Publish your data, or else we will—that's the stark warning to drug companies in a new proposal released today. Peter Doshi (shown right), a postdoctoral fellow at Johns Hopkins University in Baltimore, Maryland, and his colleagues are fed up that only about half of all clinical trials are published. They want to change that, by convincing researchers and journals to print data that have been publicly released through other means, such as litigation and Freedom of Information Act requests, but, practically speaking, are sitting dormant in the filing cabinets or computers of individual scientists.

The unusual proposal is called RIAT, for Restoring Invisible and Abandoned Trials. It was published today in BMJ and also endorsed by PLOS Medicine. Doshi, who studies comparative effectiveness research, came up with the idea when his colleague, Swaroop Vedula, was analyzing reporting biases involving the drug gabapentin. Gabapentin's maker Pfizer had been sued for the way in which they marketed the drug for unapproved indications. During litigation, Pfizer had released thousands of pages involving gabapentin trials, and Vedula was poring through them. (One of the authors of the RIAT paper, Kay Dickersin, served as an expert witness against Pfizer in gabapentin litigation.) Pfizer had published only 12 of its 20 trials in gabapentin. But Doshi's center at Hopkins had the clinical study reports detailing the results of the other eight.

At the time, "it just hits me," Doshi says. "Why are we still referring to these as unpublished trials? Why aren't we publishing them ourselves?"...

http://news.sciencemag.org/sciencein...ls.html?ref=hp

http://www.bmj.com/highwire/filestre...df/0/bmj.f2865

For the medical world, this is the big ethical problem of the past 25 years. The leaders of patient advocacy groups, the doctors and scientists, the med students, and, yes, the leaders of the pharmaceutical industry, should speak now, or forever hold your peace.

The existing situation, wherein science fraud is blithely accepted, negative trials are hidden away and successful ones are publicized, to the detriment of patients, distorting the basis on which life-and-death decisions are made, and we see that the only response from the medical and science and advocacy leaders is to shrug their shoulders; is a perfect model of a situation that cannot endure; cannot be tolerated.

Silence is the answer we most often hear in the medical milieu. The silence is deafening.
And silence is not the right answer. It is the silence of the lambs, and it is a dirty rotten shame.
The time has come to put it right. It would be better for everyone, including Pharma, to not talk falsely now. The hour is getting late.

Drug companies have a year to publish their data, or we’ll do it for them
By Dr. Tom Jefferson

As a doctor it’s my job to prescribe lotions and potions. To do so, I read information about drug trials in books and medical journals to keep me up to speed on the latest drugs, dangers and side effects.
But what if what I read is part of an elaborate marketing strategy by a drug company to use me to get to you?
…the saturation of scientific literature with commercial messages has come to the point where some of those of us who work full time in this area don’t trust the literature anymore. I can read something about a drug and find that the majority of the data about it – for example as I argued in a recent article on Tamiflu – is missing.

This is not because the work hasn’t been done, but because it has been deliberately hidden. What has been published might have important discrepancies with what probably really happened during a clinical trial. We just don’t know.
It involves everyone: scientists, pharmaceutical sponsors, editors of biomedical journals and the media. Ultimately it is you who suffers.
At school, if you made a mistake the teacher would ask you to explain it and get you to correct it in your exercise book. The same should go for unpublished and misreported trials. They should be published and formally corrected to ensure doctors and patients can rely on complete and accurate information about the treatments we use.

…we have obtained possession of hundreds of highly detailed reports of trials which were never published (invisible) or distorted in the way the results were presented. Some were even ghost written and we also know by whom and for how much money.

… we ask drug companies to publish and correct all data – including on medicines already in circulation – within the next year. Otherwise independent scientists will begin doing it themselves.
Volunteer researchers – currently being signed up – will be able to pick an invisible or distorted trial, write to the drug’s sponsor and ask them to make it visible or correct the record – and drug companies will be given a year to do it.

If the company doesn’t respond within 30 days or turns the offer down, we will publish the paper….

In the Middle Ages scientists were kept under control by physical threats, today control is exerted on what information we’re able to see.

Will this include our friend Amgen?

That would be so appropriate!

So far there is no Amgen in the hundreds of thousands of pages already obtained. But this direct action is new, and there is a crack in everything - that's how the light gets in.
Metaphorically speaking,
walls fall down, all the way to hell
never saw them when they were standing
never saw them when they fell

Sometimes I remember Tweeter
sometimes I remember Jan
But most often, I remember the Monkey Man

http://www.jsonline.com/watchdog/wat...211874181.html

Two independent reports issued Monday found Medtronic's spine surgery product known as Infuse offered little benefit over conventional spine surgery and may be linked to serious harms including cancer and a complication that can cause sterility in men.

The twist: This time the critical reviews were funded by Medtronic itself.

In 2011, the company agreed to allow Yale University to oversee the new studies after concerns identified by other independent researchers, a probe by a U.S. Senate Committee and investigative reports in the Journal Sentinel dating to 2009...


Eugene Carragee, editor in chief of the Spine Journal, which published its own critical review of BMP-2 in 2011, said early on there was an unwarranted carnival-like enthusiasm for the product.

The result, he said, was billions of dollars in extra medical costs and the increased risk of serious complications.

"The take home message from this debacle...is that the public needs better safeguards against conflicted and tainted medical research," he said.
That means medical journals should have complete access to data and get unbiased presentations from authors, said Carragee, head of spine surgery at Stanford University.

"Unless we remain vigilant, medical publications will continue to devolve into information-laundering machines and clinical studies become infomercials for their corporate sponsors," he said.

[QUOTE=Bob Dawson;993131

So far there is no Amgen in the hundreds of thousands of pages already obtained. But this direct action is new, and there is a crack in everything - that's how the light gets in.
[/QUOTE]

Actually there is one Amgen study that has been received by the rebels in the hills, but it is not a very significant one.

Any lurkers on this site, or whistle blowers, with access, now is the time to, as they say, make a difference. Publicly or anon.

All we want to do is move toward evidence-based science, and away from the infomercials of marketing-based pseudo-science.

Breaking the Seal on Drug Research
...The current system, the activists say, is one in which the meager details of clinical trials published in medical journals, often by authors with financial ties to the companies whose drugs they are writing about, is insufficient to the point of being misleading.

There is an underdog feel to this fight, with postdocs and academics flinging stones at well-fortified corporations. But they are making headway. Last fall, after prodding by Dr. Doshi and others, the drug giant GlaxoSmithKline announced that it would share detailed data from all global clinical trials conducted since 2007, a pledge it later expanded to all products dating to 2000. Though that data has not yet been produced, it would amount to more than 1,000 clinical trials involving more than 90 drugs, a remarkable first for a major drug maker.

The European Medicines Agency, which oversees drug approvals for the European Union, is considering a policy to make trial data public whenever a drug is approved. And on June 17, the medical world saw how valuable such transparency could be, as outside researchers published a review of a spinal treatment from the device maker Medtronic. The review, which concluded that the treatment was no better than an older one, relied on detailed data the company provided to the researchers.

For years, researchers have talked about the problem of publication bias, or selectively publishing results of trials. Concern about such bias gathered force in the 1990s and early 2000s, when researchers documented how, time and again, positive results were published while negative ones were not. Taken together, studies have shown that results of only about half of clinical trials make their way into medical journals...

http://www.nytimes.com/2013/06/30/bu...temail0=y&_r=0