invincible summers

in the middle of winter I at last discovered that there was in me an invincible summer. (albert camus)

update on Seroquel/FDA committee hearings April 9, 2009

I’ve been so busy today I’m just now reading about the updates on the Seroquel hearings with the FDA. Surprising considering I’ve been following this story very closely.

Here is a snippet from the Reuters story:

AstraZeneca PLC (AZN.L) won partial support from U.S. advisers on Wednesday for its bid to expand the approved uses of a blockbuster schizophrenia drug.

A committee of Food and Drug Administration advisers said Seroquel XR was safe enough for treating some patients with depression but opposed use of the drug for fighting anxiety given the serious side effects.

The panel voted 6-3 that Seroquel XR had acceptable risks if it was added to other medicines to find a workable combination to alleviate depression. Several panel members stressed that doctors should try other treatments for depression first before deciding to add Seroquel XR.

“I think this represents a second-line therapy,” said panel member Frank Greenway, an endocrinologist at Pennington Biomedical Research Center in Louisiana.

The panel split 4-4, with one abstention, when asked if it was safe enough to use Seroquel XR as the only treatment for depression in some cases. Panelists said there were safer medicines that should be tried if only one medicine was going to be used.

The FDA will consider the panel’s input as it decides whether to approve the expanded use for Seroquel XR. The agency usually follows panel recommendations.

Seroquel is AstraZeneca’s second-best-selling drug with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formula.

Doctors are free to prescribe approved medicines for any use they see fit, but winning FDA approval for wider use would allow AstraZeneca to promote Seroquel XR more widely.

It’s always bothered me that doctors are free to prescribe Seroquel (and other psych meds) when they see fit. If they really cared about their patient’s health…they would not be doing this, knowing the dangers of the drug(s). But it’s all about the money and the quick fix. Seroquel brought in sales of $4.5 billion last year. And most doctors want to get patients out of their office as quickly as possible. Some are getting kick-backs from Big Pharma. You get the picture.

And here’s a bit from The Philadelphia Inquirer:

A government panel opened the door a crack yesterday toward allowing AstraZeneca P.L.C. to sell its Seroquel XR more widely, after an emotional meeting that included stories from two families who say their loved ones died after taking the powerful antipsychotic.

The Food and Drug Administration advisory committee recommended the agency approve Seroquel XR for use as an additional therapy in patients suffering from depression who do not respond adequately to their current medications. AstraZeneca, whose U.S. headquarters are in Wilmington, had asked the panel to approve Seroquel much more broadly, to treat depression and anxiety as a single therapy.

Recommending the broader use would have dramatically expanded the market for Seroquel. The drug is currently approved to treat schizophrenia and bipolar disorder, relatively rare diseases, and generates $4.47 billion in yearly sales.

Depression and anxiety, by contrast, affect 10 percent to 20 percent of the population. Wyeth’s Effexor XR, one of the world’s top-selling antidepressants, generates about $4 billion in sales annually.

“It’s certainly going to help their bottom line, but it’s not the great victory they had hoped for,” said Daniel Carlat, a Tufts University psychiatrist who was not on the advisory panel. He said companies can use such narrow approvals to market a drug more widely.

Bristol-Myers Squibb, for example, has heavily advertised its schizophrenia drug Abilify in TV ads since winning approval for its use as an add-on treatment for depression.

The FDA could still decide to approve Seroquel for even broader uses, but the agency usually follows the recommendations of its advisory panels.

In a statement, Howard Hutchinson, chief medical officer of AstraZeneca, said, “We are pleased that the committee found Seroquel XR to be effective and acceptably safe for use as adjunctive therapy for treatment of [depression]. . . We look forward to having further discussions with the FDA.”

Basically, it seems the panel thinks Seroquel XR should only be used as an additional therapy with patients suffering from depression. As of now, AstraZeneca did not get the approval they wanted: to treat depression and anxiety as a single therapy with Seroquel XR.

So, it still boggles my mind that a drug which notoriously knocks you out, I called it my zombie drug….a drug that is linked to weight gain and diabetes (meanwhile AstraZeneca hid this data for over 10 years) is even being considered as a treatment for depression and anxiety. What kind of treatment is that? In simple terms: pretend you’re Sally Sue and you go to your doctor because you’re feeling depressed and your doctor whips out a handy sample of Seroquel provided by their pharma pimp, er, rep. Sally goes home thinking-finally, I’ll get out of this depression and instead she gets some of these side effects, straight from Seroquel’s website:

* High blood sugar and diabetes have been reported with Seroquel XR, Seroquel, and medicines like them. If you have diabetes or risk factors such as obesity or a family history of diabetes, ask your doctor about checking your blood sugar before starting Seroquel XR or Seroquel and regularly throughout treatment. If you develop symptoms of high blood sugar or diabetes, such as excessive thirst or hunger, increased urination, or weakness, contact your doctor. Complications from diabetes can be serious and even life threatening.

NOTE: I’m sorry but this is misleading-you do not need to have a family history of diabetes-many people gain TONS of weight on this drug-I was healthy and fit and gained 40 pounds to two months solely from Seroquel. I’m sick and tired of the “blame the family history” line.

* Increases in cholesterol and triglycerides, and weight gain have been reported with Seroquel XR and Seroquel.

* A rare, but potentially fatal, side effect reported with Seroquel XR, Seroquel, and medicines like them is neuroleptic malignant syndrome (NMS). Tell your doctor if you have very high fever; rigid muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness because treatment should be stopped if you have NMS.

* Another serious side effect reported with Seroquel XR, Seroquel, and medicines like them is tardive dyskinesia (TD)—uncontrollable movements of the face, tongue, or other parts of the body. TD may become permanent, and the risk of TD is believed to increase as the length of time on and the amount of these medications increase. While TD can develop in patients taking low doses for short periods, this is much less common. There is no known treatment for TD, but it may go away partially or completely if treatment is stopped.

* Before starting treatment, tell your doctor if you have high prolactin levels or have a history of, or are at risk for, seizures or a low white blood cell (WBC) count. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter. During treatment, tell your doctor if you feel dizzy or lightheaded upon standing. Suicidal thoughts or actions may occur; tell your doctor if you have thoughts about death or suicide. Since drowsiness has been reported with Seroquel XR and Seroquel, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid drinking alcohol while taking Seroquel XR or Seroquel because both drugs increase the effects of alcohol. Avoid becoming overheated or dehydrated while taking Seroquel XR or Seroquel.

NOTE: I was never told to have eye exams. and, um, you should not participate in activities such as driving or operating machinery until you know that you can do so safely???? this speaks volumes.

* Common side effects: The most common side effects are drowsiness, dry mouth, increases in cholesterol and triglycerides, dizziness, increased hunger, increases in blood sugar, constipation, weakness, tiredness, weight gain, upset stomach, abdominal pain, a sudden drop in blood pressure upon standing, sore throat, difficulty speaking, stuffy nose, abnormal liver tests, and sluggishness.

drowsiness? um, more like lifeless. Regardless-how are any of the above going to help a patient with depression or anxiety. Truly-think about it. This is absolutely absurd!

This isn’t over yet and the FDA better not disappoint any further than they already have.

I encourage you to click on all the links and read the entire stories. And I will end with this, if you are considering taking Seroquel for depression or anxiety, remember this:

Federal health experts said overwhelmingly Wednesday, April 8th, 2009 that the side effects of AstraZeneca’s schizophrenia drug Seroquel are too worrisome to make it a first choice against depression.

or think of Eric Layne, whose widow testified during Wednesday’s hearings:

Eric Layne died at home in West Virginia in January 2008 while his wife was pregnant with their second child, Jubilee, who accompanied her mother to yesterday’s hearing.

“I am the widow of Sgt. Eric Layne. I found my husband dead when our son, Shamus, was 17 months old,” Janette Layne told the committee between her tears.

“In summer of 2007, he began taking Klonopin and Seroquel. He ate excessively and would fall asleep with food in his mouth. He had tremors and was extremely lethargic. His speech was slurred to the point I couldn’t tell what he was saying. Eric did not have any of these problems before he took these medications.”

She showed a short video of her husband slumped over a table in their home and barely able to respond to her questions on Christmas, shortly before he died at age 29.

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