March 10, 2009

FDA Committee Hearing On Seroquel Needs To Hear From Patients

Most of you are aware that AstraZeneca applied last year with the FDA to have Seroquel, it's $4.4 billion a year antipsychotic, approved as a treatment for three different depression indications as well as for generalized anxiety disorder. It's a sign that something unusual is afoot since the FDA has decided to have its psychopharmacology advisory committee hear public testimony on the matter when it meets April 7 and April 8.

While I'm still trying to confirm details with the FDA, what I know so far comes from a reader of this site via the impossible-to-understand Federal Register:

"Written testimony has to be in by 3/27 to Yvette Waples. Her email is yvette.waples@fda.hhs.gov. Her fax is 301-827-6778. Phone is 301-827-7001. You have to contact her if you want to speak at the meeting, which is to be held on April 7 and 8 at the Hilton Wash. DC/Silver Spring Hotel, the Ballrooms, 8727 Colesville Rd. Silver Spring MD . When asking to speak (1-2 each day) tell name or names of presenters, brief statement of topic, and time needed.....time needed is a joke because they usually give five min. If speaking, good idea to give written copy of speech and attachments, if any, to the psychopharmacological committee. I'd say make about 20 or 30. Sometimes press take copies so put your name and phone/email on the material."

As much as I'd like to speak to the committee in person, I simply don't have the money to fly to DC, etc. I will submit written testimony, as things stand now. I'm trying to find out if the FDA will permit testimony via phone--hell, it's 2009 and federal courts allow it and video testimony to a degree. I am not sure if the written testimony can be submitted by email. I'm trying to find out from the FDA.

But those are the basics as I know them now. I'll update when I know more.

I know there are many former Seroquel users who read this site and I would strongly suggest that you all offer written testimony. The committee needs to hear from people who've taken this drug as it weighs its recommendation to the FDA.

Posted by Philip Dawdy at March 10, 2009 12:05 AM
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Comments

Personally I would really like to get a group of FS supporters to send Philip to Washington and find him a place to stay. I've participated in three of these hearings and provided written testimony for one more. The reason to be there is not just for the committee's deliberations but also for the networking with the media, other victims and even politicians. At some of these hearings television crews show up and interview people testifying during breaks. If anyone has any ideas on how to make this happen post here or contact the website www.ssristories.com. Thanks.

Posted by: Sara at March 10, 2009 08:01 AM

I agree with Sara on the importance of having Philip attend the FDA meeting - if at all possible.

Here is a Website that lists Seroquel's Adverse Events Reports from 2004 through 2008. There were 647 deaths reported which is probably the tip of the iceberg.


http://www.patientsville.com/medication/seroquel_side_effects.htm

Seroquel most reported side effects and reactions by year

Seroquel Side Effects summary
Total Seroquel reports: 5386.
Seroquel FDA safety alerts: 2002 2003 2004 .
Reported deaths: 647 Reported hospitalizations: 1555.
Take Seroquel Side Effects Survey, Discuss Seroquel with others
Seroquel Side Effects: diabetes mellitus insulin-dependent, diabetes mellitus inadequate control, diabetes mellitus non-insulin-dependent, diabetes mellitus, tardive dyskinesia, diabetic ketoacidosis, pancreatitis acute, pancreatitis chronic, pancreatitis necrotising, diabetic coma, weight increased,
Seroquel Usage.

Seroquel most reported side effects and reactions by year

Year Description Frequency
2004 COMPLETED SUICIDE 30
LEUKOPENIA 28
NEUTROPENIA 26
ALANINE AMINOTRANSFERASE INCREASED 22
ABNORMAL BEHAVIOUR 20
2005 LEUKOPENIA 36
NEUTROPENIA 29
ALANINE AMINOTRANSFERASE INCREASED 26
WHITE BLOOD CELL COUNT DECREASED 25
DEATH 23
2006 ILL-DEFINED DISORDER 904
DEATH 141
LEUKOPENIA 49
COMPLETED SUICIDE 43
DIABETES MELLITUS 26
NEUTROPENIA 26
2007 DIABETES MELLITUS 4990
DEATH 678
PANCREATITIS 533
TARDIVE DYSKINESIA 241
BLOOD CHOLESTEROL INCREASED 195
2008 DEATH 120
DIABETES MELLITUS 88
BLOOD CHOLESTEROL INCREASED 77
ABDOMINAL PAIN 22
ANAEMIA 20

Posted by: Rosie at March 10, 2009 12:56 PM

Recently I posted this chart about Seroquel thinking that Seroquel must be more powerful than many other antipsychotics. I received an email from a person with a Ph.D. in biochemistry and she explained what this chart was all about :-).

Sorry if I misled anyone. I still wonder what this chart means since Seroquel is so different in receptor potencies from all the other antipsychotics. Would like to know how this plays out in terms of symptoms, not just neurochemistry.

Beneath the chart is the explanation from the Ph.D. regarding the neurochemistry.

http://www.cmaj.ca/cgi/content/full/172/13/1703/T235


"When a drug binds a receptor, it is in constant flux between being bound and unbound (what biochemists called associated and disassociated). Imagine, by analogy, a swimming pool full of inner tubes. The tubes are like the receptors in your cell. Now introduce a bunch of children to the swimming pool. The children are like the drug molecules. The children swim around in the pool and find inner tubes. Some latch on very tightly and stay attached. Others latch on and then let go quickly to move to other play. Others might bump into an inner tube but they just bounce off of it, uninterested. An observer could measure the concentration of kids required to get half the inner tubes full. For instance, she might say "I need 100 kids per 1000 gallons of swimming pool water to get half of the inner tubes full."

Now she might try another set of kids (a different drug). These kids might like inner tubes better, so more are attached to an inner tube at any given moment. The observer might say, "Now I need 50 kids per 1000 gallons of swimming pool water to get half of the inner tubes full."

As you can see, the observer is measuring the "affinity" or "tightness" of association of kids with the inner tubes. In biochemistry, we measure this by the "dissociation constant." It is usually expressed as Kd (subscript d) but can be expressed as Ki (subscript i) when an inhibitor is used in the experiment to measure the binding of the drug to the receptor. Basically, Ki measures how tightly a drug binds a receptor. As you can see in my analogy, a LOWER Ki (50 kids per 1000 gallons water) means HIGHER AFFINITY (than the lower affinity case, 100 kids per 1000 gallons). Less drug is needed to occupy half the receptors. The drug "likes" the receptor better. So, in your table, the Ki value of 294 means that the drug does not bind as well as other drugs with lower Ki's.

The abbreviation nM stands for "nanomolar." It is a measure of concentration. In biochemistry, you can't talk about 100 kids or 50 kids needed in the pool to occupy half the inner tubes-- you always have to refer to it in the context of how much water is in the pool; thus, a concentration. 100 kids per 1000 gallons is 0.1 kids/gallon. 294 nanomolar means how much drug (dry powder) is dissolved in how much water. A HIGHER nanomolar value just means MORE drug.

So, in conclusion, more Quetiapine is needed (294 nM) to get half of the serotonin 5HT receptors occupied than the other drugs listed. So it has LESS AFFINITY for that receptor than those other drugs.

Hope this clarifies things!"

Posted by: Rosie at March 10, 2009 01:21 PM
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