a dangerous sleep…

Posted on Friday 28 June 2013

My Blog: NIMH Director
by Tom Insel
June 14, 2013

A couple of weeks ago, President Obama launched a new open data policy [pdf] for the federal government. Declaring that, “…information is a valuable asset that is multiplied when it is shared,” the Administration’s new policy empowers federal agencies to promote an environment in which shareable data are maximally and responsibly accessible. The policy supports broad access to government data in order to promote entrepreneurship, innovation, and scientific discovery…

However, not all scientists are comfortable sharing data. Some point out that data collected under different conditions or with different assessment tools should not be combined. Some have expressed concern that data will be “misinterpreted” if analyzed without the input of the researchers who collected the data. And others worry about the competitive disadvantage of sharing data before publication. In an academic culture that rewards the first to report a finding and for which publication is critical for promotion, sharing might seem unfair to early career scientists and unacceptable to more established investigators. Finally, privacy concerns may be a complex — though not insurmountable — barrier to sharing data, both for scientists and for research participants. We must not minimize these concerns. But as an agency that is ultimately focused on improving the health of patients, NIMH must find a way to balance the concerns of the academic community with our public health mission.

If “information is a valuable asset that is multiplied when it is shared,” then the question for publicly funded research is not if, but how to share. Currently, NIH policy expects a data sharing plan for all proposals over $500,000 per year in direct costs. However, some research communities have developed their own “subcultures” in which sharing is expected—and executed—for all grants, not just those over the $500,000 threshold. For example, all researchers conducting NIH-funded genome-wide association studies submit their data to the NIH Database for Genotypes and Phenotypes [dbGaP], as expected by the NIH GWAS Data Sharing Policy. In other areas, such as autism research, NIH expects all funded clinical studies to deposit data in the NIH National Database for Autism Research [NDAR].

These two trans-NIH data sharing efforts are a great start. But as a community, can we do better in other areas, such as clinical trials, by defining our standards for data sharing? For example, should we develop common data elements and create repositories for shared data in other research fields? What is the right balance between providing qualified researchers with access to data at the earliest opportunity while respecting the needs of those who collected the data? How can we incentivize sharing and data mining when many investigators do not have the funding to analyze their own data sufficiently? Should some data not be shared? NIH has been developing resources to facilitate this conversation, such as key elements to consider when preparing a data sharing plan [pdf].

Among the sticky points in the US Constitution, the wording of the First Amendment on the subject of religion has left us with two centuries of ongoing debate – a debate that will probably never end. In Dr. Insel’s discussion of Open Data, he thoughtfully outlines some of the issues involved in making scientific data freely available beyond the filing cabinets and computers of those generating it. With modern database technology, data storage capacities, and number crunching computers, it is widely hoped that access to "big data" will help us unlock all kinds of scientific secrets beyond those available to any single investigator. In the highlighted paragraph, he discusses factors that might argue against free access to data with an emphasis on matters academic, and his remarks understandably cluster around the consideration of publicly funded research.

I have no interest or opinions about such things. I see stacks of government forms and prolonged academic debates looming in the future, and can almost feel myself going to sleep as a defense against the tedium of the proceedings. But it is a dangerous sleep, because in those soporific discussions lies a grave danger. We’ve lived in an era when the wall between academic and commercial has become blurred beyond recognition. In medicine, and specifically in psychiatry, the idea of cooperative ventures has been actively promoted, all in the spirit of translational science – moving basic science quickly to the drug store. Commercial enterprise has gained access to the academic literature via funding and through "guest authors" whose credentials in academia have been used as boarding passes. It’s a ubiquitous problem and the results have grossly contaminated our journals and academic institutions. Conflicts of Interest have become the rule, at least in psychiatry.

And so back to the First Amendment [The Bill of Rights] that said, "Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances" rather than Thomas Jefferson’s "a wall of separation between church and state." In protecting the people from state interference in religion, they overlooked or chose not to deal with things going the other way – thus the endless debate. In my opinion, we need to avoid that error with an enforceable firewall between the academic and commercial domains – one where Conflict of Interest doesn’t exist except as a historical warning. We’ve tried to live without one – pretending that there could be exceptions or even mergers, and the results have been a disaster.

I see a similar problem coming in the deliberations about Open Data. If they start making exceptions or modifications based on academic concerns and ignore the fact that the boundary between academic and commercial is in name only, loopholes will pop up all over the place, particularly in the area of clinical trials. So I would suggest that up front we declare that all commercially generated data used in either academic publications or submissions for approval must be open access – no exceptions. Further, if we are going to allow commercial studies into the academic literature, let’s just do it outright, appropriately labeled, and make guest authorship the mortal sin it ought to be. No more stealth. If an academic is genuinely involved in the research – that’s authorship. But these sign-on front men like in my recent posts about Seroquel need to go. That’s not an academic enterprise. It’s fraud.

I have no interest in data-sharing for the purpose of discovery. That’s someone else’s concern. I’m interested in Open Data so we can check the results and put an abrupt end to the almost institutionalized jury-rigging of studies for commercial promotion. I don’t mind them doing it with wash-day products, but I don’t want them doing it with medications I prescribe. I didn’t sign on for that. And I took an oath that can’t be upheld if they’re allowed to muck with their data. So unfortunately, we have to stay wide awake for any and all Open Data debates…
  1.  
    wiley
    June 28, 2013 | 2:08 PM
     

    It might help if there were a law making it a crime for an author not to declare all conflicts of interests and for the journals to print them with the paper; but that would require Congress.

  2.  
    jamzo
    June 28, 2013 | 5:45 PM
     
  3.  
    wiley
    June 28, 2013 | 6:01 PM
     

    A fundamental problem with these trials is that the assertion that all the test subjects suffer from an endogenous biological depression is specious and not scientifically grounded. For test subjects who do not suffer from an endogenous biological depression, how they respond to medication or placebo is meaning-less.

  4.  
    Annonymous
    June 28, 2013 | 8:09 PM
     

    Jazmo, While I think Coyne has made some fair points about the limitations of Kirsch’s work on SSRIs, his past enthusiasm about Gibbons work gives me pause.

  5.  
    wiley
    June 28, 2013 | 8:18 PM
     

    Insel’s claim might not be much different than this:

    Nurse Practitioners in Frenzy Over “Youth Hormone”

    New Research on Growth Hormone Booster SeroVital®-hgh Has Conference Goers Buzzing…

    http://www.reuters.com/article/2013/06/20/ny-serovital-aanpconf-idUSnPNLA35336+1e0+PRN20130620

    Except his don’t have this:

    * Reuters is not responsible for the content in this press release.

    anywhere on his press releases.

  6.  
    jamzo
    June 28, 2013 | 10:21 PM
     

    what got my attention was coyne’s attitude toward psychotherapy trials compared to medicine trials

  7.  
    Annonymous
    June 29, 2013 | 2:06 AM
     
  8.  
    Johanna
    June 29, 2013 | 12:40 PM
     

    The right of a government to mandate open sharing of data is up for debate I guess, although if you are going to sell your product to the public for a profit, someone other than the hapless consumer has to make sure it’s not poison. But how about the so-called Scientific Community?

    I was taught in high-school biology class that if a discovery was not “reproducible” — if others could not get the same results by doing the same thing you did — it was not science. And it couldn’t be reproducible unless you shared all your methods and results with other scientists. In other words, if the data is not shared, then It’s Not Science. Period. And nobody should take it seriously as science. I keep wondering — when did this ironclad rule become just a suggestion?!?

  9.  
    Annonymous
    June 30, 2013 | 11:54 PM
     

    jamzo, After reading more of Coyne’s work I see your point. Given his marked skepticism, I still also remain surprised he seems such a fan of Gibbon’s work.

  10.  
    Annonymous
    July 1, 2013 | 12:18 AM
     

    I guess if there are psychiatrists who often decry medications and are psychotherapy hyper-enthusiasts, it would make sense that there are psychologists who are the reverse. One of Coyne’s recent posts:
    “Do rising rates of antidepressant prescription translate into lower rates of suicide? Evidence from 29 countries”

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