Feb. 2/16 article in "Nature" re: shoddy practices in scientific studies

This recent article is particularly pertinent at this time when we're seeing more and more articles on under-reporting of harms caused by psychiatric medications.

 

"Make journals report clinical trials properly", writes Ben Goldacre -- a physician, author and senior clinical research fellow at the University of Oxford, UK. "There is no excuse for the shoddy practice of allowing researchers to change outcomes and goals without saying so."

 

http://www.nature.com/news/make-journals-report-clinical-trials-properly-1.19280

 

 

Our group has taken a new approach to trying to fix this problem. Since last October, we have been checking the outcomes reported in every trial published in five top medical journals against the pre-specified outcomes from the registry entries or protocols. Most had discrepancies, many of them major. Then, crucially, we have submitted a correction letter, on every trial that misreported its outcomes, to the journal in question. (All of our raw data, methods and correspondence with journals are available on our website at COMPare-trials.org.)

 

Other journals have not followed the BMJ’s lead. The editors at Annals of Internal Medicine, for example, have responded to our correction letters with an unsigned rebuttal that, in our view, raises serious questions about their commitment to managing outcome-switching. For example, they repeatedly (but confusedly) argue that it is acceptable to identify “prespecified outcomes” from documents produced after a trial began; they make concerning comments that undermine the crucial resource of trial registers; and they say that their expertise allows them to permit — and even solicit — undeclared outcome-switching. Furthermore, they have declined to publish our response to their 850-word letter in the journal.

 

Thanks for posting this, Lapis! 

 

I have to say that I'm extremely hopeful about the first paragraph. This is amazing!! I love what they're doing, researching to find the discrepancies and then submitting correction letters.

 

What I'm wondering about is in the bold: Does this mean that although the trial isn't over with, prespecified outcomes are being reported, that is, what their expected outcomes will be? I've been reading Medscape, a website that many doctors read, and some of the reporting on clinical trials jump the gun, so to speak, about positive outcomes when the trial isn't even finished with. Many doctors complain about this.

 

Overall, though, I'm feeling optimistic. However, the U.S. is far, far behind in even attempting such a thing because pharma companies are so tightly woven into the framework of all aspects of the medical system, ads, and life in general in the U.S. Just terrible here!!

Hi Terry,

I think we all have to maintain healthy skepticism when it comes to medical studies. If it seems too good to be true, then......well, you know what I'm going to say. My trust in medical studies and certain fields of medicine has dropped to an all-time low.

 

Those who are challenging the results of studies and ensuring that the truth comes out have become heroes in my view. We need these people. And we all need to keep asking the tough questions.

 

 

Yes, Lapis, you're right. We need to keep asking the tough questions. That's what's going to move things forward, the fact that people start demanding to know the actual truth.

What I'm wondering about is in the bold: Does this mean that although the trial isn't over with, prespecified outcomes are being reported, that is, what their expected outcomes will be? I've been reading Medscape, a website that many doctors read, and some of the reporting on clinical trials jump the gun, so to speak, about positive outcomes when the trial isn't even finished with. Many doctors complain about this.

 

I wondered what it meant too. This article explains it well (Paxil debacle): 

 

https://www.minnpost.com/second-opinion/2016/01/how-outcome-switching-can-fool-us-thinking-certain-drugs-are-effective

 

    "Before researchers start clinical trials, they’re supposed to pre-specify which health outcomes they’re most interested in. For an antidepressant, these might include people’s self-reports on their mood, how the drug affects sleep, sexual desire, and even suicidal thoughts.

 

    "The idea is that researchers won’t just publish positive or more favorable outcomes that turn up during the study, while ignoring or hiding important results that don’t quite turn out as they were hoping.

 

    "But that doesn’t always happen. “In Study 329,” explains Ben Goldacre, a crusading British physician and author, “none of the pre-specified analyses yielded a positive result for GSK’s drug, but a few of the additional outcomes that were measured did, and those were reported in the academic paper on the trial, while the pre-specified outcomes were dropped.”

 

 

I've listened to many of his talks on YouTube in the past. He's really pushing for transparency in clinical data, which is great!

 

His website:

http://compare-trials.org/

 

67 - trials checked

9 - trials were perfect

301 - outcomes not reported

357 - new outcomes silently added

 

On average, each trial reported just 62.0% of its specified outcomes. And on average, each trial silently added 5.3 new outcomes.

 

 

 

 

 

My trust in medical studies and certain fields of medicine has dropped to an all-time low.

 

Mine's down to zero, has been for a long time. Sad state of affairs!