Breaking news in the Seroquel debacle May 21, 2009

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.

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.

Seroquel and diabetes April 6, 2009

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

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/
Out Click
Time Zone unknown
Visitor’s Time Unknown

AstraZeneca and Seroquel on front page of WP March 18, 2009

Today, AstraZeneca and the Seroquel debacle are on the front page of the Washington Post. I’m posting some of my favorite snippets but I encourage you to read the entire article linked above.

A Silenced Drug Study Creates An Uproar
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, March 18, 2009; Page A01

The study would come to be called “cursed,” but it started out just as Study 15.

It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15′s results suggested otherwise.

As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don’t like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found — and raised serious concerns about an entire new class of expensive drugs.

Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International — including nearly $12 billion in the past three years.

how to testify to the FDA on Seroquel March 17, 2009

Folks, this is so very important. If you have been on Seroquel or you’re taking Seroquel, you know the dangers and side effects of this drug.

Personally, I wish I had the money to go and testify in person. I also wish I had the money to rent a bus (or several) and head to AstraZeneca’s headquarters. We need to be heard. We must at least send a message to the FDA by testifying, this is our chance! If our voices are not heard, this drug will be most likely be approved for depression, anxiety, etc. We cannot let this happen. This is our chance to stop the cycle and save lives.

Please click HERE to find out how to testify.

same to you, Johnson & Johnson March 17, 2009

By now we all know the Wayne MacFadden story, if you don’t, you can find more at this website, google him or click here. I have no idea what the website spoke.com is, but regardless, Wayne is listed there as an employee of J & J.

Wayne Macfadden
Johnson & Johnson
1 Johnson And Johnson Plz
New Brunswick, NJ 08933-0001

Is this why Johnson & Johnson came to my site today via the Seroquel sex emails link? Who knows. But, whoever you are at J & J snooping around-see my post below to AstraZeneca. And I’ll ask you, are you taking Risperdal? Would you *pimp* this drug out to your friends, family members or children?

Of course, if MacFadden is now an employee at J & J maybe it’s him. I can just see him at his computer, popping Vicodin, googling “Wayne MacFadden sex seroquel” and ending up here. Meanwhile, he has a chat window open and he’s furiously typing away, promising to *punish* a girl over at Eli Lilly. Or Wyeth. oh, I give up….

Domain Name jnj.com ? (Commercial)
IP Address 148.177.1.# (Johnson & Johnson)
ISP Johnson & Johnson
Location
Continent : North America
Country : United States (Facts)
State : New Jersey
City : Hopewell
Lat/Long : 40.3933, -74.7855 (Map)
Language unknown
Operating System Microsoft Win2000
Browser Internet Explorer 6.0
Mozilla/4.0 (compatible; MSIE 6.0; Windows NT 5.0; .NET CLR 2.0.50727; MS-RTC LM 8)
Javascript disabled
Time of Visit Mar 17 2009 3:23:57 pm
Last Page View Mar 17 2009 3:23:57 pm
Visit Length 0 seconds
Page Views 1
Referring URL unknown
Visit Entry Page http://invinciblesum…uel-internal-emails/
Visit Exit Page http://invinciblesum…uel-internal-emails/
Out Click
Time Zone unknown
Visitor’s Time Unknown

Hello AstraZeneca, here’s a little Bob Dylan for you. March 17, 2009

Hello there. You guys are always here and I think you know my story. What is your name? What is your story? Until you’d like to share, please stop visiting. Or did my last message to you piss you off so much that it left you speechless and you simply couldn’t comment? Or maybe you were sitting at your desk snickering and thinking: another crazy girl who’s gone off her meds! No, I bet I know what it is, you’re taking Seroquel! Your speech is slurred and you can hardly type or put a sentence together! I’m surprised you’re even awake this early, it’s not easy, I know from previous experience! A few more questions for you, my dear reader:

Do you have a child or a friend or a loved one? Is he or she depressed? If so, have you suggested Seroquel for their depression? And lastly, if you are taking Seroquel, have you been to your doctor lately to check for diabetes?

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; AZ US; .NET CLR 1.0.3705; .NET CLR 1.1.4322; .NET CLR 2.0.50727)
Javascript disabled
Time of Visit Mar 17 2009 9:43:57 am
Last Page View Mar 17 2009 9:43:57 am
Visit Length 0 seconds
Page Views 1
Referring URL unknown
Visit Entry Page http://invinciblesum…re-corrupt-everyday/
Visit Exit Page http://invinciblesum…re-corrupt-everyday/
Out Click
Time Zone unknown
Visitor’s Time Unknown

I’ll end this entry with the great Bob Dylan. Maybe you’ll hear his words over and over in your head today, tomorrow and the next….

AstraZeneca-more corrupt everyday March 16, 2009

Here’s the latest on the AstraZeneca/Seroquel drama:

In the court of public opinion, AstraZeneca is taking a beating over its handling of Seroquel, the blockbuster antipsychotic pill that’s the subject of thousands of consumer lawsuits claiming it caused their diabetes. In the court of law, though, the drug maker is fighting back.

A three-day hearing in Delaware Superior Court last week offered a preview of how AstraZeneca lawyers intend to thwart plaintiffs who blame Seroquel for their diabetes. The company faces lawsuits from more than 15,000 plaintiffs, including hundreds of cases in Delaware, where Seroquel was developed and where AstraZeneca has its U.S. headquarters.

During last week’s hearing — a pretrial proceeding in what could be the first Seroquel case in the country to go to trial — AstraZeneca’s attorneys tried to convince Judge Joseph Slights III to throw out testimony from three expert witnesses who connected Seroquel use to diabetes.

Attorneys and plaintiffs are now watching to see how Slights will rule. A win for AstraZeneca could avert a trial scheduled to start June 29.

now, here is the very interesting part:

The case was brought by Kansas resident Nina Scaife, 46, who started taking Seroquel in May 2003 and was diagnosed with diabetes a year later, according to testimony.

AstraZeneca, which has said that it will litigate each Seroquel case on its individual merits, argued that Scaife’s expert witnesses failed to examine the scientific issues rigorously enough to satisfy legal requirements.

Moreover, the drug maker’s attorneys said, Scaife — and all the other plaintiffs to date — have additional risk factors for diabetes that make it impossible to single out Seroquel as the cause of the disease. In the case of Scaife, for instance, lawyers argued that factors including her obesity and African-American ethnicity had already elevated her risk of diabetes before she took Seroquel.

“I can’t see how the plaintiffs can win,” said Michael Kelly, a Wilmington-based partner in the law firm McCarter & English, who’s slated to try the Scaife case for AstraZeneca.

AstraZeneca is arguing the factors including this woman’s obesity and African-American ethnicity had already elevated her risk of diabetes before she took Seroquel. Really? Disgusting. Well, AstraZeneca, I gained 40 pounds in two months on your lovely drug, Seroquel. I am Caucasian. I was never overweight until I began my journey with psychiatric meds. My grandmother died entirely too young due to complications from diabetes and guess what- she was on psychiatric medications for many, many years.

A question for you, AstraZeneca: Tell me, how many years have you known (and hid the data) that your drug was linked to weight gain and diabetes???? Would you say, for nearly ten years??? And lastly, a note to you, AstraZeneca: excuse my language but, f**k off. you make me sick.

To read more on this story click here or here.

seroquel internal emails March 15, 2009

oh jeez. really. i am speechless. just CLICK HERE and download/read the the emails. it will take all but 5 minutes of your time. i might post more later but this crap just makes me sick. need some time to breathe. breathe. breathe.

and for more on this bizarre, truly messed up, um, um….just click here.

SICK of big pharma and doctors March 2, 2009

I must begin by saying I’ve been sick since before or on the week of February 16th, it’s been so long, I can’t remember. It began with a sinus infection and after taking a 5 day Z-pak, well, I got sicker. Go figure. I don’t know why I’m surprised. I’m thinking I’m pretty close to pneumonia at this point, I have all the symptoms minus the fever. I’ve had horrible side effects and found via this website that my side effects are not uncommon. Not to get too terribly gross here but constant diarrhea (with blood one day), no taste buds, heavy chest congestion, headaches, body aches, exhaustion, dehydration (no matter how much water I drink) and constant drainage. I’ve taken a Z-pak before, years ago, and had zero side effects. Something has changed and something tells me Big Pharma is involved. I believe Pfizer produces the Z-pak. Needless to say, this post might not make sense being that I’m way beyond feeling good. And none of this is easy dealing with when you are uninsured.

If you’re not a regular reader you might wonder why I am SICK of big pharma and doctors. First of all, let me state, I do feel lucky. Don’t get me wrong. I could be dealing with an incurable cancer, I could have an incurable disease, RRP, that my sister has. I know that I am lucky. However, for nearly 23 years I have been dealing with a mental illness. Fighting the good fight. I’ve spent tens of thousands of dollars on therapy, hospitals, medications, etc. None of which worked. period. Most importantly, I continue to run into these stories:

Recently news broke that AstraZeneca buried Seroquel studies. Just take a look at part of the story if you don’t feel like clicking on the link, but I suggest you read the entire story and do your own research:

speaking (slurring) of seroquel December 26, 2008

This news is absolutely ridiculous. pathetic. sad. infuriating.

AstraZeneca PLC said Wednesday that the U.S. Food and Drug Administration has asked for more information regarding the drug Seroquel, which AstraZeneca is trying to get approved for use by people suffering from depression.

read more here.

I’d like to hear from one person who has taken Seroquel for depression or bipolar and did not feel drugged all the time. who didn’t sleep all the time. maybe your speech was slurred or you felt underwater. I would certainly like to hear from someone who did not gain (a lot of) weight on this drug.

and let’s not forget those who were diagnosed with diabetes after taking this disgusting medication. don’t believe me? read this article, Dying from Diabetes: The mentally ill.

I am convinced Seroquel will not help those who are depressed. The only thing it will do is knock them out. How the %*$* is that helping?!?

a message to the U.S. Food and Drug Administration:
Do the right thing! Listen to the patients of the world-not Big Pharma!