adverse reactions more than doubles that of any other SSRi on the market. And people wonder why myself and others create awareness about the dangers of it!
Fid
Posted by Fiddy at 4:41 AM 0 comments Links to this post
Labels: GSK - Brushed Under The Carpet, MHRA Correspondence,
Sunday, 26 October 2008
not too many problems with Seroxat then as Sarah Venn heads a team at Hill Dickinson
Hill Dickinson to create chambers with Halliwells barrister
http://www.thelawyer.com/cgi-bin/item.cgi?id=131248&d=415&h=417&f=416
North West firm Hill Dickinson has become the latest firm to launch an in-house chambers, following in the footsteps of litigation giants Eversheds and Herbert Smith.
Barrister Sarah Venn from Halliwells has been hired to head the team. Venn did her pupillage at Erskine Chambers and Pump Court Tax Chambers before being called to the bar and worked as a Law Commission official prior to joining Halliwells.
Jason Spencer, head of Hill Dickinson's insurance practice group, said: "Our aim is to provide our clients with a more bespoke and dedicated legal service and I see this as a particularly important part of our growth strategy - particularly given the anticipated time pressures which are likely to arise from the imminent Ministry of Justice (MoJ) proposals."
Due for publication by the end of March, the MoJ proposals to reform the personal injury claims process aim to cut costs by speeding up the system.
Section: Lawyer2B: News, TL News, Firms Date: 18-Feb-2008
Author: Source: The Lawyer
http://www.thelawyer.com/cgi-bin/item.cgi?id=131248&d=415&h=417&f=416
North West firm Hill Dickinson has become the latest firm to launch an in-house chambers, following in the footsteps of litigation giants Eversheds and Herbert Smith.
Barrister Sarah Venn from Halliwells has been hired to head the team. Venn did her pupillage at Erskine Chambers and Pump Court Tax Chambers before being called to the bar and worked as a Law Commission official prior to joining Halliwells.
Jason Spencer, head of Hill Dickinson's insurance practice group, said: "Our aim is to provide our clients with a more bespoke and dedicated legal service and I see this as a particularly important part of our growth strategy - particularly given the anticipated time pressures which are likely to arise from the imminent Ministry of Justice (MoJ) proposals."
Due for publication by the end of March, the MoJ proposals to reform the personal injury claims process aim to cut costs by speeding up the system.
Section: Lawyer2B: News, TL News, Firms Date: 18-Feb-2008
Author: Source: The Lawyer
Sarah Venn, another of Mark Harvey's pet poodles - god they don't half go a strange colour
Sarah Venn has suffered severe side effects
http://news.bbc.co.uk/1/hi/programmes/panorama/3008433.stm
Derek Scott - yet another Seroxat activist happy to obtain psychiatric treatment & a cocktail of drugs
Anti-depressant nightmare relived
The Courier: Taking you to the heart of Tayside and Fife
http://www.thecourier.co.uk/output/2007/03/07/newsstory9390766t0.asp
DEREK SCOTT has first- hand experience of the side-effects experienced by thousands of people being treated with Seroxat.
Derek (36), of Linfield Street, Dundee, was addicted to the drug for almost five years and believes he has suffered permanent psychological damage by the treatment.
As a result of allegedly poor guidelines from the drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), Derek was prescribed up to three-times the recommended dose for many years.
When he tried to come off it he suffered panic attacks and nightmares, and the strain resulted in an attempt to take his own life.
Since then, with the help of a cocktail of other anti-depressants and psychiatric treatment, he has been working for a ban on the drug he is convinced has ruined his life.
“I tried coming off it in 2004 and that’s when my problems started. I had absolutely no idea that it could cause this kind of reaction. I suffered from persistent sickness, sweating, thoughts of death, nightmares and physical sensations that felt like electric shocks all over my body.”
While trawling the internet for information he found there were thousands of other people who had the same symptoms, and the same suspicions about the drug, as he did.
He decided to start a website of his own—the Online Seroxat Support Group—as a meeting place for other people to share their experiences.
He said, “The internet seems to be the best place to get people together with this type of illness.”
In 2005 Derek’s cause was taken up by MP Stewart Hosie, who submitted a petition in his name to parliament calling for suspension of new prescriptions until the drug can be investigated. Derek has been in continual correspondence with Mr Hosie since his election to the Dundee East seat in May 2005, and the list of evidence he has compiled is kept in a file over 12 inches thick.
Email the Editor with your views
antipsychotics make brains shrink - yet Paxil/Seroxat activist Rob Robinson is not against psychiatry
Dr. Nancy C. Andreasen said
"I haven't published this yet. But I have spoken about it in public lectures. The big finding is that people with schizophrenia are losing brain tissue at a more rapid rate than healthy people of comparable age. Some are losing as much as 1 percent per year. That's an awful lot over an 18-year period. And then we're trying to figure out why. Another thing we've discovered is that the more drugs you've been given, the more brain tissue you lose."
http://www.nytimes.com/2008/09/16/health/research/16conv.html?_r=1&oref=slogin
Using Imaging to Look at Changes in the Brain
Matthew Holst for The New York Times
`From the outset, I knew I wanted to do research and patient care. Because I relish complexity, I chose psychiatry.' - Nancy C. Andreasen
By CLAUDIA DREIFUS
Published: September 15, 2008
Dr. Nancy C. Andreasen concentrates on the big questions. A neuroscientist and psychiatrist at the University of Iowa, she uses M.R.I. to ask questions like: How do the nervous systems of extremely creative people differ from those of the rest of us? How is the brain physiology of the mentally ill different from that of normal people? For nearly two decades, she has been conducting a study that tracks long-term changes in the brain. We spoke this summer when she visited New York City. An edited version of a three-hour conversation follows:
Q. HOW DID YOU BECOME A PSYCHIATRIST?
A. I was an English professor in the early 1960s. I'd done a book on John Donne. Then, in 1964, I gave birth to my first child and nearly died from a postpartum infection — the very thing that had killed millions of birthing women in the centuries before antibiotics. As I recovered, I realized I had been given back my life, and that caused me to rethink everything in it. I decided to quit literature studies and go back to school to become a doctor.
From the outset, I knew I wanted to do research and patient care. Because I relish complexity, I chose psychiatry — it's more complicated than neurology. And I chose brain research because the brain is the most complicated organ in the body. I wanted to do something as important as the discovery of penicillin, the thing that had saved me.
Q. YOU PIONEERED THE USE OF IMAGING TECHNOLOGY FOR LEARNING ABOUT THE PHYSIOLOGY OF THE BRAIN. HOW DID THE IDEA OF USING CAT SCANS AND M.R.I.'S AS A RESEARCH TOOL COME TO YOU?
A. My first patient was a schizophrenic. After working with him, I wanted to understand how this terrible disease developed, how to stop it and to find better treatments. Right away, I began searching for new tests to assay brain activities. With the technology we had at that time, you couldn't see brain differences easily. A lot of our information came from autopsies done on patients, but that was of limited use because you had nothing to compare it to.
But then, in the early 1970s, CT scans came along. They got pictures of the inside of a living patient's brain. I recognized the potential immediately. The problem was convincing my colleagues. CT scans involved exposing patients to radiation. When I went to the human experimentation committee at my medical school, they went, "We don't want you subjecting patients to radiation. Besides, you're not going to find anything that way, anyway." It took a long time to convince them.
Q. TODAY, IMAGING STUDIES ARE ONE OF THE MAINSTAYS OF NEUROSCIENCE. WHEN DID ATTITUDES CHANGE?
A. In the early 1980s, when magnetic resonance imaging came on line. M.R.I.'s did not expose patients to radiation, and you could see brain structures in exquisite detail. I decided to use it for a longitudinal study of brain changes over a long period of time. We're asking: Is schizophrenia a neurodegenerative disease like Alzheimer's?
In 1989, I began to collect subjects — some with schizophrenia and some not — and began taking pictures of their brains. With the schizophrenics, we began seeing them at the first onset of their disease, which is usually at around age 24. We recruited about 538 people with schizophrenia. Eighteen years later, we're still following 305.
Q. AND WHAT HAVE YOU FOUND?
A. I haven't published this yet. But I have spoken about it in public lectures. The big finding is that people with schizophrenia are losing brain tissue at a more rapid rate than healthy people of comparable age. Some are losing as much as 1 percent per year. That's an awful lot over an 18-year period. And then we're trying to figure out why. Another thing we've discovered is that the more drugs you've been given, the more brain tissue you lose.
Q. WHY DO YOU THINK THIS IS HAPPENING?
A. Well, what exactly do these drugs do? They block basal ganglia activity. The prefrontal cortex doesn't get the input it needs and is being shut down by drugs. That reduces the psychotic symptoms. It also causes the prefrontal cortex to slowly atrophy.
If I were developing new drugs, I'd switch targets. Till now it's been chemically formulated targets. I believe we should be thinking more anatomically and asking, "With schizophrenics, which brain regions are functioning abnormally?"
Q. ARE YOU WORRIED YOUR FINDINGS MIGHT BE MISUSED?
A. The reason I sat on these findings for a couple of years was that I just wanted to be absolutely sure it was true. My biggest fear is that people who need the drugs will stop taking them.
Q. WHAT ARE THE POLICY IMPLICATIONS OF THIS FINDING?
A. Implication 1: that these drugs have to be used at the lowest possible dose, which often doesn't happen now. There's huge economic pressure to medicate patients very rapidly and to get them out of the hospital right away. Implication 2: we need to find other drugs that work on other systems and parts of the brain. Implication 3: whatever medications we use need to be combined with more nonmedication-oriented treatments, like cognitive or social therapies.
Q. IN YOUR LONGITUDINAL STUDY, ARE YOU ALSO LOOKING AT HOW THE NORMAL BRAIN AGES?
A. Yes. I've been asking, "At what point is human brain maturation complete and at what point do our brains naturally decline and lose tissue?" The answer is: the human brain continues to mature till about 25. At about 25, it plateaus for about 20 years, and at about 45, we start to lose brain tissue.
But it's interesting: we lose brain tissue, but we don't necessarily lose cognitive capacities. A lot of people at 50, 60, 70 or 80 are quite sharp. I can quantify their brain tissue and see they've lost quite a bit from what would be normal for a 45-year-old, but their cognitive abilities are not at all impaired.
"I haven't published this yet. But I have spoken about it in public lectures. The big finding is that people with schizophrenia are losing brain tissue at a more rapid rate than healthy people of comparable age. Some are losing as much as 1 percent per year. That's an awful lot over an 18-year period. And then we're trying to figure out why. Another thing we've discovered is that the more drugs you've been given, the more brain tissue you lose."
http://www.nytimes.com/2008/09/16/health/research/16conv.html?_r=1&oref=slogin
Using Imaging to Look at Changes in the Brain
Matthew Holst for The New York Times
`From the outset, I knew I wanted to do research and patient care. Because I relish complexity, I chose psychiatry.' - Nancy C. Andreasen
By CLAUDIA DREIFUS
Published: September 15, 2008
Dr. Nancy C. Andreasen concentrates on the big questions. A neuroscientist and psychiatrist at the University of Iowa, she uses M.R.I. to ask questions like: How do the nervous systems of extremely creative people differ from those of the rest of us? How is the brain physiology of the mentally ill different from that of normal people? For nearly two decades, she has been conducting a study that tracks long-term changes in the brain. We spoke this summer when she visited New York City. An edited version of a three-hour conversation follows:
Q. HOW DID YOU BECOME A PSYCHIATRIST?
A. I was an English professor in the early 1960s. I'd done a book on John Donne. Then, in 1964, I gave birth to my first child and nearly died from a postpartum infection — the very thing that had killed millions of birthing women in the centuries before antibiotics. As I recovered, I realized I had been given back my life, and that caused me to rethink everything in it. I decided to quit literature studies and go back to school to become a doctor.
From the outset, I knew I wanted to do research and patient care. Because I relish complexity, I chose psychiatry — it's more complicated than neurology. And I chose brain research because the brain is the most complicated organ in the body. I wanted to do something as important as the discovery of penicillin, the thing that had saved me.
Q. YOU PIONEERED THE USE OF IMAGING TECHNOLOGY FOR LEARNING ABOUT THE PHYSIOLOGY OF THE BRAIN. HOW DID THE IDEA OF USING CAT SCANS AND M.R.I.'S AS A RESEARCH TOOL COME TO YOU?
A. My first patient was a schizophrenic. After working with him, I wanted to understand how this terrible disease developed, how to stop it and to find better treatments. Right away, I began searching for new tests to assay brain activities. With the technology we had at that time, you couldn't see brain differences easily. A lot of our information came from autopsies done on patients, but that was of limited use because you had nothing to compare it to.
But then, in the early 1970s, CT scans came along. They got pictures of the inside of a living patient's brain. I recognized the potential immediately. The problem was convincing my colleagues. CT scans involved exposing patients to radiation. When I went to the human experimentation committee at my medical school, they went, "We don't want you subjecting patients to radiation. Besides, you're not going to find anything that way, anyway." It took a long time to convince them.
Q. TODAY, IMAGING STUDIES ARE ONE OF THE MAINSTAYS OF NEUROSCIENCE. WHEN DID ATTITUDES CHANGE?
A. In the early 1980s, when magnetic resonance imaging came on line. M.R.I.'s did not expose patients to radiation, and you could see brain structures in exquisite detail. I decided to use it for a longitudinal study of brain changes over a long period of time. We're asking: Is schizophrenia a neurodegenerative disease like Alzheimer's?
In 1989, I began to collect subjects — some with schizophrenia and some not — and began taking pictures of their brains. With the schizophrenics, we began seeing them at the first onset of their disease, which is usually at around age 24. We recruited about 538 people with schizophrenia. Eighteen years later, we're still following 305.
Q. AND WHAT HAVE YOU FOUND?
A. I haven't published this yet. But I have spoken about it in public lectures. The big finding is that people with schizophrenia are losing brain tissue at a more rapid rate than healthy people of comparable age. Some are losing as much as 1 percent per year. That's an awful lot over an 18-year period. And then we're trying to figure out why. Another thing we've discovered is that the more drugs you've been given, the more brain tissue you lose.
Q. WHY DO YOU THINK THIS IS HAPPENING?
A. Well, what exactly do these drugs do? They block basal ganglia activity. The prefrontal cortex doesn't get the input it needs and is being shut down by drugs. That reduces the psychotic symptoms. It also causes the prefrontal cortex to slowly atrophy.
If I were developing new drugs, I'd switch targets. Till now it's been chemically formulated targets. I believe we should be thinking more anatomically and asking, "With schizophrenics, which brain regions are functioning abnormally?"
Q. ARE YOU WORRIED YOUR FINDINGS MIGHT BE MISUSED?
A. The reason I sat on these findings for a couple of years was that I just wanted to be absolutely sure it was true. My biggest fear is that people who need the drugs will stop taking them.
Q. WHAT ARE THE POLICY IMPLICATIONS OF THIS FINDING?
A. Implication 1: that these drugs have to be used at the lowest possible dose, which often doesn't happen now. There's huge economic pressure to medicate patients very rapidly and to get them out of the hospital right away. Implication 2: we need to find other drugs that work on other systems and parts of the brain. Implication 3: whatever medications we use need to be combined with more nonmedication-oriented treatments, like cognitive or social therapies.
Q. IN YOUR LONGITUDINAL STUDY, ARE YOU ALSO LOOKING AT HOW THE NORMAL BRAIN AGES?
A. Yes. I've been asking, "At what point is human brain maturation complete and at what point do our brains naturally decline and lose tissue?" The answer is: the human brain continues to mature till about 25. At about 25, it plateaus for about 20 years, and at about 45, we start to lose brain tissue.
But it's interesting: we lose brain tissue, but we don't necessarily lose cognitive capacities. A lot of people at 50, 60, 70 or 80 are quite sharp. I can quantify their brain tissue and see they've lost quite a bit from what would be normal for a 45-year-old, but their cognitive abilities are not at all impaired.
Thursday, 23 October 2008
paxil victim Glitterari author of "Blind Reason" was shocked by Rob Robinson, who's father comitted suicide on Zoloft
#links
http://health.groups.yahoo.com/group/SSRI-Crusaders/message/22960
This statement really shocks me. Psychiatry is pseudoscience and considering
that Rob's father committed suicide while taking Zoloft, I would think his
opinion of all psychiatric drugs would be more critical, not just confined to
Paxil. One only needs to read the daily newspapers to see the havoc these drugs
are wreaking on society. Psychiatric drugs have cured nothing, but they've
caused a whole lot of mayhem.
Blind Reason
A novel of pharmaceutical intrigue
Think your antidepressant is safe?
Think again.
"All the truth in the world adds up to one big lie."
~ Bob Dylan ~
http://health.groups.yahoo.com/group/SSRI-Crusaders/message/22960
This statement really shocks me. Psychiatry is pseudoscience and considering
that Rob's father committed suicide while taking Zoloft, I would think his
opinion of all psychiatric drugs would be more critical, not just confined to
Paxil. One only needs to read the daily newspapers to see the havoc these drugs
are wreaking on society. Psychiatric drugs have cured nothing, but they've
caused a whole lot of mayhem.
Blind Reason
A novel of pharmaceutical intrigue
Think your antidepressant is safe?
Think again.
"All the truth in the world adds up to one big lie."
~ Bob Dylan ~
Owner/moderator of W&R Group, Catherine Creel said Rob Robinson was a liability to the movement !!
http://health.groups.yahoo.com/group/SSRI-Crusaders/message/22986
Frankly, I believe you are currently more of a liability than a
help to the movement that wants psychiatry and drug companies to stop
injuring people with psychotropic drugs. Until you find again what
you once knew and are willing to stand up and speak out about it, I,
for one, am boycotting your website, and I am suggesting to the 530
members of my psychotropic drug recovery group that they do so also.
A most puzzled and disappointed,
Catherine Creel
(Withdrawal_and_Recovery)
Entire article
Protest at GSK Criticizes Drug
http://www.philly.com/mld/inquirer/business/12749439.htm
Protest at Glaxo criticizes drug
Demonstrators, who planned a 3-day vigil, were demanding recall of
antidepressant Paxil.
By Thomas Ginsberg
Inquirer Staff Writer
Frankly, I believe you are currently more of a liability than a
help to the movement that wants psychiatry and drug companies to stop
injuring people with psychotropic drugs. Until you find again what
you once knew and are willing to stand up and speak out about it, I,
for one, am boycotting your website, and I am suggesting to the 530
members of my psychotropic drug recovery group that they do so also.
A most puzzled and disappointed,
Catherine Creel
(Withdrawal_and_Recovery)
Entire article
Protest at GSK Criticizes Drug
http://www.philly.com/mld/inquirer/business/12749439.htm
Protest at Glaxo criticizes drug
Demonstrators, who planned a 3-day vigil, were demanding recall of
antidepressant Paxil.
By Thomas Ginsberg
Inquirer Staff Writer
post 22986 from SSRI Crusaders - Owner/Moderator of Withdrawal&Recovery Group takes issue with Rob Robinson
http://health.groups.yahoo.com/group/SSRI-Crusaders/message/22986
** Rob, you don't think the use of psychiatric drugs is
necessarily bad?? Have I missed something? Isn't Paxil a psychiatric
drug?
What has happened that you won't take a stand now about these drugs
when you once did?
Do you think it's just Paxil that's a problem? Well, it isn't.
Drugs that alter brain structure in order to alter brain chemistry
(most psychotropic drugs) are just another cash cow for the
pharmaceutical industry. It has been accepted to not know the
mechanisms by which these drugs "work" (look at the clinical
pharmacology of any of them in the PDR). Because of this, drug makers
can make drugs for which they don't have to be accountable. The
psychiatric classes of drugs are rife with drugs designed not for
efficacy, but for profit.
Have you not read Peter Breggin's books? Dr. Healey's? What
about Ann Tracy's book? John Abramson's? Dr. Glenmullin's? Marcia
Angell, MD, former Editor-in-Chief of the New England Journal of
Medicine has a book titled "The Truth About the Drug Companies". Did
you read this one? How about the list of books on your very own
website?
http://paxilprotest.com/page31.html
How about the now regular exposes about the lies and deceits of the
drug industry? Have you read any of those? Do you not read the vast
number of articles written every month about the shambles made of
people's lives by these drugs? The medical journals have even begun
publishing articles that cast a negative light on these drugs and/or
the drug industry? Did you miss those, Rob?
The articles in the papers are only about those who committed
heinous crimes while on these drugs. There are thousands more who
will never be the same after being seduced by the promise of relief
from depression, anxiety, mania, and psychosis only to find that even
if they suffered only a few mild "side effects" (they're in the
minority) they will never be able to connect emotionally again as they
once did because of the chemical lobotomy they received from these
drugs. Don't forget the physical damage caused by them (adrenal
system, thyroid, circulatory system, hormonal system, etc.).
What about all the people who struggle to stop taking these drugs?
Most go through hell, some have to quit school, some have to leave
their jobs. Some lose their spouses, some their children, some their
friends. Some kill their spouses, children, or friends.
How about the children? 30% of young people entering the more
exclusive colleges in the U.S. are on psychiatric drugs. Fully 50% of
them are talking these drugs by their senior year.
Infants are now being diagnosed with psychiatric disorders and
drugged. Most young children taking psychotropic drugs now are taking
2,3, or 4 of them. This happens because the drugs don't work for what
we are told they work for. Parents note their children are no better,
and often worse and complain to their physicians. The physicians, who
have been lied to just as much as the lay public, mindlessly write for
yet another drug to be added to the drug regime because when they
phone the pharmaceutical companies to tell them the drug is not
working as intended, they are told that the child has a
"treatment-resistant illness and advise physicians to add a drug,
often one of their own. They have no evidence that this combination
works to resolve the child's "mental illness" but they don't need it
because of people who can be so easily convinced that these drugs ARE
efficacious and it must be a problem with the patient if they don't
work.
Here is an example of one of the latest excuses told by
pharmaceutical companies to physicians when physicians, who are
beginning to doubt these drugs, seek their "expertise" in sorting out
why the child (or adult) has not improved:
TJ - aged 10. On psychotropic drugs since the age of 5. 1st
diagnosis -- ADHD. When the entire drug selection targeted for this
alleged disorder had been tried with poor results and TJ was
deteriorating from having his young, developing brain assaulted by
amphetamines, TJ was given a diagnosis of bipolar disorder. Gee,
could it have been the rapid withdrawal from all the amphetamine-based
drugs given to him that made his behavior and moods unpredictable?
After being treated with more than 14 drugs, including
anti-psychotics, for this alleged disorder and being worse off than
ever, TJ's "specialists" from a large, well respected psychiatric
hospital in NY phoned one of the drug companies. They were told that
TJ's problem was that his "illness" was "progressive" and that's why
the drugs weren't working for him. A recommendation was made for a
chemical straitjacket of 5 drugs, 2 of which were anti-psychotics.
This did the trick. TJ is so drugged he can no longer participate in
school, has seizures several times a day, is unable to complete a
sentence any time he tries to talk, and is often found in the yard
sleeping on the ground while his siblings play around him. When his
parents question any of this, they are reassured that although this is
a progressive illness and TJ will always be ill, the doctors will keep
trying until they find something that "works" for TJ. The parents go
home relieved, and glad that the doctors care so much and are taking
such good care of TJ.
There are hundreds of thousands of TJs out there today, Rob, not to
mention all the adults. Do you think your comments helped or hurt
those who are trying to help them?
Did they put something in the water in your hotel that's affected
your memory, Rob? It makes absolutely no sense to me that you would
defend psychiatric medicine the way you did when you had the
opportunity to be heard.
Frankly, I believe you are currently more of a liability than a
help to the movement that wants psychiatry and drug companies to stop
injuring people with psychotropic drugs. Until you find again what
you once knew and are willing to stand up and speak out about it, I,
for one, am boycotting your website, and I am suggesting to the 530
members of my psychotropic drug recovery group that they do so also.
A most puzzled and disappointed,
Catherine Creel
(Withdrawal_and_Recovery)
Entire article
Protest at GSK Criticizes Drug
http://www.philly.com/mld/inquirer/business/12749439.htm
Protest at Glaxo criticizes drug
Demonstrators, who planned a 3-day vigil, were demanding recall of
antidepressant Paxil.
By Thomas Ginsberg
Inquirer Staff Writer
A handful of protesters began a three-day vigil yesterday outside the Center
City offices of GlaxoSmithKline P.L.C., calling on the global drugmaker to
recall its controversial antidepressant, Paxil.
"I felt like I was used by GlaxoSmithKline as a disposable lab rat to feed
their multibillion-dollar revenue stream," said Rob Robinson, the
Tennessee-based protest organizer, who contends that Paxil is addictive and
gave him anxiety attacks and violent thoughts.
GlaxoSmithKline spokeswoman Mary Anne Rhyne said the company had no plans to
recall the drug, as the protesters demanded.
"While we sympathize with anyone facing health challenges, we do not believe
science supports the claims voiced by the individuals involved in this
event," a company statement said.
Last October, the Food and Drug Administration ordered makers of all
antidepressants to label them with bold-faced warnings about the risk of
suicide and depression for children. Last year, GlaxoSmithKline said it paid
$2.5 million to settle a New York state lawsuit alleging the company hid
studies showing negative effects of Paxil. It also agreed to post on the
Internet all studies about Paxil, which was approved by the FDA in 1992.
The fine equaled about one day's worth of Paxil's annual sales revenue,
which was $950 million worldwide last year. Sales of most antidepressants
known as selective serotonin reuptake inhibitors, or SSRIs, have slumped
from fear of suicide and addictiveness.
Similar drugs include Prozac, made by Indianapolis-based Eli Lilly & Co.;
Zoloft, made by New York-based Pfizer Inc.; Forest Laboratories Inc.'s
Celexa and Lexapro; and Effexor, made by Wyeth, with pharmaceutical
headquarters in Collegeville.
Robinson, who is a member of a federal class-action lawsuit against
GlaxoSmithKline, said he broke his four-year addiction in 2002 and began
organizing the protest four months ago, starting in Philadelphia because
"this is their corporate castle in the U.S."
Standing with his wife in front of the drugmaker's 16th Street offices,
Robinson, 45, a former general contractor from Chattanooga, Tenn., said he
was not opposed to prescription drugs or to psychiatry overall. He rejected
the actor Tom Cruise's well-publicized criticism of psychiatry as
"pseudoscience."
"I don't think the use of psychiatric drugs is necessarily bad," Robinson
said.
Ryan Yorke, 17, a protester and former Paxil user from Clark, N.J., blamed
Paxil for episodes of rage and depression he said he felt since first taking
the drug following an anxiety attack. "Drugs, they're not all bad. But you
see the money the companies are making and putting money before human life,"
he said.
Robinson, with about 10 protesters supporting him, said he planned to remain
outside GlaxoSmithKline until tomorrow and has rented an airplane to fly
over the area trailing a banner opposing Paxil.
Joseph Rogers, executive director of the Mental Health Association of
Southeastern Pennsylvania, faulted drug companies for withholding negative
data, but said many people still benefited from the drugs.
"What we need is psychiatrists who are trained in these drugs," Rogers said,
"and we need consumers who have information" to make better decisions.
Read what GlaxoSmithKline, the Paxil protesters and the Food and Drug
Administration have to say about the antidepressant at
http://go.philly.com/paxil.
--
Regards,
Catherine
** Rob, you don't think the use of psychiatric drugs is
necessarily bad?? Have I missed something? Isn't Paxil a psychiatric
drug?
What has happened that you won't take a stand now about these drugs
when you once did?
Do you think it's just Paxil that's a problem? Well, it isn't.
Drugs that alter brain structure in order to alter brain chemistry
(most psychotropic drugs) are just another cash cow for the
pharmaceutical industry. It has been accepted to not know the
mechanisms by which these drugs "work" (look at the clinical
pharmacology of any of them in the PDR). Because of this, drug makers
can make drugs for which they don't have to be accountable. The
psychiatric classes of drugs are rife with drugs designed not for
efficacy, but for profit.
Have you not read Peter Breggin's books? Dr. Healey's? What
about Ann Tracy's book? John Abramson's? Dr. Glenmullin's? Marcia
Angell, MD, former Editor-in-Chief of the New England Journal of
Medicine has a book titled "The Truth About the Drug Companies". Did
you read this one? How about the list of books on your very own
website?
http://paxilprotest.com/page31.html
How about the now regular exposes about the lies and deceits of the
drug industry? Have you read any of those? Do you not read the vast
number of articles written every month about the shambles made of
people's lives by these drugs? The medical journals have even begun
publishing articles that cast a negative light on these drugs and/or
the drug industry? Did you miss those, Rob?
The articles in the papers are only about those who committed
heinous crimes while on these drugs. There are thousands more who
will never be the same after being seduced by the promise of relief
from depression, anxiety, mania, and psychosis only to find that even
if they suffered only a few mild "side effects" (they're in the
minority) they will never be able to connect emotionally again as they
once did because of the chemical lobotomy they received from these
drugs. Don't forget the physical damage caused by them (adrenal
system, thyroid, circulatory system, hormonal system, etc.).
What about all the people who struggle to stop taking these drugs?
Most go through hell, some have to quit school, some have to leave
their jobs. Some lose their spouses, some their children, some their
friends. Some kill their spouses, children, or friends.
How about the children? 30% of young people entering the more
exclusive colleges in the U.S. are on psychiatric drugs. Fully 50% of
them are talking these drugs by their senior year.
Infants are now being diagnosed with psychiatric disorders and
drugged. Most young children taking psychotropic drugs now are taking
2,3, or 4 of them. This happens because the drugs don't work for what
we are told they work for. Parents note their children are no better,
and often worse and complain to their physicians. The physicians, who
have been lied to just as much as the lay public, mindlessly write for
yet another drug to be added to the drug regime because when they
phone the pharmaceutical companies to tell them the drug is not
working as intended, they are told that the child has a
"treatment-resistant illness and advise physicians to add a drug,
often one of their own. They have no evidence that this combination
works to resolve the child's "mental illness" but they don't need it
because of people who can be so easily convinced that these drugs ARE
efficacious and it must be a problem with the patient if they don't
work.
Here is an example of one of the latest excuses told by
pharmaceutical companies to physicians when physicians, who are
beginning to doubt these drugs, seek their "expertise" in sorting out
why the child (or adult) has not improved:
TJ - aged 10. On psychotropic drugs since the age of 5. 1st
diagnosis -- ADHD. When the entire drug selection targeted for this
alleged disorder had been tried with poor results and TJ was
deteriorating from having his young, developing brain assaulted by
amphetamines, TJ was given a diagnosis of bipolar disorder. Gee,
could it have been the rapid withdrawal from all the amphetamine-based
drugs given to him that made his behavior and moods unpredictable?
After being treated with more than 14 drugs, including
anti-psychotics, for this alleged disorder and being worse off than
ever, TJ's "specialists" from a large, well respected psychiatric
hospital in NY phoned one of the drug companies. They were told that
TJ's problem was that his "illness" was "progressive" and that's why
the drugs weren't working for him. A recommendation was made for a
chemical straitjacket of 5 drugs, 2 of which were anti-psychotics.
This did the trick. TJ is so drugged he can no longer participate in
school, has seizures several times a day, is unable to complete a
sentence any time he tries to talk, and is often found in the yard
sleeping on the ground while his siblings play around him. When his
parents question any of this, they are reassured that although this is
a progressive illness and TJ will always be ill, the doctors will keep
trying until they find something that "works" for TJ. The parents go
home relieved, and glad that the doctors care so much and are taking
such good care of TJ.
There are hundreds of thousands of TJs out there today, Rob, not to
mention all the adults. Do you think your comments helped or hurt
those who are trying to help them?
Did they put something in the water in your hotel that's affected
your memory, Rob? It makes absolutely no sense to me that you would
defend psychiatric medicine the way you did when you had the
opportunity to be heard.
Frankly, I believe you are currently more of a liability than a
help to the movement that wants psychiatry and drug companies to stop
injuring people with psychotropic drugs. Until you find again what
you once knew and are willing to stand up and speak out about it, I,
for one, am boycotting your website, and I am suggesting to the 530
members of my psychotropic drug recovery group that they do so also.
A most puzzled and disappointed,
Catherine Creel
(Withdrawal_and_Recovery)
Entire article
Protest at GSK Criticizes Drug
http://www.philly.com/mld/inquirer/business/12749439.htm
Protest at Glaxo criticizes drug
Demonstrators, who planned a 3-day vigil, were demanding recall of
antidepressant Paxil.
By Thomas Ginsberg
Inquirer Staff Writer
A handful of protesters began a three-day vigil yesterday outside the Center
City offices of GlaxoSmithKline P.L.C., calling on the global drugmaker to
recall its controversial antidepressant, Paxil.
"I felt like I was used by GlaxoSmithKline as a disposable lab rat to feed
their multibillion-dollar revenue stream," said Rob Robinson, the
Tennessee-based protest organizer, who contends that Paxil is addictive and
gave him anxiety attacks and violent thoughts.
GlaxoSmithKline spokeswoman Mary Anne Rhyne said the company had no plans to
recall the drug, as the protesters demanded.
"While we sympathize with anyone facing health challenges, we do not believe
science supports the claims voiced by the individuals involved in this
event," a company statement said.
Last October, the Food and Drug Administration ordered makers of all
antidepressants to label them with bold-faced warnings about the risk of
suicide and depression for children. Last year, GlaxoSmithKline said it paid
$2.5 million to settle a New York state lawsuit alleging the company hid
studies showing negative effects of Paxil. It also agreed to post on the
Internet all studies about Paxil, which was approved by the FDA in 1992.
The fine equaled about one day's worth of Paxil's annual sales revenue,
which was $950 million worldwide last year. Sales of most antidepressants
known as selective serotonin reuptake inhibitors, or SSRIs, have slumped
from fear of suicide and addictiveness.
Similar drugs include Prozac, made by Indianapolis-based Eli Lilly & Co.;
Zoloft, made by New York-based Pfizer Inc.; Forest Laboratories Inc.'s
Celexa and Lexapro; and Effexor, made by Wyeth, with pharmaceutical
headquarters in Collegeville.
Robinson, who is a member of a federal class-action lawsuit against
GlaxoSmithKline, said he broke his four-year addiction in 2002 and began
organizing the protest four months ago, starting in Philadelphia because
"this is their corporate castle in the U.S."
Standing with his wife in front of the drugmaker's 16th Street offices,
Robinson, 45, a former general contractor from Chattanooga, Tenn., said he
was not opposed to prescription drugs or to psychiatry overall. He rejected
the actor Tom Cruise's well-publicized criticism of psychiatry as
"pseudoscience."
"I don't think the use of psychiatric drugs is necessarily bad," Robinson
said.
Ryan Yorke, 17, a protester and former Paxil user from Clark, N.J., blamed
Paxil for episodes of rage and depression he said he felt since first taking
the drug following an anxiety attack. "Drugs, they're not all bad. But you
see the money the companies are making and putting money before human life,"
he said.
Robinson, with about 10 protesters supporting him, said he planned to remain
outside GlaxoSmithKline until tomorrow and has rented an airplane to fly
over the area trailing a banner opposing Paxil.
Joseph Rogers, executive director of the Mental Health Association of
Southeastern Pennsylvania, faulted drug companies for withholding negative
data, but said many people still benefited from the drugs.
"What we need is psychiatrists who are trained in these drugs," Rogers said,
"and we need consumers who have information" to make better decisions.
Read what GlaxoSmithKline, the Paxil protesters and the Food and Drug
Administration have to say about the antidepressant at
http://go.philly.com/paxil.
--
Regards,
Catherine
"I don't think the use of psychiatric drugs is necessarily bad," - Robinson, try telling that to this guy with TD !!
"I don't think the use of psychiatric drugs is necessarily bad," Robinson
said. http://www.philly.com/mld/inquirer/business/12749439.htm
GSK Seroxat class action member Rob Robinson was " not opposed to prescription drugs or to psychiatry overall "
Robinson, who is a member of a federal class-action lawsuit against
GlaxoSmithKline, said he broke his four-year addiction in 2002 and began
organizing the protest four months ago, starting in Philadelphia because
"this is their corporate castle in the U.S."
Standing with his wife in front of the drugmaker's 16th Street offices,
Robinson, 45, a former general contractor from Chattanooga, Tenn., said he
was not opposed to prescription drugs or to psychiatry overall. He rejected
the actor Tom Cruise's well-publicized criticism of psychiatry as
"pseudoscience."
"I don't think the use of psychiatric drugs is necessarily bad," Robinson
said.
http://www.philly.com/mld/inquirer/business/12749439.htm
GlaxoSmithKline, said he broke his four-year addiction in 2002 and began
organizing the protest four months ago, starting in Philadelphia because
"this is their corporate castle in the U.S."
Standing with his wife in front of the drugmaker's 16th Street offices,
Robinson, 45, a former general contractor from Chattanooga, Tenn., said he
was not opposed to prescription drugs or to psychiatry overall. He rejected
the actor Tom Cruise's well-publicized criticism of psychiatry as
"pseudoscience."
"I don't think the use of psychiatric drugs is necessarily bad," Robinson
said.
http://www.philly.com/mld/inquirer/business/12749439.htm
So what does Rob Robinson think about Psychiatric drugs & psychiatry ?
http://www.philly.com/mld/inquirer/business/12749439.htm
Protest at Glaxo criticizes drug
Demonstrators, who planned a 3-day vigil, were demanding recall of
antidepressant Paxil.
By Thomas Ginsberg
Inquirer Staff Writer
A handful of protesters began a three-day vigil yesterday outside the Center
City offices of GlaxoSmithKline P.L.C., calling on the global drugmaker to
recall its controversial antidepressant, Paxil.
"I felt like I was used by GlaxoSmithKline as a disposable lab rat to feed
their multibillion-dollar revenue stream," said Rob Robinson, the
Tennessee-based protest organizer, who contends that Paxil is addictive and
gave him anxiety attacks and violent thoughts.
GlaxoSmithKline spokeswoman Mary Anne Rhyne said the company had no plans to
recall the drug, as the protesters demanded.
"While we sympathize with anyone facing health challenges, we do not believe
science supports the claims voiced by the individuals involved in this
event," a company statement said.
Last October, the Food and Drug Administration ordered makers of all
antidepressants to label them with bold-faced warnings about the risk of
suicide and depression for children. Last year, GlaxoSmithKline said it paid
$2.5 million to settle a New York state lawsuit alleging the company hid
studies showing negative effects of Paxil. It also agreed to post on the
Internet all studies about Paxil, which was approved by the FDA in 1992.
The fine equaled about one day's worth of Paxil's annual sales revenue,
which was $950 million worldwide last year. Sales of most antidepressants
known as selective serotonin reuptake inhibitors, or SSRIs, have slumped
from fear of suicide and addictiveness.
Similar drugs include Prozac, made by Indianapolis-based Eli Lilly & Co.;
Zoloft, made by New York-based Pfizer Inc.; Forest Laboratories Inc.'s
Celexa and Lexapro; and Effexor, made by Wyeth, with pharmaceutical
headquarters in Collegeville.
Robinson, who is a member of a federal class-action lawsuit against
GlaxoSmithKline, said he broke his four-year addiction in 2002 and began
organizing the protest four months ago, starting in Philadelphia because
"this is their corporate castle in the U.S."
Standing with his wife in front of the drugmaker's 16th Street offices,
Robinson, 45, a former general contractor from Chattanooga, Tenn., said he
was not opposed to prescription drugs or to psychiatry overall. He rejected
the actor Tom Cruise's well-publicized criticism of psychiatry as
"pseudoscience."
"I don't think the use of psychiatric drugs is necessarily bad," Robinson
said.
Ryan Yorke, 17, a protester and former Paxil user from Clark, N.J., blamed
Paxil for episodes of rage and depression he said he felt since first taking
the drug following an anxiety attack. "Drugs, they're not all bad. But you
see the money the companies are making and putting money before human life,"
he said.
Robinson, with about 10 protesters supporting him, said he planned to remain
outside GlaxoSmithKline until tomorrow and has rented an airplane to fly
over the area trailing a banner opposing Paxil.
Joseph Rogers, executive director of the Mental Health Association of
Southeastern Pennsylvania, faulted drug companies for withholding negative
data, but said many people still benefited from the drugs.
"What we need is psychiatrists who are trained in these drugs," Rogers said,
"and we need consumers who have information" to make better decisions.
Read what GlaxoSmithKline, the Paxil protesters and the Food and Drug
Administration have to say about the antidepressant at
http://go.philly.com/paxil.
--------------------------------------------------------------------------------
Contact staff writer Thomas Ginsberg at 215-854-4177 or
tginsberg@phillynews.com.
--------------------------------------------------------------------------------
© 2005 Philadelphia Inquirer and wire service sources. All Rights Reserved
Protest at Glaxo criticizes drug
Demonstrators, who planned a 3-day vigil, were demanding recall of
antidepressant Paxil.
By Thomas Ginsberg
Inquirer Staff Writer
A handful of protesters began a three-day vigil yesterday outside the Center
City offices of GlaxoSmithKline P.L.C., calling on the global drugmaker to
recall its controversial antidepressant, Paxil.
"I felt like I was used by GlaxoSmithKline as a disposable lab rat to feed
their multibillion-dollar revenue stream," said Rob Robinson, the
Tennessee-based protest organizer, who contends that Paxil is addictive and
gave him anxiety attacks and violent thoughts.
GlaxoSmithKline spokeswoman Mary Anne Rhyne said the company had no plans to
recall the drug, as the protesters demanded.
"While we sympathize with anyone facing health challenges, we do not believe
science supports the claims voiced by the individuals involved in this
event," a company statement said.
Last October, the Food and Drug Administration ordered makers of all
antidepressants to label them with bold-faced warnings about the risk of
suicide and depression for children. Last year, GlaxoSmithKline said it paid
$2.5 million to settle a New York state lawsuit alleging the company hid
studies showing negative effects of Paxil. It also agreed to post on the
Internet all studies about Paxil, which was approved by the FDA in 1992.
The fine equaled about one day's worth of Paxil's annual sales revenue,
which was $950 million worldwide last year. Sales of most antidepressants
known as selective serotonin reuptake inhibitors, or SSRIs, have slumped
from fear of suicide and addictiveness.
Similar drugs include Prozac, made by Indianapolis-based Eli Lilly & Co.;
Zoloft, made by New York-based Pfizer Inc.; Forest Laboratories Inc.'s
Celexa and Lexapro; and Effexor, made by Wyeth, with pharmaceutical
headquarters in Collegeville.
Robinson, who is a member of a federal class-action lawsuit against
GlaxoSmithKline, said he broke his four-year addiction in 2002 and began
organizing the protest four months ago, starting in Philadelphia because
"this is their corporate castle in the U.S."
Standing with his wife in front of the drugmaker's 16th Street offices,
Robinson, 45, a former general contractor from Chattanooga, Tenn., said he
was not opposed to prescription drugs or to psychiatry overall. He rejected
the actor Tom Cruise's well-publicized criticism of psychiatry as
"pseudoscience."
"I don't think the use of psychiatric drugs is necessarily bad," Robinson
said.
Ryan Yorke, 17, a protester and former Paxil user from Clark, N.J., blamed
Paxil for episodes of rage and depression he said he felt since first taking
the drug following an anxiety attack. "Drugs, they're not all bad. But you
see the money the companies are making and putting money before human life,"
he said.
Robinson, with about 10 protesters supporting him, said he planned to remain
outside GlaxoSmithKline until tomorrow and has rented an airplane to fly
over the area trailing a banner opposing Paxil.
Joseph Rogers, executive director of the Mental Health Association of
Southeastern Pennsylvania, faulted drug companies for withholding negative
data, but said many people still benefited from the drugs.
"What we need is psychiatrists who are trained in these drugs," Rogers said,
"and we need consumers who have information" to make better decisions.
Read what GlaxoSmithKline, the Paxil protesters and the Food and Drug
Administration have to say about the antidepressant at
http://go.philly.com/paxil.
--------------------------------------------------------------------------------
Contact staff writer Thomas Ginsberg at 215-854-4177 or
tginsberg@phillynews.com.
--------------------------------------------------------------------------------
© 2005 Philadelphia Inquirer and wire service sources. All Rights Reserved
Wednesday, 8 October 2008
& the bit Fiddaman didn't quote - Healy speaks for Pharma, runs trials for them and admits to bias !!!
HEALY: But Dr. Garfinkle and I get money from the pharmaceutical industry. We speak for pharmaceutical companies, run trials for them, and it does bias you. We probably all hope that the bias is going to be a small little bias and it's a risk we just have to take. It's only not going to be an option as long as people don't feel that people like me and Paul Garfinkle haven't just become drug dealers. That we're like car salesman who sell you the car regardless of the hazards. They want people, want us to be people who will weigh the benefits and the risks and will let you know about the benefits and the risks, the pros and the cons and maybe even advise in some instances that you shouldn't have the pills at all.
http://www.pharmapolitics.com/cbcnational.html
http://www.pharmapolitics.com/cbcnational.html
sensational conclusions by Fiddaman - Did Glaxo/Lilly pay Nemeroff to discredit David Healy?
http://fiddaman.blogspot.com/
Wednesday, October 08, 2008
Did Glaxo/Lilly pay Nemeroff to discredit David Healy?
Why was Charles Nemeroff so concerned with David Healy's research back in 2001 regarding SSRi's? Was he told by GlaxoSmithKline and/or Eli Lilly to 'warn' Healy off? Judging by this transcript it appears that not only is Nemeroff a lying fraudulent scuzball - he's an intimidating bastard as well! -
That's my opinion. Your thoughts?
"Dr. Nemeroff came up to me in the course of the meeting in what was a very scary meeting between him and me and told me that my career would be destroyed if I kept on showing results like the ones that I'd just shown, that I had no right to bring out hazards of the pills like these." - David Healy
Actual script from 'Dr. David Healy' CBC News and Current Affairs
Broadcast on Tue 12 Jun 2001
DARROW MACINTYRE: A quiet, small town in North Wales. It seems an unlikely place to find a man like David Healy, university professor and psychiatrist, renowned in medical circles from New York to Paris to London as one of Europe's eminent scientist. This time last year, Healy was about to leave Wales. Lured to Toronto by this university teaching hospital, the Centre for Addiction and Mental Health and the promise of his own research clinic there. Then one day last November, something strange happened. After almost two years of courting Dr. Healy and finally offering him the big job, senior staff at the centre abruptly decided to dump him. They say they found out just in a nick of time that Healy held certain unscientific views about a number of psychiatric drugs, views they say could harm patient care. But many in the academic community think their decision had less to do with science and more to do with money. What this is really about, they say, is the role drug companies play in influencing scientific debate. When it comes to anti-depressants there are few people who know more than Dr. Healy. Especially about a group of drugs called S.S.R.I. Or Selective Seratonin Re-uptake Inhibitors. The best known of these is Prozac, the most widely prescribed anti-depressant in the world. But for a decade now, research has suggested that drugs like Prozac may actually cause some people to have suicidal urges. Nobody really knows how often, but Healy thinks often enough to be concerned.
DAVID HEALY: Let's say in the case of Prozac that it causes the problem, it will cause people to commit suicide at a rate of one in 1,000 people who actually go on the drug. To most people here a figure like that, that sounds like a fairly low figure. It sounds like a reasonable trade-off almost. But if 50 million people go on the drug, then that becomes 50,000 suicides which is maybe higher than there has been, but it becomes an awfully big figure. It's what the FDA call the public health multiplier which is a small hazard distributed among millions of people becomes a big problem.
MACINTYRE: Recently David Healy conducted studies aimed at trying to figure out just who is at risk and who isn't. Are you opposed to the use of S.S.R.I.'s?
HEALY: Absolutely not. No. My Ph.D. Thesis was on the seratonin re-uptake system and I've been, I was one of the people when the S.S.R.I.'s came out first who would have been much quicker than most of the rest of my colleagues to use this new group of drugs. I continue to put a very large number of people that I see on the drugs. And I believe as the research that we've done indicates that if you're really going to use the drugs properly and I'm in the business of using these drugs to treat people, is you're really going to find out who does well on these drugs, what you find out at the same time is who does poorly.
MACINTYRE: Dr. Healy's not the first one to document this problem. Doctors at Harvard University raised concerns about S.S.R.I.'s and suicide years ago. Harvard lecturer and psychiatrist Joseph Glen Mullen wrote about it in his book "Prozac Backlash". He says more doctors should listen to Healy.
JOSEPH GLEN MULLEN: Dr. Healy for many, many years has been widely regarded as one of the leading psychiatrist in Europe and really in the world. His research is outstanding. And he's one of the few people who has continued to do research on the suicidality issue in particular and been a strong proponent of patients needing to get this kind of information.
MACINTYRE: Last summer, the centre made it official. They wanted Healy as the top scientist in their mood and anxiety disorders clinic. They offered him the director's job and he accepted.
HEALY: I felt very good about it. And I also brought over my family and certainly they all seemed reasonably open to the move as well. So we all began to get fairly excited.
MACINTYRE: At the time the centre had no problem with Healy's research. But someone else did.
CHARLES NEMEROFF: Hello. My name is Charles Nemeroff.
MACINTYRE: Chair of the Department of Psychiatry at Atlanta's prestigious Emory University, Dr. Charles Nemeroff is a highly respected and influential scientist. And a paid consultant to a dozen drug companies. A leading psychiatric magazine recently profiled him under the headline Boss of Bosses. Is the brash and controversial Charles Nemeroff, the most powerful man in psychiatry. Inside the authors wrote, Nemeroff is among the most coveted advisors to the pharmaceutical industry. And he fully expects to lead the corporate strategies of those he advises. Those who do not heed his advice are often the recipients of his wrath. Last summer at Cambridge University in England, Healy had a brush with the boss of bosses.
HEALY: Dr. Nemeroff came up to me in the course of the meeting in what was a very scary meeting between him and me and told me that my career would be destroyed if I kept on showing results like the ones that I'd just shown, that I had no right to bring out hazards of the pills like these.
MACINTYRE: In a written statement, a doctor who witnessed the confrontation told us, when it became clear that David Healy would not back down from his points of view, Nemeroff said that what Healy was publishing might harm the drug industry, specifically Eli Lilly. He, Charles Nemeroff, said that these people were ruthless and would go to great lengths to make life hard for academics who published articles associating suicide with Prozac.
HEALY: It was a fairly short encounter. It lasted about two or three minutes but a very scary one.
MACINTYRE: James Turk is with the Canadian Association of University Teachers. He says to a drug company concerned about profits, researchers like Healy could be seen as dangerous.
JAMES TURK: I mean he's one of the world's leading scholars on anti-depressants. He's done clinical trials for some of the drug companies. But what he isn't is not in the drug companies' pockets. And Healy's argument is that S.S.R.I.'s are suitable for some patients but in fact can be very harmful for others. And the impression I get is that the drug companies want 100 percent of the market whereas if you do that research and Healy's right, that there are 40 percent or 50 percent of the people who currently get S.S.R.I.'s for whom it's not appropriate, then the market is cut in half.
FULL SCRIPT - http://www.pharmapolitics.com/cbcnational.html
Posted by Fiddy at 8:40 AM 0 comments Links to this post
Labels
Wednesday, October 08, 2008
Did Glaxo/Lilly pay Nemeroff to discredit David Healy?
Why was Charles Nemeroff so concerned with David Healy's research back in 2001 regarding SSRi's? Was he told by GlaxoSmithKline and/or Eli Lilly to 'warn' Healy off? Judging by this transcript it appears that not only is Nemeroff a lying fraudulent scuzball - he's an intimidating bastard as well! -
That's my opinion. Your thoughts?
"Dr. Nemeroff came up to me in the course of the meeting in what was a very scary meeting between him and me and told me that my career would be destroyed if I kept on showing results like the ones that I'd just shown, that I had no right to bring out hazards of the pills like these." - David Healy
Actual script from 'Dr. David Healy' CBC News and Current Affairs
Broadcast on Tue 12 Jun 2001
DARROW MACINTYRE: A quiet, small town in North Wales. It seems an unlikely place to find a man like David Healy, university professor and psychiatrist, renowned in medical circles from New York to Paris to London as one of Europe's eminent scientist. This time last year, Healy was about to leave Wales. Lured to Toronto by this university teaching hospital, the Centre for Addiction and Mental Health and the promise of his own research clinic there. Then one day last November, something strange happened. After almost two years of courting Dr. Healy and finally offering him the big job, senior staff at the centre abruptly decided to dump him. They say they found out just in a nick of time that Healy held certain unscientific views about a number of psychiatric drugs, views they say could harm patient care. But many in the academic community think their decision had less to do with science and more to do with money. What this is really about, they say, is the role drug companies play in influencing scientific debate. When it comes to anti-depressants there are few people who know more than Dr. Healy. Especially about a group of drugs called S.S.R.I. Or Selective Seratonin Re-uptake Inhibitors. The best known of these is Prozac, the most widely prescribed anti-depressant in the world. But for a decade now, research has suggested that drugs like Prozac may actually cause some people to have suicidal urges. Nobody really knows how often, but Healy thinks often enough to be concerned.
DAVID HEALY: Let's say in the case of Prozac that it causes the problem, it will cause people to commit suicide at a rate of one in 1,000 people who actually go on the drug. To most people here a figure like that, that sounds like a fairly low figure. It sounds like a reasonable trade-off almost. But if 50 million people go on the drug, then that becomes 50,000 suicides which is maybe higher than there has been, but it becomes an awfully big figure. It's what the FDA call the public health multiplier which is a small hazard distributed among millions of people becomes a big problem.
MACINTYRE: Recently David Healy conducted studies aimed at trying to figure out just who is at risk and who isn't. Are you opposed to the use of S.S.R.I.'s?
HEALY: Absolutely not. No. My Ph.D. Thesis was on the seratonin re-uptake system and I've been, I was one of the people when the S.S.R.I.'s came out first who would have been much quicker than most of the rest of my colleagues to use this new group of drugs. I continue to put a very large number of people that I see on the drugs. And I believe as the research that we've done indicates that if you're really going to use the drugs properly and I'm in the business of using these drugs to treat people, is you're really going to find out who does well on these drugs, what you find out at the same time is who does poorly.
MACINTYRE: Dr. Healy's not the first one to document this problem. Doctors at Harvard University raised concerns about S.S.R.I.'s and suicide years ago. Harvard lecturer and psychiatrist Joseph Glen Mullen wrote about it in his book "Prozac Backlash". He says more doctors should listen to Healy.
JOSEPH GLEN MULLEN: Dr. Healy for many, many years has been widely regarded as one of the leading psychiatrist in Europe and really in the world. His research is outstanding. And he's one of the few people who has continued to do research on the suicidality issue in particular and been a strong proponent of patients needing to get this kind of information.
MACINTYRE: Last summer, the centre made it official. They wanted Healy as the top scientist in their mood and anxiety disorders clinic. They offered him the director's job and he accepted.
HEALY: I felt very good about it. And I also brought over my family and certainly they all seemed reasonably open to the move as well. So we all began to get fairly excited.
MACINTYRE: At the time the centre had no problem with Healy's research. But someone else did.
CHARLES NEMEROFF: Hello. My name is Charles Nemeroff.
MACINTYRE: Chair of the Department of Psychiatry at Atlanta's prestigious Emory University, Dr. Charles Nemeroff is a highly respected and influential scientist. And a paid consultant to a dozen drug companies. A leading psychiatric magazine recently profiled him under the headline Boss of Bosses. Is the brash and controversial Charles Nemeroff, the most powerful man in psychiatry. Inside the authors wrote, Nemeroff is among the most coveted advisors to the pharmaceutical industry. And he fully expects to lead the corporate strategies of those he advises. Those who do not heed his advice are often the recipients of his wrath. Last summer at Cambridge University in England, Healy had a brush with the boss of bosses.
HEALY: Dr. Nemeroff came up to me in the course of the meeting in what was a very scary meeting between him and me and told me that my career would be destroyed if I kept on showing results like the ones that I'd just shown, that I had no right to bring out hazards of the pills like these.
MACINTYRE: In a written statement, a doctor who witnessed the confrontation told us, when it became clear that David Healy would not back down from his points of view, Nemeroff said that what Healy was publishing might harm the drug industry, specifically Eli Lilly. He, Charles Nemeroff, said that these people were ruthless and would go to great lengths to make life hard for academics who published articles associating suicide with Prozac.
HEALY: It was a fairly short encounter. It lasted about two or three minutes but a very scary one.
MACINTYRE: James Turk is with the Canadian Association of University Teachers. He says to a drug company concerned about profits, researchers like Healy could be seen as dangerous.
JAMES TURK: I mean he's one of the world's leading scholars on anti-depressants. He's done clinical trials for some of the drug companies. But what he isn't is not in the drug companies' pockets. And Healy's argument is that S.S.R.I.'s are suitable for some patients but in fact can be very harmful for others. And the impression I get is that the drug companies want 100 percent of the market whereas if you do that research and Healy's right, that there are 40 percent or 50 percent of the people who currently get S.S.R.I.'s for whom it's not appropriate, then the market is cut in half.
FULL SCRIPT - http://www.pharmapolitics.com/cbcnational.html
Posted by Fiddy at 8:40 AM 0 comments Links to this post
Labels
Tuesday, 7 October 2008
Eli Lilly has agreed to pay $62 Million in Zyprexa Case Settlement: as usual patients get nothing !!
$62 Million in Zyprexa Case Settlement
http://www.nytimes.com/2008/10/07/business/07zyprexa.html?ref=business
By ALEX BERENSON
Published: October 6, 2008
Eli Lilly has agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.
The settlement, to be announced Tuesday, ends an 18-month investigation led by the offices of the attorneys general of Illinois and Oregon, which contended that Lilly had violated consumer protection laws by urging doctors to prescribe Zyprexa to patients who did not need it.
It is the largest settlement paid by a drug company in a state consumer protection case, topping the $58 million that Merck paid to settle similar allegations about Vioxx, lawyers for the states said.
The agreement may also be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia. In that case, Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa.
"We know they're working hard to get that settlement done," said James D. Kole, the chief of the consumer fraud bureau for the Illinois office.
The states' investigation and the Philadelphia case center on Lilly's marketing of Zyprexa, a potent brain tranquilizer that calms the hallucinations associated with schizophrenia and bipolar mania. Internal Lilly documents and e-mail messages appear to show that the company marketed it for patients with dementia and milder forms of bipolar disorder, a violation of federal law.
Zyprexa can cause severe weight gain and an increase in blood sugar in many patients and is more likely to cause diabetes than most other medicines for schizophrenia and bipolar disorder, according to the American Diabetes Association.
Once the Food and Drug Administration approves a drug for sale, doctors can prescribe it for whatever disease they see fit because the F.D.A. does not regulate the practice of medicine. But pharmaceutical companies can market and advertise their medicines only for the uses specified on the drug's label.
"The company's deceptive marketing practices were illegal and highly dangerous," Lisa Madigan, the attorney general of Illinois, said in a statement.
A spokesman and a lawyer for Lilly did not return a call and an e-mail message for comment.
David Hart, senior assistant attorney general for Oregon, said, "We're trying to send a message to the pharmaceutical industry that consumer fraud is something we're going to investigate and prosecute."
http://www.nytimes.com/2008/10/07/business/07zyprexa.html?ref=business
By ALEX BERENSON
Published: October 6, 2008
Eli Lilly has agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.
The settlement, to be announced Tuesday, ends an 18-month investigation led by the offices of the attorneys general of Illinois and Oregon, which contended that Lilly had violated consumer protection laws by urging doctors to prescribe Zyprexa to patients who did not need it.
It is the largest settlement paid by a drug company in a state consumer protection case, topping the $58 million that Merck paid to settle similar allegations about Vioxx, lawyers for the states said.
The agreement may also be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia. In that case, Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa.
"We know they're working hard to get that settlement done," said James D. Kole, the chief of the consumer fraud bureau for the Illinois office.
The states' investigation and the Philadelphia case center on Lilly's marketing of Zyprexa, a potent brain tranquilizer that calms the hallucinations associated with schizophrenia and bipolar mania. Internal Lilly documents and e-mail messages appear to show that the company marketed it for patients with dementia and milder forms of bipolar disorder, a violation of federal law.
Zyprexa can cause severe weight gain and an increase in blood sugar in many patients and is more likely to cause diabetes than most other medicines for schizophrenia and bipolar disorder, according to the American Diabetes Association.
Once the Food and Drug Administration approves a drug for sale, doctors can prescribe it for whatever disease they see fit because the F.D.A. does not regulate the practice of medicine. But pharmaceutical companies can market and advertise their medicines only for the uses specified on the drug's label.
"The company's deceptive marketing practices were illegal and highly dangerous," Lisa Madigan, the attorney general of Illinois, said in a statement.
A spokesman and a lawyer for Lilly did not return a call and an e-mail message for comment.
David Hart, senior assistant attorney general for Oregon, said, "We're trying to send a message to the pharmaceutical industry that consumer fraud is something we're going to investigate and prosecute."
Monday, 6 October 2008
Saturday, 4 October 2008
Cymbalta sales up 26% Effexor up 5% whilst Seroxat down 18%. So in who's best interests is Fiddaman etal acting ??
Cymbalta (pictured) is growing at 26% and Effexor is growing at 5% (off the largest base). By contrast, Paxil sales declined by 18% (
http://industry.bnet.com/pharma/1000246/bnet-focus-on-antidepressants-part-1-sales-and-strategy/
BNET Focus on Antidepressants: Part 1, Sales and Strategy
By Jim Edwards
September 30th, 2008 @ 6:00 am
0 Comments
Ever since Eli Lilly launched Prozac in the U.S. in 1987, Americans have had a love affair with anti-depressants. Prozac isn't just a pill. It was the cultural touchstone of 1990s — as a lifesaver, punchline and punching bag.
When Prozac went off-patent in 2001, something interesting happened: the market for new anti-depressants stayed robust instead of being swept away by cheap generics. Today, branded antidepressants are a $2.4 billion-per-quarter market that is still growing.
This remarkable mix of business, psychiatry and chemistry deserves a closer look. This is the first of three posts in which BNET will look at the state of the branded antidepressant market in the wake of Prozac. Part 1, today, deals with current sales and strategies. Part 2 will look at controversies in the category. And Part 3 will examine the future of the market as more pills head toward generic status.
Second quarter sales of branded antidepressants:
Effexor XR … Wyeth … $1.02 billion
Lexapro … Forest Labs … $583 million
Cymbalta … Eli Lilly … $519 million
Paxil CR … GSK … $253 million
Total: … $2.4 billion
The market is essentially divided into two halves: Cymbalta and Effexor vs. Lexapro and Paxil. This is because Cymbalta (pictured) is growing at 26% and Effexor is growing at 5% (off the largest base). By contrast, Paxil sales declined by 18% (in part due to currency exchange bias) and Lexapro's dollar sales were only up a relatively anemic 5.6%, and it is losing share, according to Deutsche Bank.
Now that Paxil has gone generic, GlaxoSmithKline is essentially trying to keep alive a brand that is essentially in a zombie state. What's interesting here is that while generic Paxil is eating Paxil CR alive, Wyeth has essentially the same problem with generic Effexor and Effexor XR and yet has held onto a massive amount of business. This is due in part to Wyeth's successful legal strategy, which held off the appearance of a generic XR version until 2011, and gave Wyeth time to shore up its franchise.
Lilly has been exceptionally aggressive in its promotion of Cymbalta, with heavy spending on a TV advertising campaign, titled "Depression Hurts." Lilly has also pursued new indications for the drug, with has been approved for nerve pain and fibromyalgia.
Forest, meanwhile, has obtained praise from analysts for its ability to keep Lexapro in a favorable position on formularies despite the many generic alternatives available.
The strategic lesson to be learned is that simply launching a new patent-protected pill is not enough. Marketing, legal and formulary strategy must all ride in-sync. Even so, as GSK is currently learning with Paxil, all good things must come to an end.
http://industry.bnet.com/pharma/1000246/bnet-focus-on-antidepressants-part-1-sales-and-strategy/
BNET Focus on Antidepressants: Part 1, Sales and Strategy
By Jim Edwards
September 30th, 2008 @ 6:00 am
0 Comments
Ever since Eli Lilly launched Prozac in the U.S. in 1987, Americans have had a love affair with anti-depressants. Prozac isn't just a pill. It was the cultural touchstone of 1990s — as a lifesaver, punchline and punching bag.
When Prozac went off-patent in 2001, something interesting happened: the market for new anti-depressants stayed robust instead of being swept away by cheap generics. Today, branded antidepressants are a $2.4 billion-per-quarter market that is still growing.
This remarkable mix of business, psychiatry and chemistry deserves a closer look. This is the first of three posts in which BNET will look at the state of the branded antidepressant market in the wake of Prozac. Part 1, today, deals with current sales and strategies. Part 2 will look at controversies in the category. And Part 3 will examine the future of the market as more pills head toward generic status.
Second quarter sales of branded antidepressants:
Effexor XR … Wyeth … $1.02 billion
Lexapro … Forest Labs … $583 million
Cymbalta … Eli Lilly … $519 million
Paxil CR … GSK … $253 million
Total: … $2.4 billion
The market is essentially divided into two halves: Cymbalta and Effexor vs. Lexapro and Paxil. This is because Cymbalta (pictured) is growing at 26% and Effexor is growing at 5% (off the largest base). By contrast, Paxil sales declined by 18% (in part due to currency exchange bias) and Lexapro's dollar sales were only up a relatively anemic 5.6%, and it is losing share, according to Deutsche Bank.
Now that Paxil has gone generic, GlaxoSmithKline is essentially trying to keep alive a brand that is essentially in a zombie state. What's interesting here is that while generic Paxil is eating Paxil CR alive, Wyeth has essentially the same problem with generic Effexor and Effexor XR and yet has held onto a massive amount of business. This is due in part to Wyeth's successful legal strategy, which held off the appearance of a generic XR version until 2011, and gave Wyeth time to shore up its franchise.
Lilly has been exceptionally aggressive in its promotion of Cymbalta, with heavy spending on a TV advertising campaign, titled "Depression Hurts." Lilly has also pursued new indications for the drug, with has been approved for nerve pain and fibromyalgia.
Forest, meanwhile, has obtained praise from analysts for its ability to keep Lexapro in a favorable position on formularies despite the many generic alternatives available.
The strategic lesson to be learned is that simply launching a new patent-protected pill is not enough. Marketing, legal and formulary strategy must all ride in-sync. Even so, as GSK is currently learning with Paxil, all good things must come to an end.
Nemeroff Steps Down As Emory Psychiatry Chair
Nemeroff Steps Down As Emory Psychiatry Chair
http://www.pharmalot.com/2008/10/nemeroff-steps-down-as-emory-psychiatry-chair/
3 Comments
By Ed Silverman // October 3rd, 2008 // 11:17 pm
The move by well-known psychiatrist Charles Nemeroff comes in response to the investigation by the Senate Finance Committee into allegations of undisclosed conflicts of interest, according to an e-mail written by Claudia Adkison, an Emory University associate dean.
At issue is whether universities are adequately policing disclosures in an effort to maintain scientific integrity and objectivity. The committee is investigating up to 30 academic psychiatrists who allegedly accepted grants from the NIH and pharma, but failed to properly report payments, which universities are required to monitor. The NIH is being leaned on to yank grants when disclosure is inadequate.
So far, the committee has singled out Stanford University’s Alan Schatzberg, Harvard University’s Joe Biederman, Brown University’s Martin Keller, University of Texas’ Karen Wagner and John Rush, and Melissa DelBello at the University of Cincinnati. The back story on Nemeroff can be read here, here and here. This is Adkison’s e-mail….
From: cadkison@emory.edu
Subject: Announcement re Sen. Grassley’s allegations about Dr. Nemeroff
Date: October 3, 2008 9:05:01 PM EDT
To: Medicine-Faculty@EMORY.EDU
Reply-To: cadkison@emory.edu
Senator Charles Grassley (R-Iowa) has raised a number of questions about whether Emory’s chairman of psychiatry and behavioral sciences, Dr. Charles Nemeroff, has properly disclosed his financial relationships with pharmaceutical companies. We at Emory take this matter very seriously and are working diligently to determine whether our policies have been observed consistently with regard to the matters cited by Senator Grassley.
In view of the ongoing internal and external investigations into these allegations, Dr. Nemeroff will voluntarily step down as chairman of the department, effective immediately, pending resolution of these issues.
Dr. Nemeroff is recognized internationally as a leader in psychiatric research, education and practice. He has made fundamental contributions to the field over many years. The length and complexity of the history outlined by Senator Grassley will require careful review of underlying payment records from the pharmaceutical companies, which we have requested from Senator Grassley’s office. We have also requested that Dr. Nemeroff provide us with relevant information and documentation so that we will have all the facts before us.
Dr. Nemeroff has assured us that: “To the best of my knowledge, I have followed the appropriate University regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness. I will cooperate fully and work with Emory to respond to the alleged conflicts of interest issues raised by Senator Grassley and his staff.”
Emory is committed to maintaining strong conflict of interest policies and procedures and will conduct a fair, thorough, and evenhanded investigation of these claims.
* Medicine-Faculty Web Page:
http://WWW.LISTSERV.Emory.Edu/Archives/Medicine-Faculty.HTML
http://www.pharmalot.com/2008/10/nemeroff-steps-down-as-emory-psychiatry-chair/
3 Comments
By Ed Silverman // October 3rd, 2008 // 11:17 pm
The move by well-known psychiatrist Charles Nemeroff comes in response to the investigation by the Senate Finance Committee into allegations of undisclosed conflicts of interest, according to an e-mail written by Claudia Adkison, an Emory University associate dean.
At issue is whether universities are adequately policing disclosures in an effort to maintain scientific integrity and objectivity. The committee is investigating up to 30 academic psychiatrists who allegedly accepted grants from the NIH and pharma, but failed to properly report payments, which universities are required to monitor. The NIH is being leaned on to yank grants when disclosure is inadequate.
So far, the committee has singled out Stanford University’s Alan Schatzberg, Harvard University’s Joe Biederman, Brown University’s Martin Keller, University of Texas’ Karen Wagner and John Rush, and Melissa DelBello at the University of Cincinnati. The back story on Nemeroff can be read here, here and here. This is Adkison’s e-mail….
From: cadkison@emory.edu
Subject: Announcement re Sen. Grassley’s allegations about Dr. Nemeroff
Date: October 3, 2008 9:05:01 PM EDT
To: Medicine-Faculty@EMORY.EDU
Reply-To: cadkison@emory.edu
Senator Charles Grassley (R-Iowa) has raised a number of questions about whether Emory’s chairman of psychiatry and behavioral sciences, Dr. Charles Nemeroff, has properly disclosed his financial relationships with pharmaceutical companies. We at Emory take this matter very seriously and are working diligently to determine whether our policies have been observed consistently with regard to the matters cited by Senator Grassley.
In view of the ongoing internal and external investigations into these allegations, Dr. Nemeroff will voluntarily step down as chairman of the department, effective immediately, pending resolution of these issues.
Dr. Nemeroff is recognized internationally as a leader in psychiatric research, education and practice. He has made fundamental contributions to the field over many years. The length and complexity of the history outlined by Senator Grassley will require careful review of underlying payment records from the pharmaceutical companies, which we have requested from Senator Grassley’s office. We have also requested that Dr. Nemeroff provide us with relevant information and documentation so that we will have all the facts before us.
Dr. Nemeroff has assured us that: “To the best of my knowledge, I have followed the appropriate University regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness. I will cooperate fully and work with Emory to respond to the alleged conflicts of interest issues raised by Senator Grassley and his staff.”
Emory is committed to maintaining strong conflict of interest policies and procedures and will conduct a fair, thorough, and evenhanded investigation of these claims.
* Medicine-Faculty Web Page:
http://WWW.LISTSERV.Emory.Edu/Archives/Medicine-Faculty.HTML
Friday, 3 October 2008
Senator Says Emory Psychiatrist Didn't Disclose $500,000 in Payments from GSK !!
Senator Says Emory Psychiatrist Didn't Disclose $500,000 in Payments
http://online.wsj.com/article/SB122304669813202429.html?mod=googlenews_wsj
A prominent Emory University psychiatrist failed to tell the school about $500,000 in payments from drug maker GlaxoSmithKline while he was serving as the primary investigator for a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.
The payments to Charles Nemeroff, the chair of the Atlanta university's psychiatry department, were mainly for his work speaking to other doctors across the country about Glaxo drugs, including its big-selling anti-depressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.
In correspondence with Emory officials who police conflict of interest issues, Dr. Nemeroff repeatedly denied having a significant financial relationship with Glaxo, according to the records cited by Sen. Grassley. The Iowa Republican is the ranking minority member of the Senate Finance Committee, which is responsible for federal outlays for government health insurance programs.
A financial relationship is considered significant by Emory and other schools if the researcher is paid more than $10,000 a year, and Emory instructed Dr. Nemeroff not to exceed that amount, the records cited by Sen. Grassley indicate.
Dr. Nemeroff has been put in the spotlight before over his financial ties to the medical industry. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote a favorable review in the journal of a new device for treating depression but didn't disclose his financial ties to the device's maker. The review concerned a small device from Cyberonics Inc. that is implanted in the chest and delivers mild electrical pulses to the vagus nerve in the neck.
Dr. Nemeroff served from 2003 until this past summer as the primary investigator on a collaborative grant between Emory, Glaxo and the National Institute of Mental Health, a government agency that is part of the National Institutes of Health. Sen. Grassley wrote that the NIH budgeted $3.95 million for the project with about $1.35 million paid directly to Emory for overhead costs. He said that Dr. Nemeroff apparently received some payment for his salary from the grant, although the specific amount is unknown.
The research effort, called the Emory-GSK-NIMH Collaborative Mood Disorders Initiative, examined five Glaxo drugs considered for use as possible antidepressants. GSK stands for GlaxoSmithKline. The NIH requires that universities police their academics to avoid financial conflicts of interest.
Emory, in a statement, said the allegations made by Sen. Grassley are "serious" and that the university is "working diligently to determine whether our policies have been observed consistently with regard to the matters cited" by the senator. Dr. Nemeroff did not return a call to his office. But the university said it had spoken to Dr. Nemeroff, who told the school that "to the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures."
Glaxo, in a statement, said it has "rigorous guidelines governing our interaction with healthcare professionals who participate in GSK-supported speaking events," and that it requires them to "proactively disclose" these relationships.
Getty Images
The senator alleges Dr. Nemeroff did not report that he was giving promotional talks for Glaxo on the anti-depressant Paxil.
When questioned by Emory officials, Dr. Nemeroff apparently failed to report all of his ties with Glaxo's speaker's bureau, the Sen. Grassley said, citing an Oct. 1, 2003 email in which Dr. Nemeroff described his outside activities to the school:
"I have to dig up the agreement and send it to you, GSK no standing contract, I chair their ad board 2-3 times per year and I am paid per board meeting at a standard rate of $5K per weekend."
In 2003, however, Sen. Grassley said records show Dr. Nemeroff was an active member of Glaxo's speaker board and was paid $119,000 in fees and expenses. The senator alleges Dr. Nemeroff did not report that he was giving promotional talks for Glaxo on Paxil, and another drug, Lamictal, a medication often used to treat bipolar disorder.
On March 19, 2004, the senator said Dr. Nemeroff addressed questions from Emory's Conflicts of Interest Committee in a letter, in which he wrote: "Apart from speaking at national symposia, such as the American Psychiatric Association, for which GSK might serve as a sponsor, my consultation to the company is limited to chairing their Paroxetine Advisory board and for that, I am remunerated $15,000 per year." Paroxetine is the chemical name for Paxil.
Just three days earlier, however, Glaxo paid Dr. Nemeroff $3,500 for a talk he gave on Paxil in Orlando, Fla., Sen. Grassley alleges. The next day, March 17, he gave another $3,500 talk about Paxil in Kissimmee, Fla. In the week after writing to the conflict of interest committee, Dr. Nemeroff gave three talks on Paxil, for $3,500 each, at various locations in New York, according to the senator.
On July 6, 2004, Dr. Nemeroff promised the university he would limit his consulting work to Glaxo to under $10,000 a year, according to records cited by Sen. Grassley.
A week later, in two days of work, he exceeded that limit, according to records provided the senator. He saif that on July 12, 2004, GSK paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for a talk he gave on Paxil at the Larkspur Restaurant and Grill in Las Vegas; and that on the next day, hje was paid $7,000 for two talks he gave for Glaxo.
The university required annual payments from Glaxo had to be limited to $10,000 as long as he was involved in the government collaborative studying Glaxo drugs, according to university records cited by Sen. Grassley.
In an Aug. 4, 2004 letter to a university dean, Dr. Nemeroff said he had "taken the necessary steps to be in compliance with the recommendations" of the Emory conflicts-of- interest committee, "namely my consulting fees from GSK will be less than $10,000 per year throughout the period of this NIH grant, its renewals and final collections of data. GSK has been informed of this change and certainly understand the reasons for this decision and is supportive of my compliance with the university recommendations."
But according to Glaxo records, Dr. Nemeroff exceeded the $10,000 limit that month. The payments included a $3,500 fee for a teleconference with the Louisiana State University Psychiatry Department; talks on Paxil at two restaurants in New York —the Passion Fish Restaurant in Woodbury and Burton and Doyles in Great Neck – that paid a total of $7,000; and a $3,500 payment for another teleconference.
The Paxil talks for Glaxo continued until at least January 2006. It appears the university questioned Dr. Nemeroff's Glaxo relationship later that year, in November. In response to that questioning, Sen. Grassely says Dr. Nemeroff wrote that any suggestion he had a financial relationship with Glaxo is "absolutely untrue." In all, Sen. Grassley said Dr. Nemeroff apparently failed to report about a half million dollars in fees and expenses from Glaxo for dozens of talks he gave to promote the company's drugs.
Emory said it has asked Sen. Grassley for copies of the records he cited and promised a "fair, thorough, and evenhanded investigation of these claims."
http://online.wsj.com/article/SB122304669813202429.html?mod=googlenews_wsj
A prominent Emory University psychiatrist failed to tell the school about $500,000 in payments from drug maker GlaxoSmithKline while he was serving as the primary investigator for a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.
The payments to Charles Nemeroff, the chair of the Atlanta university's psychiatry department, were mainly for his work speaking to other doctors across the country about Glaxo drugs, including its big-selling anti-depressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.
In correspondence with Emory officials who police conflict of interest issues, Dr. Nemeroff repeatedly denied having a significant financial relationship with Glaxo, according to the records cited by Sen. Grassley. The Iowa Republican is the ranking minority member of the Senate Finance Committee, which is responsible for federal outlays for government health insurance programs.
A financial relationship is considered significant by Emory and other schools if the researcher is paid more than $10,000 a year, and Emory instructed Dr. Nemeroff not to exceed that amount, the records cited by Sen. Grassley indicate.
Dr. Nemeroff has been put in the spotlight before over his financial ties to the medical industry. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote a favorable review in the journal of a new device for treating depression but didn't disclose his financial ties to the device's maker. The review concerned a small device from Cyberonics Inc. that is implanted in the chest and delivers mild electrical pulses to the vagus nerve in the neck.
Dr. Nemeroff served from 2003 until this past summer as the primary investigator on a collaborative grant between Emory, Glaxo and the National Institute of Mental Health, a government agency that is part of the National Institutes of Health. Sen. Grassley wrote that the NIH budgeted $3.95 million for the project with about $1.35 million paid directly to Emory for overhead costs. He said that Dr. Nemeroff apparently received some payment for his salary from the grant, although the specific amount is unknown.
The research effort, called the Emory-GSK-NIMH Collaborative Mood Disorders Initiative, examined five Glaxo drugs considered for use as possible antidepressants. GSK stands for GlaxoSmithKline. The NIH requires that universities police their academics to avoid financial conflicts of interest.
Emory, in a statement, said the allegations made by Sen. Grassley are "serious" and that the university is "working diligently to determine whether our policies have been observed consistently with regard to the matters cited" by the senator. Dr. Nemeroff did not return a call to his office. But the university said it had spoken to Dr. Nemeroff, who told the school that "to the best of my knowledge, I have followed the appropriate university regulations concerning financial disclosures."
Glaxo, in a statement, said it has "rigorous guidelines governing our interaction with healthcare professionals who participate in GSK-supported speaking events," and that it requires them to "proactively disclose" these relationships.
Getty Images
The senator alleges Dr. Nemeroff did not report that he was giving promotional talks for Glaxo on the anti-depressant Paxil.
When questioned by Emory officials, Dr. Nemeroff apparently failed to report all of his ties with Glaxo's speaker's bureau, the Sen. Grassley said, citing an Oct. 1, 2003 email in which Dr. Nemeroff described his outside activities to the school:
"I have to dig up the agreement and send it to you, GSK no standing contract, I chair their ad board 2-3 times per year and I am paid per board meeting at a standard rate of $5K per weekend."
In 2003, however, Sen. Grassley said records show Dr. Nemeroff was an active member of Glaxo's speaker board and was paid $119,000 in fees and expenses. The senator alleges Dr. Nemeroff did not report that he was giving promotional talks for Glaxo on Paxil, and another drug, Lamictal, a medication often used to treat bipolar disorder.
On March 19, 2004, the senator said Dr. Nemeroff addressed questions from Emory's Conflicts of Interest Committee in a letter, in which he wrote: "Apart from speaking at national symposia, such as the American Psychiatric Association, for which GSK might serve as a sponsor, my consultation to the company is limited to chairing their Paroxetine Advisory board and for that, I am remunerated $15,000 per year." Paroxetine is the chemical name for Paxil.
Just three days earlier, however, Glaxo paid Dr. Nemeroff $3,500 for a talk he gave on Paxil in Orlando, Fla., Sen. Grassley alleges. The next day, March 17, he gave another $3,500 talk about Paxil in Kissimmee, Fla. In the week after writing to the conflict of interest committee, Dr. Nemeroff gave three talks on Paxil, for $3,500 each, at various locations in New York, according to the senator.
On July 6, 2004, Dr. Nemeroff promised the university he would limit his consulting work to Glaxo to under $10,000 a year, according to records cited by Sen. Grassley.
A week later, in two days of work, he exceeded that limit, according to records provided the senator. He saif that on July 12, 2004, GSK paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for a talk he gave on Paxil at the Larkspur Restaurant and Grill in Las Vegas; and that on the next day, hje was paid $7,000 for two talks he gave for Glaxo.
The university required annual payments from Glaxo had to be limited to $10,000 as long as he was involved in the government collaborative studying Glaxo drugs, according to university records cited by Sen. Grassley.
In an Aug. 4, 2004 letter to a university dean, Dr. Nemeroff said he had "taken the necessary steps to be in compliance with the recommendations" of the Emory conflicts-of- interest committee, "namely my consulting fees from GSK will be less than $10,000 per year throughout the period of this NIH grant, its renewals and final collections of data. GSK has been informed of this change and certainly understand the reasons for this decision and is supportive of my compliance with the university recommendations."
But according to Glaxo records, Dr. Nemeroff exceeded the $10,000 limit that month. The payments included a $3,500 fee for a teleconference with the Louisiana State University Psychiatry Department; talks on Paxil at two restaurants in New York —the Passion Fish Restaurant in Woodbury and Burton and Doyles in Great Neck – that paid a total of $7,000; and a $3,500 payment for another teleconference.
The Paxil talks for Glaxo continued until at least January 2006. It appears the university questioned Dr. Nemeroff's Glaxo relationship later that year, in November. In response to that questioning, Sen. Grassely says Dr. Nemeroff wrote that any suggestion he had a financial relationship with Glaxo is "absolutely untrue." In all, Sen. Grassley said Dr. Nemeroff apparently failed to report about a half million dollars in fees and expenses from Glaxo for dozens of talks he gave to promote the company's drugs.
Emory said it has asked Sen. Grassley for copies of the records he cited and promised a "fair, thorough, and evenhanded investigation of these claims."
don't feel too bad about being hoodwinked by them tho' - your in good company
UKsurvivors post 34907
But don't feel too bad about being hoodwinked by them tho' -- the
BBC, Paul Flynn, journalist and several other notable people have been succoured to ... although they probably just saw a quick and easy way to get some publicity whilst seeming to support those who have been affected!!
http://groups.yahoo.com/group/uksurvivors/message/34907
Perhaps you overlooked this article …..
http://www.guardian.co.uk/theobserver/2002/apr/28/features.magazine37
Simon Garfield
The Observer,
Sunday April 28 2002
Article history
"Mark Harvey says he is still 'shaking the tree' to see how many
people are suffering from the sort of severe withdrawal symptoms
afflicting Jenny Stanaway. People are learning of his interest at the
rate of about two a week."
September 2002 Hugh James set up
http://www.seroxatusergroup.org.uk/Documents/newsletterissue1.pdf
along with a second SeroxatUserGroup (SUG) on network 54 - which
Sarah Venn headed because Derek was too self obsessed to let his
group be used and shared with other committee members – he wouldn't
relinquish total control!
Supposedly a `support' group but to gain access to it you were
directed through the Hugh James Web site and had to fill out a
questionnaire about your drug experiences before being allowed to
join.
Derek on his Yahoo SeroatUserGroup did his bit to ALL new members
were directed to Hugh James web site instead of being given answers
to questions and advice.
Mark Harvey's "Shaking the tree" with the help of Goodrelations – the
additional publicity of the Panorama programs worked really well -- 2
years after the Observer article when he stated "People are learning
of his interest at the rate of about two a week finding 2 people a
fortnight" - it was reported by the SeroxatUserGroup and Dereks group
renamed the OnlineSeroxatSupportGroup (OSSG) (with early archives
removed to get rid of indiscreet posts) at a meeting with the EMEA,
that they were representing 10,000 people.
http://www.seroxatusergroup.org.uk/EMEA%20minutes%20April%202004.pdf
Meeting with EMEA on Monday 19th April 2004
"Janice Simmons then introduced everyone present from the. SUG/OSSG
and their guests. ... Janice said the group represents over 10000
people all of ..."
Bob which ever way you look at this it's definitely trawling for
clients – that makes them ambulance chasers!
So as you're still out there with the 'Single Issue Seroxat Tub
Thump' that was instigated in the UK by Mark Harvey after he liaised
with Baum/Hedlund in the USA – I guess Hugh James are still pulling
your strings!! By keep highlighting the Seroxat furore and
litigation your working for them paid or not …… and if that is true
…… ?
But don't feel too bad about being hoodwinked by them tho' -- the
BBC, Paul Flynn, journalist and several other notable people have
been succoured to ... although they probably just saw a quick and
easy way to get some publicity whilst seeming to support those who
have been affected!!
As Cyndi says the people behind this ALL have their own agendas -
even those who set up 'supposed' support groups ……… and it's not
helping the worthy litigants!!
Now you can answer my question.
But don't feel too bad about being hoodwinked by them tho' -- the
BBC, Paul Flynn, journalist and several other notable people have been succoured to ... although they probably just saw a quick and easy way to get some publicity whilst seeming to support those who have been affected!!
http://groups.yahoo.com/group/uksurvivors/message/34907
Perhaps you overlooked this article …..
http://www.guardian.co.uk/theobserver/2002/apr/28/features.magazine37
Simon Garfield
The Observer,
Sunday April 28 2002
Article history
"Mark Harvey says he is still 'shaking the tree' to see how many
people are suffering from the sort of severe withdrawal symptoms
afflicting Jenny Stanaway. People are learning of his interest at the
rate of about two a week."
September 2002 Hugh James set up
http://www.seroxatusergroup.org.uk/Documents/newsletterissue1.pdf
along with a second SeroxatUserGroup (SUG) on network 54 - which
Sarah Venn headed because Derek was too self obsessed to let his
group be used and shared with other committee members – he wouldn't
relinquish total control!
Supposedly a `support' group but to gain access to it you were
directed through the Hugh James Web site and had to fill out a
questionnaire about your drug experiences before being allowed to
join.
Derek on his Yahoo SeroatUserGroup did his bit to ALL new members
were directed to Hugh James web site instead of being given answers
to questions and advice.
Mark Harvey's "Shaking the tree" with the help of Goodrelations – the
additional publicity of the Panorama programs worked really well -- 2
years after the Observer article when he stated "People are learning
of his interest at the rate of about two a week finding 2 people a
fortnight" - it was reported by the SeroxatUserGroup and Dereks group
renamed the OnlineSeroxatSupportGroup (OSSG) (with early archives
removed to get rid of indiscreet posts) at a meeting with the EMEA,
that they were representing 10,000 people.
http://www.seroxatusergroup.org.uk/EMEA%20minutes%20April%202004.pdf
Meeting with EMEA on Monday 19th April 2004
"Janice Simmons then introduced everyone present from the. SUG/OSSG
and their guests. ... Janice said the group represents over 10000
people all of ..."
Bob which ever way you look at this it's definitely trawling for
clients – that makes them ambulance chasers!
So as you're still out there with the 'Single Issue Seroxat Tub
Thump' that was instigated in the UK by Mark Harvey after he liaised
with Baum/Hedlund in the USA – I guess Hugh James are still pulling
your strings!! By keep highlighting the Seroxat furore and
litigation your working for them paid or not …… and if that is true
…… ?
But don't feel too bad about being hoodwinked by them tho' -- the
BBC, Paul Flynn, journalist and several other notable people have
been succoured to ... although they probably just saw a quick and
easy way to get some publicity whilst seeming to support those who
have been affected!!
As Cyndi says the people behind this ALL have their own agendas -
even those who set up 'supposed' support groups ……… and it's not
helping the worthy litigants!!
Now you can answer my question.
My recent meeting with the MHRA appeared to be fruitful, had I known at the time that they were planning to team up with Pharma to dispel information about their drugs on websites and blogs then I would have taken what was said at the meeting with a pinch of salt.
I am hugely disappointed, more so because my attention has now been drawn once again to the conflict of interests between the MHRA and pharmaceutical companies when I should really be focused on GSK and withdrawal victims.
http://fiddaman.blogspot.com/
Thursday, 2 October 2008
mind you they failed before & no doubt will fail again - what ever happened to the Seroxat withdrawal centres ?
http://groups.yahoo.com/group/uksurvivors/message/36104
"We're going to ask GlaxoSmithKline to set up centres all over the US to help them." Hundreds of thousands are believed to be suffering. said Scientology lawyer Skip Murgatroyd
http://www.guardian.co.uk/world/2001/sep/06/medicalscience.businessofresearch
"We're going to ask GlaxoSmithKline to set up centres all over the US to help them." Hundreds of thousands are believed to be suffering. said Scientology lawyer Skip Murgatroyd
http://www.guardian.co.uk/world/2001/sep/06/medicalscience.businessofresearch
Scientologist Lawyers Baum Hedlund state up to $1 mill donated to charity !! - will that be a Hubbard charity ??
Judge Approves $40 Million Settlement in Second Phase of National Pediatric Paxil Class Action
http://www.expertclick.com/NewsReleaseWire/default.cfm?Action=ReleaseDetail&ID=23377
Minneapolis, MN October 1 2008
U.S. Judge Michael J. Davis of the District of Minnesota has approved the final settlement of $40M to reimburse insurance companies, as third-party payers, for their costs in insuring Paxil purchases paid for by the parents of minors prescribed Paxil or Paxil CR.
Baum, Hedlund, Aristei & Goldman originated the class actions and litigated the heart of the case based on internal GSK (GlaxoSmithKline) documents showing that GSK promoted Paxil as an effective medication for children and adolescents despite internal communications acknowledging that Paxil's pediatric depression clinical trials failed to out-perform sugar pills, yet had higher suicidality rates than sugar pills. Notwithstanding, GSK promoted Paxil as being "remarkably safe and effective" for depressed children.
Paxil was never approved for children, so there were no explicit warnings for pediatric use on Paxil's warning label. Thus, the prescription and sale of Paxil to children was all "off label", which is permitted, but with severe restrictions on such "off-label" promotion and marketing.
"Off-label marketing of drugs is prohibited, with limited exceptions that allow scientific trial results to be presented as long as they are truthful and accurate," stated Michael Baum, senior partner at Baum, Hedlund, Aristei & Goldman. "Here GSK should not have promoted Paxil for kids' use when GSK's own pediatric clinical trials showed Paxil was no more effective than sugar pills and, in fact, caused pediatric Paxil patients to experience increased suicidality. Litigation like this helps remove the incentive for drug companies to take advantage of the off-label marketing loophole."
Similar class actions were filed in several courts seeking restitution of money paid by insurance companies that paid for minors' Paxil, which were ultimately consolidated as a national class action before Judge Davis in Minneapolis. The first phase of these cases, the class action for the individual Paxil payments, were resolved in April, 2007 when GSK agreed to reimburse parents for the money they paid out-of-pocket for their children's Paxil prescriptions.
The class representatives in the insurance company phase are Universal Care Inc., the Carpenters and Joiners Welfare Fund, and Philadelphia Firefighters Local 22 Health and Welfare Fund (Carpenters and Joiners Welfare Fund, et al. v. SmithKline Beecham Corp., doing business as GlaxoSmithKline, No. CV 04-3500, D. Minn.). Each were class representatives of four individual class actions in California, Minnesota and Pennsylvania that sought a refund of monies paid by third-party payers who purchased Paxil for patients under 18 from Jan. 1, 1998, to Dec. 31, 2004.
In addition to Baum Hedlund, the team of law firms representing the insurance company class representatives are Brian Strange of Strange & Carpenter in Los Angeles; J.D. Horton of Quinn, Emanuel in Los Angeles; Christopher Coffin of Pendley, Baudin & Coffin in Plaquemine, LA; Shawn Raiter of Larson King in St. Paul; Stephen Swedlow of Swedlow & Associates in Chicago; Paul Dahlberg of Meshbesher & Spence in Rochester, MN; Michael Perrin of Bailey Perrin Bailey in Houston; and William Marvin of Cohen, Placitella & Roth in Philadelphia. GSK is represented by Dwight Davis and Meghan Magruder of King & Spalding.
Through the team's skillful negotiating, especially Steve Swedlow's, all objections to the class were handled and withdrawn. The settlement team also handled, with King & Spalding's assistance, nearly all of the companies that had considered opting out of the class, addressing their concerns and shepherding them back into the settlement, as well.
These lawyers coordinated a unique settlement that has the entire proceeds being paid out by GSK, not just the amount claimed.
Judge Davis pointed out that the case was "heavily litigated" and noted that the amount of opposition to the settlement was de minimis. Davis ruled that if the aggregate amount of claimed benefits does not exceed the $40 million settlement amount, up to $1 million will be donated to one or more charitable organizations whose primary purpose includes mental health affecting children and the rest will be distributed pro rata among the claimants.
Under the settlement terms, class members would be refunded up to 40 percent of their actual cost for Paxil if they provide proof that a patient under 18 with diagnosis of a major depressive disorder was prescribed Paxil or Paxil CR. Class members would receive 15 percent of their actual cost if the diagnosis is not included.
Each of the insurance companies were class representatives of four class actions in California, Minnesota and Pennsylvania. The class consists of "[a]ll third-party payors in the United States and its territories, including administrators and benefits managers, who reimbursed, purchased, or paid for Paxil or Paxil CR prescribed for consumption by any person under the age of 18, between Jan. 1, 1998, and Dec. 31, 2004."
About Baum, Hedlund:
Baum, Hedlund, Aristei & Goldman has the longest and most successful track-record handling SSRI (selective serotonin reuptake inhibitor antidepressants such as Prozac, Paxil and Zoloft) cases, having litigated more antidepressant cases, over 3,000, in the past 18 years than any other law firm in the country.
Robin McCall
Media Relations Director
Baum, Hedlund, Aristei & Goldman, PC
Los Angeles, CA
Phone : 310-207-3233
Fax : 310-820-7444
http://www.expertclick.com/NewsReleaseWire/default.cfm?Action=ReleaseDetail&ID=23377
Minneapolis, MN October 1 2008
U.S. Judge Michael J. Davis of the District of Minnesota has approved the final settlement of $40M to reimburse insurance companies, as third-party payers, for their costs in insuring Paxil purchases paid for by the parents of minors prescribed Paxil or Paxil CR.
Baum, Hedlund, Aristei & Goldman originated the class actions and litigated the heart of the case based on internal GSK (GlaxoSmithKline) documents showing that GSK promoted Paxil as an effective medication for children and adolescents despite internal communications acknowledging that Paxil's pediatric depression clinical trials failed to out-perform sugar pills, yet had higher suicidality rates than sugar pills. Notwithstanding, GSK promoted Paxil as being "remarkably safe and effective" for depressed children.
Paxil was never approved for children, so there were no explicit warnings for pediatric use on Paxil's warning label. Thus, the prescription and sale of Paxil to children was all "off label", which is permitted, but with severe restrictions on such "off-label" promotion and marketing.
"Off-label marketing of drugs is prohibited, with limited exceptions that allow scientific trial results to be presented as long as they are truthful and accurate," stated Michael Baum, senior partner at Baum, Hedlund, Aristei & Goldman. "Here GSK should not have promoted Paxil for kids' use when GSK's own pediatric clinical trials showed Paxil was no more effective than sugar pills and, in fact, caused pediatric Paxil patients to experience increased suicidality. Litigation like this helps remove the incentive for drug companies to take advantage of the off-label marketing loophole."
Similar class actions were filed in several courts seeking restitution of money paid by insurance companies that paid for minors' Paxil, which were ultimately consolidated as a national class action before Judge Davis in Minneapolis. The first phase of these cases, the class action for the individual Paxil payments, were resolved in April, 2007 when GSK agreed to reimburse parents for the money they paid out-of-pocket for their children's Paxil prescriptions.
The class representatives in the insurance company phase are Universal Care Inc., the Carpenters and Joiners Welfare Fund, and Philadelphia Firefighters Local 22 Health and Welfare Fund (Carpenters and Joiners Welfare Fund, et al. v. SmithKline Beecham Corp., doing business as GlaxoSmithKline, No. CV 04-3500, D. Minn.). Each were class representatives of four individual class actions in California, Minnesota and Pennsylvania that sought a refund of monies paid by third-party payers who purchased Paxil for patients under 18 from Jan. 1, 1998, to Dec. 31, 2004.
In addition to Baum Hedlund, the team of law firms representing the insurance company class representatives are Brian Strange of Strange & Carpenter in Los Angeles; J.D. Horton of Quinn, Emanuel in Los Angeles; Christopher Coffin of Pendley, Baudin & Coffin in Plaquemine, LA; Shawn Raiter of Larson King in St. Paul; Stephen Swedlow of Swedlow & Associates in Chicago; Paul Dahlberg of Meshbesher & Spence in Rochester, MN; Michael Perrin of Bailey Perrin Bailey in Houston; and William Marvin of Cohen, Placitella & Roth in Philadelphia. GSK is represented by Dwight Davis and Meghan Magruder of King & Spalding.
Through the team's skillful negotiating, especially Steve Swedlow's, all objections to the class were handled and withdrawn. The settlement team also handled, with King & Spalding's assistance, nearly all of the companies that had considered opting out of the class, addressing their concerns and shepherding them back into the settlement, as well.
These lawyers coordinated a unique settlement that has the entire proceeds being paid out by GSK, not just the amount claimed.
Judge Davis pointed out that the case was "heavily litigated" and noted that the amount of opposition to the settlement was de minimis. Davis ruled that if the aggregate amount of claimed benefits does not exceed the $40 million settlement amount, up to $1 million will be donated to one or more charitable organizations whose primary purpose includes mental health affecting children and the rest will be distributed pro rata among the claimants.
Under the settlement terms, class members would be refunded up to 40 percent of their actual cost for Paxil if they provide proof that a patient under 18 with diagnosis of a major depressive disorder was prescribed Paxil or Paxil CR. Class members would receive 15 percent of their actual cost if the diagnosis is not included.
Each of the insurance companies were class representatives of four class actions in California, Minnesota and Pennsylvania. The class consists of "[a]ll third-party payors in the United States and its territories, including administrators and benefits managers, who reimbursed, purchased, or paid for Paxil or Paxil CR prescribed for consumption by any person under the age of 18, between Jan. 1, 1998, and Dec. 31, 2004."
About Baum, Hedlund:
Baum, Hedlund, Aristei & Goldman has the longest and most successful track-record handling SSRI (selective serotonin reuptake inhibitor antidepressants such as Prozac, Paxil and Zoloft) cases, having litigated more antidepressant cases, over 3,000, in the past 18 years than any other law firm in the country.
Robin McCall
Media Relations Director
Baum, Hedlund, Aristei & Goldman, PC
Los Angeles, CA
Phone : 310-207-3233
Fax : 310-820-7444
" A third of the settlement will be paid to the law firms. "
The settlement this week resolves the case on behalf of some 42,000 health plans across the country that paid for the drug, said Paul Dahlberg, an attorney with Meshbesher & Spence, one of nine law firms involved in the case. A third of the settlement will be paid to the law firms.
http://www.startribune.com/lifestyle/health/30071004.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aULPQL7PQLanchO7DiUI
http://www.startribune.com/lifestyle/health/30071004.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aULPQL7PQLanchO7DiUI
Sreoxat (Paxil) suit settled by Glaxo for $40 million - naturally the children get nothing but don't expect Fiddaman to tell you this
Health plans that paid for kids and adolescents to get the antidepressant had sued the drugmaker.
By JOSEPHINE MARCOTTY, Star Tribune
Last update: October 1, 2008 - 9:37 PM
Featured comment
Amazing how we can see a settlement like this when Paxil is still actively being prescribed to children....and lawsuits filed on behalf of … read more a child are lost in the preemption battle. Yes, the children are paying the price for the lack of disclosure of potentially fatal/life altering adverse reactions by GSK. Yeah, lets give the "balance of the fund" non profits who continue to advocate for Paxil's use and deny those adverse reactions. Our children deserve better.
http://www.startribune.com/lifestyle/health/30071004.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aULPQL7PQLanchO7DiUI
In a settlement approved Tuesday in U.S. District Court in Minneapolis, British drugmaker GlaxoSmithKline agreed to pay $40 million to reimburse health plans that paid for children and adolescents to receive the antidepressant Paxil.
The agreement brings to a close the long-standing class-action litigation against Glaxo, which was sued for allegedly withholding negative information about the safety and efficacy of Paxil for teenagers and children. In 2007, Glaxo agreed to pay $63.9 million to consumers in another class-action settlement. In both cases Glaxo did not admit wrongdoing.
The settlement this week resolves the case on behalf of some 42,000 health plans across the country that paid for the drug, said Paul Dahlberg, an attorney with Meshbesher & Spence, one of nine law firms involved in the case. A third of the settlement will be paid to the law firms.
Although Paxil is not approved by the Food and Drug Administration (FDA) for use by children, doctors may prescribe it for them. Studies have shown that Paxil and other antidepressants in some instances lead to increased thoughts of suicide in adolescents. Last year the FDA ordered drugmakers to add a "black box" warning of the drug's risks after parents and other consumer advocates raised questions about the safety of antidepressants for those under age 18.
Under the settlement, GSK will pay insurers who paid for a Paxil prescription for use by a minor between January 1998 and December 2004. They may claim a refund of 40 percent of their actual costs of the drugs prescribed to children and adolescents diagnosed with a major depression, or 15 percent of the cost if the diagnosis was unknown.
If the settlement account is not exhausted, the unclaimed balance will be donated to nonprofits involved in mental health causes.
http://groups.yahoo.com/group/uksurvivors/message/36779
By JOSEPHINE MARCOTTY, Star Tribune
Last update: October 1, 2008 - 9:37 PM
Featured comment
Amazing how we can see a settlement like this when Paxil is still actively being prescribed to children....and lawsuits filed on behalf of … read more a child are lost in the preemption battle. Yes, the children are paying the price for the lack of disclosure of potentially fatal/life altering adverse reactions by GSK. Yeah, lets give the "balance of the fund" non profits who continue to advocate for Paxil's use and deny those adverse reactions. Our children deserve better.
http://www.startribune.com/lifestyle/health/30071004.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aULPQL7PQLanchO7DiUI
In a settlement approved Tuesday in U.S. District Court in Minneapolis, British drugmaker GlaxoSmithKline agreed to pay $40 million to reimburse health plans that paid for children and adolescents to receive the antidepressant Paxil.
The agreement brings to a close the long-standing class-action litigation against Glaxo, which was sued for allegedly withholding negative information about the safety and efficacy of Paxil for teenagers and children. In 2007, Glaxo agreed to pay $63.9 million to consumers in another class-action settlement. In both cases Glaxo did not admit wrongdoing.
The settlement this week resolves the case on behalf of some 42,000 health plans across the country that paid for the drug, said Paul Dahlberg, an attorney with Meshbesher & Spence, one of nine law firms involved in the case. A third of the settlement will be paid to the law firms.
Although Paxil is not approved by the Food and Drug Administration (FDA) for use by children, doctors may prescribe it for them. Studies have shown that Paxil and other antidepressants in some instances lead to increased thoughts of suicide in adolescents. Last year the FDA ordered drugmakers to add a "black box" warning of the drug's risks after parents and other consumer advocates raised questions about the safety of antidepressants for those under age 18.
Under the settlement, GSK will pay insurers who paid for a Paxil prescription for use by a minor between January 1998 and December 2004. They may claim a refund of 40 percent of their actual costs of the drugs prescribed to children and adolescents diagnosed with a major depression, or 15 percent of the cost if the diagnosis was unknown.
If the settlement account is not exhausted, the unclaimed balance will be donated to nonprofits involved in mental health causes.
http://groups.yahoo.com/group/uksurvivors/message/36779
Wednesday, 1 October 2008
Selective Serotonin Reuptake Inhibitor Induced Neonatal Abstinence Syndrome
Selective Serotonin Reuptake Inhibitor Induced Neonatal Abstinence Syndrome
http://www.redorbit.com/news/health/1551180/selective_serotonin_reuptake_inhibitor_induced_neonatal_abstinence_syndrome/
Posted on: Thursday, 11 September 2008, 03:00 CDT
By Klinger, Gil Merlob, Paul
Abstract: Depression is common in women of childbearing age and especially during pregnancy and the postpartum period. Selective serotonin reuptake inhibitors (SSRIs) are increasingly being used to treat depression prior to and throughout pregnancy. Up to 30% of the newborn infants exposed to SSRIs may present with clinical signs during the first days after birth. Neonatal abstinence syndrome (NAS) describes this clinical syndrome resulting from prior prolonged exposure to SSRI induced by cessation of the drug. NAS includes a wide spectrum from mild to severe non-specific symptoms which were categorized into four groups of effects: central nervous system (depression followed by excitation), gastrointestinal, autonomie and respiratory. A protocol for observation of SSRI- exposed newborns is presented including an objective method (Finnegan score) to monitor onset, progression and improvement of NAS symptoms. Introduction
Depression is common in women of childbearing age (1). During pregnancy increased stress may aggravate depression resulting in a prevalence of up to 12.9% of this disorder (2, 3). The prevalence of depression during the postpartum period continues to be high with 19.2% of women experiencing a major depressive episode within the first three months after delivery (2). Because many women experience depression during the postpartum period, it is often dismissed as part of the "normal" physiological changes that are associated with childbirth (4). However, if untreated, perinatal depression can have severe consequences for the fetus and newborn, as well as for the mother. Although psychotherapy is the first-line treatment for depression during pregnancy or after birth, antidepressant treatment is warranted in some patients. Because selective serotonin reuptake inhibitors (SSRIs) are perceived as safer than alternative medications, they are increasingly being used to treat depression prior to and throughout pregnancy. A recent survey has shown that 2.8% of women use SSRIs for the entire duration of pregnancy (5). This figure translates to 92,000 of approximately 4 million annual live births in the United States. Prolonged fetal exposure to SSRIs may be associated with a neonatal abstinence syndrome (NAS) affecting 30% of newborns (6). The widespread use of SSRIs during pregnancy and the resulting occurrence of NAS warrant a thorough review.
Pharmacokinetics
SSRIs are a group of psychotropic drugs that is chemically unrelated to tricyclics, tetracyclics, monoamine oxidase inhibitors or other antidepressants. They are used to treat depression, but also for obsessive-compulsive and other disorders. The action of SSRIs is thought to be linked to their inhibition of prejunctional reuptake of serotonin, but they do not have receptor-blocking effects. The side-effects of tricyclic and tetracyclic antidepressants may be worrisome in pregnancy and their narrow therapeutic range increases the risk of overdose. SSRIs have a safer therapeutic profile because of their relatively benign side-effects and their safety in overdose (4). The SSRI group is comprised of the following drugs:
1. Fluoxetine (Prozac, Prizma, Flutine, Affectine)
2. Paroxetine (Seroxat, Paxet, Paxol, Paroxetine)
3. Sertraline (Lustral, Zoloft)
4. Fluvoxamine (Favoxil, Luvox)
5. Citalopram (Cipramil, Recital)
6. Escitalopram (Ciprodex, Cipralex)
Venlafaxine (Efexor, Venla, Viepax) is a selective norepinephrine- serotonin reuptake inhibitor (SNSRI) that is closely related to the SSRIs.
The pharmacokinetic properties of SSRIs (7) are presented in Table 1. This table lists the most commonly recorded adult drug half- life of SSRIs because there is little or no information regarding the newborn. It is of note that during the newborn period, drug half- life is prolonged for most medications, but this is also dependent on drug metabolism. Of the SSRI half-lives, fluoxetine, sertraline and citalopram have a long one with fluoxetine having the longest, paroxetine and fluvoxamine have an intermediate one and venlafaxine has the shortest. A relatively short or intermediate drug half-life has been implicated with an increased risk of NAS after third- trimester exposure.
Transplacental passage determines fetal drug exposure. For drugs with no placental metabolism, transplacental passage is inversely related to molecular weight. SSRIs have a low molecular weight (around 300) with the exception of citalopram (405) and theoretically are able to cross the placental barrier. Placental drug transfer is also determined by duration of drug exposure, liposolubility, protein binding, volume of distribution and other pharmacokinetic factors. Placental transfer of SSRIs has been demonstrated experimentally both in animals and in humans. Pohland et al. (8) demonstrated in the rat that C14 labeled fluoxetine and norfluoxetine traversed the placenta during the periods of organogenesis and postorganogenesis and were distributed within the embryonic/fetal tissue, preferentially to the brain and thymus. Stowe et al. (9) studied the passage of SSRIs across the human placenta by measuring their concentrations in maternal serum and umbilical cord blood at delivery. No evidence of accumulation of fluoxetine, paroxetine, or sertraline in the fetal circulation was found. The fetal : maternal drug ratios for fluoxetine, sertraline and paroxetine were 0.94, 0.43 and 0.67, respectively. Hendrick et al. (10) studied transplacental transfer in paired maternal and umbilical serum samples at delivery showing that umbilical cord SSRI concentrations were invariably lower than corresponding maternal concentrations (the mean ratios of umbilical cord to maternal serum concentrations ranged from 0.29 to 0.89). Sertraline and paroxetine had the lowest ratios while citalopram and fluoxetine had the highest. These data suggest fetal drug exposure near delivery may be decreased for sertraline and paroxetine compared to fluoxetine. As fetal drug clearance at term is decreased and approximates only one- third that of adults, it is reassuring to know that third trimester maternal SSRI use does not result in fetal drug accumulation.
Drug protein binding is inversely related to transplacental passage because a protein bound drug cannot cross the placenta. The protein binding of SSRIs is variable (Table 1). This variation in protein binding may explain differences in the ratios for cord-to- maternal-serum concentrations (10). Sertraline is the most highly protein-bound (98%) of the SSRIs, and thus it can traverse the placenta only in minute quantities. Citalopram (80%) and especially Venlafaxine (27%) have the lowest protein binding allowing for increased transplacental drug passage to the fetus.
Definition of SSRI-induced Neonatal Abstinence Syndrome
Some controversy exists regarding the definition of the syndrome seen in newborns following prolonged in-utero exposure to SSRIs. The general terms "neonatal complications" (11), "transient neonatal symptoms" (12) or "neonatal effects" (13) have been used by some authors with no attempt at characterization of a specific syndrome. Moses-Kolko et al. (14) and Zeskind and Stephens (15) have used the terms "neonatal behavioral syndrome" or "behavioral symptoms" to describe the transient symptoms seen in the newborn after a minimum of third trimester exposure to SSRIs. "Serotonin syndrome" assumes a direct SSRI drug effect of serotonin or its metabolites. This terminology has been suggested by Isbister et al. (16) and by Laine et al. (17). "Withdrawal syndrome" or "discontinuation syndrome" are used to denote a causal relationship between discontinued exposure to a drug and moderate to severe symptoms (18). These terms have been used in SSRI exposed newborns by Sanz et al. (19), Costei et al. (20) and others (21, 22). Overlap between symptoms caused by drug withdrawal or direct serotonin effects likely exists. Correlation in some infants between symptom severity and cord blood (16) and infant serum levels (23) suggest the possible causative role of serotonin in the clinical syndrome. Conversely, withdrawal syndrome can be proved in symptomatic infants with very low or undetectable levels of drug or active metabolites. This has been shown repeatedly (24-26). Withdrawal can also be demonstrated by showing that timing of peak symptoms does not correspond with peak exposure but appears after a delay of days, which is compatible with drug withdrawal but not with a direct drug effect (6, 27). Also a prolonged duration of symptoms without continued drug exposure is suggestive of drug withdrawal (6, 26).
NAS describes the clinical syndrome resulting from prior prolonged exposure followed by cessation of a causative drug (28). NAS includes a wide spectrum from mild to severe symptoms. Although many of the symptoms are non-specific, the combination of symptoms together with prior exposure to a drug known to cause NAS suggests its possibility. Moderate to severe NAS symptoms are compatible with the definition of a withdrawal syndrome. As NAS includes both mild and severely affected newborns, it is preferable to alternative characterizations of SSRI exposed newborns that do not include all symptomatic newborns.
Clinical Presentation of SSRI-induced Neonatal Abstinence Syndrome
The clinical spectrum of NAS is variable. Factors that increase drug exposure prior to delivery aggravate the clinical syndrome. Specific factors that increase symptom severity include: increased transplacental transfer, decreased drug metabolism and elimination, type of medication (variable effect), increased duration of use during pregnancy (mainly third trimester use), increased dose, decreased time elapsed from last drug use until birth and term delivery (prematurity possibly decreases symptoms). The onset of symptoms often occurs shortly after birth or within the first few days of life. Infants who do not exhibit symptoms within the first 48 hours of life are unlikely to become symptomatic (6). Shorter drug half-life and a longer elapsed time since last maternal drug dose are associated with earlier onset of symptoms in the newborn infant.
Clinical symptoms are common and seen in 30% of newborns (6, 12). NAS symptoms can be categorized into four groups of effects: central nervous system (CNS), gastrointestinal, autonomie and respiratory effects. The various symptoms are described in Table 2. Symptoms may vary with time. In our experience, initial CNS effects are often those of depression with hypoactivity, hypotonia, lethargy and a weak cry. These symptoms rapidly evolve to those of CNS excitation (23). Commonly seen symptoms are irritability (14, 17, 19), jitteriness (14, 29), abnormal crying (14, 19, 29), altered behavior (14, 15), sleep abnormalities (14, 15), poor feeding (14, 19), vomiting (19), hypotonia (12, 29), hypertonia (14), respiratory distress (12, 14, 20, 29) and increased reflexes (14, 17). Less common symptoms are lethargy, a weak cry or seizures (6, 19). Although most symptoms are non-specific, some symptoms such as transient aphonia (30) have only been reported as a result of SSRI exposure. A previous association of hemorrhage with SSRI exposure (31) has not been recently substantiated (32). Some neonatal outcomes or symptoms seen in SSRI-exposed newborns are not part of the NAS. One such outcome associated with SSRI exposure is persistent pulmonary hypertension (5, 33). Newborns should be screened for all neonatal outcomes including those that are not part of the NAS (Table 3). Duration of symptoms is variable. For most infants symptoms peak up to 96 hours after birth and then spontaneously subside within a few days (6). Occasionally infants may remain symptomatic for weeks (34).
Protocol for Observation of an SSRI-Exposed Newborn
The various effects of SSRIs should all be considered when following an infant with prolonged in-utero SSRI exposure. Table 3 summarizes a protocol (6) that has been in use since 1998. The Finnegan score (6, 35, 36) may be used to follow signs of NAS. This score is an objective method used to monitor onset, progression, and improvement of NAS symptoms in passively exposed neonates. The score rates 21 symptoms most commonly seen in drug-exposed neonates, and is also used to assess the need for pharmacological intervention and the response to treatment. The total score is determined by adding the score assigned to each symptom group. Higher scores represent more severe abstinence symptoms. A score of 8 or higher in three consecutive measurements is considered an indication for pharmacotherapy. The score should be performed at intervals of 8 hours, unless severe symptoms are noted (Finnegan score >/= 8), in which case the intervals should be shortened. The newborn should be placed in an incubator and followed closely until signs of NAS normalize (Finnegan score
Unresolved Issues
The long-term effects of in-utero exposure to SSRIs have not been sufficiently studied. Oberlander et al. (37) have shown altered biobehavioral pain reactivity of exposed infants at 2 months suggesting the possibility of sustained neurobehavioral effect beyond the newborn period. Nulman et al. (38) studied 55 preschool children exposed to fluoxetine and also found no effect on global IQ, language development or behavioral development. Oberlander et al. (12) and Casper et al. (39) assessed exposed infants by the Bayley Scale of Infant Development at the ages of 8 months and 6-40 months, respectively. Both studies found the mental development index to be unaffected but showed a subtle effect on motor development. Although a single study has shown no difference between non-symptomatic and symptomatic infants (12), the long-term effects on the select group of SSRI-exposed infants who develop severe symptoms suggestive of a withdrawal syndrome have not been evaluated.
Treatment of SSRI-induced NAS is controversial. For most infants with NAS, "physiological" reversal of NAS is most readily achieved by reintroduction of the causative drug. For example, when narcotics cause a NAS, giving a similar narcotic allows control of abstinence symptoms. After symptom control, the drug can then be gradually tapered. In SSRI-induced NAS, this approach is not feasible because drug safety has not been established in infants. Therefore, the only currently available therapy is symptomatic treatment. For infants with severe NAS or for infants who develop seizures, phenobarbital is a possible treatment.
Breast-feeding has been shown to decrease the duration and severity of NAS (35). Currently breast feeding is not contraindicated for infants with SSRI-induced NAS, but no randomized controlled trials have been performed in breast-fed infants. Long- term follow-up studies on breast-fed infants are lacking.
Recommendations
* The risk benefit ratio of maternal treatment during pregnancy should be evaluated. If the indication for treatment is unchanged, then treatment should be continued.
* Tapering of SSRIs during the last month of pregnancy should theoretically prevent both NAS and direct drug effects. However, it is not known if tapering of medications reduces the risk of NAS.
* Infants born following third trimester exposure to SSRIs should be monitored for NAS symptoms for a minimum period of 48-72 hours with a standardized protocol including the Finnegan score. Infants who develop a NAS should remain under observation until symptom resolution. Neonatal Intensive Care Unit observation is recommended for severely effected infants.
* Breast-feeding is allowed but infants should be observed for any abnormal behavior.
* Treatment of infants with SSRI-induced NAS is symptomatic.
* Therapeutic drug monitoring may be indicated to differentiate between NAS and direct drug affect.
References
1. Campagne DM. The obstetricians and depression during pregnancy. Eur J Obstet Gynecol Reprod Biol 2004; 116:125-130.
2. Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression. A systematic review of prevalence and incidence. Obstet Gynecol 2005;106:1071-1083.
3. Bennet HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: Systematic Review. Obstet Gynecol 2004;103:698-709.
4. Gupta S, Masand PS, Rangwani S. Selective serotonin reuptake inhibitors in pregnancy and lactation. Obstet Gynecol Survey 1998;53:733-736.
5. Reefhuis J, Friedman JM. Selective serotonin-reuptake inhibitors and persistent pulmonary hypertension of the newborn. N Engl J Med 2006;354:2188-2189.
6. Levinson-Castiel R, Merlob P, Linder N, Sirota L, Klinger G. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med 2006; 160:173-176.
7. Hale TW. Medications and mothers milk. 11th ed. Amarillo, Texas: Pharmasoft, 2004.
8. Pohland RC, Byrd TK, Hamilton M, Koons JR. Placental transfer and fetal distribution of fluoxetine in the rat. Toxicol Appl Pharmacol 1989;98:198-205.
9. Stowe ZN, Llewellyn AM, Strader JR, Kitts CD, Ritchie JC, Nemeroff CB. Placental passage of antidepressants. Amer Psychiatr Assoc, San Diego, May 1997.
10. Hendrick V, Stowe ZN, Altshuler LL, Hwang S, Lee E, Haynes D. Placental passage of antidepressant medications. Am J Psychiatry 2003;160:993-996.
11. Hendrick V, Smith LM, Suri R, Hwang S, Haynes D, Altshuler L. Birth outcomes after prenatal exposure to antidepressant medication. Am J Obstet Gynecol 2003; 188:812-815.
12. Oberlander TF, Misri S, Fitzgerald CE, Kostaras X, Rurak D, Riggs W. Pharmacologic factors associated with transient neonatal symptoms following prenatal psychotropic medication exposure. J Clin Psychiatry 2004;65:230-237.
13. Kallen B. Neonate characteristics after maternal use of antidepressants in late pregnancy. Arch Pediatr Adolesc Med 2004;158:312-316.
14. Moses-Kolko EL, Bogen D, Perel J, Bregar A, Uhl K, Levin B, Wisner KL. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors. Literature review and implications for clinical applications. JAMA 2005;293:2372-2383.
15. Zeskind PS, Stephens LE. Maternal selective serotonin reuptake inhibitor use during pregnancy and newborn neurobehavior. Pediatrics 2004;113:368-375.
16. Isbister GK, Dawson A, Whyte IM, Prior FH, Clancy C, Smith AJ. Neonatal paroxetine withdrawal syndrome or actually serotonin syndrome? Arch Dis Child Fetal Neonatal Ed 2001;85:F147-148.
17. Laine K, Heikkinen T, Ekblad U, Kero P. Effects of exposure to selective serotonin reuptake inhibitors during pregnancy on serotonergic symptoms in newborns and cord blood monoamine and prolactin concentrations. Arch Gen Psychiatry 2003;60:720-726. 18. American Academy of Pediatrics Committee on Drugs. Neonatal drug withdrawal. Pediatrics 1998;101: 1079-1088.
19. Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: A database analysis. Lancet 2005;365:482-487.
20. Costei AM, Kozer E, Ho T, Ito S, Koren G. Perinatal outcome following third trimester exposure to paroxetine. Arch Pediatr Adolesc Med 2002;156:1129-1132.
21. Nordeng H, Lindemann R, Perminov KV, Reikvam A. Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors. Acta Paediatr 2001;90:288-291.
22. Nijhuis IJ, Kok-Van Rooij GW, Bosschaart AN. Withdrawal reactions of a premature neonate after maternal use of paroxetine. Arch Dis Child Fetal Neonatal Ed 2001;84:F77.
23. Knoppert D, Nimkar R, Principi T, Yuen D. Paroxetine toxicity in a newborn after in utero exposure. Clinical symptoms correlate with serum levels. Ther Drug Monitor 2006;28:5-7.
24. Jaiswal S, Coombs RC, Isbister GK. Paroxetine withdrawal in a neonate with historical and laboratory confirmation. Eur J Pediatr 2003;62:723-724.
25. Santos RP, Pergolizzi JJ. Transient neonatal jitteriness due to maternal use of sertraline (Zoloft). J Perinatol 2004;24:392- 394.
26. Stiskal JA, Kulin N, Koren G, Ho T, Ito S. Neonatal paroxetine withdrawal syndrome. Arch Dis Child Fetal Neonatal Ed 2001;84:F134-135.
27. Bot P, Semmekrot BA, van der Stappen J. Neonatal effects of exposure to selective serotonin reuptake inhibitors during pregnancy. Arch Dis Child Fetal Neonatal Ed 2006;91:F153.
28. Johnson K, Gerada C, Greenough A. Treatment of neonatal abstinence syndrome. Arch Dis Child Fetal Neonatal Ed 2003;88:F2-5.
29. Chambers CD, Johnson KA, Dick LM, Felix RJ, Jones KL. Birth outcomes in pregnant women taking fluoxetine. N Engl J Med 1996;335:1010-1015.
30. Morag I, Batish D, Keidar R, Bulkenstein M, Heyman E. Paroxetine use throughout pregnancy: Does it pose any risk to the neonate? J Toxicol Clin Toxicol 2004;42: 97-100.
31. Nelva A, Guy C, Tardy-Poncet B, Bevens MN, Ratrema M, Benedetti C, Ollajnier M. Hemorrhagic syndromes related to selective serotonin reuptake inhibitor (SSRI) antidepressants. Seven case reports and review of the literature. Rev Med Interne 2000;21:152- 160.
32. Maayan-Metzger A, Kuint J, Lubetsky A, Shenkman B, Mazkereth R, Kenet G. Maternal selective serotonin reuptake inhibitor intake does not seem to affect neonatal platelet function tests. Acta Haematol 2006;115: 157-161.
33. Chambers CD, Hernandez-Diaz S, Van Marter LJ, Louik C, Jones KL, Mitchell AA. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 2006;354: 579-587.
34. Franssen EJF, Meijs V, Ettahar F, Valeric PG, Keesen M, Lameijer W. Citalopram serum and milk levels in mother and infant during lactation. Ther Drug Monitor 2006;28:2-4.
35. Abdel-Latif ME, Pinner J, Clews S, Cooke F, Lui K, Oei J. Effects of breast milk on the severity and outcome of neonatal abstinence syndrome among infants of drug-dependent mothers. Pediatrics 2006;117:e1163-e1169.
36. Finnegan LP. Neonatal abstinence syndrome. In: Nelson N, editor. Current Therapy in Neonatal Perinatal Medicine-2. Toronto: BC Decker, 1990; pp. 314-320.
37. Oberlander TF, Grunau RE, Fitzgerald C, Papsdorf M, Rurak D, Riggs W. Pain reactivity in 2-month-old infants after prenatal and postnatal serotonin reuptake inhibitor medication exposure. Pediatrics 2005;115: 411-425.
38. Nulman I, Rovet J, Stewart DE, Wolpin J, Gardner HA, Theis JG, Kulin N, Koren G. Neurodevelopment of children exposed in utero to antidepressant drugs. N Engl J Med 1997;336:258-262.
39. Casper RC, Fleisher BE, Lee-Ancajas JC, Gilles A, Gaylor E, DeBattista A, Hoyme HE. Follow-up of children of depressed mothers exposed or not exposed to antidepressant drugs during pregnancy. J Pediatr 2003; 142:402-408.
Gil Klinger, MD, and Paul Merlob, MD
Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel, and the Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Israel
Address for Correspondence: Gil Klinger, MD, Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel, 14 Kaplan Street, Petah Tikva 49202, Israel. E-mail: gilkl@post.tau.ac.il
Copyright Gefen Publishing House Ltd. 2008
(c) 2008 Israel Journal of Psychiatry and Related Sciences, The. Provided by ProQuest LLC. All rights Reserved.
Source: Israel Journal of Psychiatry and Related Sciences, The
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http://www.redorbit.com/news/health/1551180/selective_serotonin_reuptake_inhibitor_induced_neonatal_abstinence_syndrome/
Posted on: Thursday, 11 September 2008, 03:00 CDT
By Klinger, Gil Merlob, Paul
Abstract: Depression is common in women of childbearing age and especially during pregnancy and the postpartum period. Selective serotonin reuptake inhibitors (SSRIs) are increasingly being used to treat depression prior to and throughout pregnancy. Up to 30% of the newborn infants exposed to SSRIs may present with clinical signs during the first days after birth. Neonatal abstinence syndrome (NAS) describes this clinical syndrome resulting from prior prolonged exposure to SSRI induced by cessation of the drug. NAS includes a wide spectrum from mild to severe non-specific symptoms which were categorized into four groups of effects: central nervous system (depression followed by excitation), gastrointestinal, autonomie and respiratory. A protocol for observation of SSRI- exposed newborns is presented including an objective method (Finnegan score) to monitor onset, progression and improvement of NAS symptoms. Introduction
Depression is common in women of childbearing age (1). During pregnancy increased stress may aggravate depression resulting in a prevalence of up to 12.9% of this disorder (2, 3). The prevalence of depression during the postpartum period continues to be high with 19.2% of women experiencing a major depressive episode within the first three months after delivery (2). Because many women experience depression during the postpartum period, it is often dismissed as part of the "normal" physiological changes that are associated with childbirth (4). However, if untreated, perinatal depression can have severe consequences for the fetus and newborn, as well as for the mother. Although psychotherapy is the first-line treatment for depression during pregnancy or after birth, antidepressant treatment is warranted in some patients. Because selective serotonin reuptake inhibitors (SSRIs) are perceived as safer than alternative medications, they are increasingly being used to treat depression prior to and throughout pregnancy. A recent survey has shown that 2.8% of women use SSRIs for the entire duration of pregnancy (5). This figure translates to 92,000 of approximately 4 million annual live births in the United States. Prolonged fetal exposure to SSRIs may be associated with a neonatal abstinence syndrome (NAS) affecting 30% of newborns (6). The widespread use of SSRIs during pregnancy and the resulting occurrence of NAS warrant a thorough review.
Pharmacokinetics
SSRIs are a group of psychotropic drugs that is chemically unrelated to tricyclics, tetracyclics, monoamine oxidase inhibitors or other antidepressants. They are used to treat depression, but also for obsessive-compulsive and other disorders. The action of SSRIs is thought to be linked to their inhibition of prejunctional reuptake of serotonin, but they do not have receptor-blocking effects. The side-effects of tricyclic and tetracyclic antidepressants may be worrisome in pregnancy and their narrow therapeutic range increases the risk of overdose. SSRIs have a safer therapeutic profile because of their relatively benign side-effects and their safety in overdose (4). The SSRI group is comprised of the following drugs:
1. Fluoxetine (Prozac, Prizma, Flutine, Affectine)
2. Paroxetine (Seroxat, Paxet, Paxol, Paroxetine)
3. Sertraline (Lustral, Zoloft)
4. Fluvoxamine (Favoxil, Luvox)
5. Citalopram (Cipramil, Recital)
6. Escitalopram (Ciprodex, Cipralex)
Venlafaxine (Efexor, Venla, Viepax) is a selective norepinephrine- serotonin reuptake inhibitor (SNSRI) that is closely related to the SSRIs.
The pharmacokinetic properties of SSRIs (7) are presented in Table 1. This table lists the most commonly recorded adult drug half- life of SSRIs because there is little or no information regarding the newborn. It is of note that during the newborn period, drug half- life is prolonged for most medications, but this is also dependent on drug metabolism. Of the SSRI half-lives, fluoxetine, sertraline and citalopram have a long one with fluoxetine having the longest, paroxetine and fluvoxamine have an intermediate one and venlafaxine has the shortest. A relatively short or intermediate drug half-life has been implicated with an increased risk of NAS after third- trimester exposure.
Transplacental passage determines fetal drug exposure. For drugs with no placental metabolism, transplacental passage is inversely related to molecular weight. SSRIs have a low molecular weight (around 300) with the exception of citalopram (405) and theoretically are able to cross the placental barrier. Placental drug transfer is also determined by duration of drug exposure, liposolubility, protein binding, volume of distribution and other pharmacokinetic factors. Placental transfer of SSRIs has been demonstrated experimentally both in animals and in humans. Pohland et al. (8) demonstrated in the rat that C14 labeled fluoxetine and norfluoxetine traversed the placenta during the periods of organogenesis and postorganogenesis and were distributed within the embryonic/fetal tissue, preferentially to the brain and thymus. Stowe et al. (9) studied the passage of SSRIs across the human placenta by measuring their concentrations in maternal serum and umbilical cord blood at delivery. No evidence of accumulation of fluoxetine, paroxetine, or sertraline in the fetal circulation was found. The fetal : maternal drug ratios for fluoxetine, sertraline and paroxetine were 0.94, 0.43 and 0.67, respectively. Hendrick et al. (10) studied transplacental transfer in paired maternal and umbilical serum samples at delivery showing that umbilical cord SSRI concentrations were invariably lower than corresponding maternal concentrations (the mean ratios of umbilical cord to maternal serum concentrations ranged from 0.29 to 0.89). Sertraline and paroxetine had the lowest ratios while citalopram and fluoxetine had the highest. These data suggest fetal drug exposure near delivery may be decreased for sertraline and paroxetine compared to fluoxetine. As fetal drug clearance at term is decreased and approximates only one- third that of adults, it is reassuring to know that third trimester maternal SSRI use does not result in fetal drug accumulation.
Drug protein binding is inversely related to transplacental passage because a protein bound drug cannot cross the placenta. The protein binding of SSRIs is variable (Table 1). This variation in protein binding may explain differences in the ratios for cord-to- maternal-serum concentrations (10). Sertraline is the most highly protein-bound (98%) of the SSRIs, and thus it can traverse the placenta only in minute quantities. Citalopram (80%) and especially Venlafaxine (27%) have the lowest protein binding allowing for increased transplacental drug passage to the fetus.
Definition of SSRI-induced Neonatal Abstinence Syndrome
Some controversy exists regarding the definition of the syndrome seen in newborns following prolonged in-utero exposure to SSRIs. The general terms "neonatal complications" (11), "transient neonatal symptoms" (12) or "neonatal effects" (13) have been used by some authors with no attempt at characterization of a specific syndrome. Moses-Kolko et al. (14) and Zeskind and Stephens (15) have used the terms "neonatal behavioral syndrome" or "behavioral symptoms" to describe the transient symptoms seen in the newborn after a minimum of third trimester exposure to SSRIs. "Serotonin syndrome" assumes a direct SSRI drug effect of serotonin or its metabolites. This terminology has been suggested by Isbister et al. (16) and by Laine et al. (17). "Withdrawal syndrome" or "discontinuation syndrome" are used to denote a causal relationship between discontinued exposure to a drug and moderate to severe symptoms (18). These terms have been used in SSRI exposed newborns by Sanz et al. (19), Costei et al. (20) and others (21, 22). Overlap between symptoms caused by drug withdrawal or direct serotonin effects likely exists. Correlation in some infants between symptom severity and cord blood (16) and infant serum levels (23) suggest the possible causative role of serotonin in the clinical syndrome. Conversely, withdrawal syndrome can be proved in symptomatic infants with very low or undetectable levels of drug or active metabolites. This has been shown repeatedly (24-26). Withdrawal can also be demonstrated by showing that timing of peak symptoms does not correspond with peak exposure but appears after a delay of days, which is compatible with drug withdrawal but not with a direct drug effect (6, 27). Also a prolonged duration of symptoms without continued drug exposure is suggestive of drug withdrawal (6, 26).
NAS describes the clinical syndrome resulting from prior prolonged exposure followed by cessation of a causative drug (28). NAS includes a wide spectrum from mild to severe symptoms. Although many of the symptoms are non-specific, the combination of symptoms together with prior exposure to a drug known to cause NAS suggests its possibility. Moderate to severe NAS symptoms are compatible with the definition of a withdrawal syndrome. As NAS includes both mild and severely affected newborns, it is preferable to alternative characterizations of SSRI exposed newborns that do not include all symptomatic newborns.
Clinical Presentation of SSRI-induced Neonatal Abstinence Syndrome
The clinical spectrum of NAS is variable. Factors that increase drug exposure prior to delivery aggravate the clinical syndrome. Specific factors that increase symptom severity include: increased transplacental transfer, decreased drug metabolism and elimination, type of medication (variable effect), increased duration of use during pregnancy (mainly third trimester use), increased dose, decreased time elapsed from last drug use until birth and term delivery (prematurity possibly decreases symptoms). The onset of symptoms often occurs shortly after birth or within the first few days of life. Infants who do not exhibit symptoms within the first 48 hours of life are unlikely to become symptomatic (6). Shorter drug half-life and a longer elapsed time since last maternal drug dose are associated with earlier onset of symptoms in the newborn infant.
Clinical symptoms are common and seen in 30% of newborns (6, 12). NAS symptoms can be categorized into four groups of effects: central nervous system (CNS), gastrointestinal, autonomie and respiratory effects. The various symptoms are described in Table 2. Symptoms may vary with time. In our experience, initial CNS effects are often those of depression with hypoactivity, hypotonia, lethargy and a weak cry. These symptoms rapidly evolve to those of CNS excitation (23). Commonly seen symptoms are irritability (14, 17, 19), jitteriness (14, 29), abnormal crying (14, 19, 29), altered behavior (14, 15), sleep abnormalities (14, 15), poor feeding (14, 19), vomiting (19), hypotonia (12, 29), hypertonia (14), respiratory distress (12, 14, 20, 29) and increased reflexes (14, 17). Less common symptoms are lethargy, a weak cry or seizures (6, 19). Although most symptoms are non-specific, some symptoms such as transient aphonia (30) have only been reported as a result of SSRI exposure. A previous association of hemorrhage with SSRI exposure (31) has not been recently substantiated (32). Some neonatal outcomes or symptoms seen in SSRI-exposed newborns are not part of the NAS. One such outcome associated with SSRI exposure is persistent pulmonary hypertension (5, 33). Newborns should be screened for all neonatal outcomes including those that are not part of the NAS (Table 3). Duration of symptoms is variable. For most infants symptoms peak up to 96 hours after birth and then spontaneously subside within a few days (6). Occasionally infants may remain symptomatic for weeks (34).
Protocol for Observation of an SSRI-Exposed Newborn
The various effects of SSRIs should all be considered when following an infant with prolonged in-utero SSRI exposure. Table 3 summarizes a protocol (6) that has been in use since 1998. The Finnegan score (6, 35, 36) may be used to follow signs of NAS. This score is an objective method used to monitor onset, progression, and improvement of NAS symptoms in passively exposed neonates. The score rates 21 symptoms most commonly seen in drug-exposed neonates, and is also used to assess the need for pharmacological intervention and the response to treatment. The total score is determined by adding the score assigned to each symptom group. Higher scores represent more severe abstinence symptoms. A score of 8 or higher in three consecutive measurements is considered an indication for pharmacotherapy. The score should be performed at intervals of 8 hours, unless severe symptoms are noted (Finnegan score >/= 8), in which case the intervals should be shortened. The newborn should be placed in an incubator and followed closely until signs of NAS normalize (Finnegan score
Unresolved Issues
The long-term effects of in-utero exposure to SSRIs have not been sufficiently studied. Oberlander et al. (37) have shown altered biobehavioral pain reactivity of exposed infants at 2 months suggesting the possibility of sustained neurobehavioral effect beyond the newborn period. Nulman et al. (38) studied 55 preschool children exposed to fluoxetine and also found no effect on global IQ, language development or behavioral development. Oberlander et al. (12) and Casper et al. (39) assessed exposed infants by the Bayley Scale of Infant Development at the ages of 8 months and 6-40 months, respectively. Both studies found the mental development index to be unaffected but showed a subtle effect on motor development. Although a single study has shown no difference between non-symptomatic and symptomatic infants (12), the long-term effects on the select group of SSRI-exposed infants who develop severe symptoms suggestive of a withdrawal syndrome have not been evaluated.
Treatment of SSRI-induced NAS is controversial. For most infants with NAS, "physiological" reversal of NAS is most readily achieved by reintroduction of the causative drug. For example, when narcotics cause a NAS, giving a similar narcotic allows control of abstinence symptoms. After symptom control, the drug can then be gradually tapered. In SSRI-induced NAS, this approach is not feasible because drug safety has not been established in infants. Therefore, the only currently available therapy is symptomatic treatment. For infants with severe NAS or for infants who develop seizures, phenobarbital is a possible treatment.
Breast-feeding has been shown to decrease the duration and severity of NAS (35). Currently breast feeding is not contraindicated for infants with SSRI-induced NAS, but no randomized controlled trials have been performed in breast-fed infants. Long- term follow-up studies on breast-fed infants are lacking.
Recommendations
* The risk benefit ratio of maternal treatment during pregnancy should be evaluated. If the indication for treatment is unchanged, then treatment should be continued.
* Tapering of SSRIs during the last month of pregnancy should theoretically prevent both NAS and direct drug effects. However, it is not known if tapering of medications reduces the risk of NAS.
* Infants born following third trimester exposure to SSRIs should be monitored for NAS symptoms for a minimum period of 48-72 hours with a standardized protocol including the Finnegan score. Infants who develop a NAS should remain under observation until symptom resolution. Neonatal Intensive Care Unit observation is recommended for severely effected infants.
* Breast-feeding is allowed but infants should be observed for any abnormal behavior.
* Treatment of infants with SSRI-induced NAS is symptomatic.
* Therapeutic drug monitoring may be indicated to differentiate between NAS and direct drug affect.
References
1. Campagne DM. The obstetricians and depression during pregnancy. Eur J Obstet Gynecol Reprod Biol 2004; 116:125-130.
2. Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression. A systematic review of prevalence and incidence. Obstet Gynecol 2005;106:1071-1083.
3. Bennet HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: Systematic Review. Obstet Gynecol 2004;103:698-709.
4. Gupta S, Masand PS, Rangwani S. Selective serotonin reuptake inhibitors in pregnancy and lactation. Obstet Gynecol Survey 1998;53:733-736.
5. Reefhuis J, Friedman JM. Selective serotonin-reuptake inhibitors and persistent pulmonary hypertension of the newborn. N Engl J Med 2006;354:2188-2189.
6. Levinson-Castiel R, Merlob P, Linder N, Sirota L, Klinger G. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med 2006; 160:173-176.
7. Hale TW. Medications and mothers milk. 11th ed. Amarillo, Texas: Pharmasoft, 2004.
8. Pohland RC, Byrd TK, Hamilton M, Koons JR. Placental transfer and fetal distribution of fluoxetine in the rat. Toxicol Appl Pharmacol 1989;98:198-205.
9. Stowe ZN, Llewellyn AM, Strader JR, Kitts CD, Ritchie JC, Nemeroff CB. Placental passage of antidepressants. Amer Psychiatr Assoc, San Diego, May 1997.
10. Hendrick V, Stowe ZN, Altshuler LL, Hwang S, Lee E, Haynes D. Placental passage of antidepressant medications. Am J Psychiatry 2003;160:993-996.
11. Hendrick V, Smith LM, Suri R, Hwang S, Haynes D, Altshuler L. Birth outcomes after prenatal exposure to antidepressant medication. Am J Obstet Gynecol 2003; 188:812-815.
12. Oberlander TF, Misri S, Fitzgerald CE, Kostaras X, Rurak D, Riggs W. Pharmacologic factors associated with transient neonatal symptoms following prenatal psychotropic medication exposure. J Clin Psychiatry 2004;65:230-237.
13. Kallen B. Neonate characteristics after maternal use of antidepressants in late pregnancy. Arch Pediatr Adolesc Med 2004;158:312-316.
14. Moses-Kolko EL, Bogen D, Perel J, Bregar A, Uhl K, Levin B, Wisner KL. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors. Literature review and implications for clinical applications. JAMA 2005;293:2372-2383.
15. Zeskind PS, Stephens LE. Maternal selective serotonin reuptake inhibitor use during pregnancy and newborn neurobehavior. Pediatrics 2004;113:368-375.
16. Isbister GK, Dawson A, Whyte IM, Prior FH, Clancy C, Smith AJ. Neonatal paroxetine withdrawal syndrome or actually serotonin syndrome? Arch Dis Child Fetal Neonatal Ed 2001;85:F147-148.
17. Laine K, Heikkinen T, Ekblad U, Kero P. Effects of exposure to selective serotonin reuptake inhibitors during pregnancy on serotonergic symptoms in newborns and cord blood monoamine and prolactin concentrations. Arch Gen Psychiatry 2003;60:720-726. 18. American Academy of Pediatrics Committee on Drugs. Neonatal drug withdrawal. Pediatrics 1998;101: 1079-1088.
19. Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: A database analysis. Lancet 2005;365:482-487.
20. Costei AM, Kozer E, Ho T, Ito S, Koren G. Perinatal outcome following third trimester exposure to paroxetine. Arch Pediatr Adolesc Med 2002;156:1129-1132.
21. Nordeng H, Lindemann R, Perminov KV, Reikvam A. Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors. Acta Paediatr 2001;90:288-291.
22. Nijhuis IJ, Kok-Van Rooij GW, Bosschaart AN. Withdrawal reactions of a premature neonate after maternal use of paroxetine. Arch Dis Child Fetal Neonatal Ed 2001;84:F77.
23. Knoppert D, Nimkar R, Principi T, Yuen D. Paroxetine toxicity in a newborn after in utero exposure. Clinical symptoms correlate with serum levels. Ther Drug Monitor 2006;28:5-7.
24. Jaiswal S, Coombs RC, Isbister GK. Paroxetine withdrawal in a neonate with historical and laboratory confirmation. Eur J Pediatr 2003;62:723-724.
25. Santos RP, Pergolizzi JJ. Transient neonatal jitteriness due to maternal use of sertraline (Zoloft). J Perinatol 2004;24:392- 394.
26. Stiskal JA, Kulin N, Koren G, Ho T, Ito S. Neonatal paroxetine withdrawal syndrome. Arch Dis Child Fetal Neonatal Ed 2001;84:F134-135.
27. Bot P, Semmekrot BA, van der Stappen J. Neonatal effects of exposure to selective serotonin reuptake inhibitors during pregnancy. Arch Dis Child Fetal Neonatal Ed 2006;91:F153.
28. Johnson K, Gerada C, Greenough A. Treatment of neonatal abstinence syndrome. Arch Dis Child Fetal Neonatal Ed 2003;88:F2-5.
29. Chambers CD, Johnson KA, Dick LM, Felix RJ, Jones KL. Birth outcomes in pregnant women taking fluoxetine. N Engl J Med 1996;335:1010-1015.
30. Morag I, Batish D, Keidar R, Bulkenstein M, Heyman E. Paroxetine use throughout pregnancy: Does it pose any risk to the neonate? J Toxicol Clin Toxicol 2004;42: 97-100.
31. Nelva A, Guy C, Tardy-Poncet B, Bevens MN, Ratrema M, Benedetti C, Ollajnier M. Hemorrhagic syndromes related to selective serotonin reuptake inhibitor (SSRI) antidepressants. Seven case reports and review of the literature. Rev Med Interne 2000;21:152- 160.
32. Maayan-Metzger A, Kuint J, Lubetsky A, Shenkman B, Mazkereth R, Kenet G. Maternal selective serotonin reuptake inhibitor intake does not seem to affect neonatal platelet function tests. Acta Haematol 2006;115: 157-161.
33. Chambers CD, Hernandez-Diaz S, Van Marter LJ, Louik C, Jones KL, Mitchell AA. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 2006;354: 579-587.
34. Franssen EJF, Meijs V, Ettahar F, Valeric PG, Keesen M, Lameijer W. Citalopram serum and milk levels in mother and infant during lactation. Ther Drug Monitor 2006;28:2-4.
35. Abdel-Latif ME, Pinner J, Clews S, Cooke F, Lui K, Oei J. Effects of breast milk on the severity and outcome of neonatal abstinence syndrome among infants of drug-dependent mothers. Pediatrics 2006;117:e1163-e1169.
36. Finnegan LP. Neonatal abstinence syndrome. In: Nelson N, editor. Current Therapy in Neonatal Perinatal Medicine-2. Toronto: BC Decker, 1990; pp. 314-320.
37. Oberlander TF, Grunau RE, Fitzgerald C, Papsdorf M, Rurak D, Riggs W. Pain reactivity in 2-month-old infants after prenatal and postnatal serotonin reuptake inhibitor medication exposure. Pediatrics 2005;115: 411-425.
38. Nulman I, Rovet J, Stewart DE, Wolpin J, Gardner HA, Theis JG, Kulin N, Koren G. Neurodevelopment of children exposed in utero to antidepressant drugs. N Engl J Med 1997;336:258-262.
39. Casper RC, Fleisher BE, Lee-Ancajas JC, Gilles A, Gaylor E, DeBattista A, Hoyme HE. Follow-up of children of depressed mothers exposed or not exposed to antidepressant drugs during pregnancy. J Pediatr 2003; 142:402-408.
Gil Klinger, MD, and Paul Merlob, MD
Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva, Israel, and the Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Israel
Address for Correspondence: Gil Klinger, MD, Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel, 14 Kaplan Street, Petah Tikva 49202, Israel. E-mail: gilkl@post.tau.ac.il
Copyright Gefen Publishing House Ltd. 2008
(c) 2008 Israel Journal of Psychiatry and Related Sciences, The. Provided by ProQuest LLC. All rights Reserved.
Source: Israel Journal of Psychiatry and Related Sciences, The
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