MedPage: Negative Data on Seroquel Suppressed by Drug’s Maker

Update January 2011: Be sure to read the comments, which have links to many valuable resources.

This item today, from MedPage, underscores the importance of having our eyes open about the human frailties in the research process that our lives can depend on.

ORLANDO, Feb. 27 — Newly unsealed court documents suggest that AstraZeneca tried to minimize the risk of diabetes and weight gain associated with its antipsychotic drug quetiapine (Seroquel), in part by “cherry-picking” data for publication. … lawsuits by some 9,000 people who claim to have developed diabetes while taking the drug. … a 1999 e-mail indicating that the company had “buried” three clinical trials and was considering doing so with a fourth. … Another … discussed ways to “minimize” and “put a positive spin” on safety data from a “cursed” study — one of those later described as “buried.”

As patients become empowered and active participants in their care, they/we need to learn how to understand the limitations of published research. I’m writing this not to rant about corruption, though such a rant might be considered justified; I’m writing it to teach. Consider what there is to learn:

Why you should care: It’s important for us patients to understand this as we take a more active, informed, empowered, participating role in making our care decisions, including which drugs we accept:

  • In the past few months the e-patient blog has written several times about understanding statistics
  • Last fall on my own blog I wrote about the pros and cons of evidence-based medicine
  • For your safety – your parents’ safety, your children’s safety – drug makers are required to do research before releasing a drug, and tell what they found. This process is subject to human frailties.
  • Recently this blog has reported on the substantial conflicts of interest attached to some journal articles. Since those same journal articles are widely considered the gold standard of reliable evidence, we need to be aware that there can be limitations to that reliability.

Business Week seems to consider it a business problem:

How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?

Simply because, huh?

Here’s a question to ask yourself: if you want to know the best possible information about a drug, where do you go?

My guess is that our ability to know what we can trust (and to protect ourselves) will improve when patients routinely go online to share their experiences and routinely go online to check what others have said.

Who else can we trust? I mean, we’re talking about putting potent chemicals into our system, and evidently it’s sometimes “optimized” for revenue, with people willfully hiding warnings from us.

I went to PeoplesPharmacy.com, a web site run by e-patient working group members Joe and Terry Graedon, and searched for the drug’s name. Look what I found in the top article:

It’s no wonder that patients and families are nervous about these medicines, especially when you consider that they can cause other complications such as dramatic weight gain, diabetes, strokes and irregular heart rhythms.

A 2005 article there didn’t talk about those issues but had a warning that the cost might not be worth it:

A new study demonstrates, however, that the more recent drugs are not much of an advance.

We need to share our experiences more often. Think about it: 9,000 people allege harm, yet the PeoplesPharmacy article only noted that risk this month. Not enough of us spread the word soon enough.

Let’s spread the word to each other: let’s do our own research, and for heaven’s sake let’s post our experiences online for others to discover.

ACOR founder Gilles Frydman has numerous stories of benefits of cancer patients sharing drug experiences, good and bad. I’ll ask him to respond with more in the comments here.

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Comments

13 Responses to “MedPage: Negative Data on Seroquel Suppressed by Drug’s Maker”

  1. John Grohol says:

    It’s long been known that most newer atypical antipsychotics such as this have been linked to weight gain and possibly diabetes. Read Furious Seasons if you’d like to stay up-to-date on the psychiatric drug world’s conflict of interests (it seems a month doesn’t go by without a new disclosure), and I also highly recommend the Carlat Psychiatry Blog:

    http://www.furiousseasons.com/
    http://carlatpsychiatry.blogspot.com/

    The Wall Street Journal broke this most recent story, from what I’ve read.

  2. Susannah Fox says:

    Another consumer drug guide available online is Public Citizen’s Worst Pills, Best Pills database (some of which is subscription-only):

    https://www.worstpills.org/index.cfm

    There’s a print book, too, and you can search its contents for info on Seroquel on Google Books:

    http://books.google.com/books?id=eLZVYWRe0TcC&printsec=frontcover&dq=Worst+Pills

  3. Carey says:

    e-patient Dave, thank you for the post and the thoughts about research, among other things! We certainly need to share our experiences more often. It seems like design matters here. That is, a research design. Getting people talking is a step in the right direction and connecting those voices in a new way will help to dynamically connect R&D teams in the evolving process and development where the product undergoes constant evaluation and assessment. And getting particular populations involved in the initial research design behind specific drugs might be effective as well. An agenda that fosters collaborative contributions and continuous feedback (or stories) seems like it would make a difference not only in understanding the human frailties in the research process but also the limitations humans will experience without embracing patient care based in collaboration about very important issues: our life.

  4. Hi Carey – you talk like someone with a perspective that comes from some specific experience. (Or, I’m just crazy. :–)) Do you have any suggestions, or are you with an organization that has a particular perspective?

    Thanks for stopping in –

  5. Carey says:

    Hi e-patient Dave, a variety of experiences so you’re not crazy :-) but there is a group: http://www.syndicom.com/spineconnect/ that has a particular perspective and some potential suggestions for at least having people talk about the issues you addressed differently. Let me know what you think. Thanks again — I very much enjoy stopping in…always an exciting visit….

  6. ePatientDave says:

    @serious_skeptic Yup, see our post on #Seroquel #AstraZeneca http://ow.ly/AsE

  7. ePatientDave says:

    Jon Stewart is ranting about not understanding Twitter! :) #dailyshow http://is.gd/lavY

  8. ePatientDave says:

    @PolarWisdom Yikes, I like the quiz http://is.gd/lFPC but grossed out at the Seroquel ad! (Our post about that: http://is.gd/lavY)

  9. […] Negative data on Seroquel suppressed by manufacturer (2/09) […]

  10. […] MedPage: Negative Data on Seroquel Suppressed by Drug’s Maker […]

  11. […] MedPage: Negative Data on Seroquel Suppressed by Drug’s Maker (Feb 2009) […]

  12. […] Feb 2009: MedPage: Negative Data on Seroquel Suppressed by Drug’s Maker […]

  13. You actually make it seem so easy with your presentation but I find this topic to be really something which I think I would never understand.
    It seems too complicated and extremely broad for me.

    I am looking forward for your next post, I will try
    to get the hang of it!

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