Selective publication on antidepressant efficacy and data

After the release of the U of Hull study on Tuesday, the AFP has written an article about doctors who are urging patients on antidepressants to continue taking them.

Louis Appleby, national clinical director for Mental Health, told the Press Association: "… the message to patients and doctors remains the same — anti-depressants are an appropriate treatment for moderate or severe depression."

I agree that patients on antid's should not cease medication cold turkey. (Trust me on this one. Even with proper tapering, the side effects are not pretty.) I waver on the idea that antid's are "appropriate treatment" for moderate-to-severe depression rather than a "form of treatment." Antidepressants can help, but I'm not sure I like the term "appropriate." But I likely am arguing semantics.

Since the results of the study originate from Britain (despite the fact that it also includes data from the FDA), I can only assume that news reports on this are more widespread over there. In my Philadelphia, USA-world, it seems a little bit off the radar to me. Let me know if I'm wrong.

To Mr. Appleby's credit, he has acknowledged that the British government plans to rigorously pursue routes of alternative treatment in light of the study.

The government has plans to expand the availability of psychological therapies as an alternative to drugs, Appleby explained, with extra investment and more psychological therapists.

"The evidence shows that these therapies are effective and often preferred by patients."

WebMD also covered the recent study.  Dr. Nada Stotland of the American Psychiatric Association insists that the study is not reflective of real psychiatry.

"We know that many people who are depressed do not respond to the first antidepressant they try," she says. "It can take up to an average of three different antidepressants until we find the one that works for a particular individual. Therefore, testing any single antidepressant on a group of depressed individuals will show that many of them do not improve."

Stotland has a point. Patients usually do not respond to the first antidepressant that is prescribed to them. About 30 percent of patients do not respond to antidepressants or experience no improvement until several weeks later.  Even then, patients who are on antidepressants for long-term maintenance, experience the return of depressive symptoms. An article from The New England Journal of Medicine evaluated the selective publishing of antidepressant trials with a positive efficacy:

Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.

The authors' conclusion: "Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients." It's an obvious statement; so obvious, it can be easily overlooked.

While it's important to shed light on the issue of treating depression with antidepressants, it seems as though many authors are cherry-picking favorable results to publish. Considering that much of these research studies are backed by drug companies, it's no surprise. Also, I can't fault the authors only. I recently freelanced for a medical publication and learned that many of the submitted articles are heavily rewritten by the editors. Editors are hard-pressed (and probably loath) to publish a piece that criticizes antidepressants when their biggest advertisers include such big names as Wyeth, Eli Lilly, and GlaxoSmithKline. Run enough of those pieces and a publication is quickly on its way to folding.

That's why it's stunning to read the U of Hull study that has somewhat of a negative slant toward antidepressants' effectiveness. While doctors are wisely advising patients to continue any antidepressants they may be on, currently drug makers have launched into damage-control mode.

In a statement, GlaxoSmithKline (GSK) representatives express "disappointment" at how the study was being reported by the media, suggesting that news reports may have caused "unnecessary alarm and concern for patients."

Of course these news reports are "unnecessary" to GSK. Letting patients know that their antidepressants might not work better than sugar pills isn't good for business. However, GSK's reps were kind enough to balance out their statement, adding "counseling and lifestyle changes" also are important aspects of treating depression. Then, the company accuses the researchers of selectively reporting their data:

"GSK fully endorses public disclosure of clinical trial results for its medicines and is actively committed to communicating data relevant to patient care," the statement reads. "All the data related to GSK's clinical trial results of [Paxil], regardless of study outcome, are available at the company's clinical trials register at 20 www.gsk.com."

Tell that to the estimated 5,000 Americans who have filed a lawsuit against GSK regarding Paxil. Still, Kirsch, who has received consulting fees from Squibb and Pfizer, insists "the [drug companies] certainly do publish selectively."

I'm inclined to agree.

1 Comment

  1. BOB FIDDAMAN said,

    February 28, 2008 at 5:50 pm

    GSK hits back over ‘alarmist’ antidepressant analysis!
    Well you didn’t expect them to actually admit it now did you?
    They have a history of admitting no liability so why change?
    The statement can be read at Pharma Times.
    Keeping with GSK tradition I’d like to summarise it for you – as they do with their clinical trial results. Hope you don’t mind Glaxo – I mean, what’s good for the goose eh?
    GSK “believe that it has caused unnecessary alarm and concern for patients”.
    Hmmm.
    Great let’s put the onus on the patients. Let’s spin this on its head to show the patients that we really care about their fears. Have GSK EVER listened to their patients?
    …antidepressants “remain an important option, in addition to counselling and lifestyle changes, for patients suffering from depression”.
    But GSK know that counselling costs money, money that this government are not prepared to offer up. Sure, promises were made yesterday as UK Health Secretary Alan Johnson unveiled plans for a major new programme to train an extra 3,600 psychological therapists. But actions speak louder than words.
    “we strongly believe that the authors’ interpretation is incorrect and is clearly at odds with the benefits of antidepressants routinely observed in actual clinical practice”.
    This is a little gem isn’t it? You notice how they use the term ‘antidepressants’ and NOT ‘Seroxat’? Tell me, What are the benefits of Seroxat? I bet you I can give you at least 10 risks to one benefit!
    “regulatory bodies around the world have conducted extensive reviews of published and unpublished data for licensed antidepressants and have concluded that these medicines provide benefit to patients”.
    There’s that word again, ‘benefit’ – and why the omission once more of the word ‘Seroxat’? The truth is GSK, you are being investigated for not submitting published and unpublished data to the very same people you claim have conducted extensive reviews. Extensive reviews of the data you provided them maybe – but we all know the data you DO NOT give them clearly shows that your drug (in this case, Seroxat) is defective. And while we are on the subject, the Medicines Regulator here in the UK have been less than satisfactory when reviewing data. One only has to look at the MMR/Autism debacle. They messed up then and they have clearly messed up again regarding Seroxat… and will continue to do so as long as there is a conflict of interest, ie; Alisdair Breckenridge & Ian Hudson – you remember them don’t you Glaxo? Sure you do – they now work for the MHRA – Can you ever remember them working for you?
    GSK says that “contrary to what has been reported”, the study has only examined a small subset of the total data available for antidepressants. With paroxetine for example, “this study only considers data from 16 trials out of a total database of more than 170 trials involving at least 14,000 patients”.
    And did you offer all your data to the medicines regulator regarding Paxil Study 329? C’mon, we really can see right through you Glaxo.
    With regards to Paxil, “all trial data published and unpublished were submitted to regulators, at the time of registration”, GSK notes, saying that all the data related to paroxetine, “regardless of study outcome”, are available at the company’s clinical trials register on its website.
    Well, we know that’s a lie. Glenmullen’s report shows that it is as does Breggin’s report from 2001. Tell me Glaxo, why are the MHRA currently investigating you?
    “rejects any suggestion that we deliberately withheld data on paroxetine”
    Is this from a Pinocchio cartoon?
    In addition, however, GSK responded to a request for data on the use of paroxetine in children. The spokesperson noted that the company provided a list of the studies that had either been completed or were underway, “however this was an unlicensed indication and was subject to an ongoing regulatory review by the Medicines and Healthcare products Regulatory Agency. It was therefore not appropriate to provide these data to NICE ahead of the MHRA’s conclusions.”
    So now a criminal investigation becomes a ‘review’? As far as I am aware, the MHRA are investigating you! This is no review. If it is merely a review, it will probably be laden with errors.
    Alison Cobb, treatments expert at mental health group Mind, said that the study “makes a serious challenge to the predominance of drugs in treating depression”
    At last! someone with compassion!
    Fid
    SEROXAT SUFFERERS BLOG
    http://fiddaman.blogspot.com


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