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‘this cursed study’ - more about Seroquel…

Posted on Sunday 2 January 2011



From 1993 through 1995, Astrazeneca undertook a large, multi-center trial

comparing one of the older antipsychotics, Haldol, to several different dose

ranges of their new drug, Seroquel [study 15]. This was prior to Seroquel’s

approval by the FDA. Study 15 didn’t come out like they wanted. The internal

memo above is from a high ranking Astrazeneca official praising AZ Physician,

Arvanitis, for her ’smoke-and-mirrors’ job in trying to discount the

actual results ['smoke-and-mirrors' in red]. As it turned out, Astrazeneca

" buried " this study along with several others.

4.1.4 Summary of time to withdrawal / time to relapse

There was no statistically significant dose response among SEROQUEL groups in

the time to withdrawal from the trial in the intent to treat population, which

was the primary efficacy variable. Pairwise comparison showed no statistically

significant differences among any treatment group, including haloperidol, in the

time to withdrawal from the trial. There was also no statistically significant

dose.response among the SEROQUEL groups in the time to withdrawal from the trial

for psychotic relapse. Times to psychotic relapse were generally longer in the

haloperidol group. Pairwise comparisons of the time to withdrawal for psychotic

relapse revealed statistically significant differences between the haloperidol

group and each SEROQUEL group. However, there was an imbalance in the reasons

for withdrawal from the trial between the SEROQUEL and haloperidol treatment

groups with proportionally more patients in the haloperidol group withdrawing

for adverse events. Since proportionally more censoring for relapse occurred in

the haloperidol treatment group, any contrasts between the haloperidol and

SEROQUEL groups for time to withdrawal for psychotic relapse may not reflect

true differences in the relapse distributions among the groups and therefore are

non.informative. Results of the analysis of the time to withdrawal in the

secondary population showed a similar trend as seen in the intent to treat

population. The analysis of prognostic variables indicated that only the

interaction between treatment groups and the need for neuroleptic medication to

be tapered during Segment A were significantly associated with time to

withdrawal.



Haldol won the trial hands down - one of several examples of Astrazeneca

suppressing it’s own studies because they didn’t play well with their

marketing strategy [PsychRights has a treasure trove of equally incriminating

documents]. As we know, Seroquel went on to be FDA approved with extension for a

variety of conditions. It’s now the most lucrative of the Atypical

Antipsychotics, themselves the most lucrative drugs in the American

pharmacopeia.

Another example of Astrazeneca’s sleight of hand with data was the CAFE Study.

It was planned to compare the response of first-break Schizophrenic patients to

the Atypical Antipsychotics - Seroquel, Zyprexa, and Risperdal. According to the

published results: " CONCLUSIONS: Olanzapine, quetiapine, andrisperidone

demonstrated comparable effectiveness in early psychosis patients, as indicated

by similar rates of all-cause treatment discontinuation. " But there was much

more to say about this study [The Deadly Corruption of Clinical Trials, " Making

a Killing " : New Carl Elliott Article in Mother , Was the CAFE study

manipulated by AstraZeneca? Maybe Not, Comment by Dr. Carroll]. First off, the

CAFE study, financed by Astrazeneca, was in marked contrast to the CATIE Study,

an NIMH funded study, where Seroquel came out on the bottom of the three. Carl

Elliot [author of The Deadly Corruption of Clinical Trials and White Coat, Black

Hat: Adventures on the Dark Side of Medicine] has reported on the tragic suicide

of Dan Markingson, one of the patients in the CAFE Study. Elliot is a

bioethicist at the University of Minnesota. After convincingly dissecting why

the CAFE study was strictly a marketing ploy by Astrazeneca, he ends The Deadly

Corruption of Clinical Trials with:

…Yet another problem with the CAFE study is its failure to compare Seroquel to

any older antipsychotics. " It’s quite a marketing exercise to put all patients

in the CAFE study on atypical antipsychotics, " says Dr. Glen Spielmans, an

associate professor of psychology at Minnesota’s Metropolitan State

University. " It removes the older drugs from the discussion. " One reason

AstraZeneca may have done this, he suggests, is that Study 15 had already shown

Seroquel to be inferior to the older antipsychotic, Haldol.

The bluntest assessment of the study came from Dr. Healy, a senior

psychiatrist at Cardiff University in Wales. Healy is a former consultant to

AstraZeneca, among other pharmaceutical companies, and a prominent critic of the

industry. " This is a non-study of the worst kind, " he said. " It is designed not

to pick up a difference between the three drugs. It looks like an entirely

marketing-driven exercise. "

If these experts are right, then the study in which Dan Markingson committed

suicide was not simply a matter of inadequate informed consent, or financial

conflicts of interest, or even failure to monitor a subject’s care. The

ethical breach was built into the study from the start. It is one thing to ask

people to take risks for science, or the common good, or to help other people.

It is another thing entirely to ask them to risk their lives for the marketing

goals of AstraZeneca.

The account of the case of Dan Markingson is horrific by any account. He was a

26 years old guy who became flagrantly psychotic, threatening his mother’s

life and lost in a set of bizarre delusions. In spite of his dangerousness, and

in spite of his mother’s protests, he was allowed to volunteer for the CAFE

Study. He was put on Seroquel, and even though he did not respond, he was moved

to a halfway house where he ultimately killed himself [brutally], in spite of

his mother’s desperate attempts to get him out of the study. It was a

travesty. He shouldn’t have been allowed to be in the study. He shouldn’t

have been released from the hospital. He should’ve been changed to a drug that

controlled his symptoms. But, beyond that, he was in a study that shouldn’t

have been done in the first place. 

Study 15 and the CAFE Study both used as the outcome how long the patients

stayed on their medication. That’s a mighty soft criteria for success. But

besides that, Dan Markingson was in a halfway house contingent on staying on his

medication. If he stopped taking it, he faced being committed back to the

hospital, something he didn’t want. What kind of study is that? Had he not

suicided, he would have been recorded as a treatment success for Seroquel in

spite of remaining dangerously ill!

Buried Studies, Smoke and Mirrors, Jury-Rigged Trials, paying over a billion

dollars for lost suits, etc. The reports are all over the place, yet Seroquel, a

weak Atypical Antipsychotic with some dangerous side effects, remains a

best-selling drug world-wide. And the web-site clinicaltrials.gov currently

lists 100 ongoing trials recruiting subjects for studies using Seroquel for a

wide variety of conditions, 30 sponsored by Astrazeneca. In spite of the

evidence that dates from before the drug was approved to the present, nothing

seems able to stop the Pharmaceutical machine that drives this freight train.

All of this story hinges on one simple fact. Every Seroquel pill that’s taken

is because some Physician has signed a prescription for it. As much as we might

rale about the deceit of the Pharmaceutical Industry and the invasion of

Academic Medicine by corporate profit motives, the " gatekeeper " function of

Physicians has been corrupted beyond recognition. It seems that any intervention

has to start there. I’m beginning to see why so many people who understand

what has happened here focus on the Continuing Medical Education [C.M.E.]

system. Seroquel has obviously been successfully imprinted on the collective

practitioners’ consciousness as safe and effective. Both designations are

questionable at best, sometimes dead wrong…

2 Comments for '‘this cursed study’ - more about Seroquel…'

 

Stephanyâ 

January 2, 2011 | 11:34 am

 

It is a grave concern of mine, that Seroquel XR is currently being studied at

UMN and trialed by the same doctor (Schulz) as the one in the CAFE study where

Dan Markingson fell victim to this scandalous that never should have been

approved for marketing by the FDA (and never should have been recently approved

for use in 10 yr olds! w this background).

The FDA has done nothing to protect people from the unethical, corrupt and

for-profit marketing tactics used by big pharma such as the Seroquel scandal.

This story has a life of its own, with the sex-for-secrets stunt pulled by Wayne

MacFadden, the buried study 15 that doctors never saw–and now AstraZeneca is

in a huge push trialing the drug up against placebo! for patent

extension–sealing the use of the drug for more psych labels is their goal.

I’d like to see a group of doctors speak at an FDA hearing to ask for this

drug to be removed from the market. For the sake of children who are going to be

innocent victims of a drug with a black box warning for diabetes and in

litigation process for that.

 

Stephanyâ 

January 2, 2011 | 11:49 am

 

PS–another reason this drug is so dangeous now is due to the antidepressant

advertising campaign AstraZeneca is promoting. Innocent ppl go to the doctor,

walk out w a rx for what they think is an antidepressant and it is in fact a

neuroleptic with a black box warning and a scandoulous background. AstraZeneca

is promoting this drug heavily for antidepressant use, similar to how Cymbalta

by Lilly was re-marketed for back pain, knee pain and fibro…many ppl used it

did not know it was an antidepressant and suffered withdrawals.

Besides the drug is abused for street sale, (Seroquel) and abused such as ‘Maq

Ball’ Q-ball, ‘Quell’ and snorted in prisons….this is a drug that should

be a controlled substance on top of everything else.

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