November 17, 2009

AstraZeneca Whines About Chicago Tribune's Seroquel Coverage

Yesterday, a letter to the editor appeared in the Chicago Tribune, penned by AZ's chief spokesman Tony Jewell and critical of a recent article in the paper concerning the company's antipsychotic Seroquel. The paper had written about AZ giving $490,000 to a Chicago psychiatrist who prescribed tons of Seroquel, plenty of it off-label, and also authored a study claiming patients lost weight on the drug. In part, it reads (via Soulful Sepulcher):

"Since first approved in 1997 for the treatment of schizophrenia, the U.S. Food and Drug Administration has approved Seroquel as safe and effective for three indications in bipolar disorder, as well as in a new formulation for additional treatments in schizophrenia and bipolar disorder. Today Seroquel and Seroquel XR are the only medicines approved as monotherapy by the FDA to treat both the acute depressive and manic episodes associated with bipolar disorder.

"The safety and efficacy of Seroquel has been evaluated in clinical trials with thousands of patients and AstraZeneca has shared all required data with the FDA, both before and after the agency approved it as safe and effective.

"AstraZeneca believes the totality of the science around Seroquel -- including company-sponsored studies, research sponsored by the federal government and physician experience -- confirms it is an effective and appropriate treatment choice for many patients who suffer from schizophrenia and bipolar disorder."

OK, fine. But since Jewell is relying so much upon the FDA's blessing of the drug to make his case to the public that Seroquel is safe and effective and that AZ plays by the rules, then I need to point out that last December the FDA busted AZ for off-label marketing of Seroquel for depression. To date, the agency has refused to answer any questions about its finding or to reveal what sanctions it might impose on the company. It's almost one year later and high time the FDA did something.

Posted by Philip Dawdy at November 17, 2009 12:03 AM
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Comments

At least I got my questions in as a comment!

Posted by: pharmagossip at November 17, 2009 01:38 AM

I really don't understand how Seroquel (or any other major tranquillizer) is supposed to alleviate depression. Is the theory that it just zones you out so much that you're not aware you're depressed? Helps regulate sleep cycle?

Posted by: Francesca Allan at November 17, 2009 08:39 AM

I can only surmise that when AstraZeneca signed that last Corporate Integrity Agreement with the Department of Justice over similar admitted illegal actions in 2003; they really had no intention of changing any of their unethical and illegal behaviors.

Now here we are again in 2009; as it appears they still intend to continue their criminal ways.

After all, its more profitable for these huge corporations to cheat and lie. What's a little fine, some bad press (which Tony is paid to spin), and another CIA that's isn't worth the paper its printed on.

Posted by: AZ at November 17, 2009 08:55 AM

I left this comment at the Trib:

I would like to know if any of the AstraZeneca upper level company officials will pay personal fines or serve time in prison for the knowledge of information that was withheld (even from the FDA, ie "study15") and continued to market the drug Seroquel with known weight gain and diabetes issues as side effects.

The recent recommendation by the FDA drug committee to give Seroquel approval for use in children with this background, is an assault on the health and safety of our children and teens. The drug should be removed from the market, considering litigation, it only makes sense.

What does the Department of Justice plan on doing to ensure patients injured by the drug get monetary settlements for their lifetime care needs?

Posted by: Stephany at November 17, 2009 09:55 AM

I tried to contact AZ about something, got a "representative" and was hung up on. Thank goodness I didn't want anything important. (Yes I hate seroquel)

Their response to my email(which prompted my call to them)


Thank you for contacting AstraZeneca.

At this time, we would like to ask you to call the Information Center at AstraZeneca at 1-800-236-9933. Our business hours are Monday through Friday, 8 AM to 6 PM eastern time, excluding holidays. We would like to obtain more specific information about your request so that we may answer your question accurately.

Sincerely,

Information Center at AstraZeneca

Posted by: Lili at November 17, 2009 10:34 AM

"I really don't understand how Seroquel (or any other major tranquillizer) is supposed to alleviate depression." That is because you have bought into the idea that "depression" is a thing with a specific pathology and specific biologic intervention. It is not. All psychotropic drugs work like shotguns mostly. "Antipsychotics" work as a general CNS depressant to blunt emotion and perception. Are they better than any other sedating drug like a BNZ. No

Posted by: Dr John at November 17, 2009 02:24 PM

Dr. John... now THAT is fascinating... the first time I have really heard a psychiatrist say that. I have read it in many metanalyses of comparisons between benzos and APs though... but have always been confused because I know a benzo is used as the "placebo" arm of studies in acute bipolar mania, so that would point to the idea that APs are ipso facto more effective. But then, I have my doubts that a double-blind study is even possible where APs are concerned.

Would love to pick your brain sometime, really.

Posted by: kimbriel at November 17, 2009 05:58 PM

Sadly Kimbriel I do not doubt this is the first time you may have heard a psychiatrist say this because most are buffoons who are too stupid, blind or self promoting to look past the bogus paradigm they were taught in training and all the myths it perpetuates. I am always open to offering my real world "first do no harm" perspective on trying to help people within this toilet we call psychiatric medicine. My email is jsorboromd@yahoo.com. I would strongly suggest you read "The Myth of The Chemical Cure" by Joanna Moncrief from England. It is brilliant writing on the philosophy of pharmacology.Take care. Dr John

Posted by: Dr John at November 18, 2009 03:58 AM

Seroquel doesnt just make you drowsy, that's just a side effect of how it effects the histamin receptors, it's real job is to effect dopamine and some seratonin levels. Since sleep can be a problem for people with depression and/or anxiety it can help two fold: help you get some Z's and boost some neuro-transmitters that might help during the day.

I actually HAVE lost weight while taking seroquel because the only time I get go the gym and actually complete a workout is when I takes meds, otherwise i'm way too agitated and anxious to exercise (even tho i know, intellectually, exercise will help those feelings). But I take a VERY low dose (25mg) and watch my diet very closely.

Posted by: David at November 18, 2009 08:23 PM

David,

Just so you know that at 25 mg seroquel is not a therpeutic dose (in adults) - it has literally no activity on either dopamine or serotonin. You're basically sedating yourself with a powerful anti-histamine. You're not getting a "neurotransmitter boost" at that level.

I'm not suggesting your improved feelings aren't real, but I can assure you that seroquel cannot be affecting your mood directly at the dosage you indicate. However, it is remarkable what a good night's sleep can for you... I wouldn't take seroquel for it's sedative qualities. Any OTC anti-histamine would be preferable to seroquel from a safety standpoint. Regardless, none of these drugs are suitable for anything other than emergency acute care situations imo.

Prescribing an antipsychotic (a major tranquilizer) as a sleep aid shouldn't be considered consistent with proper medical care.

Paul

Posted by: Paul at November 19, 2009 04:50 AM

Paul,

Thanks for chiming in as the expert on my body chemistry. You should win a nobel prize for being able to prescribe meds to people over the internet without ever meeting them or knowing anything about their problems. I'll stop taking my seroquel and run out and try those OTC drugs on your recommendation right now!!! NOT. Paul, I'm very sensitive to meds, I always have been and have always required the lowest doses that are considered "subtherapeutic" that's because i'm an individual human being not an aggregate. You sound like a drug company pushing their dosing standards.

FYI PAUL: I worked with Vistaril for several MONTHS (it's a histamine drug, like the OTC's you recommend) and all it did was knock me out cold, worse than seroquel ever has. It left me groggy all day long at the smallest doses, again, I'm VERY sensitive. With the seroquel I sleep but then I wake up and feel fine all day long, and I'm smiling for the first time in years. If it's just the histamine sleep than the Vistaril would have done that for me too but it didn't. Before you recommend drugs to people you might want to find out if they've already taken them, that's what actual doctors do.

I'm amazed at how unbelievably arrogant people can be on the internet, especially people with opinions on meds, they're usually much more confident than actual practicing doctors.

I happen to have a very good doctor and I'm receiving first-class care. My doc is a sensitive, contentious man who doesn't stick me into diagnostic categories or think just because I feel or behave a certain way any particular drug will work for me. He admits most drugs are garbage and are pushed by big pharma and actually is a very humble person. However, he recognized after several meetings and several hours of talking with me that I had a very real agitated depression. I'm committed to therapy and I'm extremely active in 12-step groups so I spend a LOT of time working on my attitude and my approach to life. Despite all this work I still had a baseline of depression that has been with me for 3+ years.


Posted by: David at November 19, 2009 10:42 AM

"it's real job is to effect dopamine and some seratonin levels. Since sleep can be a problem for people with depression and/or anxiety it can help two fold: help you get some Z's and boost some neuro-transmitters"

Now if you can show us all an accurate test and measurement; while giving some sort of consistent number to derive these absolutely amazing conclusions of some chemical brain chemistry imbalance; this statement you have made above might have reasonable credibility. Unfortunately this data does not exist in reality.

Do happen to know what is considered the reasonable normal level of these compounds seratonin and dopamine in human beings?


Maybe if you could just crack open your skull so everyone could see those under achieving neuro-transmitters taking a nap; then I can envision an actual Nobel Prize in your future.

Yet, seeing as you can not produce the actual evidential goods in your chemical imbalance theory; you just have the personal conjecture argument that really isn't worth any more weight than the 12 step groups you frequent.

I honestly hope for you all the best with your melancholy disposition which ever modality you wish to follow.

Self determination is actually a wonderful thing to have working for you. If you happen to believe a drug treatment works for you; then you should certainly follow that path for your self.

But to spout off on how effective this or any dangerous drug is when you take such a low dose; does come across as little short sighted and unwise considering consequences involved with all the drugs in these specific classifications have inherent life threatening adverse side effects.

There are those out here in the real world numbering in the tens and even hundreds of thousands; living the real devastating effects from this and like drugs. So please don't be surprised when those people become mildly incensed when others make light of resulting ramifications from Seroquel use and like compounds.

Posted by: MsPiggy at November 19, 2009 02:40 PM

I was prescribed Seroquel for insomnia (off-label! go AZ!)and that shit knocked me out, but the sleep was horrible, torture-type nightmares, and trainwreck fog in the morning that lasted 12-14 hours after the 50-75mg dose.

Benedryl does have the same effect and is dirt cheap compared to Seroquel and doesn't cause diabetes, and let's not forget the lawsuits (which are people)

I think Philip called it the "5th of whiskey head", so anyone who takes it and feels good, yay you.

Posted by: anonymous at November 19, 2009 04:19 PM

David,

Perhaps I could have been a bit more thorough. My apologies. 25 mg of seroquel is a very different drug, pharmacologically, than 250 mg in any human. Seroquel binds to a variety of receptors, but the receptor affinities are not equal. Seroquel is a very different drug at "sub-therapeutic" doses.

What this means is that seroquel will bind (near exclusively) with the receptor it has the highest affinity (histamine in this case) until saturation before it will seek others. Obviously this is a simplification, but there it is. At 25 mg, seroquel is a very potent anti-histamine. There are no pharmacological "anti-depressant" effects at this dose. You'd have to take 150 - 300 mg before you'd see any appreciable binding at 5HT or D2.

My point was that if you take 25mg seroquel for sleep (and sleep is a very good thing), then there are other cheaper, safer alternatives that have the same pharmacological effect.

And, yes a strong anti-histamine can be very sedating. Benadryl isn't innocuous but it is vastly safer then taking low dose seroquel for sleep - ymmv. Whether it is sufficiently effacacious is different question I admit.

Vistaril has been around since the mid 50's and is also an anti-cholinergic which can be problematic for some people. There are other alternatives to histamine blockers.

Informed consent is what concerns me most. I don't care what people do if they understand the implications. Anti-psychotics are exceedingly dangerous and it is my non-inexpert opinion that their use should be reserved for emergency, acute usage.

Also, regarding drug sensitivity. I've been discussing this with some colleagues for some time, and we have noticed that there seems to be sort connection with endocrine issues. I can't say whether this is a physiologic or pathway issue in the HPA or HPT axis, but it has my attention at least. I'm suspicious.

Oh, the Nobel prize? Apparently you can win the Peace prize without doing anything at all! No thanks, I'll stick to my day job.

Posted by: Paul at November 19, 2009 08:43 PM

"Also, regarding drug sensitivity. I've been discussing this with some colleagues for some time, and we have noticed that there seems to be sort connection with endocrine issues. I can't say whether this is a physiologic or pathway issue in the HPA or HPT axis, but it has my attention at least. I'm suspicious."

How very interesting. As most people here may know (ad nauseaum, no doubt) I had undiagnosed hypothyroidism for 25 years, during which time I was pumped full of the usual constellation of drugs. Treating the hypothyroidism lifted most of the depression (Vitamin D and walking took care of the rest).

Coincidentally, I have always been very sensitive to drugs. My PCP knows and understands this. The psychiatrists, of course, always refused to listen. Oh well, they're out of my life now.

When I was in my wild twenties I only took 1/3 of an LSD tab when others took a whole one. It wasn't until years later I discovered that even at that dose my trips were longer and much, much more hallucinogenized than those of my peers.

I never connected any of this with my endocrine disorder. I don't take pills at all, other than the thyroid and vitamin so I have no idea if I'm still sensitive to drugs. I try not to say anything about it to doctors anyway because I think I may as well wear a tee shirt that says "Annoying, Neurotic Patient" as use the word "sensitive" in any way to describe myself.

Thanks for the observation, Paul.

Posted by: Sherry at November 20, 2009 07:04 AM

FA: "I really don't understand how Seroquel (or any other major tranquillizer) is supposed to alleviate depression."

Dr. John: "That is because you have bought into the idea that "depression" is a thing with a specific pathology and specific biologic intervention."

Uh, actually, Dr. John, no I haven't.

Posted by: Francesca Allan at November 20, 2009 08:36 AM

http://bipolarsoupkitchen-stephany.blogspot.com/2009/10/astrazeneca-financial-ties-to-nobel.html

You might not want to aspire for the Nobel Prize anyhow:

From the article Dec, 2008 (link found in my blog post link up there)

"Questions are being raised about a web of financial ties between the drug maker AstraZeneca and the Nobel Prize Foundation. According to reports from Pharmalot and Discover Magazine, AstraZeneca has financially sponsored two of the Nobel Foundation subsidiaries and maintains strong financial ties to decision makers who actually award the Nobel Prize."

AND

"But that's not all: A member of the Nobel Committee serves on the AstraZeneca board, and another top representative of the Nobel Committee received money from AstraZeneca in 2006." (conflict of interest; COI)

Posted by: Stephany at November 20, 2009 01:00 PM
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