FDA hearings 2006

I’ve been meaning to start this thread for a while now – last December (2006) the FDA held hearings into suicidality risks in adults (in connection with SSRIs).

Documentary maker Phil Lawrence went along to film. Here’s his take of it:

2.20.2006
Trip to Washington DC
Last week, we packed up the gear and headed to Washington for the FDA’s hearings to review the suicidality risks in adults. I’ll have to admit, at first, it was a little intimidating – I mean, this is the real deal – the FDA! So, we show up at the meeting room an hour or so early to get settled in and get the cameras set up – we sign in and were lucky enough to wedge ourselves in between the CNN and ABC News cameras. My heart was pounding – I was about to witness one of the processes that makes our country great. Unfortunately, once the hearings got underway, I was no longer intimidated or in awe. I was just disappointed. I wanted to believe that this type of public debate was going to reveal some kind of truth – or provide answers to some of the issues at hand. It had every opportunity to be a reaffirming moment for me – especially to prove that there is some value and credibility in the way our system works. Sadly, that was not the case. In my opinion, it came off as a show – nothing more than a media event designed to give the FDA a boost in public opinion – which is timely considering that FDA reform is likely just around the corner. It was almost comical watching these public officials posturing for the cameras.

On the other hand, it was excruciating to watch and listen to the testimonies from the families and relatives who lost loved ones to suicide. It wasn’t excruciating because of the stories – those were brutal and heart wrenching. It was excruciating because of the way the panel of experts and members of the FDA treated them – it was as if they all put up a shield to keep from getting emotional. But why? What’s wrong with getting emotional? I couldn’t understand – why wouldn’t they look at them?

Why wouldn’t they listen to what these people have to say? It was beyond rude – it was cold-hearted – dismissive. Personally, I had never met these people before, yet as I stood there videotaping them – hearing their stories, I fought back tears. What’s wrong with that? It doesn’t reveal what side of the argument I fall on – its empathy, its caring about others – its being a human being regardless of your political agenda, title or responsibilities.

Everyone who was brave enough to stand up in front of this panel and pour their hearts out has my utmost respect. I assure you that your stories did not fall on deaf ears – and will never be forgotten or dismissed.

To put Phil’s comments into perspective this is the kind of thing the committee sat through:

Hello.

My name is Angela Heck.

My husband William and I are both here of our own accord from Toledo, Ohio. My husband and I had been together for 12 years at the time he attacked me tried to kill me with a knife (weeping). Approximately, three years ago, my husband was prescribed Paxil for anxiety. My husband is not an alcoholic. He has never tried illegal drugs in his lifetime. In addition, he has no prior history of assault, violence, or aggressiveness issues. He does not have any history of mental illness. He is a normal, healthy male.

Do you know what it is like to be trapped in your own bedroom thinking you’re going to be wrapped in a blanket and your parents are not going to know what happened to you? Or, do you know what it’s like to wonder how you could do something so terrible, so contradictory to your values and beliefs?

My husband and I do because of what a well-respected psychiatrist stated in the attached letter regarding the whole incident, and I quote: “I find it to be consistent with dissociative episode and in all likelihood caused by serotonin reuptake inhibitor, Paxil. You are familiar with the details of the unfortunate assault on his wife during that dissociative episode.”

To this day, he still does not remember what happened on that horrible day. He only knows what has happened from me telling him. This tragic event turned out lives upside down. Resentment and anger do not even begin to describe how we feel towards the makers of these dangerous antidepressants. I always knew that money made the world go around, but I did not think a company was so greedy that they would not care how many people’s lives are ruined or lost. I know some people have trouble believing that a drug like Paxil could cause something like this. If it wasn’t me and how well I know my husband, I would probably be one of those people.

There is no doubt in my mind that these drugs have several terrible side-effects. If I had any doubt, I would not be back with my husband. I also strongly believe that the drug companies are aware of these side-effects as well or they would not have hidden the clinical trials for so long. I strongly urge the FDA to do something about SSRIs and how they are prescribed. These drugs are being given to people as though they are as safe as Tylenol. We all know this is not the case.

Antidepressants are something that either should not be used at all or as a last resort. They have become the first choice for all sorts of problems due to a lot of expensive marketing by the drug companies. We trusted the medical profession, drug companies, and the FDA to give us safe medication, and that obviously has not happened.

The drug companies have gained control of the entire process with their deep pockets. We hope and pray that the FDA finally makes a drastic change regarding antidepressants as these drugs are extremely dangerous and family physicians should not be prescribing.

Thank you for your time.

and this:

My name is Laurie Yorke. I’m a registered nurse of 22 years. I am here at my own expense. While I don’t represent any official organization, I do represent 4,000 members of Paxilprogress.org. This is a website created by a Canadian man that I have taken over in the last two years. We have over 200,000 visitors, guests, per month on the site, and we are now exceeding 3.1 million hits per month. This is a peer-support website for those going through withdrawal from an SSRI. You have also written testimony from some who couldn’t get a spot to speak today or those who would be violating a gag order instituted as the result of a class action lawsuit. I am here to speak for them.

This hearing is about suicidality, but you cannot address that without addressing withdrawal. The sudden violent acts seen at the start of SSRI use are only part of the story. Suicide, homicide, and other violent acts are seen in withdrawal from this category of drugs every day. I have personally sat at my computer begging a poster to give me their phone number when they came to the website massively suicidal in an attempt to prevent that suicide. I have talked to those who have had no idea that the possibility existed, yet they sit with a knife in their hand begging on the Internet for help.

There are people who are put on antidepressants for a multitude of reasons: depression, anxiety, freshman jitters, irritable bowel, school phobia, gallstones, et cetera. Some of these people were given a prescription instead of a CAT scan. Some have died as a result of misdiagnosis and drug reactions.

These are not isolated cases. We see this reaction every single day in people from all over the world. It amazes me that we, as the general public, have seen these stunningly similar patterns of withdrawal, yet the doctors have not. The FDA consistently refers to all 12-week trials, and you hang your decision on thefact that there were no completed suicides. Well, gentlemen and ladies, look beyond the 12-week use and you will see hundreds of completed suicides and thousands of lives devastated by Paxil withdrawal.

This is a post by a recent visitor to the site regarding FDA warnings: “Do doctors actually receive this stuff to read? Because my doctor told me last February that suicidal risks don’t happen with adults, just children. She said this after I told her that every time I try a new antidepressant I get thoughts of wanting to die. So basically she didn’t believe a word I said. She said I felt that way because I was reading the wrong warning labels,” that it didn’t apply to her.

This is what the public is dealing with. Talk about the stigma of depression, trying to get a doctor to take you seriously when you are in withdrawal, you have now become a nonperson. Denying suicidality does not make it go away. We hear psychiatrists report, “I never had a patient become suicidal on an SSRI,” when the bottom line is if withdrawal is denied the patient leaves and goes through withdrawal on their own, with the help of the Internet, and never comes back. I will continue my vigilance on the Internet until I feel that the FDA is meeting its legislative mandate.

I’ll post some more testimony in the near future, and I’d personally like to thank everyone who spoke for standing up and doing so. It can’t have been easy for you.

2 Responses to “FDA hearings 2006”

  1. Important new Paxil withdrawal documentary finally completed « seroxat secrets… Says:

    […] and his documentary in my previous posts:Corruption? Glaxo? FDA?I’m not buying it. Not any more.FDA hearings 2006Update on Phil Lawrence and his Paxil withdrawal documentary… Posted in Anti-depressant, […]


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