Wednesday, August 25, 2010

AstraZeneca - Seroquel - Walk Down Memory Lane - Carl Elliott - "Making A Killing"

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Note: I thought I would bring this post written March 22, 2010 back to the top today, Since it so closely related to the News of the Day, and the Mother Jones Article By Carl Elliott MD "Making A Killing". Is this "Deja Vu" or just another scary reminder that in the pharmaceutical corporate world nothing really changes except the buried names of the victims.

AstraZeneca - Seroquel the powerful tranquilizer anti-psychotic being advertised as an anti-depressant. How lies and misleading marketing work.

A hat tip goes out to pharmagossip for bringing this above ad to my attention. So now after misleading a jury in a New Jersey court room: this is how a so called responsible corporation "AZ" acts as they again purposely market and hide dangerous side effects associated with the drug Seroquel.

It's appears Big Pharma never learn when greed/profit are always their ultimate master; as here we go again with AZ using the same misleading lies and marketing tactics in Canada.

I have to wonder out loud when our Government, the DOJ, and the FDA will wake up and smell all this extreme marketing bullshit AZ constantly throws at consumers and doctors.

Bipolar depression doesn't consume you folks. AstraZeneca consumes you, they want to consume your bank account, and your personal health until death do you part.



Update/Addition: Some might be thinking to themselves that I'm being to harsh on these pharmaceutical corporate criminals here on this site even though Pharma Corporations have bought/purchased conflict of interest influence directly through many trumped up advocacy groups/organizations (direct Pharma marketing fronts such as with NAMI), being one of the largest lobbying spenders in federal and state capitals (including a wide open door to the Obama White House with untold millions in cash for policy deals), and how they have basically hooked/addicted university's and doctors on their steady flow of cash which in all cases tarnish and brings into the question the ethical and moral underpinnings in each of the proceeding entities mentioned here.

So your life and health have been virtually sold to the highest bidder so to speak.

My question is how many people have to be permanently disabled or killed before we start holding each link in this chain of blatant criminal inhumanity responsible for their unquenchable greed and evil self serving ways.

This is an interesting article over at Pharmalot worth reading related to the topic of Pharmaceutical corporate shenanigans within medicine and it's results upon public perception.
Psychiatrists And Pharma: Undue Influence?

You can also read about how anti-psychotics are being marketed to our armed forces with the devastating consequences that are created in their personal lives, diminish their effectiveness in war zone situations, and in the end may damage our national security. Why Are So Many Soldiers On Antipsychotics?

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The comment section on this topic has been buzzing with such good information, that I have decided to add some of those comments to the front page here.

mike howard said...

One only has to look at Dr. Charles Schulz from the University of Minnesota and see how profitable pimping for AstraZeneca and seroquel is. It's never about researching for a cause/cure for mental illness, it's solely about just "treating" the symptoms and keeping the patient barely functioning as to keep the drug/cash flowing. Until America wakes up and realizes they have duped by the so-called psychiatric society things will just go on the same way. With psychiatric research its come down to "we don't care how the patient is doing, just how many have you enrolled. "First do no harm" went out the window long ago.


One only has to look at Dr. Charles Schulz at the University of Minnesota. He has the legend in his own mind mentality as far as pimping for AstraZeneca and falsifying Seroquel trial data. It's never about researching for a cause/cure for any psychiatric disease, it's more profitable to just keep people alive and "treat" the symptoms.

March 26, 2010 3:47 AM

Delete

Blogger Stephany said...

Well, here he is:

http://www.psychiatry.umn.edu/faculty/schulz/home.html

Founder and Director, Schizophrenia Program, MCV, 1980-83
Medical Director, Schizophrenia Module, University of Pittsburgh, 1983-86
Schizophrenia Research Branch, NIMH, 1986-89
Professor and Chair, Department of Psychiatry, Case Western Reserve University, 1989-99

Responsibilities/Activities in this Residency:
Head of Department of Psychiatry
Course director, Resident didactics
Lecturer, Resident didactics
Research supervisor

Research/Scholarly Interests:
Schizophrenia
Borderline personality disorder
Psychiatric illnesses in adolescents

--
http://www.ahrp.org/cms/content/view/548/70/

"By early 2000, Seroquel had been on the market for three years. Psychiatrist Charles Schulz MD--who received hundreds of thousands of dollars as a paid consultant to AstraZeneca and Eli Lilly--presented a report at the APA meeting that he said was based on his analysis of 1,800 patients in four separate trials. His conclusion: patients on Seroquel were more likely to show marked improvement...that Seroquel was significantly superior to other drugs.

However, the company's analysis of the data contradicted his pronouncements. Minnesota press reports describe internal emails by AstraZeneca officials, such as John Tumas, warning on March 23, 2000, after an internal company analysis of the raw data that:

"The data don't look good...What seems to be the case is that we were highlighting the only good stuff... It is clear that a claim of superiority for Seroquel over Haloperidol (Haldol) could not be generated using these data...In fact, I don't think we can even get a paper out of this."

Nevertheless, when Dr. Schulz presented his report, AstraZeneca issued a news release headlined "An analysis suggests Seroquel (R) has greater efficacy than Haloperidol." It quoted Schulz saying: "I hope that our findings help physicians better understand the dramatic benefits of newer medications like Seroquel.''

Glen Spielmans, an assistant professor of psychology at Metropolitan State University, who has reviewed the documents smelled something fishy: "These two things, they don't go together. Either the (company) analysis was wrong or Schulz's presentation was wrong."

Looks like another AZ pimp, like Reinstein and the rest of them, these people DESERVE PRISON TIME.

March 26, 2010 8:28 AM

Delete

Blogger Stephany said...

The above links to that doctor as well as this one could seriously be a post, but here it is:

http://www.twincities.com/ci_9292549

Patient dies in drug trial in the doctor's care

"He was then transferred to the University of Minnesota Medical Center, Fairview.

Weiss said discussions about research started right away at the hospital. Markingson was placed in Fairview's Station 12, a new unit at the time created to treat psychotic patients and screen them for research. Olson and Dr. Charles Schulz, head of the U's psychiatry department, helped launch the unit in part to enhance the hospital's startup schizophrenia program and meet the U's mandate to bring in more research dollars."

"A judge agreed Nov. 20 with Olson's new recommendation, requiring Markingson to follow the doctor's treatment plan. The next day, Markingson signed a consent form to be part of a national anti-psychotic drug study, Comparison of Atypicals for First Episode, or CAFE.

Weiss didn't understand. How could her son be deemed incapable of making decisions one day and then consent to a drug study the next?

The study, funded by drugmaker AstraZeneca and spread among 26 institutions, compared the effectiveness of three commonly used anti-psychotic drugs — Seroquel, Zyprexa and Risperdal."

"Full participation required Markingson to take one anti-psychotic drug for up to a year and to appear at the U for checkups. Markingson received AstraZeneca's Seroquel. As Subject 13, Markingson was worth $15,000 to the U, with some of that going to Olson's salary and the psychiatry department. Switching or adding medications could have disqualified Markingson and halted payments to Olson and the department from AstraZeneca."

"The state ombudsman raised concerns after Markingson's suicide, including the method of ensuring that patients were taking their pills and the ethics of one doctor both recruiting and treating a patient. The report also questioned whether Markingson was truly eligible for the study, because he wasn't diagnosed with schizophrenia until several weeks after he had enrolled."

---

We know how "informed consent" works in these places, what a tragic nightmare.

Update: April 14, 2010

This story never seems to end, just like AstraZeneca's criminal greed mongering never ends.

Here is a eye opening list of "Doctor Death's" gravy train payoffs from AZ to perpetrate dangerous lies as a spokes person and distribution icon for AstraZeneca Pharmaceuticals


Photo of Doctor Death

All 20 pages of them!

Please go read this pdf: both quite disturbing and eye opening: link: Source

The back story of Doctor Death's and AstraZeneca's pay to poison scheme- @ pharmagossip Back story here.

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Update: August 29, 2010 - at the Apologist - Carlat Psychiatry blog there is a good conversation going on about Carl Elliott's article "Making A Killing", and the AstraZeneca Seroquel CAFE study. Carlat is starting to play both sides of the fence now, while backtracking somewhat from his first post that was more critical involving this issue. This comes as no surprise really, He has played apologist for J. Beiderman because he was a supposed OK guy when he was not drugging up preschoolers and hiding huge unethical Big Pharma payoffs. The main reason I'm linking and directing people to this post is for the comment section, where there is some excellent discourse going on with some well articulated points being made. Well worth your time to peek in on.
Was the CAFE study manipulated by AstraZeneca? Maybe Not.

This is one great & stellar example of a comment section being much more informative and enlightening than the blog article itself. read for yourself, I believe you will find it both interesting and quite educational:


Bernard Carroll said...

Upon re-reading the CAFE report, I am struck by how the entanglement with a commercial entity has influenced the scientific agenda of these academic investigators. There is little doubt that AstraZeneca’s participation shaped the study design and the reporting. A few observations will make this clear. The main CAFE report is McEvoy JP et al American Journal of Psychiatry 2007;164:1050-1060. It helps to read it along with a companion paper: Perkins DO et al Journal of Clinical Psychiatry 2008;69:106-113.

1. AZ was the primary sponsor of the trial (see ClinicalTrials.gov).
2. AZ paid for the study.
3. Three of the named authors are AZ employees.
4. The focus was restricted to the comparison of three second generation (‘atypical’) antipsychotic drugs, excluding classical agents like perphenazine that performed so well in CATIE. This decision is pure marketing. It is like the Coke versus Pepsi ads that portray a choice as though no other options existed. This decision confirms that the study is an experimercial, designed to feature the sponsor’s drug in a market niche, which in this case is first episode psychosis.
5. The featured primary endpoint of retention over 12 months has no intuitive clinical meaning – a good number dropped out because they achieved response and disliked the medication. Not all of these discontinued against medical advice. There is no breakout of the numbers – once again the focus is not on clinical process or patient satisfaction.
6. Thus the featured primary endpoint is not an acceptable surrogate for patient improvement. In this non-inferiority trial, choosing an administrative rather than a clinical primary endpoint biases the study towards finding no difference between treatments. That would be consistent with the sponsor’s hopes.
7. There is evidence of cutting corners in patient recruitment. An unknown number of cases were enrolled with just 2 weeks duration of symptoms (see Table 1). By definition, these cases could not meet the diagnostic criteria for any of the relevant diagnoses – schizophrenia or schizoaffective disorder or schizophreniform disorder. This evidence suggests that there was pressure to achieve enrolment targets. Typically, such pressure originates with sponsors.
8. An important clinical question is whether outcomes differed by diagnosis. For instance, one might expect better improvement in cases with diagnoses of schizophreniform disorder, who comprised 29% of the full sample. No information is given on this matter. Really, clinicians would like to know.
9. Concomitant medication was used by over a quarter of the cases. However, no information is given about whether these cases overall fared better or worse than the others. The Perkins report addresses the issue of clinical predictors of dropout, and noted poor treatment response, substance abuse and depression as important factors. Really, clinicians would like to know whether adding other medications makes a difference in this population.
10. The overall rate of categorical treatment response “at some point during the study” was approximately 60% but no information was given about the timing of these responses by drug. An improvement by 12 weeks is very different from an improvement by 52 weeks. Really, clinicians would like to know how the drugs compared on this measure.
11. Finally, in resonance with my earlier comment about treating patients as commodities, there is no mention of follow-up. How many patients who discontinued after responding later relapsed, and when? How many patients received diagnostic reassignment during the 12 months of the study or later from schizophreniform to schizophrenia or from schizophrenia to bipolar disorder? These are important clinical issues that seem to have been neglected.

Joel Hassman, MD said...

You know what, someone has to go out on the proverbial limb and call Astra Zeneca for what their agenda has been since 2000--pushing the ceiling too high!!!

I go to a drug dinner, my last I think, to hear this doc from Chicago talk of how you can easily go to 1000mg and most patients tolerate it. Well, I was not well received in challenging it the room, and the honeymoon was over for me to look to Seroquel as a medication thereafter, especially when the anxiolytic agenda was revealed about two years ago!

Docs know what are equivalent doses for what diagnosis we are applying antipsychotics for, and for these drug companies to be so bold and flagrantly manipulative to do otherwise is, well, disgusting!

So, as you know well from me, no sugar coating here! And do not get me started on Bristol Myers marketing campaign regarding Abilify! And to push more than 10mg as an adjunct, !?!?.

But, another story, another time. Enjoy this weekend in New England, I know I will!!!

Anonymous said...

All I know is that whenever Nemeroff was outed for his less than stellar ethics regarding his Pharma reporting, Lieberman was always quoted as a defender of Chuckie's reputation. Go figure.

Neuroskeptic said...

"The CAFE study was wholly investigator initiated and we determined the doses for each drug. There was a clear rationale for the higher quetiapine dose relative to the other drugs which I am happy to explain to you."

Whatever the rationale, and we have no way of knowing, after the fact, what the investigators were thinking - shouldn't this trial have been called "Comparison of Low Dose Atypicals vs. High Dose Quetiapine in First Episode Psychosis"?

Not quite as catchy as CAFE I admit...

Uma said...

The comment by Bernard Carroll really opened my eyes. At the end of this study, nobody asked if patients got any better! It was simply not a criterion. All they care about is reverse engineering the findings. oh my!! The plot gets thicker and murkier....

Carl Elliott said...

The dosing disparities are striking, but manipulating doses is a fairly crude way of rigging a study. The critics I quoted in the Mother Jones article had different concerns: the small sample size, which was unlikely to show a difference between the three drugs; the outcome measure -- "all-cause treatment discontinuation," with no explanation why patients were choosing to stop taking their drugs; and the failure to include a first-generation antipsychotic as a control drug. AstraZeneca had already conducted a study in which Seroquel had performed worse than Haldol, and the unsealed litigation documents make it clear that the company was trying to find ways to spin or bury that study.

The 2006 AJP article by Heres, Davis, et al that I cited -- "Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine" -- found that 90% of industry-sponsored trials of atypicals came out in favor of the sponsor's drugs. It is worth noting that three of the biased publications examined in that study came from AstraZeneca.

As to the claim that this study was completely "investigator-initiated: the phrase "investigator-initiated" loses some of its meaning when three of the investigators named as authors are AstraZeneca employees, and four others are paid AstraZeneca consultants.

I would like to know why the investigators who initiated this study decided not to exclude patients at risk of homicide or violence. Among the adverse events listed in the AJP report was one "alleged homicide." It would be useful to know more about this homicide. Of course, Dan Markingson was also recruited into the study despite having been involuntarily committed for threatening homicide. Was the decision to include potentially homicidal subjects an oversight, or a deliberate decision?

The AJP report on the CAFE study also includes this questionable statement: that two suicides occurred in the CAFE study "despite the close attention provided in clinical aftercare programs." As I hope my article has made clear, there was no such "close attention" provided to Dan Markingson, or else he would still be alive.

Sara said...

To me, the first sentence of the CAFE study is very revealing, "Patients experiencing a first episode of psychosis have a better therapeutic response to antipsychotic medications than do chronic, multiepsiode patients." Well, by golly -- what I want to know is whether patients who have a first episode of psychosis have a better chance of getting better over the long term if they are given antipsychotics (and then left on them for 52+ weeks besides) or not. Let's compare patients who are given antipsychotics for a first episode with those who aren't. That's the important issue. These guys are off base before they even start. In a way my mind just boggles that clinicians and scientists don't see this. They are so brain washed by that immediate sedating effect of these meds and the "benefit" that brings that they don't see anything beyond that. The big picture is completely lost. I think it's a disgrace.

Alex Pirie said...

I coordinate health studies and health care information through an immigrant health networking group and a major concern among the parents in the communities we serve revolves around the use of psychotropic medications. I can't tell you how much we appreciate your dogged asking of tough and discomforting questions and your diligence in ferreting out the answers. Thanks!

Anonymous said...

Uma,

They never care.

G Spielmans said...

I don't know the motivations of the individual CAFE investigators. However, I do know that internal AstraZeneca documents show that the company had data which indicated that the first-generation antipsychotic drug haloperidol worked better than Seroquel on measures of schizophrenia symptoms. AstraZeneca did its best to keep such information hidden. More details on this and other related items can be found in this article.

Since AZ was aware that Seroquel performed worse than Haldol across multiple trials, there was a good reason for AZ to not include a first-generation antipsychotic in CAFE.

If AZ really had no role in designing this study, then I wonder why the independent investigators would not have been curious about how an older drug would have compared to the newer medications.

Dr. Carroll's lengthy critique about the study's methods should be read thoroughly when interpreting the results of CAFE. But even if this study were perfectly designed, the ethical lapses raised in Dr. Elliott's article would still be far beyond appalling.

Sara said...

Interesting article by The Last Psychiatrist on low vs. high doses of Seroquel. Not the linear progression you might expect and could be relevant to this study. You will have to copy and paste the link.

http://thelastpsychiatrist.com/2007/07/
the_most_important_article_on.html

And I agree that Dr. Carroll brings up many good points about the study overall. I wouldn't have put it as graciously as he does. Relevant patient outcomes, to say nothing of actual improved well being, were routinely ignored and dismissed.

John M. Nard MD said...

The Study: At week 52, all-cause treatment discontinuation rates were 68.4%, 70.9%, and 71.4% for olanzapine, quetiapine, and risperidone, respectively...
CONCLUSIONS: Olanzapine, quetiapine, and risperidone demonstrated comparable effectiveness in early-psychosis patients, as indicated by similar rates of all-cause treatment discontinuation.

Dr. Carroll makes the obvious point above that "The featured primary endpoint of retention over 12 months has no intuitive clinical meaning." But more than that, in "Making a Killing", Dr. Elliot's article about Dan Markingson who ws in that study, we read: "After Dan was enrolled, he stayed at Fairview for about two more weeks. By that point, Olson thought Dan’s symptoms were under control, but Mary was still very worried by his erratic behavior. She recalls meeting with the doctor: “Olson came in and sat down and opened his file and said, ‘Oh, Dan is doing so well.’ And I said, ‘No, Dr. Olson, Dan is not doing well.’ I think he was taken aback.” Even so, on December 8, 2003, Dan was transferred to Theo House, a halfway house in St. Paul. He was required to sign an agreement confirming that he understood he could be involuntarily committed if he didn’t continue taking his medication and keeping his cafe study appointments."

Am I misreading something? How can a study use an outcome like "all-cause treatment discontinuation" when people in the study are threatened with commitment if they discontinue their medication?

In the tragic case on Dan Markingson, he didn't discontinue his medicine, he discontinued his life [while floridly psychotic]. But until the time of his death he was a treatment success? What folly...

Uma said...

About the dosing disparities:
Let me give you an example from my own life. I have a choice of 2 meds for my disorder (hyperprolactinemia). I take 2.5 mg bromocriptin daily and it can be replaced by 0.5 mg cabergolin every other day (which works out to a tenth of the bromocriptin). Both are said to have the same effect in lowering my prolactin levels. so...isn't this an established fact that dosages don't have to be the same? If I increase the cabergolin or decrease the bromocriptin to a tenth, then bromocriptin will come out as ineffective! I actually prefer bromocriptin as it's cheaper. But when I have an upset tummy I take caberlin. I have also read that bromocriptin is more effective with shrinking small pituitary tumors (which I do have) as compared to cabergolin. So anyways....Dr Carlat you seem to be barking up the wrong tree.

Uma said...
This post has been removed by the author.
Uma said...

what I don't get is, once they have FDA approval why don't they proceed to convert as many doctors as they can (with money) instead of funding universities to prove their lies? or just get Oprah to invite teary eyed happy patients who want to share incredible stories of recovery...
(don't mind my comments, I am nuts)

mike howard said...

I remember well the first published reference on the Cafe study. "Landmark Study Indicates Equivalent Effectiveness of Atypical Antipsychotics in the Treatment of First-Episode Psychosis" from exotic Vienna, Austria, at the 8th World Congress of Biological Psychiatry. The study, known as CAFE(Comparison of Atypicals in First Episode Psychosis), is the first to examine the comparative effects of these three agents in this setting and provides clinicians with valuable insight into how to optimize atypical antipsychotic treatment in this important patient population.

Now, there you have it. We should now have thousands of "clinicians" world wide knowing exactly how to optimize treatment for all their first episode patients. I guess it's a little scary to even think that before CAFE came out our "clinicians" had no idea on how to treat first episode psychosis patients. The drugs had only been on the market for let's say 5-10 years. Again, that's a little scary for me as a consumer, one can only hope that if you ever need treatment for your first episode, you better hope that your "clinician" reads all the current first episode data. Sorry, if CAFE meant anything beyond marketing Seroquel, there would have had numerous follow up studies then and still now. Guess what? checked with Pubmed and that doesn't seem to be the case. AstraZeneca got what they wanted and paid for, there own bragging rights. Carl Elliott could not have been more accurate. Dr.s McEvoy and Lieberman are never far from the publicity and money, they often leave quite a paper trial, the real problem for me is, I don't believe them. Read a few of the internal e-mails regarding McEvoy and CAFE, and quickly came to the judgment that it was recruit, recruit, recruit at all costs. In the six years since Dan Markingson died, NOTHING has changed with how first episode patients are treated based on the results from the CAFE study. AstraZeneca knew all along that in CATIE they would not fair very well. So they devised CAFE to run concurrently so they could at least manipulate those results. In an era of Conflict-of-Interest popping up everywhere with these so-called researchers, does anyone else question why and how Lieberman and McEvoy and almost all the CAFE site investigators were also doing CATIE? One last thing, Bernard Carroll has it right, is there really such a thing as a first episode diagnosis within two weeks of symptoms? The reason of course is simple, it's marketing. Get em early and keep them late.

mike howard said...

The definition of insanity applies to anyone trying to accurately disseminate the data from the CAFE study. Doing the same thing over and over again in the same way but expecting different results. McEvoy and Lieberman were/are paid by AstraZeneca to produce marketable results. End of that story. How is it that these drugs had already been on the market for years before CAFE came along; are we to believe that treating clinicians had no clue on how to use and dose them? AstraZeneca knew that if the CATIE results held true they would not look good; therefore, CAFE was designed so Zeneca could 'manage' the results and control bragging rights. And what has changed in the 5 years since CAFE ended, absolutely nothing. I really seriously doubt that any treating clinician looks up and refers to the landmark CAFE study when facing a first episode patient.

mary weiss said...

Dr. Carlat,

In your blog you leave room for the possibility that perhaps the study was designed with no ulterior motives by AstraZeneca. I ask, are you going to exhibit the same 'open-mindedness' another dozen years from now when these drugs will have been on the market for a quarter century? How can it be that a simply layman such as myself, whose initial confrontation with these drugs was the death of my son Dan, understand simple marketing better than you, a well-educated, learned doctor? Do you really believe that these pharmaceutical companies and their 'doctors' are driven by altruism and not pure greed?
Dr. Jeffrey Lieberman in the Washington Post 10/3/06 said, as an explanation for the dismal results of these drugs: "The claims of superiority for the [newer drugs] were greatly exaggerated...the aggressive marketing of these drugs may have contribtued to this enhanced perception of their effectiveness..." Very succinctly put, not open to misinterpretation!
Your comments prompt me to put you on the lefthand side of my balance sheet, with Lieberman, Nemeroff, Garfinkel, olson, schulz, etal.

Mary Weiss

P.S. You call a dose of 506 mg. Seroquel high? Dan was given 800 mg - and not because he needed it! At one point, olson left instructions for Dan's dosage to be increased, and then for it to be increased 3 days after that without seeing him!!

Uma said...
This post has been removed by the author.
Uma said...

@Dr Carlat (wrt Mary Weiss' comment) This was a double bind study and Dan's psychiatrist was not supposed to know what Dan was on...so how did he know the dosage? or did he increase the dosage without knowing what drug Dan was being given? Did he know the actual dosage Dan was taking? Or did he increase the dosage without knowing the dosage of the unknown drug?

John M. Nardo MD said...

To Mary Weiss,

I appreciate your comments here and on Stephany's blog. It's encouraging to have the voices of people directly impacted by these Pharmatrocities in the mix. It helps keep the focus where it needs to be - on the clinical care of patients...

Keep talking...

Joel Hassman, MD said...

Hmmm, I guess Ms Weiss called you on her interpretation of this blog posting. You did not post my last comment I submitted to this thread on Friday night, because it was, what, too harsh on Astra Zeneca's behaviors? I do not know if you work in any kind of community mental health clinic or service, but believe me, Seroquel gets written like pez by a good many providers, and at dosages outside psychosis that would give some pause if you equated it to use of Risperdal or Zyprexa.

Are you willing to go on record for what you would write for treating anxiety with Seroquel, and do so as a solo med?

I will: never as a solo, rarely as an intervention, and if exhausted more reasonable choices, maybe use 25 to 100mg max, and not interested in XR.

Interesting AZ has basically eliminated 25mg as a dose of consideration. Because insurers expect you to split 50mg, or, they (AZ) didn't make XR in this dose and doesn't want providers to think about it when Seroquel IR loses patent!?

gewisn said...

I choose to interpret Dr Carlat's interpretation thusly:
He simply forgot to include the rolling eyes emoticon. Maybe even the wink. His conclusion, "There you have it," was sarcastic.
And he let the rest of us supply the anti-Pharma rant.

If I'm wrong, PLEASE don't tell me.

Daniel Carlat, M.D. said...

Many good points have been raised here. I have no great love for either Seroquel or AstraZeneca. Seroquel is a good antipsychotic but no better than the others. It causes more weight gain than most, and causes profound sedation, which can be a positive for some patients but a negative for many. I've called AstraZeneca out for its bad behavior more than once on this blog.

However, it's important not to paint every AstraZeneca study with the same broad brush of accusation. I give AZ some credit for sponsoring a study comparing Seroquel with two other atypicals. They could have just left their efforts at placebo controlled trials and called it a day. The fact that Seroquel ended up being dosed at roughly double the required dose rightfully arouses suspicion. The investigators claim that dosing decision was made independently of the company's input. You can call them liars if you want, but there's no evidence to support that supposition.

That said, I have no doubt that the CAFE study was manipulated in some ways for promotional intent--for example, the choice to omit a conventional antipsychotic from the trial seems odd, especially since these same investigators pushed hard to include a conventional in the CATIE trial. My guess is that Dr. Lieberman or one of the other investigators brought up the idea of including a conventional and that it was shot down by somebody with AZ, most likely on the grounds that it would be too hard to recruit enough patients to populate a fourth arm of the trial. You can argue that this was a legitimate decision, but it is convenient that this and other design decisions ended up benefitting the sponsor's drug sales.

Ultimately, Dr. Lieberman and his CAFE colleagues are suffering a credibility gap, but it is not necessarily of their own making. There are plenty of researchers in psychiatry who are in it because they care about patients, and who genuinely want to find a cure for mental illness. In fact, the majority of researchers who I have come to know would fit that profile.

The worst actors tend to be the lower tier hired guns, those who are not passionate enough about research to make a successful career out of it.

Regarding the specific points that many commenters have discussed, they are legitimate questions, and I would hope the CAFE investigators might see fit to respond to them here.

mike howard said...

Dr Carlat--- I think Lieberman and McEvoy better get their facts straight. I personally have a copy of the protocol for the CAFE study and on pages 13-14 it discusses the dosing design. By day 7,8 the recommended dose of study drug is 2capsules AM and 2capsulespm. Someone on seroquel therefore would be receiving 400mg a day by day 8. And from then on it's up to the investigator and their decision on how high to dose based on the subjects tolerability and clinical response. And contrary to what McEvoy stated regarding no reference on first episode , it says right on the same pages that the dosing range takes into account that first episode patients , compared to chronic patients, usually respond to lower doses of antipsychotic medication , and will be more likely to develop adverse effects if the highest dose range is used. etc-etc-etc. Be more than happy to give you a copy if you have not already read it.

Evelyn Pringle said...

American consumers should count themselves very lucky that highly qualified and busy professionals such as Dr Carroll (and more recently others), will put in the time it takes to track all the corrupt academics on the take from the drug makers and warn us about the rigged studies.

While the highly paid quacks rake in millions from Pharma (much of it undisclosed until recently), they get paid nothing for their efforts. Plus they stand a good chance of having their reputations attacked mercilessly.

Hardly an incentive to keep at it - but Dr Carroll obviously can not be deterred.

mary weiss said...

Dr. Carlat,

In your blog you state, "the worst actors tend to be the lower tier hired guns who are not passionate enough about research to make a successful career of it."

Dr. Carlat, is Dr. Joseph Biederman of Harvard, who received 1.6 mllion from drug companies from 2006-2007 in this 'lower tier'? Is Dr. Melissa del Bello of the University of Cincinnati, who received $100,000 from AZ in 2003, and $238,000 from 2005-2007 from AZ also in this 'lower tier'? What about Minnesota psychiatrist George Realmuto who said "Academics don't get paid very much. If I were an entertainer, I think I would certainly do a lot better." (hey! me too!)Or Dr. John Simon, another Minnesota 'actor' who said "most of the doctors who are really good have ties to [the drug] industry." Lower tier? That begs the question, Dr. Carlat, what is the definition nowadays of a really good doctor?

In my book it is Bernard Carroll, who is truly passionate about the truth - not these so-called doctors (who probably never cured anyone of anything) whose only interest is the condition of their bank account - not the condition of their patient. And believe me, I speak from experience!

So don't even try to imply that psychiatry has not been taken over by greed!

And you can read my book, "A Mother's Sorrow" to learn more of the truth!

Mary Weiss, mother of Dan





UPDATE August 30, 2010 - from 1 boring old man blog -

we don’t need it…

"Here are the facts as I know them:
  • There is no real reason for Seroquel to be on the market at all. It is primarily an atypical antipsychotic drug introduced for the treatment of Schizophrenia. It is less effective than the drugs it was purported to replace in that condition. In many ways, it is more toxic than the drugs it was supposed to replace. It’s other uses are either fabricated or simply because it is anxiotytic. We have more than enough anxiolytic drugs.It has no real niche.
  • Besides being no more effective than the alternatives, it is much more expensive. This is no time for us to be driving up the cost of medicine.
  • For any psychiatric drug, particularly this one, to be "the fifth best-selling drug in the world" is absolutely absurd. If people don’t like how life feels and we’re going to go along with that, legalize marijuana - it’s safer and a lot cheaper.
  • By any report, AstraZeneca is near the top for bogus stunts in marketing, and that’s saying a lot in light of the overall corruption in the psycho-pharmaceutical industry [see this particularly clear summary of stunts].
If David Brennan wants to do "the right thing, not the easy thing" he should simply take the drug off the market. We don’t need it. And it hurts lots of people, apparently killing some…"








3 comments:

Stan said...

I wonder where "V" has been? You know those well paid Corporate Spies AstraZeneca employed to keep tabs on the truth seekers and information gatherers?

I'm pretty sure this couldn't be Byrne or one of his minions reading and downloading away here? -LMAO

Maybe they just received Tony Jewell's fan club application for this blog, and were just about to pass it along in prudent fashion.

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Stan said...

Now I wonder why anyone would want to come to the comment section from this email server?

The only rational conclusion I can draw from this busy bee activity, is that I will have many more loyal adoring fans soon showering me with compliments and admiration.....lol


http://mail.v-fluence.com/exchweb/bin/redir.asp?URL=http://bipolar-stanscronicle ...

Stephany said...
This comment has been removed by the author.

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