Sunday, 30 September 2012

Education: Conflicts of Interest:The case of Missing patents

Someone stated that there was this Doc who always declared conflicts of interests and that we were a bit wrong to suggest that they did not, so maybe time to refresh on Conflicts of Interest

What is a competing interest well this is one papers stance (PLOS)


It is increasingly recognized that everyone — authors, authors' employers (e.g., an academic institution, government department, commercial company, or other), sponsors of the work, reviewers, editors, and publishers — has competing interests of some sort. It is difficult for individual readers to assess objectively whether competing interests could have biased the presentation of, peer review of, or decision to publish a given work. Transparency of competing interests allows readers to better evaluate the possibility of such bias. Authors must declare all relevant competing interests for consideration during the review process. 

Editors (professional or academic, paid or unpaid) and reviewers must declare their own competing interests and if necessary disqualify themselves from involvement in the assessment of a paper. 



A competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. See below for definitions and examples of various competing interests.

Who needs to declare competing interests?
Everyone involved in authorship, funding, review, and editorial decision-making of submitted articles, or who wishes to comment on or rate published articles, must declare any and all relevant competing interests

Financial competing interests include but are not limited to:
ownership of stocks or shares;

paid employment or consultancy;

board membership;

patent applications (pending or actual), including individual applications or those belonging to the institution to which the authors are affiliated and from which the authors may benefit;
research grants (from any source, restricted or unrestricted);
travel grants and honoraria for speaking or participation at meetings;gifts.

Authors must declare all potential financial competing interests involving people or organizations that might reasonably be perceived as relevant. Similarly, reviewers and academic and professional editors, paid or unpaid, must declare any financial relationships that could reasonably be perceived as relevant and/or could influence their objective review of the paper; if a financial competing interest exists, these individuals should recuse themselves from handling the paper. Anyone wishing to comment on or rate a published paper must also disclose any relevant financial interests. As a guide, any competing interest that arose within the five years either before or after the commencement of the research described, or within five years of the article being written, or within five years of events described in the article, should be declared. However, interests outside this time-frame might also be relevant; if so, they should also be declared so that their relevance can be judged by the journal editorial team.

Non-financial

Non-financial competing interests include but are not limited to:Professional:

acting as an expert witness;
membership in a government or other advisory board;
relationship (paid or unpaid) with organizations and funding bodies including nongovernmental organizations, research institutions, or charities;
membership of lobbying or advocacy organizations;
writing or consulting for an educational company.

Personal:

personal relationships (i.e. friend, spouse, family member, current or previous mentor, adversary) with individuals involved in the submission or evaluation of a paper, such as authors, reviewers, editors, or members of the editorial board;

personal convictions (political, religious, ideological, or other) related to a paper's topic that might interfere with an unbiased publication process (at the stage of authorship, peer review, editorial decision-making, or publication).


Authors, reviewers, editors, and anyone wishing to comment on a published paper must disclose any non-financial interests that might influence their reporting, handling, or review of the paper, or that might be negatively or positively affected by publication of the paper.

For example, authors are required to declare whether they have served or currently serve on the editorial board of the journal to which they are submitting, have acted as an expert witness in relevant legal proceedings, or have sat or currently sit on a committee for an organization that may benefit from publication of the paper.

Reviewers are required to declare whether they have held grants, co-authored papers, or worked in the same institution or organization with the authors of the study they are asked to review, or if they are in an adversarial relationship with the authors.


Similarly, editors — academic or professional, paid or unpaid — are required to recuse themselves from deliberations if they cannot evaluate a paper in an objective way because of personal relationships with the authors.


Finally, anyone who comments on or rates published papers must declare non-financial competing interests at the time of posting their comments and/or rating.



HERE IS ANOTHER (BMC Journal.well well)
A competing interest exists when your interpretation of data or presentation of information may be influenced by your personal or financial relationship with other people or organizations. Authors must disclose any financial competing interests; they should also reveal any non-financial competing interests that may cause them embarrassment were they to become public after the publication of the manuscript.

Authors are required to complete a declaration of competing interests. All competing interests that are declared will be listed at the end of published articles. Where an author gives no competing interests, the listing will read 'The author(s) declare that they have no competing interests'.

When completing your declaration, please consider the following questions:

Financial competing interests
I
n the past five years have you received reimbursements, fees, funding, or salary from an organization that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? Is such an organization financing this manuscript (including the article-processing charge)? If so, please specify.
Do you hold any stocks or shares in an organization that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? If so, please specify.
Do you hold or are you currently applying for any patents relating to the content of the manuscript? Have you received reimbursements, fees, funding, or salary from an organization that holds or has applied for patents relating to the content of the manuscript? If so, please specify.
Do you have any other financial competing interests? If so, please specify.

Non-financial competing interests

Are there any non-financial competing interests (political, personal, religious, ideological, academic, intellectual, commercial or any other) to declare in relation to this manuscript? If so, please specify.

If you are unsure as to whether you, or one your co-authors, has a competing interest please discuss it with the editorial office.

BOTH OF THESE JOURNALS LIST FILING A PATENT AS A CONFLICT. NOW WHO PUBLISHES PAPERS AND FORGETS TO MENTION THAT THEY HAVE FILED PATENTS... I WONDER? 

e.g. BMC Medical Genetics 2012, 13:70 doi:10.1186/1471-2350-13-70 and WO2012123785 

Lippert S, Callaham ML, Lo B. Perceptions of conflict of interest disclosures among peer reviewers. PLoS One. 2011;6(11):e26900. Epub 2011 Nov 2.

Disclosure of financial conflicts of interest (COI) is intended to help reviewers assess the impact of potential bias on the validity of research results; however, there have been no empiric assessments of how reviewers understand and use disclosures in article evaluation. We investigate reviewers' perceptions of potential bias introduced by particular author disclosures, and whether reviewer characteristics are associated with a greater likelihood of perceiving bias. We recommend that the monetary amount of all financial relationships be reported with manuscript submissions, lead authors certify that they have unrestricted access to data, and reviewers disclose any financial ties to industry whether or not they are related to the manuscript under review. Further research is required to better understand reviewers' perceptions of financial relationships between authors and industry in order to develop clear and consistent guidelines for incorporating the perception of potential bias into manuscript assessments.

We recommend that the monetary amount of all financial relationships....This is all very noble but is very unlikely to happen and is wishful thinking. The Universities would be itching to get a hands on the cash...Oh they probably have already and taking most or all of it. It is a year old and no one has cited this I wonder why?. This could be a first. 

Would half a million from a company that goes to pay for a clinical study of which you get nothing be worse than two grand consultancy that could go in your pocket or should I say the taxman's pocket or be used to send a student to a meeting or pay for lab work to be done. So unless you say what you use the cash for then it is even more complex. Team G would not exist in its present form if we did not generate funds from what ever source.

14 comments:

  1. "e.g. BMC Medical Genetics 2012, 13:70 doi:10.1186/1471-2350-13-70 and WO2012123785"

    The above mentioned article was originally submitted on Sep 9th, 2011.
    http://www.biomedcentral.com/1471-2350/13/70/prepub

    The above mentioned patent was filled on March 11th, 2011, that is 6 months earlier than the article.
    http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012123785&recNum=53&docAn=IB2011051032&queryString=&maxRec=14012804

    In the Description tab of the patent link just above one may find the exact content of the article. What does that mean? It means that the writers of the article invented a procedure, they tested it and protected their work via patent prior to going public with the results. Should they have declared COIs? Typically, yes. How bad is it that they didn't? Well, i wonder how probable it is to get a blood test for diagnosis and prognosis of MS in the next 20 years. I mean, none exists so far. And if eventually such a test gets accepted, it will mean that the results of the original study will have been reproduced numerous times, ruling out whatever the bias of the COIs.

    So, it is not a mysterious case of earning dark income by patenting a blood test, but rather a protection of ones intellectual work. This kind of COIs is totally different to saying that "aspirin is probably more dangerous than natalizumab" and not reveal financial connections with Biogen. In this case one is obliged to declare COIs (as it happens) since natalizumab makes billions of profit as we speak.

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  2. The above mentioned article was originally submitted on Sep 9th, 2011.

    The above mentioned patent was filled on March 11th, 2011, that is 6 months earlier than the article.

    Yes that is normally the way you do it. If you file the article first then this is public disclosure and the paatent is therefore toilet paper because it is worthless if their has already been public disclosure as there would be nothing inventive becuase we would already know what to do.

    That the patent was filed first means therefore that the authors knew about the patent and did not disclose that in the subsequent publication. This is the whole point.

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  3. "Should they have declared COIs? Typically, yes. How bad is it that they didn't.."

    Well this means that the comment made by a poster that Prof Z declares his CoI is clearly not true. Simple as that and End of story. Having been chastised for the same thing in the past you would think he would learn.

    He did not declare his interests years ago when CCSVI was given an airing and is still not doing it now.

    Do you know what is going to make millions and what is not. How much money was made out of HIV tests? Does the publication encourage investors

    Anyway what about your CoI..You could be anyone, Prof Z in disguise and women in disguise, a neuro in disguise, a scientist in disguise.......working for pharma, working for a clinic peddling unproven treatments etc.




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  4. Whats your website you have set up a blog so you say but keep it secret?

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  5. This post has been very informative.

    When Prof G posted about about Zamboni's missing COI disclosures in the past I thought he's making a minor matter into a big issue. After going through all this I realise it is not a minor matter at all.

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  6. Is Zamboni not a fraud then?

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  7. No I would personally not call it fraud, but bad practise.

    I would hope that the authors believe their results when they were published. There are lots of things in the scientific literature that prove to be wrong

    Selling unproven practises as treatments to cash-in on people however is another matter.

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  8. I think he is a fraud. The fact that people have died as a complication of liberation procedures and lots of people are making money out of doing these procedures, including Zamboni himself, makes me wonder why you say that he is not a fraud.

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  9. Remember It is also not always about cash....it could be fame that a dubious paper leads to....

    I suspect that there is alot of work in the sp called quality journals that is unrepoducible and wrong,

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  10. There was a leading scientist who I reviewed a paper for recently and they did not declare their patents. When challenged on this they swore that it was not a CoI issue.

    Likewise we see EAE papers that I consister contain unethical data.

    This is why publication guidelines can help inform people about content.

    Many people do not read them and journals do not enforce them as we will see when one of our papers comes out.

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  11. I wish you did the same amount of search for CCSVI itself. You can start from here:

    http://www.ncbi.nlm.nih.gov/pubmed/207127
    [Cavo-spinal phlebography in myelopathies. Stenoses of internal jugular and azygos veins, venous compressions and thromboses].

    You might see that Zamboni did not invent a disease, but redescribed a known pathology in new context. You might as well want to explain your readers what myelopathies are. I'll give them a hint:

    http://www.ncbi.nlm.nih.gov/pubmed/22323754
    Solitary sclerosis: progressive myelopathy from solitary demyelinating lesion.

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  12. You can start here
    http://www.ncbi.nlm.nih.gov/pubmed/207127

    Afraid Not!

    Being multi-lingual may be one up on us, but the article you mention was written in French.
    Like it or not English has become the language of Science. I am sorry to say I do not report on non-English manuscripts. I can do a bit of german but my French is pretty, pretty bad.

    "Jam on my lapel MouseDoc"
    see what I mean;-)

    Do we report on every publication? Of cause not.

    Myelopathy according to Collins dictionary refers to pathology of the spinal cord and was apparently first used in 1891.

    Amazing we can use dictionaries...Simples

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  13. The title is eloquent. Do you notice which veins did the French physician implicated in myelopathies? Strangely, all the veins of CCSVI. When? 1976.

    Here is a study in English by a German, 2007. I posted it before but you promised not to look at it:
    http://www.ncbi.nlm.nih.gov/pubmed/17161550

    See how a compressed left renal vein can cause migraines. See how they were resolved by daily aspirin for 200 days at most.

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  14. I looked.....There you go,

    I think I said that you would wait a long time to get answer I was never going to answer but I implied that Prof G to whom I thought the question was asked would probably not comment on the nutcracker phenomenon as you are only trying to bust his balls:-).

    Is aspirin the cure of MS..I think we know the answer to this?

    As I have said before. You should write a paper of your own vision and get it published. Surely things have moved on since you sent me the work of Dr schelling. You could bring it into the 21 centuary and condense it in to a digestable format in your own words using modern references.

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