invincible summers

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

Breaking news in the Seroquel debacle May 21, 2009

Filed under: antipsychotics,big pharma,corruption — clementine @ 4:07 am
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I’ve been following this for far too long…I had to post something. PLEASE click on this link as Furious Seasons has been covering this story in great detail for quite a long time.

FS sums it up best: AstraZeneca Exec Admits “Fuck-Ups” In Seroquel Study, Published Article.

I wish I could comment more, but I can’t. I’m about to delve into some heavy sexual abuse therapy. I have found a wonderful, loving, compassionate place and I’m feeling very hopeful for the first time in a long time. I’ll be facing the trauma/rape I experienced at 15. Although this will be a very painful process, my hope is, I will come out stronger, healthier and happier. I am still traveling the alternative path after ‘waking up’ and seeing/experiencing the dangers of the many medications I have been prescribed and taken for nearly 20 years. Seroquel being the worst. You can find my experiences with Seroquel by simply searching here but first, please click on the link mentioned above and well, yeah, just do it.

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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. (more…)

 

Seroquel and diabetes April 6, 2009

Filed under: big pharma,corruption,evil corporations,FDA — clementine @ 12:52 am
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So, in case you don’t know (and if you’re a regular reader, yes, I know you do) Seroquel is linked to diabetes and a host of other illnesses and ailments. We know that the maker of Seroquel, AstraZeneca, buried studies for nearly 10 years in regards to all of this. Of course I’m disgusted by this. We all are.

And something that is equally disturbing, which I have voiced here before, the makers of these drugs that lead to weight gain and diabetes almost always have a drug that treats diabetes.The FDA is considering two new drugs to improve blood sugar control in people with diabetes. And you guessed it, AstraZeneca is behind this. Their new drug to treat diabetes? ONGLYZA™.

Once again, I’ll end with Bill Maher:

The government isn’t your nanny-they’re your dealer….
There’s no money in healthy people.

 

paging Bill Maher and Sen. Grassley April 5, 2009

thanks to Stan for alerting me of this new information and here’s a snippet from the Philadelphia Inquirer:

AstraZeneca P.L.C. paid Florida child psychiatrist Jorge Armenteros to talk to other doctors about prescribing Seroquel, the company’s powerful antipsychotic.

And until yesterday, Armenteros also was listed as the chair and a voting member of a Food and Drug Administration advisory committee with a lot of power over Seroquel, which generated $4.45 billion in sales last year for AstraZeneca, whose U.S. headquarters are in Wilmington.

On Wednesday, the advisory committee is expected to decide whether to expand dramatically the use of Seroquel XR, an extended-release version of the drug, which is used to treat depression and anxiety. But five members – including Armenteros, who did not return a call to his Coral Gables, Fla., office seeking comment – will not be voting.

Why not?

Paul Pennock and Steve Sheller, lawyers who are suing AstraZeneca and other makers of antipsychotics on behalf of patients who say the drugs triggered their diabetes, say it’s because they uncovered company documents revealing potential conflicts of interest.

AstraZeneca said yesterday it had no say regarding which committee members vote, and referred questions to the FDA.

Company spokesman Tony Jewell said, “AstraZeneca believes the Advisory Board and the FDA will make the appropriate scientific and medical determination concerning the benefit-risk profile of the company’s supplemental new drug applications for Seroquel XR in major depressive disorder and generalized anxiety disorder.”

FDA spokeswoman Sandy Walsh said that temporary members sometimes replace standing committee members but that the agency does not say why such substitutions occur. Armenteros remains the chair of the standing committee until his term expires in June, she said.

So, this news seems to debunk my Bob Dylan, the times they are a changin’ theory. We can’t trust anyone. Why am I surprised? This news is extremely disturbing and I take it personally because well, I took Seroquel. I continue to see doctors push it. My grandmother died from complications of diabetes and she’d been on psych meds most of her life. This is not a game. We are not guinea pigs. We are human beings.

I’d like to see Senator Grassley on this committee. Also, let’s see, um, Bill Maher. And the millions of patients that have taken Seroquel. Sure some of us may have a conflict of interest but it would be something desperately needed here: THE TRUTH.

 

Seroquel documents at FDA website April 4, 2009

Filed under: antipsychotics,big pharma,FDA — clementine @ 12:37 pm
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From the WSJ health blog:

The FDA was a bit quick on the trigger in making public some documents about AstraZeneca’s Seroquel this morning.

The agency posted briefing documents on its Web site for an advisory committee meeting coming up on Wednesday to discuss AstraZeneca’s application for approval of an extended-release version of Seroquel for generalized anxiety disorder and major depression. Later, the documents were taken down.

Since some people had already gotten their hands on the documents before they disappeared, AstraZeneca responded by posting them on its own site “to ensure that all investors have access to the information contained in the previously released FDA briefing materials,” the company said.

The FDA also returned the documents to its site. FDA spokeswoman Sandy Walsh tells the Health Blog that the materials “were inadvertently posted by the FDA” the first time around. Normally, such documents are made available 48 hours before the meeting, she explains. But given they went up early, the documents “should have remained posted,” Walsh says. “We regret any confusion that may have resulted.”

As for the documents’ contents, Jennifer Corbett-Dooren of Dow Jones Newswires managed to get this article done amid the snafus. The FDA expressed concern about expanding use of Seroquel to a wide population amid possible increased risk of heart problems, Corbett-Dooren reports.

 

Oh Jesus H. Joe… March 21, 2009

I’m pretty much speechless here. Actually, I’m also quite tired and simply cannot find the words. Sooo….

From the IN VIVO blog:

Do you remember Joseph Biederman?

He’s the Harvard University psychiatrist who is one of several prominent academics being investigated by the US Senate Finance Committee for allegedly failing to properly disclose payments from the pharmaceutical industry, while also conducting grants for the National Institutes of Health (see background).

In Biederman’s case, he allegedly failed to fully report approximately $1.6 million in consulting fees from various drugmakers between 2000 and 2007, according to the committee. And court documents released late last year suggested he also pushed Johnson & Johnson to fund a research center at Massachusetts General Hospital that would advance J&J’s commercial goals (take a look).

As a result, Biederman is currently enmeshed in litigation in the Superior Court of New Jersey, where three drugmakers – AstraZeneca, Eli Lilly and J&J’s Janssen unit -are being sued in connection with risks associated with their antipsychotic medications. Attorneys for the families who filed suit fought to interview Biederman under oath because his work has been crucial to the widespread acceptance of the pediatric usage of antipsychotics.

Now, though, Biederman is hoping Superior Court Judge Jamie Happas will agree to have his deposition sealed, because he doesn’t want the extent of his involvement with the companies publicized. However, we understand The New York Times is already gearing up for a story, which prompted Biederman’s attorneys to write this letter to Happas.

What’s in the deposition? Dozens and dozens of pages of detail relating to Biederman’s activities, but we encourage you to peruse both sections of the document.

Please visit the IN VIVO blog to download the deposition.

When Biederman is quizzed about his professional ranking at Harvard, well, here is his response:

Lawyer: “What does that mean?”

Biederman: “To move in the ranks from one rank, for example, at Harvard, there is instructor, from instructor you move to assistant professor, from assistant professor you move to associate professor, from associate professsor you move to full professor.”

Lawyer: “Full professor?”

Biederman: “Hm…mmm.”

Lawyer: “What rank are you?”

Biederman: “Full professor.”

Lawyer: “What’s after that?”

Biederman: “God”

Lawyer: “Did you say God?”

Biederman: “Yeah.”

yeah. you read that correctly.

and then there’s this:

Q. And do you agree that you are one of the most forceful advocates of the aggressive treatment of preschoolers?

A.(Biederman)It is her statement about me.

Q.I didn’t ask you if it was her statement about you.I’m asking you if you agree that you are one of the most forceful advocates of the aggressive treatment of preschoolers.

A.(Biederman) I am.

lock this guy up now for the love of, um, GOD…

opinions of this story are all over the place. here’s the NY Times piece, Furious Seasons, Beyond Meds, soulful sepulcher, The Carlat Psychiatry Blog and the Boston Globe to name a few.

 

AstraZeneca, you’re back! March 18, 2009

Dear AstraZeneca,

So, you’ve decided to visit three times between and 10:40am and 11:35am. And that was before I posted the link on the story at the Washington Post airing your dirty laundry. Here’s another link, just for fun, from the LA Times where they too have the WP story. You guys can’t buy your way out of this press. It also looks like you noticed the link explaining how patients (we are human beings, not guinea pigs) can now testify in regards to your hearings on applications to have your antipsychotic Seroquel approved by the FDA for depression, anxiety and whatnot. Did you not like the Bob Dylan video in my previous post to you? Well, here’s another version, enjoy it while you can!!!

Domain Name (Unknown)
IP Address 156.70.222.# (Astra Zeneca)
ISP Astra Zeneca
Location
Continent : North America
Country : United States (Facts)
State : Pennsylvania
City : Concordville
Lat/Long : 39.8886, -75.5143 (Map)
Language unknown
Operating System Microsoft Win2000
Browser Internet Explorer 6.0
Mozilla/4.0 (compatible; MSIE 6.0; Windows NT 5.0; SV1; @; .NET CLR 1.0.3705; .NET CLR 1.1.4322; .NET CLR 2.0.50727)
Javascript disabled
Time of Visit Mar 18 2009 11:34:15 am
Last Page View Mar 18 2009 11:35:29 am
Visit Length 1 minute 14 seconds
Page Views 2
Referring URL unknown
Visit Entry Page http://invinciblesum…you-johnson-johnson/
Visit Exit Page http://invinciblesum…seroquel-experience/
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