Access To Clinical Trial Data: Privacy rights, property rights and phoney rights

December, 3, 2012 | 4 Comments


  1. “The paradox here is that almost all the advances in medicine and in science come from sharing rather than ownership.”

    “The idea of progress through sharing might sound like something close to socialism. It’s not intended to be.”

    You’re so right!

  2. “If you are taking risks with your life and health you can only have what the drug company decides you can have. The historical record shows that company perceptions of what information you should have are shaped more by their commercial interests than any concern for your wellbeing.”
    Isn’t this the problem for consumers/patients? It’s all about the filthy lucre. How can we in Europe change this? We vote for governments who promise reforms here there and everywhere and who ultimately settle for pharma big bucks and fail their citizens at their most vulnerable. Shame and more shame on all of them.

  3. If GSK and big Pharma feel sufficiently threatened by the European Medicines’ Agency or the FDA obliging them to surrender data, they will simply move their game up a notch. This shift upwards may not happen overnight and be a bit more expensive for them, but whatever their costs they are always recoverable.

    Pharma might decide to simplify their lives and improve their image, after all shipping data offshore might stir up suspicions of wrongdoing, never mind the perception of guilt; –while the strategy of ghostwriting articles has been exposed for what it is, a scam that has hopefully been put to rest (but don’t blink …). Question: might those arguably misguided adventures be seen by industry as just part of their own growing pains?
    Pharma might decide to move back ‘up the food chain’ to the genuine old RCTs, absorbing and then recovering the costs that such a step backward might involve: a strategy involving a backwards move while planning the next move forwards, so to speak. This revolves around the idea that data can be altered at source, at the point it is collected, in order to generate a desired result.

    But what about data verification? Data verification in RCTs only confirms the validity of essential data as transcribed from source, there being no verification of data that has been fabricated from thin air, and most people don’t know the difference. The internal validity of a trial can therefore be tossed together like a garden salad rather than be generated from a scientific discovery process. And external validity is something different again.

    The opportunities for falsification of data at source are many and these manipulations can be done off site. But there is a difference: one thing is transcribing from extant patient records (patients’ files) thereby leaving an inconvenient paper trail, and it is another to collect data electronically (EDC) on electronic CRFs (eCRFs), where the ‘meaningful’ part of yet-to-be-derived data can be falsified as it is captured; –data is not fabricated because the participants actually do exist and there is compliance with the protocol.

    Should additional tweaks be needed a computer literate, perhaps even well intentioned summer student can be paid a few dollars an hour to access the database, code to find ‘every elevated LDL level collected on 45-49 year old men taken on alternate Thursdays’, adjust the readings upwards by 8.5 percent, close and leave without a trace, all of which could be undetectable. So this now becomes genuinized data that can be released to the world and no one would know.

    The reason Pharma is currently fighting the release of their data is probably that they know very well their data manipulation has been somewhat clumsy having dealt with it at the back-end, rather than genuinizing it at the front-end, and that those mistakes are going to cost them.

    The only way to stop corruption and fraud in the long run is by regulating the activity of clinical research. This does not mean regulating the trialing process itself. So that individuals in any way connected to a clinical research activity would have to be trained, qualified, certified, registered and licensed in clinical research by a regulatory college, as professionals are in every other health related activity. They might then be held accountable as individuals. Clinician-investigators would presumably start howling against any such proposition; meanwhile Pharma continues to laugh all the way to the bank.

  4. I had an interesting conversation with my local pharmacist today. I live in a small community in which everyone seems to know everyone else. His comments re SSRIs: “I haven’t seen anyone get better on them.” “They’re no better than placebo.” “I have only two patients on MAOIs – there should be more.” “Why don’t they just prescribe a placebo – it would be just as good.”
    My experience in major teaching hospitals has been that physicians listen to the pharmacist more than to anyone else. In the community – at least this community – he’s whistling in the wind.

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