Thursday, March 19, 2009

SEROQUEL: WHERE THERE'S SMOKE, THERE'RE MIRRORS

Scuzzophrenia

The Seroquel cover-up story continues to develop, as reported in yesterday's Washington Post.

http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html

Every time you think it can't get worse, it gets worse. As many will know, a number of the court documents were summarized and made public a week ago by the Wall Street Journal. The Post reporters have brought us a few more particulars about "study 15," the "cursed one, which was still a bit of a mystery.

No longer.

41 comments:

  1. I wonder if they used smoke and mirrors in any of their sex games! Bad girl! You read Risperdal paper! Now I am going to have to hurt you!

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  2. Who in the “H” are these people? Are they really the ones charged with finding remedies for illness?

    AstraZeneca referred to Seroquel’s "Study 15" as a “Curse” because test results didn’t say what they wanted them to say. Their Executive Decision solution was to bury the info and let patients suffer rather than their $Billion sales. Not quite what the public would hope for. Their best defense would be permanent insanity.

    Please…tell me someone at AZ is going to suffer.

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  3. One of the more poignant (and pitiful) excerpts from one of the released documents, is the manager who uses an email to wonder out loud whether AZ's relatively good ethical reputation in the past still has enough value to figure into a decision about burying a study. Or whether it's time to bail even on the appearance of propriety.

    The moment could stand as a microcosm for the industry as a whole.

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  4. Did he come from the Work Release Program?

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  5. This comment has been removed by the author.

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  6. No. In context, this guy was a saint. He suggested they release the study but do everything possible to get no one to notice.

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  7. Unfortunately, information like this is not so shocking anymore. The problem is that we are hearing about these types of things all too frequently.

    Interestingly, in reading through the documents you get a sense of "schizophrenic" like activities at AZ. They want to keep information away from the doctors, they want to work with information from the doctors. Maybe they should all take Seroquel....

    ReplyDelete
  8. Hiding test results and misleading the public and physicians seems to be SOP at all of the pharmaceutical companies. It also appears a majority of the new medications offered and sold at a premium price are no more effective then existing therapies.
    Then on top of that you have the supposed protector of public safety telling us we cannot legally reveal information for a drug which a study shows may be unsafe.
    While the recent actions by the Financial Industry and the complicity of the SEC in helping perpetate fraud on the American Public is egregious, the Pharmaceutical industry along with FDA complicity has unleashed a far greater threat to the American Public in that they are gambling with an individual's mental and physical well being.

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  9. Here's an interesting "In the Pipeline" blog entry today. It discusses the reliability of pharma sponsored research vrs. academic research. It's relevant to some discussions we've had on this site and at Pharmalot.

    http://pipeline.corante.com/archives/2009/03/20/drug_industry_research_reliable_or_not.php

    ReplyDelete
  10. A large part of science is politically as well as financially motivated.
    Just mention that you do not believe in global warming and a large majority of people will look at you and believe you are a complete moron, even though these people have no scientific background of their own. Meanwhile there are a number of scientists who question global warming but because they are in the minority the public assumes they are just shills for Big Oil.
    As far as academic research goes; funding for research is provided in part by the Pharmaceutical Industry, so again is it really unbiased? Also, in too many instances the drug companies will go to great lengths to avoid disclosing harmful drugs.
    However, I have no problem with who conducts the studies; I just have a problem with non-disclosure of unfavorable studies and attempts to bury negative information.
    In addition the article provided avoids the key issue with Reubens and that is off label promotion of existing drug therapies.

    ReplyDelete
  11. Good piece, Nathan. Of course, everyone has bias. But I am not sure all bias is equal in terms of the likelihood of a study's result seeing the light of day. This is a empirical question. While it wouldn't be easy to study, it could be done.

    Derek writes: "The whole idea of scientific research is that you don't operate like this, of course, and eventually these things do get settled out."

    Needless to say, when risk data are part of what is being designed away, a lot of sdg bad things can happen besides loss of truth during the "eventually" period.

    In any event, the key issue is, indeed, not what goes into studies but what comes out. The AZ saga is mainly about "burying," not "biasing."

    So the relevant comparison would be rate at which serious risk data is buried by academic researchers (without ties) versus by industry-sponsored researchers.

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  12. The point here is that we would and will all applaud when a break through drug comes to market as the result of carefully conducted research and trials. When this happens it highlights the very best of humanity, we can all be proud.

    In cases like this one, Seroquel, the evidence is telling us that this was not so great a drug after all. It also looks like the sales and market share that were captured because of it were not "wholesome" and "Organic".

    Seriously, I think it time to stop levying fines solely against the companies who get caught doing this. I think it is time to start holding the individuals in the companies accountable as well. Corporations, like guns, do not commit the crimes. It is we the humans who cause the problems.

    In this particular situation the entire team "conspired" to commit fraud, by concealing the facts and result of the study.

    This story reveals important information about the management at AZ. There was obviously nothing in place to stop this malicious behavior by some of their senior employees. Very disturbing.

    I would have to agree with Justices comments above.

    At this point I can only say that studies stating industry's research results as being better than academia, well, in order to determine that we would need to be ensured of complete transparency. I do not think that industry is "there" YET!

    ReplyDelete
  13. This whole thing, either way you look at it, highlights the fundamental truth that where large sums of money are at stake some people will find a way to get some of it, even by unscrupulous means if they have to. And there is a direct correlation between the degree of poor scruples or criminality and the amount of money available.

    Few industries can claim more access to money than the pharmaceutical industry. Therefore all kinds of people with poor morals can be found within or surrounding the industry licking their chops and devising devious way to cash in.

    The Pharmaceutical industry is not the only realm where greed can override ethics but it is one of the few in which the resulting fallout can be seriously harmed or dead people.

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  14. Tom Moore, who is no muckraker or pharma-basher, wrote this (that complements Jaynesday's point):

    "Today our modern medical system stands capable of producing catastrophes of a magnitude uequaled by any other human endeavor except war and genocide."

    Obviously, the same system stands capable of producing miracles unequaled by any other human endeavor. One goes with the other. But one does not "balance out" the other. At least not when there is some human agency and moral choice involved, as there obviously has been in the Seroquel case.

    I agree with Former that we are overdue for the greater use of criminal justice. It will never be a primary sanction for a range of reasons having to do with cost, the nature of corporate crime, etc.. But the best studies have shown that it is much easier than sometimes supposed to pinpoint responsible individuals. And the sociological notion of "diffusion of responsibility" has served as much as smokescreen as explanation.

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  15. A Seroquel XR update from “Seeking Alpha”...

    “The Seroquel (quetiapine) XR sNDA is a pending application by AZN to expand the drug's label to treat adults with major depressive disorder and generalized anxiety disorder. The FDA issued a complete response letter (CRL) on 2/27/09 and a FDA advisory panel meeting was conducted on 4/8/9 to address concerns about potentially exposing a greatly expanded patient population (an estimated 20 million people in U.S. alone with anxiety and depression) to a drug with known metabolic side effects (e.g. high blood sugar/diabetes), a possible risk of tardive dyskinesia (which causes involuntary, repetitive movements which can become permanent), and the potential for heart problems.

    Seroquel is AZN's 2nd best-selling drug, with $4.5B in 2008 sales. Seroquel XR is an extended-release version of the medicine with a longer patent life than the original formulation. Seroquel is already sold for treatment of schizophrenia and bipolar disorder, which were not a part of the FDA advisory committee review. The FDA Adviosry Panel concluded the following: (1) Seroquel XR is safe as an add-on therapy for depression; (2) Serqoquel XR was rejected as a stand-alone treatment for depression; and (3) Seroquel XR was rejected as a treatment for anxiety.”

    Source:
    http://seekingalpha.com/article/130319-updated-fda-clinical-trial-calendars-myriad-pharma-announces-phase-1-trial

    More smoke, more mirrors...

    According to the FDA Web site, the extended release formula for quetiapine fumarate, Seroquel XR, was approved on May 17, 2007. The statement "Label is not available on this site" appears where the new drug label should be posted. The new label was elusive on the company's Web site as well. Why weren't the approval documents posted?

    Subsequent updated drug labels posted on the FDA Web site stated that Seroquel XR contained quetiapine fumarate, however documents prepared by FDA personnel for the April 8 committee meeting state that Seroquel XR contains quetiapine maleate.

    Studies of Seroquel SR (quetiapine fumarate, sustained release) were used to support the approval of Seroquel XR (quetiapine maleate, extended release). The name of the drug was changed during the FDA approval process. This action created a discrepancy between the drug information posted on ClinicalTrials.gov and the drug information published in scientific journals. When the NIH pointed this out to the company in December 2008, the following statement was added to study descriptions in the ClinicalTrials.gov database: "PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA." Why didn't the company update the information on its own accord?

    According to a letter posted on the FDA Web site, the drug name Seroquel SR (quetiapine fumarate) was changed to Seroquel XR during the approval process. Which drug formula was tested in the clinical trials, quetiapine fumarate or quetiapine maleate?

    Mysterious changes aside, if a particular individual must take quetiapine, why not use the immediate release form of Seroquel, which is easier to titrate? Consider the clinical trials data (consider the source as well) drug price, potential for generics in the future, and the underutilization of nonpharmacological therapies. There is no justification for expanding the drug's label to treat adults with major depressive disorder and generalized anxiety disorder.

    ReplyDelete
  16. Sounds to me like the Cheshire Cat ate the Mad Hatter.

    ReplyDelete
  17. Smoky Alice, your assumption is correct...just deserts for painting the roses red. : )

    Click on Caterpillar for the back-story.

    ReplyDelete
  18. Off with their heads!!!

    Oh, never mind, we did that already....It didn't help....

    ReplyDelete
  19. A former Harvard assistant professor gets 3 years' supervision for painting the roses red.

    Click on Caterpillar for the story.

    ReplyDelete
  20. “I moved numbers around to make the data look like there was something there,” he said. “I never really thought through the consequences, and once I did this I got myself into a loop that I found I couldn’t get out of.”

    WSJ Health Blog
    April 10, 2009

    ReplyDelete
  21. How much of evidenced-based medicine is really evidence based? How much of the scientific literature (on which evidence-based medicine is based) contains make-believe data?

    ReplyDelete
  22. What the doormouse saidApril 10, 2009 at 12:58 PM

    Goodness gracious. Aren't we all "make-believe data" in the end?

    Feed your head, kids. Or work at Harvard. Either one works.

    ReplyDelete
  23. Does anyone have a key?

    Or, like, a sledgehammer?

    ReplyDelete
  24. Hey, Alice! Don't hit the mirror where I'm leaning please.

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