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Our group (western Europe/Switzerland) has submitted a review on a device that generates a lot of money (i.e. multibillion $ industry). Our results speak mildly against the use of said device, although we have low confidence in those results (meta data warns about the possibility of a false positive).

Since the inception of the study, we have been queried multiple times by a VP of the relevant (US-based) company through email, asking us to share our data (which we refused). Since submission, the VP is asking for a meeting in person and there are rumors of them not being happy about our results (which are BTW still unpublished). We did not respond. In the meantime, the company also reached to our head of dept. to express that they were worried about our work.

They are obviously treading very carefully so we can't accuse them of exerting pressure on us. But we are worried about the risk of retaliation on publication (i.e. legal action). Our boss told us not to worry and discouraged us from seeking legal advice. Neither the study nor our group are financially supported. How can we protect ourselves? Are there organizations specializing in / providing (free?) researcher protection?

Edit:

  • our work is not funded. Period. No money. Nada. It is not unusual at all to do unfunded research aside from one's professional activity in my field (medicine).

  • we do not promote (nor are we interested in doing so) an alternative device. The review compares the process using device to the usual process without device. The comparison is made upon patient outcomes (cured, harm, death, etc.).

  • The company hinted sharing data with us, but then refused to do so when explicitly asked. It seems that they were already worried about the results by that time.

  • The company asked us for our results ahead of publication. We refused, as we would have had to state that in our manuscript, which would have made our readers suspicious and would have reflected badly on our work. There was no reason given for our refusal.

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  • @scaaahu We are not supported financially. With our boss telling us not to worry, we are alone for the time being. I don't know if there's a plan in case of problem, but knowing our institution I strongly suspect that there's absolutely no plan or anticipation going on.
    – Raoul
    Sep 23 at 9:17
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    I can't help to wonder if the reason for the company trying other channels to get your data is that no reason has been given to them. If your study can affect them economically, it is not really surprising that they try other ways of getting the data because the reason for not sharing the data may be something they can influence. Perhaps it makes sense to discuss with your legal department whether it makes sense to provide the actual reason to the company, because it appears to be a good one to me.
    – DCTLib
    Sep 23 at 11:09
  • @DCTLib indeed, that a good point I hadn't really considered. Thanks for your input!
    – Raoul
    Sep 23 at 12:21
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    the question said: "there are rumors of them not being happy about our results (which are BTW still unpublished)". Maybe the rumors are coloring the interpretations of their actions?
    – NKCampbell
    Sep 23 at 18:36
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    "Our results speak against the use of said device, with low confidence in the evidence presented." means that the low confidence is in the evidence presented in favour of using the said device, or that you have low confidence in your results?
    – EarlGrey
    Sep 23 at 21:47
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Do you, or any of your co-authors, work for a university. If so you could contact and speak to the legal department about how to protect yourself legally.

Alternatively (or in addition) I read a book called "merchants of doubt" which talks about disinformation campaigns against research and researchers who threatened the products of certain industries. There is a website associated to the book here: https://www.merchantsofdoubt.org/ .

While I doubt they would be able to help directly, the authors may be able to point you any relevant groups to guide you in protecting yourself both legally and publicly (if the company in question is malicious then they may not just use legal means to try to bury the results). The book was mainly focused on things that happened in the US so there may be some differences to your case, though if the company in question is US then this may be a benefit to you.

Broadly, since neither I nor many people on this site, are lawyers then legal advice should not be sought from us. Your boss' concerns about legal advice may also be from a worry of agitating the company and making them act. While you don't want to trigger anything (if you are big and have a lot of money you don't need to win a lawsuit to win) getting proper advice regarding what you should keep a written record of and what kinds of behaviours to avoid for legal or public reasons is not a bad idea.

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Merely asking to see your data, and expecting open scientific work, is not at all inappropriate, and nothing you have described so far amounts to anything untoward by this VP. You are certainly right to tread carefully, but you may be getting ahead of yourself in regard to concerns about "pressure" and "retaliation". Indeed, I would go further and say that it is desirable that scientific researchers should generally be under some pressure to make the data for their work available either to the public or other researchers. (I am also sceptical of characterising legal action as "retaliation"; see further commentary below.**)

You will have to decide if you intend to make your data public, or make it available to other researchers, etc. If you are withholding access then you should have a good reason for this, and it should be commuicated to people who seek access to the data. When you publish your research, the journal might also impose requirements on you in respect to data availability. Whatever your decision, it is certainly a bad look if you refuse to give access to your data to other researchers on the basis that they take an opposing view of the efficacy of the research to your own (or on the basis that they have interests that conflict with yours). Ideally, you will be able to formulate a reasonable way for other researchers to get access to your data, perhaps subject to reasonable restrictions that do not constrain their ability to oppose your own findings. Perhaps you can even negotiate some data-sharing arrangement where each organisation provides a quid pro quo in terms of data access.

In any case, by your own description, you have "low confidence" in the evidence adverse to the device. Presumably that assessment will be incorporated into your published work on the topic, so that the reader is aware both of the direction and strength of the evidence. You will need to decide whether the evidence is strong enough to assert a conclusion at all, or if it is so weak that it would be irresponsible to make a clear conclusion on the device. The fact that you have low confidence in your result does not necessarily mean that you cannot state it, but you should be careful to impose appropriate caution and caveats.

I note that the company asked for access to your manuscript prior to publication, and you have refused this on the basis that you think it might raise a suspicion of collusion by readers. That is not a fanciful objection, but it is unlikely to occur in a context where you are making findings that are adverse to their product. In any case, it is also worth noting that it is handy to have a dissenting pair of eyes review your work prior to publication, since they will likely push back on anything in the manuscript that is in error or is weak. This is also handy if you are concerned about legal action, since it will give you an opportunity to see what, if any, objections the company raises against your work pre-publication. If the matter proceeds to legal action later, it will be hard for the company to raise new objections if they have already been given an opportunity for feedback and review prior to publication of the work. Consequently one thing to consider here is whether it would be worth having a member of this company provide a referee report prior to or during peer review. (You would not normally need to give data access for this to occur.) The advantage of this is that you then get pre-publication information on what they object to, and you can make changes if you think that any of their criticisms have merit. Manuscripts do not usually disclose the identities of referees, but in this case you might ask the journal editor for guidance.

In terms of possible legal action by this company, that is something you should speak to a lawyer about. In principle, a publication giving an adverse review of a product could amount to defamation, product disparagement, or a related tort. If your research work is negligent then it could also amount to a tort of negligence. A lawyer will be able to advise you more specifically on these matters, but one thing to bear in mind here is that one element of the tort of product disparagement is knowledge of falsity of an assertion or "reckless disregard" of its truth or falsity. The latter will be much easier for the company to prove if they can show that they tried to talk to you about the research (to raise objections) and you refused to listen to them or communicate with them at all.


On characterising legal action as "retaliation": One thing that bothers me a great deal when I see these kinds of reactions (as in your post) is this tendency to characterise legal action as "retaliation", in the sense often used in procedures to prevent victimisation of complainants. This type of characterisation smacks of bad faith --- if the taking of legal action is "retaliation", in the sense used in procedures for victimisation of complainants, then the speaker is implicitly saying that other people/companies should not have any legal rights in regard to their own conduct. Of course, some laws and legal procedures are indeed abused, but some laws exist as genuine protections of rights, and it is perfectly reasonable for people/companies to avail themselves of those protections when appropriate.

Aside from being quite sociopathic in its own right, such talk is also potentially legally dangerous, insofar as it gives evidence of bad faith and reckless disregard for the rights of others (which can be elements of torts on these matters). If you start out these types of negotiations by considering the possibility of legal action by the other side as "retaliation" you essentially have a total disregard for them having any legal rights in relation to your own conduct. You are effectively saying: I should be above the law. Ask yourself, if the shoe was on the other foot, and someone was thinking about publishing commentary that was adverse to your skills as a researcher, your professional competence, etc., would you like to be treated this way? Wouldn't you be glad that you have some legal protections? Would you consider the exercise of your valid legal protections (by taking legal action if necessary) to be a form of "retaliation"? (To take a more extreme example: If a rape-victim reports their rapist to the police, and maybe also sues them in civil court, would you characterise that as "retaliation"?)

I don't intend for this to be a severe criticism, because I think some people just use this term "retaliation" rather flippantly, because they get extremely defensive and nervous at the thought of legal processes, and they let this override any real assessment of the implications. A much better approach in these matters is to go into the matter with a genuine respect for the rights of the other party, and give genuine consideration to whether or not your actions are lawful and fair to them. Instead of regarding legal action as "retaliation" against you for your (presumed) perfect conduct, regard it as a thing that might happen to resolve a dispute by the ruling of a third-party (the court) if that becomes necessary. Give proper consideration to the fact that you might do something wrong if you are not careful, and seek information that will ensure that you do not do something wrong. Don't be afraid of legal action per se --- be afraid of doing something that breaches the rights of another party.

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    I think that the sentence "Our results speak against the use of said device, with low confidence in the evidence presented." means that the low confidence is in the evidence presented in favour of using the said device.
    – EarlGrey
    Sep 23 at 21:29
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    Ah, okay, that would change things. I interpreted it differently, and I'm not sure that's clear from the original question, so I will leave my post as it stands unless clarified by OP. In the case where your interpretation is accurate (which seems quite possible given the structure of a hypothesis test) then it would be best for them not to say the results "speak against use of the device" at all. Instead, they would be better saying something like "Our analysis found no evidence of efficacy of the device (p = ...)".
    – Ben
    Sep 23 at 21:41
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    I asked for clarifications to OP
    – EarlGrey
    Sep 23 at 21:48
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    The results conclude to the product being potentially detrimental (low evidence against the null hypothesis of absence of effect), but the data is if low quality, which prevents us from drawing strong conclusions (possible false positive). BTW, I view 'retaliation' in this case as a much weaker term than you do, it seems. Our group is in favour of letting our legal dept deal with communication to avoid misunderstandings and 'faux-pas'. Only our boss advised against it.
    – Raoul
    Sep 23 at 23:23
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    No, the hypothesis test rejects the null hypothesis of no effect and the direction goes the way of being detrimental (2-sided test). Low confidence in results is because of meta data not captured by the hypothesis test.
    – Raoul
    Sep 23 at 23:30

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