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Proposed Revision to "Journals' Role in Managing Conflict of Interest Related to Funding of Research"
June 30 to July 7, 2008
Please review and provide any comments by July 21. Comments for discussion with other members may be sent to the listserve, but specific comments should be sent directly to me or Bob Fletcher.
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Insert as a new paragraph after #4 in the current policy statement:
No generally accepted standard, nor evidence base, exists for precisely defining the degree of financial conflict of interest that creates substantial risk of bias. Judgments can be affected by many factors including the amount of money, goods, or services exchanged; how recently they were received; and whether payments are expected in the future, as well as the kinds of services provided in return. Journals should state their own standards as precisely as possible and expect authors to provide a description of all potentially relevant financial ties so that editors can decide whether enough conflict of interest exists to warrant disclosure
Redrafted by Bob Fletcher after feedback from the Executive Board and the Editorial Policy Committee June 26, 2008
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Margaret A Winker
President, WAME
Deputy Editor, JAMA
________________________
The solution is not the WAME policy on a virtual site; the
solution is an independent body such as WAME (that most members find the idea
of funding by its own members erroneous), which will have absolute power over
all medical journals. I remind WAME members that if WAME becomes great, its goal
will be easily achieved. Its members are key to its growth. Do not think
that Father Christmas will drop gifts!
Hnid Karim
________________________
Somebody once said that a man with a watch will know what
time it is, but a man with two watches will not be so sure. There will always
be conflicting evidence, and this does not by itself constitute data
manipulation. That said, there are plenty of other reasons to suspect that
data manipulation occurs routinely, and not only is not punished, but in fact
is rewarded. So you are right that something needs to be done about
it. However, it is naive to believe that the need for action will then
lead to corrective action (other than self-serving action that will not in fact
address the problem, but rather will use it as an excuse for further manipulations). All
I can think of is a grass-roots approach, in which the very, very few of us who
care enough to be a part of the solution do what we can, as individuals, to
expose research malpractice whenever we see it. Well, that may be a bit
ambitious, given how prevalent it is, so perhaps we need to pick our battles.
Vance Berger
________________________
There are no small differences. There are differences
totally opposable to each other. For example, those who say that atenolol
has no effect on the central blood pressure and those who say the atenolol
possess the best action on the central blood pressure than all the drugs
lowering blood pressure These are not a small differences! I let you
examine other great differences in other pathology; WAME will not have any
punishing ability, but will exclude all journals that will not execute the
right policy (a dream?).
Hnid Karim
________________________
I have tried before to call for reforms, and for the most
part have been ignored. So no, I do not hold out much hope that WAME will be
part of the solution. Does saying this get me censored? Oh, no, of
course not, because nobody is listening anyway. Even some murderers and
rapists give to charity. So it is here with WAME. We all hold hands, and
sing, and dance to the same tune, then go off and do whatever it is that we do
in the rest of our lives. We all seem to talk a good game, but the action
comes from taking responsibility, to the extent possible, for what appears in
your respective journals. I cannot say with any certainty that nobody is doing
this, but at least as regards randomized clinical trials, the consistent lack
of methodological quality would be comical, if not for the serious repercussions
it has for human health. So you will forgive me if I am a bit dubious about the
very same editors publishing this nonsense now talking about how much they really
want to make things better. Clean up your own house first.
Vance
________________________
No organization can have absolute power, and no organization
will ever control pages published in every medical journal. The key
to improving the accuracy and validity of the medical literature is education
of authors (whose work editors can evaluate but can't control), peer reviewers
(who are already asked to do a great deal without pay), and, most
importantly to WAME, the editors. Ultimately the editor makes the decision to
publish, so the onus is on the editor to educate himself/herself about
the many important issues to consider in evaluating study methodology,
statistical analysis, reporting, and interpretation. WAME can help and we
are working to facilitate editors' education, but the editor needs to
take the initiative. Many resources are freely available now to editors willing
to take the initiative, and hopefully many more will become available in the
near future. We must continually be learning if we are to do our
jobs effectively.
This forum can be an excellent resource for educating ourselves and each other, but we need to maintain that focus.
Margaret A. Winker
President, WAME
Deputy Editor, JAMA
________________________
1. We must integrate a lot of editors across the world at gradual
levels in WAME;
2. When a medical journal does not respect the WAME policy, it should be
blacklisted, all the scientific community should be warned, and results should be
ignored by the scientific community linked to WAME;
3. WAME cannot prohibit the sale of a medical journal, but should push the
scientific community to not believe in the results that the journal published;
4. In the future, medical journals will
think very carefully about this before doing anything outside of the rules!
Hnid Karim
________________________
In a primary school for example, if the master said to the
students that student X is a cheater, all the students will
believe that student X is a cheater. Student X will continue his studies
in the same school, but no one will believe in him;more imortant, all
other students avoid cheating spontaneously or will be pointed to as cheat. It's
the essence of the design that I propose.
Hnid Karim
________________________
I think the history of the world shows that absolute power
is not a good thing—the suggested solution seems worse than the problem to me.
David Ames
________________________
In order to not remain in the abstract, I invite you to
explain to us the bad things that will be generated by the solutions issued,
and also, in order to give us the chance to explain our point of view. To say
that this is a bad solution without explaining why will not allow things to
grow forward! Let us be friends and let us make the things easier. I
respect your point of view, but tell me why not?
Hnid Karim
________________________
I would have thought it is obvious.
If one organisation has 'absolute power' over journal publication, it will be open to abuse.
David
________________________
Why use terms that cause fear? Absolute power will not have
a place! A boat is guided by 1 captain, not by multiple opinions (which are likely
to sink the boat). WAME will have no power over any medical journal. However, if
a medical journal publishes erroneous data, WAME— after receiving a specified
number ofcomplaints—could form a reading committee (from the same speciality) to
analyze the data and work with the medical journal to investigate all data from
the study. If the committee finds that the study is erroneus, it can ask the
journal to withdraw the study or notify the scientific community. It goes
without saying that WAME will need several specialized divisions. Therefore, we
must grow the financial plan. First by membership fees.
I remind you that the FDA is not an absolute power, but an absolute clarity.
Hnid Karim
________________________
Interesting discussion, but there are some questions:
1- Who can prove that the master is right and the student cheated, really? Many times masters make big mistakes. Besides, most of the time we believe the master is right because we need to pass the course!
2- Who believes that WAME has the mastership criteria? And what are the criteria indeed? I have always thought that this is a board to share the ideas.
3- Pointing out someone as cheater does not essentially inhibit others to cheat. It may teach them that this method of cheating is obsolete!
I still believe that the theme is good, but needs more evaluation and regulations.
Behrooz Astaneh
Deputy Editor, Iranian
Journal of Medical Sciences
________________________
WAME will never have the same value as a teacher. WAME is an
organization made up of several departments. To establish an article as a fraud,
committee X will be pre-established to receive complaints. This committee will
consist of more than 100 scientists. It will be established prior so that only
complaints that meet some criteria will be taken over (for example receive more
than 20 complaints from different source or receive a complaint from a medical
association or society...). It must be an overwhelming majority (80% for example
from committee X to decide to prosecute. The study will be issued to an expert committee
(cardiologists for a study on cardiology for example) constitued by over 100
experts, who will evaluate the study and work with the medical journal that published
the study. 80% of this expert committee must say that the study is a fraud
study or normal. The results will be communicated to committee X. The president
of WAME will contact the medical journal and ask the journal to withdraw the
study or WAME will notify the scientific community if 80% of the expert committee
think so.
This has nothing to do with one only person (the master, I mean).
Hnid Karim
________________________
I'm not sure what is behind this diatribe, but it has no
place on the WAME listserve. I assume that like me, most of those in WAME
joined to be better at being editors. I have learned a lot from other WAME
members through this Web site and hope that I have contributed a bit, too.
Diatribes with no constructive thoughts have no place here.
As for the topic being discussed here, we all know that there are financial conflicts of interest that can sometimes result in manipulation of data and results to serve a financial (usually commercial) end. On this Web site, we have discussed a number of ways to identify (and avoid publishing) marketing activities masquerading as research, and we have promulgated approaches to publication bias such as signing onto the ICMJE policy requiring that all randomized trials be registered in a public Web site before the trial starts. Those and similar efforts are how we will improve our minimizing of the effects of financial conflicts of interest. Perfection is an asymptote—we will never reach it. But we all have a responsibility to improve how we deal with such conflicts, and WAME is one important resource for identifying tools and approaches to help us do so.
Bill Tierney
________________________
With all due respect, my efforts to propose constructive
ways to improve the process have been ignored. Now I am pointing this out,
as it did seem to tie in to the post to which mine replied. I did not
start this thread. But OK, back to constructive.
Randomized clinical trials remain antiquated in methodological quality. As a rule, the methods of randomization are not very good, and could (should) be better. The biases allowed by sub-optimal randomization methods can be tested for, but almost never are. This being the case, the validity of the findings are just about always open to criticism. And this is but one example. Approximate analyses are used routinely when the very quantities they are trying to approximate are readily available. Surrogate endpoints are used too often, as are artificially dichotomized endpoints. The use of a run-in phase can completely invalidate the results of the trial. This has all been documented in the literature. Yet no progress has been made in any of these areas.
It is constructive, then, to consider where the problem lies. I have done that. And I think I found an answer. I hold up this mirror now to let you know where the problem lies. If somebody—anybody—has constructive suggestions for how I can do my job better, then I will listen. And yet nobody here extends me the same courtesy. Why? None of you can be bothered to try to improve the methodological quality of the studies you publish when it would not even be difficult to do so? Why? What inference can we draw when once again this message gets ignored, and not a single WAME member asks the question "OK, so what is the next step?". This is a question you should ask not out of respect for me (I know that we are way past that now), but for the constituency you ostensibly serve. No?
Vance
________________________
When I advance an idea, 98% of members are against it, and
there are also those who treat me by bad word because, from their perspective,
I said a stupid thing, the height, there is no member who has been able to
convene meetings of this 98 % opinions in the same meaning.
I believe that the profession of doctor is an art that few people understand. A
doctor, knowing that a person is on the wrong side, gently tries to persuade
that person—without touching his personality. Also, a doctor must have good interactions
with his colleagues, even if these colleagues have a different opinion on
a given point.
What to say about doctors who treat the
opinions of their colleagues despicably? I made a mistake on advancing absolute
power, it is not an absolute power to request to throw out all ideas that you
don’t like or you find stupid ?
I believe that as long as we cannot bear that other doctors do not think like
us, no solutions will see the day!
In addition, at the level of present solutions (actual WAME policy), many
studies have been falsified, and many scientifics sold on the skin of patients
at a very low price; and if some one wants to know about falsified studies, he
or she can ask me, and I will show and prove it to him or her with references!
