Why Opening Up Clinical Trials Data Is Good For Pharma Companies Too

from the everybody-wins dept

Earlier this year we wrote about how AbbVie, the pharma company spun out of Abbott Laboratories, had gone to court to stop the European Medicines Agency (EMA) from releasing clinical trials information about one of its drugs. Despite what AbbVie claimed, this was not commercially sensitive in any way, but simply basic data about safety and efficacy.

It's often overlooked that this data is mostly obtained by testing new drugs on volunteer members of the public who take the medicines in order to establish their safety. By definition, these volunteers are putting themselves at risk. They selflessly offer to do that in order to advance medicine and confer benefits on society as a whole. That means the clinical data obtained from such tests belongs to the public that made them possible, at least from a moral viewpoint.

If a company seeks to prevent the free dissemination of that safety data, as AbbVie is doing in Europe, it is breaking the implicit compact it made with the people who agreed to try out its drugs. Those invited to take part in future trials of AbbVie's drugs might then begin to ask why they should endanger their health and even lives purely to boost one company's profits.

But even if AbbVie is resistant to the argument that it has a moral obligation to allow the clinical trials data to be released, and is not concerned that the public might think that it has something to hide, perhaps it will be won over by a recent article in The New England Journal of Medicine (NEJM), written by four people from the EMA. This puts forward a quite different argument, that releasing test data will directly benefit pharma companies themselves, and offers a number of reasons why.

First, access to the full data sets of completed studies will lead to improvements in the design and analysis of subsequent trials.
Basically, the more information that drug companies have about what works and what doesn't, the better they can design their future tests.
Second, lessons from past trials about the heterogeneity of treatment effects not only will streamline drug development but also may enhance a drug's value in the marketplace. Identification of a population with high unmet need in which a new treatment may be more cost-effective than other available treatments can aid sponsors during reimbursement negotiations.
Again, the more information companies have about how different groups of patients responded to a drug, the easier it will be to spot particular sub-groups in the population who derive particular benefit. Selling products for that sub-group will be both easier, more profitable and more ethical than simply trying to sell to everybody, since the drug may be ineffective or even inappropriate for many of the general population.
Third, since several possible treatments for one medical condition are often available, comparative-effectiveness information is important to patients, prescribers, and sponsors seeking to position their products.
For a given condition, there may be several possible treatments. Making clinical test data available allows them to be compared, and the best one selected for future drug development, instead of investing huge sums in what may well be a relatively ineffective approach.
Finally, one of the inherent inefficiencies of data secrecy is the repetition of trials and projects that are doomed from the outset; drug developers may continue to pursue a given target even though clinical trials conducted by others have demonstrated the effort's futility.
In many ways this is the most important reason. If the results of clinical trials are kept secret, companies run the risk of repeating the mistakes already made by others. Not only is that a waste of time and money that could be better spent on more fruitful avenues, it is putting test subjects at risk unnecessarily. As the NEJM points out:
In at least one documented case, the availability of data from completed trials could have spared trial subjects a potential health risk and saved millions of research dollars.
The article concludes:
A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders. What is sometimes labeled as "free riding" may ultimately pay dividends for innovative companies and for public health. It is ironic that the organizations that most resist wider access to data are the ones that stand to benefit so much from greater transparency.
In fact, this is no mere theoretical possibility. We know this approach works, because it is precisely what we see in the field of open source. Sharing the code freely creates a level playing-field that allows companies to innovate faster because they can build on the work of others. The rise of a multi-billion dollar software industry based around such sharing, and the unprecedented rate of innovation this drives, are yet more reasons that companies like AbbVie should be striving to promote, not prevent, the release and dissemination of clinical trials information as open data.

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Reader Comments (rss)

(Flattened / Threaded)

  1.  
    identicon
    Anonymous Coward, Nov 5th, 2013 @ 4:52am

    "Third, since several possible treatments for one medical condition are often available, comparative-effectiveness information is important to patients, prescribers, and sponsors seeking to position their products."

    That is precisely why they don't want this data available.

    Their new 'ever-greened' drug is just as effective as the older, cheaper, generic version. I wonder which one I would buy?

     

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  2. This comment has been flagged by the community. Click here to show it
     
    identicon
    out_of_the_blue, Nov 5th, 2013 @ 5:37am

    Pieces like this are always disconnected from reality.

    This piece fosters the demonstrably false notion that pharmaceutical mega-corporations care about efficacy at all, let alone over profits.

    The only real question raised is "fool or knave": whether these Pollyannas actually believe idealistic notions that corporations are interested in doing good, or are cynical hacks grinding out standard PR as part of the massive advertising machine (that has as its goal excess and unnecessary drug use).

    "We know this approach works, because it is precisely what we see in the field of open source." -- HA! False analogy (as all are), and hopelessly naive: you're comparing for-profit mega-corporations to people writing non-profit code? Sheesh. Up to that point, I gave you benefit of doubt, but when you stretch that far...

    Since to even argue these notions, one must ignore the long record of pharmaceutical mega-corporations putting profits over not just efficacy but patients lives, I regard these as yet more fools who believe they're knaves, but are actually just tools of the real knaves.

    Actual user testimonial: Techdirt helps me think right because provides an obviously wrong reference point.

    01:37:06[b-370-6]

     

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  3.  
    identicon
    Anonymous Coward, Nov 5th, 2013 @ 5:48am

    Re: Pieces like this are always disconnected from reality.

    You understand of course that open source (non-profit as you say) code has been used by the majority of large corporations and helped them make billions of dollars?

     

    reply to this | link to this | view in thread ]

  4.  
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    Ninja (profile), Nov 5th, 2013 @ 7:53am

    Opening up clinical trials data may expose lousy, hasty researching and more intense collateral effects than advertised. Be wary of those resisting it at all costs.

     

    reply to this | link to this | view in thread ]

  5.  
    identicon
    Anonymous Coward, Nov 5th, 2013 @ 8:40am

    Those volunteers are getting paid (compensated). Never mind that there is a notable underground group of willing participants who travel around nation to participate in different studies (and live off that)

     

    reply to this | link to this | view in thread ]

  6.  
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    John Fenderson (profile), Nov 5th, 2013 @ 9:40am

    Re: Pieces like this are always disconnected from reality.

    you're comparing for-profit mega-corporations to people writing non-profit code?


    Open source != nonprofit. There are plenty of for-profit companies producing open sourced code.

     

    reply to this | link to this | view in thread ]

  7.  
    identicon
    Anonymous Coward, Nov 5th, 2013 @ 2:58pm

    Re:

    compensation for clinical trials is the norm. As for the other part? [citation needed]

     

    reply to this | link to this | view in thread ]

  8.  
    identicon
    Anonymous Coward, Nov 5th, 2013 @ 5:01pm

    Re: Pieces like this are always disconnected from reality.

    out_of_the_blue hates it when due process is enforced.

     

    reply to this | link to this | view in thread ]


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