Kim and Sara's e-mails to FDA

Philip Dawdy has published his written testimony to FDA at this post:
"Why The FDA Should NOT Approve Seroquel For Depression And Anxiety"
Sara and Kim left their message to FDA on the comment area of this post and I felt like posting it.
Here they are:

Kim:

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.

Posted by kim at March 27, 2009 02:27 PM

_____________________________________________________________________

Sara:

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.)

Posted by Sara at March 27, 2009 03:29 PM

In August 26th, 2008 I wrote a post "Give Virtual activism a chance" with a link to a letter Stephany has send to FDA and an e-mail Philip Dawdy has written for two reporters of the Wall Street Journal.
Some people don't give up sending them e-mails and believe they are right and of course they don't expect for any reply. But it's worthy.