Clinical trials doctors claim they own patients' data, want others to pay for access

Image from "Honoring our promise: clinical trial data sharing"

at the NIH Director's blog.

Earlier this month, a consortium of 282 clinical trials doctors, in an article in the New England Journal of Medicine, threw down the gauntlet against the notion that they should share data. Under the misleading title “Towards fairness in data sharing,” these scientists, who label themselves The International Consortium of Investigators for Fairness in Trial Data Sharing, put forward the breathtakingly arrogant claim that doctors who collect data from patients should control it essentially forever.

I wonder what their patients would think if they knew.

This is the second salvo from NEJM this year. Back in January, the editors of NEJM published an opinion piece that used the derogatory phrase “research parasites” to describe scientists who want to re-analyze data from other scientists’ experiments. This caused an outcry, with many scientists pointing out serious flaws in the editors’ arguments. As I wrote at the time,   

“Drazen and Longo [the NEJM editors] are saying, essentially, that only the people who originally collect a data set can truly understand it, and anyone else who wants to take a look is a parasite.”

Keeping scientific data locked away is a recipe for bad science. In the absence of data sharing, flawed results may go unchallenged for years. If someone has distorted or misinterpreted data, we need someone else–someone not invested in proving the same result–to take a second look. This is how science corrects itself.

Even so, at least Drazen and Longo endorsed some data sharing. The authors of this new article (P.J. Devereaux, Gordon Guyatt, Hertzel Gerstein, Stuart Connolly, and Salim Yusuf, all from Ontario’s McMaster University) and their consortium are vehemently opposed to sharing their data with anyone, ever.

Let’s go through their arguments. First, they point out that it takes years of work to set up and run a clinical trial. Absolutely right–no argument there. But then they explain why they conduct these trials:

“A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data. The original investigators almost always intend to undertake additional analyses of the data and explore new hypotheses.”

Oh really? This is why they run clinical trials, in order to publish papers? Somehow I doubt that is what they tell the patients as they are asking for informed consent. Not “we want to figure out what is making you sick” or “we want to find a cure”, but “we want to publish a paper, or maybe several papers!” I’m sure that patients would be lining up around the block to join these studies.

Don’t get me wrong: of course the scientists want to publish their findings, and of course they would like to mine the data for more papers, year after year. That’s what some investigators do now. In this world, doctors running clinical trials would never share data. Why would they, when things are working so well for their careers?

But they seem to have forgotten THE motivation for clinical trials: curing disease. I am honestly dumbfounded that Devereaux and his colleagues don’t mention the words “disease” or “illness” in their article, not even once. Instead they focus on “risks” of sharing data, by which they mean the risk that someone else will make a discovery that they didn’t think of, versus the “benefits,” which in their world means either confirming the original study or possibly testing a new hypothesis. They seem oblivious to the notion that re-analyzing the data to contradict the original claims might actually be a benefit to the rest of the world.

Appalling. Did they feel this way when they first went into medical research? Probably not, but somewhere in the competitive struggle to succeed as researchers, they lost their way.

It gets worse. Devereaux and his consortium go on to lay out what they might be willing to consider:

• Exclusive use of the data for a minimum of 2 years after the first publication
• Another 6 months of exclusivity for every year the trial lasted, up to 5 years of exclusivity
• Anyone who wants the data should pay the original investigators “for their efforts and investments in the trial.”

This last point is the most outrageous of all. Hello? Investigators in clinical trials are already paid for their efforts (though the patients are not), often totaling millions of dollars, and often from taxpayers’ money. Now they want to be paid again by each scientist who wants to look at the data?

These guys need to get over it. The reason we fund clinical trials is to cure disease, not to allow Devereaux and company to publish papers. Publication is the means by which we communicate results, but it’s not the reason that anyone pays for the experiments.

Interestingly, in the same issue of NEJM, U.S. Senator Elizabeth Warren writes about data sharing, expressing quite the opposite view from Devereaux and company. I won’t attempt to summarize her points here, but instead let me quote from one of the public comments published in response to the anti-data-sharing doctors:

“ `This is not working. I just hope that my death will not be in vain and someone learns from it so that others don't have to go through this’ was what my husband said when it became clear that the new drug combination was not working fast enough for us…. My husband died now more than 4 years ago. I have watched his and others' lives been plotted on curves at conferences like ASCO or EMSO and it is deeply upsetting that there are more than 280 researchers who are more concerned about their own careers than the lives of the patients on whom those careers are built. Claiming rights to data paid for with the lives of others has nothing to do with fairness.” Bettina Ryll, M.D., Ph.D., Melanoma Patient Network Europe

I couldn’t say it any better than that. The International Consortium of Investigators for Fairness in Trial Data Sharing–as the 282 investigators called themselves–should be ashamed.