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The World Health Organization (WHO) has published a statement calling for public disclosure of all clinical trial results:
Before any clinical trial is initiated (at any Phase) its details are to be registered in a publicly available, free to access, searchable clinical trial registry complying with WHO's international agreed standards. The clinical trial registry entry should be made before the first subject receives the first medical intervention in the trial.
All clinical trial registry sites are to be updated as necessary to include final enrolment numbers achieved, and the date of actual study completion (defined as the last data collection timepoint for the last subject for the primary outcome measure). If clinical trials are terminated, their status is to be updated to note the termination, and to report the numbers enrolled up to the point of termination.
It is noted that several journals allow open access publication of clinical trial findings. Some journals have an explicit policy of supporting publication of negative trials. These 12 month and 24 month timeframes represent the longest possible acceptable timeframe for reporting and shorter timeframes are strongly encouraged. It should be possible in most instances for reporting to occur in shorter timeframes.
Unreported clinical trials conducted in the past are to be disclosed in a publicly available, free to access, searchable clinical trial registry. In addition it is desirable that unreported clinical trials are published in a peer reviewed journal.
The benefit of sharing research data and the facilitation of research through greater access to primary datasets is a principle which WHO sees as important. This statement is not directed towards sharing of primary data. However WHO is actively engaged with multiple initiatives related to data sharing, and supports sharing of health research datasets whenever appropriate. WHO will continue to engage with partners in support of an enabling environment to allow data sharing to maximise the value of health research data.
Pharmaceutical companies and researchers have brushed away "negative" results in the past. In the case of Tamiflu, the UK government stockpiled £424 million worth of the drug before learning of negative results hidden by F. Hoffmann-La Roche AGM. AllTrials has published reactions from "campaigns, doctors, patients and consumer groups" to the statement. PLOS Medicine has also published a rationale of the WHO's new position.
(Score: 4, Interesting) by MichaelDavidCrawford on Tuesday April 28 2015, @03:04PM
one morning I was puzzled to find the pages of a technical book stuck together with dried egg yolk. After a while I recovered some vague memories have having gone out for a late-night "breakfast", then attempting but failing to read the book at the restaurant, which was about three miles by car from my home.
Later I was puzzled to find my digital camera shot full of pictures of my cat. Pictures that I still have no memory of taking.
Then one morning I found a tub of ice cream on its side on my couch. My freezer door was open, everything in it was thawed.
Then finally I realized in the middle of an Ambien blackout what was going on; despite being in a stupour I called my psychiatrist to ask him to stop prescribing it.
About ten years later the blackouts that other people experiences made headlines; one person reported "eating cigarettes".
This resulted in a Black Box warning, in the Physician's Desk Reference as well as the patient prescribing information. Ambien blackouts are quite common - why was there no such warning yet, when I took Ambien ten years before?
Now consider that antidepressants can cause suicide, the zyprexa antipsychotic can cause diabetes etc.
Yes I Have No Bananas. [gofundme.com]
(Score: 3, Interesting) by DeathMonkey on Tuesday April 28 2015, @04:52PM
This is listed on the pamphlet (which I am sure you read) that comes with Ambien:
Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem.
Maybe it's a newer warning but I have been aware of Ambien "blackouts" for the 5 years I have been taking it.
(Score: 2) by MichaelDavidCrawford on Tuesday April 28 2015, @06:41PM
Filter error: Comment too short.
Yes I Have No Bananas. [gofundme.com]
(Score: 3, Touché) by DeathMonkey on Tuesday April 28 2015, @07:00PM
Yeah, I realized that about 1 ms after I hit submit.
(Score: 3, Informative) by Non Sequor on Wednesday April 29 2015, @02:19AM
When I used Ambien, I had this feeling I couldn't shake that it didn't create "real" sleep.
Write your congressman. Tell him he sucks.
(Score: 2) by MichaelDavidCrawford on Wednesday April 29 2015, @04:45PM
-ful.
I have that problem sometimes.
I found that ambien usually helped me get to sleep but it did nothing to make the insomnia go away. Treating the underlying cause with antidepressants worked better; ironically imipramine cleared up my depression, it was one of the first antidepressants and so cheap as dirt.
Yes I Have No Bananas. [gofundme.com]