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How many children died because peer reviewed data was buried and results cherry-picked?

This example below shows the dangers of cherry picked and buried data. It shows how great news and joy can be reported from rancid results, and the only protection against this is open access. When the taxpayer funds research that is not fully and transparently public, and immediately available, the people are funding PR rather than science. “Peer review” does little to stop this, little to clean up the mess after it happens, and the truth can take years to  be set free.

Ten percent of teenagers taking an anti-depressant harmed themselves or attempted suicide. This was ten times the rate of the teens on the placebo. The results of this clinical trial were published in 2001, but those alarming statistics were not reported. The drug went on to be widely used. A new reanalysis of the data, reported in the BMJ, revealed the dark and hidden dangers. The company that funded the research, Glaxo Smith Kline, has already faced record fines of $4.2 billion. The Journal of the Ameri­can Academy of Child and Adoles­cent Psychiatry won’t retract the paper.

There are many ways to hide data. In this case, the results of the trial include 80,000 records which were provided in a form that could only be accessed one at a time.

There are many branches of science, and psycho-science where the data is partially withheld, or unavailable, or provided in a difficult-to-use form. David Jones of the Australian BOM was caught in the climate gate emails saying “we have a policy of providing any complainer with every single station observation when they question our data (this usually snows them).” Stefan Lewandowsky did a survey and held back a quarter of the results. John Cook and the University of Queensland threatened to sue people making their data public.

All publicly funded data must be made available upon publication; the public shouldn’t need to ask for it.  If they have to FOI, the government funded system of “science” has already failed.

Data from a peer-reviewed antidepressant trial misleading: 

An Australian-led study of a popular antidepressant has shown that it can tip young people­ into suicide.

In a rare re-analysis of a contro­versial clinical trial, the researchers­ found that the drug paroxetine — touted in 2001 as safe and effective for teenagers — was neither.

The new study, published in the journal BMJ, proves the long-suspected dangers of the drug also known as Paxil, Aropax, Extine­ and Paxtine. Study leader Jon Jureidini said it raised wider implications about the need for medical researchers to publish their underlying data — standard practice in genomics and astronomy, but rare in medicine.

 Big money at stake, and bad statistics go unspoken:

The controversy eventually contributed to a record $4.2 billion fine against GlaxoSmithKline, whose constituent company SmithKline Beecham had funded the study during the 1990s, for withholding data and misleading consumers. But the Journal of the Ameri­can Academy of Child and Adoles­cent Psychiatry, which published the 2001 paper, dismissed retraction calls.

The new study re-analysed records extracted from the company during legal proceedings and subsequent negotiations. It found that more than 10 per cent of the teenagers who took paroxetine during the trial had harmed themselves or attempted suicide, compared with about 1 per cent of patients who took a placebo.

There are many ways to hide data:

A GSK spokeswoman said the side-effects of the drug were now well understood, and the company no longer owned the product in Australia. She said the company was committed to open disclosure of trial data and had allowed the Adelaide researchers access to the Study 329 records. “We disagree with any suggestion that we didn’t help the team with its analysis,” she said.

Professor Jureidini said GSK had granted access to the data via a server that allowed the researchers to look at the 80,000-odd records only one at a time, and repeatedly logged them out. One researcher had spent more than 1000 hours painstakingly extracting information.

Two million prescriptions to children:

The “blockbuster” drug, paroxetine, which is sold under the brand names Aropax here and Paxil overseas, was prescribed more than two million times to children in the US alone until warnings emerged that it may be causing suicidal behaviour in some children.

Study co-author Jon Jureidini, from the University of Adelaide’s Critical and Ethical Mental Health Research Group, said previously unreleased patient records and other documents showed far higher rates of serious incidents in children taking the drug than previously thought, and no evidence the drug worked for depression.

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