Brava!!!

Excellent!

Here is a link where I have listed the info specifics about that meeting and the roster list of who is on the committee for people interested.

Meeting of psychopharmacologic drugs link.

This does not sound like a very good option, particularly from how you describe the more questionable ways of using it. Still, I suppose there will always be people clamoring for more solutions to depression. http://www.prozac.bz

Philip,
I think you didn't notice that there's a SPAM at the thread.

Posted by prozac at March 27, 2009 01:15 AM

The link is for Prozac ad.

This is a real good way of activism.
I wish it would be considered as an example to us.
Thank you Philip.
This is great.

Hi Phillip,
Thank you for writing this to the FDA. I had only taken Seroquel as a tranquilizer when I was really "worked up." I am now successfully off all psych meds. I really began questioning psych-drugs is when I moved to a new town, and a new psychiatrist wanted to put me on Seroquel a couple times a day... every day. You can bet I practically ran out of his office.
I thought he was crazy. Why would I take this drug ever single day, especially when I was doing so well?

I feel so bad for people who take this drug every day.

Thank you for posting your written testimony. Those of us asking to speak have heard nothing, though we were to have been informed by March 23.

I will not be requesting a new black box for this drug. The existing black box for atypicals - for seniors with dementia - is ignored, while the FDA itself does not honor its existing black box warnings (suicidality warning on SSRIs for those up to age 24) as proven by its recent approval of Lexapro for adolescents with depression. If given an chance to speak, I will ask that both Seroquel and Zyprexa be withdrawn from the market, unless it can be proven that at least four other measures have been given due trial and failed for an individual with acute psychosis. Further, given the now-surfaced hidden written documents for both atypicals proving both companies knew of and hid lethal side effects, I will recommend the Advisory Committee to call for criminal investigation for either manslaughter or second-degree murder for those dead from these two drugs.

I was on Seroquel for generalized anxiety disorder when I was a teenager. A lot of teens are prescribed Seroquel for OCD. Frequently, Seroquel is the first thing they give to teens and pre-teens for OCD. If a teen has OCD, the first thing they'll throw out is an antipsychotic and they'll put an antidepressant with it. Teens who have OCD who don't respond well to antidepressants, which is just about everyone, are put on several antipsychotics to use to augment the antidepressant. OCD, bipolar, generalized anxiety disorder, depression, SAD and schitzophrenia are interchangable. It's the same meds for every condition.

Antipsychotics are prescribed for everything in and out of the DSM to teenagers and adolescents. Off label use is very common. I used to be on Seroquel, I got off it a long time ago. For some reason I didn't have many side effects with Seroquel which was probably because I was taking like six or seven medications at the time which all canceled out each other effects and side effects, so I didn't really get any side effects from Seroquel so they kept raising my dose. I don't really remember Seroquel well, but when you take it it is not that fun. I know I didn't get side effects from Seroquel the first year I was on it, the second year I was on so many medications that I don't know whether raising the Seroquel dose caused side effects or it was one of the other six or so drugs I was on. There are some medications to take to cancel out some of Seroquel's effects, but usually patients aren't told that, but if you are already on them, it will cancel out Seroquel's side effects. Seroquel will be prescribed for off label use in children, teenagers, adolescents off label whether or not it's approved by the FDA. I really like your site and articles, Philip.

I don't see how the abuse of the drug on the streets should play into whether or not it gets approved for depression or anxiety. According to the accepted practice shouldn't the criteria for it's approval for depression and anxiety be based on whether or not it alleviates these experiences within a statistically relevent number of people?

Philip Dawdy responds: it's my opinion that it's importand and relevant and i wanted to make the cmte aware of the situation since they likely know nothing about it. you're welcome to have a different opinion. besides, if we used the standard you just laid out pot would be legal.

Philip, you ROCK!

Philip,

I happen to absolutely believe pot should be legal. Beyond the therapeutic possibilities for pot as a treatment for anxiety and other mental problems there's the waste of money and innocent lives that are destroyed by the "war on drugs" and that's not even getting into the revenue that could be generated by legal pot sales. I don't use pot but I definitely believe in it as an effective natural remedy for many people. Although with the munchies it might be as bad as Seroquel with the weight thing.

;-)

I think all recreational drugs should be legal. They can help with depression and anxiety so much more than prescription drugs. Everyone I know does street drugs anyway. They should make all drugs legal. If doctors can give antipsychotics to kids, adolescents and teenagers, all street drugs should be legal. Street drugs can bring euphoria and happiness and the pharmaceautical companies have double standards.

You know legal prescriptions becoming street worthy in sales is relevant; and frankly if Seroquel doesn't work for psychosis it won't for depression or anxiety, it's a marketing planned target to extend the patent, and patient wellness is NOT AstraZeneca's goal. But the FDA SHOULD have it for theirs.

Legally bombed is what I call using Seroquel.(from experience used for insomnia)I'll never take it again. And at 800mg per day my daughter was wildly psychotic on the drug, actually WORSE.

Excellent! And I'm so happy you included the prison and street use/abuse of this drug.

My written testimony was much shorter but I do hope her email box was full. Yvette did respond by saying "I am confirming the receipt of your written submission for April 8, 2009 Psychopharmacologic Drugs Advisory Committee."

My message read as follows:

I would like my voice to be heard in regards to the hearings being held for AstraZeneca's applications to have its antipsychotic Seroquel approved by the FDA for one of three depression indications and anxiety.

My experience on the medication is simple, frightening and not uncommon:
40 pounds weight gain in two months
I slept 12-18 hours a day
Slurred speech
Constant zombie state
Memory loss
and many more side effects that I cannot remember thanks to the memory loss.

I had a psychiatrist in Knoxville, TN prescribe this medication for depression and bipolar and she knowingly did so after I told her about my family history of diabetes. Numerous other doctors tried the same. It's frightening-this drug should only be prescribed in dire cases-those that are truly psychotic----hence the name, antipsychotic. If someone is suffering from depression-this medication will not lift that, it will most certainly make their life even more miserable, dare I say, they will not have a life at all. This is not what I consider to be proper treatment or care nor should the FDA or doctors. This medication is dangerous. Period.

By the way, I am not some crazy patient writing. I have a very successful career in the film industry, worked on numerous Oscar-winning films and consider myself to be completely sane. I have trauma in my past and I am currently dealing with that in a healthier manner.

Thank you very much for your time.

Here's what I submitted:

As a drug awareness and safety advocate who lost a daughter to toxic effects of an antidepressant and antipsychotic interaction, I urge the committee to turn down the new drug applications sought for Seroquel in the treatment of depression and generalized anxiety.

For one thing, the original approval of Seroquel for bipolar disorder should now be under investigation due to allegations appearing in the media in recent weeks about serious misconduct during the trial process leading up to the application for approval. It is probable that the approval of Seroquel was made under false pretenses and with evidence compiled by individuals with conflicts of interest behaving in unethical ways. The former U.S. Medical Director for Seroquel at Astra Zeneca is accused of exchanging sexual favors both with a clinical researcher and a ghostwriter involved in the approval trials. He used the sexual liaisons to obtain information about competitors and offered to prescribe prescription painkillers in exchange for information and to encourage presentation of data favorable to Seroquel. These were with women who were in charge of compiling evidence and writing it up. Certainly it would seem appropriate to revisit the data that was obtained in the trials to see if it was manipulated in favor of the drug company interests.

Astra Zeneca, after all, has a track record of not presenting data accurately. This too has been in the media in recent weeks. A study called Study 15, dating from 1996, which runs to a few thousand pages was never written up for publication in medical journals and, along with several other trials, demonstrated that Seroquel was not superior to the older, generic competitor Haldol, except perhaps at very high doses, or to other atypical antipsychotics. Furthermore the study shows a very high percentage of drop out among the patients randomized to Seroquel. In fact 85% dropped out at 75mg, 84% at 300 mg, and 76% at 600 mg. 66% of the Haldol patients dropped out but only a third of those were for psychotic relapse. In the case of Seroquel two thirds dropped out for psychotic relapse. This is a shocking demonstration of failure of the drug to work for its intended purpose – to relieve and stop psychosis.

Given this history of misrepresentation of evidence why is Seroquel being considered for further applications? The hearing should be revisiting earlier approvals, not extending new ones.

My concern with extending approval of Seroquel to new applications, however, goes well beyond the sorry history of prior approvals. I am sure the committee is going to be hearing plenty of testimony about weight gain, the onset of diabetes, and tardive dyskinesia, all well known effects of Seroquel. My area of concern is its interaction with other drugs and the onset of serotonin syndrome. The irony here is that Seroquel and other drugs in its class (atypical antipsychotics) are often prescribed unwittingly to patients having adverse reactions to antidepressants (especially SSRIs) that have mistakenly been interpreted as symptoms of worsening mood disorders rather than adverse drug effects or iatrogenesis. My own daughter died from a toxic interaction of an SSRI and an atypical antipsychotic that led to the onset of serotonin syndrome. These were the symptoms: confusion, disorientation, agitation, irritability, unresponsiveness and anxiety; pallor, and shivering; temperature dysregulation, rapid heart beat and dilated pupils. These sensations led her to take her own life in a sleep-disordered state of semi-consciousness. I am certain that this is far more widespread than is currently being recognized.

In particular, there have been a number of deaths of servicemen by those taking multiple psych drugs, including Seroquel. Seroquel is linked to fatal heart arrhythmias and irregularities (a symptom of serotonin syndrome). Doctors are simply not being taught to recognize the symptoms of serotonin syndrome (really drug toxicity) and, often far from removing the offending agents, they prescribe more of them. Suicides by soldiers are skyrocketing and there are many examples on the website www.ssristories.com that could well be the result of akathisia and/or the onset of serotonin syndrome in these victims.

The fact that this hearing is taking place at all is a symptom of the failure to educate our medical professionals about adverse psychiatric drug reactions. So called “treatment resistant depression” is often really treatment exacerbated depression since over the long term medications damage the brain with their toxicity and make mood disorders worse not better. Doctors mistakenly prescribe new medications to “treat” iatrogenic symptoms when less medication would be much more beneficial, not more. Please do not compound the problem by making the use of Seroquel more widespread than it already is. It is a debilitating and harmful drug whose consumers face the risk of serious disability.

(P.S. The original has several footnotes supporting the points in this testimony.)

Sara, you are the first parent I have heard describe the lethal effect of polypharmacy between an SSRI and an antipsychotic. Perhaps you can obtain my email from Philip or I can obtain yours and we can talk further on this point. I was aware of lethal impact (death in one's sleep) for soldiers with PTSD given this cocktail, but not a story such as yours.

I only wish you could be there in person, speaking. If I ever am given a time - so far, no notice - of when I am to speak, I would like to include mention of the tragedy you suffered. My original testimony speaks only of friends' children dead due to Zyprexa and Seroquel - causes such as profound hyperglycemia, pancreatitis, etc.

I have emailed Dr. Sharfstein, to be number two at FDA, at his current post as Commissioner of Baltimore Public Health Department, my Senators, my Representative, etc., alerting them to the fact that, so far, so one I know who applied to speak has been given any notice or time to speak.

I am very sorry to hear of your terrible loss.

I can be reached through the contact page at www.ssristories.com. Someone I know did hear late today that she has been given a slot to speak. It's typical not to hear until about a week before the hearing. I have testified in the past and it is a very powerful experience. I wish all of you who are speaking out the best of luck and sock it to 'em.

Sara,
That was excellent. Thank you for sharing it. My heart is wrenched for you and for your daughter. I've come so close to the edge of iatrogenically induced suicide myself not to feel a connection to your situation.

anonymous, I've testified at state legislative hearings. With the exception of one hearing, it was a deeply positive experience in which I felt heard. Even in the less positive experience, which was more of a kangaroo court, I could see some of the committee members were able tune out the shenanigans of the people chairing the hearing. Those people were listening intently and the billed, in the end, failed to pass. So I guess were were heard, despite all that static.

I wish you both well. anon, if you do get to testify, please do come back and let us know how it goes.

Sherry (watching all this with a great deal of interest)

Thanks for the encouragement, those who gave it to me above. I have testified before various FDA Advisory Committees about ten times now. Sometimes, the HEAD of the CDER Division of Psychotropics of FDA - no names mentioned - appears to be falling asleep during public testimony. Perhaps he is meditating....who knows. But one time, at the end of my spiel, I had had it and said something like "It appears that the culture of the FDA includes never offering condolences, shaking my hand, showing any affect, or in any way acknowledging that a life has been lost due to the drug. I must be at the wrong hearing, as I mistakenly thought the FDA was about protecting the public health".....believe you me, after that little tirade, the entire committee (I think it was a DTC Hearing) lined up to shake my hand, offer their cards, etc...If I get a chance to speak on April 8, maybe I'll do something like that again.

Considering the committee is all but 2 or so psychiatrists, I have a lot of doubt. Seroquel has been used off label so much now, the FDA is, in my opinion "checking off the public input" from the list before it approves the Seroquel This is only an advisory committee, and look what the FDA has approved already: Abilify and Risperdal for kids! If that doesn't show lack of concern for the safety of a human being, I don't know what does.

I'm not getting my hopes up at all. This is too corrupt, like gas prices, it's never going back to anywhere good....all ppl can do is be informed on their own.

I was first diagnosed with bipolar disorder 33 years ago, and I'm pretty sure I've taken every psych med. I'm currently on 1500mg of generic lithium and 200mg of Seroquel for sleep after a full-blown episode last August.




On every level, my condition has improved markedly since then, and I realized why... (This won't be a scientific opinion, nor will it be popular on this thread.) I haven't smoked marijuana since 2000, and the last time I took lithium was roughly 1998. During the honesty phase of 12-Step recovery, I decided that using a powerful hallucinogen like marijuana and claiming it had some benign, helpful effect on my mental health was denial at work.




Since I left the hospital, I have lost about five pounds, and yes I do sleep about ten hours a night. Delicious, glorious sleep.




I totally support anyone's right to free speech, including speaking before legislative bodies.

I have posted Kim and Sara's e-mails at my blog.
http://justana-justana.blogspot.com/2009/03/kim-and-saras-e-mails-to-fda.html
Thank you all who are writing to them knowing that the reply is not the aim.
But I'm sure it's not ignored.
Ana

My son had a serious head injury and was put into a induce coma for almost three weeks, when taken of the verset my son was put on seroquel. My son's adjitation was getting worst and he was declining quickley. I looked at the drugs that the doctor at UCLA Trauma Center had him on and looked up seroquel every single adverse side effect that was on the internet was my son's symtoms. I had the doctor take my son off the seroquel and now he is making great progress. Bad drug.

Just came across this site. My 15 yr. old has been taking 1000mg depakote/36mg concerta/100mg zoloft and just added 25mg seroquel at night. Diagnosed with mood disorder (NOS), depression, anxiety. Lately, her anger/anxiety is on the rise. Any comments/suggestions/advise? (She has been on all except seroquel for approx. 2 years.) Many Thanks.