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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 13 of 13. This is the beginning of the thread.
Posted by poser938 on July 8, 2013, at 17:02:34
http://www.bmj.com/content/346/bmj.f2865
Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond
Well designed and well performed randomised controlled trials are considered to provide the most reliable evidence on the effects of health related interventions. However, the credibility of findings from individual trials and from summaries of trials examining a similar research question (that is, systematic reviews and meta-analyses) has been undermined by numerous reporting biases in the published medical literature. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Reporting biases are often difficult to detect, but have the potential to discredit earnest efforts towards evidence based decision making.
Two basic problems of representation are driving growing concerns about relying on published research to reflect the truth. 10 15 The first is no representation (invisibility), which occurs when a trial remains unpublished years after completion. The second is distorted representation (distortion), which occurs when publications in medical journals present a biased or misleading description of the design, conduct, or results of a trial. 1 6 10 14 Both go against the fundamental scientific and ethical responsibility that all research on humans be used to advance knowledge and are symptomatic of a general culture of data secrecy. The end result is that the healthcare, biomedical research, and policy communities may, despite best intentions and best practices, end up drawing scientifically invalid conclusions based on only those parts of the evidence base they can see.
A call to publishor be published
Despite near universal agreement that reporting biases are harmful, efforts to correct the problem have largely focused on forward looking initiatives. Prospective registration of trials has made major strides in ensuring that the biomedical community is aware of trials at their inception, but at best only around half of registered trials on ClinicalTrials.gov were registered before they began enrolling patients. 16 Recent studies have also shown that even when disclosure of study findings is mandated by law, results often remain invisible. 17 18 19 In addition, trial registration does not address the problems of invisibility and distortion for trials that took place before registers were widely used. Most importantly, those demanding correcting action lacked the data required to actually correct the scientific record. However, with increasing amounts of data entering the public domain, it is now becoming possible to move from words to action and publish (or republish) abandoned trials.
We have access to around 178 000 pages of previously confidential company research documents (table 1⇓, box). For drugs such as paroxetine, quetiapine, and gabapentin, litigation over illegal off-label marketing put thousands of pages of trial reports in the public domain. Other trial reports, such as for oseltamivir and clopidogrel, were obtained through new freedom of information policies at the European Medicines Agency (EMA) that have revolutionised the publics ability to access trial data. 20 21 22 23 The documents are a substantial resource of information about trials. We expect that other independent groups will also have access to many additional trial reports.
The documents we have obtained include trial reports for studies that remain unpublished years after completion (such as Roches study M76001, the largest treatment trial of oseltamivir, and Pfizers study A945-1008, the largest trial of gabapentin for painful diabetic neuropathy). We also have thousands of pages of clinical study reports associated with trials that have been published in scientific journals but shown to contain inaccuracies, such as Roches oseltamivir study WV15671, GlaxoSmithKlines paroxetine study 329, and Pfizers gabapentin study 945-291. 3 12 24 25 We consider these to be examples of abandoned trials: either unpublished trials for which sponsors are no longer actively working to publish or published trials that are documented as misreported but for which authors do not correct the record using established means such as a correction or retraction (which is an abandonment of responsibility) (box 1). 25 Because abandonment can lead to false conclusions about effectiveness and safety, we believe that it should be tackled through independent publication and republication of trials.
There is much more to read in the link at the top of the page.
Posted by poser938 on July 8, 2013, at 17:07:46
In reply to The RIAT Act, posted by poser938 on July 8, 2013, at 17:02:34
:D
Posted by Phillipa on July 8, 2013, at 18:45:30
In reply to This is good news for all of us***, posted by poser938 on July 8, 2013, at 17:07:46
Why I don't understand it? Phillipa
Posted by poser938 on July 8, 2013, at 19:56:34
In reply to Re: This is good news for all of us*** » poser938, posted by Phillipa on July 8, 2013, at 18:45:30
> Why I don't understand it? Phillipa
Many clinical trials on medications millions take everyday never had the results published for review, leading to an incomplete view of how well the drug works for the condition it is used to treat. The RIAT Act aims to correct this.
Posted by poser938 on July 8, 2013, at 20:06:25
In reply to Re: This is good news for all of us***, posted by poser938 on July 8, 2013, at 19:56:34
> > Why I don't understand it? Phillipa
>
>
> Many clinical trials on medications millions take everyday never had the results published for review, leading to an incomplete view of how well the drug works for the condition it is used to treat. The RIAT Act aims to correct this.
>The information will be obtained through new policies in the the Freedom Of Information Act.
Now we will be much closer to knowing how well these drugs work, and also have a much more complete list of its side effects.
Posted by Phillipa on July 8, 2013, at 21:17:35
In reply to Re: This is good news for all of us***, posted by poser938 on July 8, 2013, at 20:06:25
I thought that was it but figured I should ask. I don't assume things that I'm not an expert in. So the unpublished trials will be revealed when? Phillipa
Posted by poser938 on July 8, 2013, at 21:31:33
In reply to Re: This is good news for all of us*** » poser938, posted by Phillipa on July 8, 2013, at 21:17:35
i think the original article was from April of this year. it says that it will give the drug companies or who ever a year to release the complete information on their clinical trials. if they dont do it by then, an independant organizations will access the information themselves and release it to the public. (if i understood it right).
im interested in seeing all the effects this will have. if it might even cause some drugs to be taken off the market, after the full clinical trial information is released. if there will be lawsuits with people suing the drug company selling them a drug that they already knew wasnt effective. or because the risk to benefit ratio was not worth it. hmm
Posted by Phillipa on July 8, 2013, at 22:01:23
In reply to Re: This is good news for all of us***phillipa, posted by poser938 on July 8, 2013, at 21:31:33
Like I read the article Jeroen posted on minocycline and saw it had been put on the FDA watch list in 2009. And the docs are still prescribing it. So what happens when they find that certain meds do nothing? It's possible? Phillipa
Posted by SLS on July 9, 2013, at 5:38:56
In reply to Re: This is good news for all of us***phillipa, posted by poser938 on July 8, 2013, at 21:31:33
> i think the original article was from April of this year. it says that it will give the drug companies or who ever a year to release the complete information on their clinical trials. if they dont do it by then, an independant organizations will access the information themselves and release it to the public. (if i understood it right).
>
> im interested in seeing all the effects this will have. if it might even cause some drugs to be taken off the market, after the full clinical trial information is released. if there will be lawsuits with people suing the drug company selling them a drug that they already knew wasnt effective. or because the risk to benefit ratio was not worth it. hmmDid you know that there was a study that reported that both Prozac and Cymbalta were less effective than placebo? How might this be interpreted?
- Scott
Posted by poser938 on July 9, 2013, at 17:32:38
In reply to Re: This is good news for all of us***phillipa » poser938, posted by SLS on July 9, 2013, at 5:38:56
your guess is as good as mine. but eventually it might be interpreted that my very antidepressant trial with Cymbalta might have been more successful if i had been prescribed a tictac instead.
Posted by Phillipa on July 9, 2013, at 20:10:40
In reply to Re: This is good news for all of us***phillipa, posted by poser938 on July 9, 2013, at 17:32:38
Meds don't work? Is this why so many meds are added to try to make a med work?
Posted by poser938 on July 10, 2013, at 16:36:26
In reply to Re: This is good news for all of us***phillipa » poser938, posted by Phillipa on July 9, 2013, at 20:10:40
> Meds don't work? Is this why so many meds are added to try to make a med work?
too often these meds dont work as well as they should to be able to deserve FDA Approved status.
and in my experience, as well as the experience of many, many others, they can be too dangerous. And those who deny this statement shoukd be extremely thankful they havent had the experience to realize how dangerous medications can be.
but, the RIAT Act isnt just targeting psychiatric meds. it is also going after other meds.
Posted by Phillipa on July 10, 2013, at 20:47:30
In reply to Re: This is good news for all of us***phillipa, posted by poser938 on July 10, 2013, at 16:36:26
I know in all seriousness right now a 48 year old female nothing ever wrong with her was given Dilantin for a head injury that caused focal seizures. And she's been in ICU with rare reaction. Temp l05, lupus like syndrome, liver failure, and kidney failure. The temp is down as pumped full of IV antibiotics cause 7 specialists still can't figure out what's wrong with her. The liver is resolving the kidney dialysis is every day or every other day depending on creatinine levels. This person doesn't even take aspirin till this. So for the time being the diagnosis is induced as drug reaction to Dilantin which she was only on for 2 weeks. Phillipa
This is the end of the thread.
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