Check out this recent article in the British Medical Journal:

US drug regulators should consider adding adults to
SSRI suicide warning, says campaigner

Ed Silverman

Millburn, New Jersey

A British doctor who campaigned for the public to be warned about increased suicide risk in young people taking
antidepressants has said that US drug regulators should consider including adults in warnings.

David Healy, a psychiatry professor at Bangor University, called for the warnings after GlaxoSmithKline (GSK) was ordered to
pay $3m (£2.34m; €2.75m) to the widow of a US man who killed himself shortly after starting generic paroxetine.

The jury in the case of Stewart Dolin, a 57 year old attorney, concluded that GSK had failed to properly warn the public about
the increased risk of suicide when taking paroxetine. The jury reached its verdict after lawyers for Dolin’s widow, Wendy,
presented evidence in the Chicago federal court suggesting that GSK knew that paroxetine posed a risk to adults but had
concealed or manipulated data.

Dolin stepped in front of a train in July 2010 shortly after starting a generic version of paroxetine that was sold by Mylan
Pharmaceuticals. Mylan was originally named in the lawsuit but was later dismissed because of regulations and a Supreme
Court ruling that a generic company cannot be sued if the brand name company does not first change product labelling.
Warnings about the increased risk of suicidal thoughts and behaviour in children and young adults were added to the labels
of antidepressants in the US and Europe more than a decade ago.

In the US, however, labels do not warn of these risks for anyone over 24 years old. Many consumers have tried to hold drug makers responsible for suicides in adults without success. But the legal team representing Wendy Dolin argued that GSK had artificially inflated the number of suicides and suicide attempts that occurred among people who were given a placebo during clinical trials of paroxetine. They said that this alleged move made the antidepressant look better by comparison, since it appeared to minimise the risk of suicide associated with the drug.

The lawyers also argued that GSK had used averages for all selective serotonin reuptake inhibitors (SSRIs) to demonstrate
that paroxetine did not raise the risk of suicide in adults aged over 24. Court documents also indicated that paroxetine
displayed a much higher risk than all but one of the SSRI drugs. Wendy Dolin declared the verdict “a great day for consumers.”
After the verdict she told the Chicago Tribune, “This for me has not just been about the money. This has always been about
awareness [of] a health issue, and the public has to be aware of this.”

Healy, who spearheaded the campaign to upgrade suicide warnings on antidepressants and testified as an expert witness
on behalf of Wendy Dolin, said that the findings in the case should prompt the US drug regulator to review the evidence on
SSRIs and suicide risk in adults.

“When it becomes so clear cut that a jury finds there is a problem, it suggests the evidence is strong enough to look at
the issue,” Healy told The BMJ. “If it’s that clear to the average man on the street, and the FDA [the US Food and Drug
Administration] doesn’t do something about it, we have an odd situation.”

GSK, which markets paroxetine under the brand name Paxil in the US, has said that it will appeal the verdict. “GSK maintains
that because it did not manufacture or market the medicine ingested by Mr Dolin, it should not be liable,” it said in a
statement. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this
lawsuit.”

GSK added, “The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm, or suicidal thinking in adult patients. In 2007, FDA revised the labelling for the entire class of SSRI drugs (including generic paroxetine and Paxil). The label includes statements that studies did not show an increased risk of suicidality (attempts or ideation) in adults over the age of 24, and that there appeared to be a protective effect in adults over 64.”

1 Eaton L. Regulator restricts use of SSRIs in children. BMJ 2005.www.bmj.com/content/
330/7498/984.2.
Published by the BMJ Publishing Group Limited. For permission to use (where not already
granted under a licence) please go to http://group.bmj.com/group/rights

Read Wendy’s exclusive and in-depth interview with prominent blogger Bob Fiddaman, who followed the trial closely and wrote about it almost daily throughout. You’ll learn about some behind-the-scenes goings on that she couldn’t discuss during the trial, and why this case was so vitally important to her mission.

We are so excited to announce that MISSD founder Wendy Dolin won her lawsuit last week against the pharmaceutical company GSK. The jury heard six weeks of testimony and found that it was dangerous drug reaction akathisia that led to Wendy’s husband Stewart’s death. We are so grateful to our supporters for raising awareness about this deadly side effect of many medications. This is even more validation for us to continue this important work.

For more information about the trial, read below.

https://www.baumhedlundlaw.com/press-releases/

MISSD board members Marcey Berman and Wendy Dolin attended a MISSD sponsored event, “You Will Never Walk Alone,” on March 3rd with K9s for Veterans. The nonprofit organization we are thrilled to collaborate with trains and presents service dogs to veterans suffering from PTSD. Mike Tellerino, founder of K9s for Veterans, thought that the message of MISSD was an important one for veterans because so many vets are being given record numbers of medications and are unknowingly experiencing (or have lost their lives to) akathisia. Wendy spoke to more than 400 attendees who were very appreciative to learn about MISSD’s mission. Thanks to so many generous people who devote their time and funds to MISSD, we are able to support and attend events like this one.

For more information on K9s for Veterans, visit http://www.nbcchicago.com/blogs/making-a-difference/canines-for-veterans-415370233.html

MISSD founder Wendy Dolin (with director Jenna Sachman and board members Cindy Klinger and Jeff Dritz, shown here) presented about her story and akathisia to some of Loyola’s School of Social Work grad students yesterday. The topic and discussion were well-received by the students, who were interested in learning more so they could take the information to their internship sites. Special thanks to Dr. Marcia Spira for allowing MISSD to bring awareness to this important topic!

MISSD is thrilled that our educational video about akathisia has been included in a recent article of the online version of one of the UK’s largest and most widely read and respected newspapers, the Daily Mail. The piece, which you can read here, describes side effects of psychotropic medications and the long-term risks that affect some patients. It also highlights a variety of interesting studies about drugs and placebo effects, discusses long-term conditions and shares one individual’s story. It explains the fact that even after stopping medications, withdrawal effects can sometimes last years or even become a permanent condition. Although MISSD is not anti-drug and does not support all the views described in this article, we do take a stand for truth in labeling. Our mission is to raise awareness of akathisia and medication-induced suicides.

Read the article and let us know what you think!

http://www.nbcchicago.com/investigations/Woman-Blames-Prescription-Drug-For-Husbands-Suicide-260870061.html

We thank NBC 5 for its continual support of MISSD and for updating their story to share our educational video on akathisia.

MISSD held its fourth annual fundraiser, its biggest yet, at The Montgomery Club in Chicago October 20th. The venue was open but warm and cozy, with an array of food and drinks to help guests mingle and learn more about our mission. The nearly 300 people in attendance came from all corners of the US and abroad, including reporters, activists, former akathisia victims and their friends and family. Lisa Parker from Chicago’s NBC 5 was the keynote speaker, and gave a touching talk about her appreciation for MISSD and her connection to MISSD’s founder, Wendy Dolin. As always, we hosted a successful and varied silent auction to raise money to continue our awareness-focused goals. And this year, we had a special unveiling: we premiered our short educational video that describes akathisia through sophisticated animation and the words of sufferers. This targeted, powerful video will allow us to reach more people not only in the US, but throughout the world to spread the word about akathisia and what to do if you or a loved one is experiencing this life-threatening medication side effect. Thank you to everyone in attendance who makes our continued success possible!

Bruce Springsteen’s song called “Restless Nights” seems more apt than ever after reading an excerpt that seems to describe akathisia in his newly released book “Born to Run.” After a bout with medication that left him weepy came something altogether harrowing:

“I had an attack of what was called an ‘agitated depression.’ During this period, I was so profoundly uncomfortable in my own skin that I just wanted OUT. It feels dangerous and brings plenty of unwanted thoughts. I was uncomfortable doing anything. Standing…walking…sitting down…everything brought waves of an agitated anxiety that I’d spend every waking minute trying to dispel. Demise and foreboding were all that awaited and sleep was the only respite. During waking hours, I’d spend the day trying to find a position I would feel all right in for the next few minutes. I was not hyper. I was too depressed to concentrate on anything of substance.

I’d pace the room looking for the twelve square inches of carpet where I might find release. If I could get myself to work out, that might produce a short relief, but really all I wanted was the bed, the bed, the bed, the bed and unconsciousness. I spent good portions of the day with the covers up to my nose waiting for it to stop. Reading, or even watching television, felt beyond my ability. All my favorite things–listening to music, watching some film noir–caused such unbearable anxiety in me because they were undoable. Once I was cut off from all my favorite things, the things that tell me who I am, I felt myself dangerously slipping away. I became a stranger in a borrowed and disagreeable body and mind.

This lasted for six weeks. All the while we were overseas. It affected me physically, sexually, emotionally, spiritually, you name it. It all went out the door. I was truly unsure if I could ever perform in this condition. The fire in me felt like it had gone out and I felt dark and hollow inside. Bad thoughts had a heyday. If I can’t work, how will I provide for my family? Will I be bedridden? Who the fuck am I? You feel the thinness of the veil of our identity and an accompanying panic that seems to be just around the corner.

I couldn’t live like this, not forever. For the first time, I felt I understood what drives people toward the abyss. The fact that I understood this, that I could feel this, emptied my heart out and left me in a cold fright. There was no life here, just an endless irritating existential angst embedded in my bones. It was demanding answers that I did not have.

And there was no respite. If I was awake, it was happening. So…I’d try to sleep; twelve, fourteen hours weren’t enough. I hated the gray light of morning. It would mean the day was coming. The day, when people would be waking up, going to work, eating, drinking, laughing, fucking. The day when you’re supposed to rise and shine, be filled with purpose, with life. I couldn’t get out of bed. Hell, I couldn’t even get a hard-on. It was like all my notorious energy, something that had been mine to command for most of my life, had been cruelly stolen away. I was a walking husk.”

If it can happen to Bruce Springsteen, it can happen to anyone. We’re thankful he offered this raw description of an insufferable drug side effect, and thrilled he pulled out of it and feels like himself again. Unfortunately, far too many others don’t. This is why MISSD continues to carry out its mission to make people aware of how serious and life-threatening this condition can be.