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Dr Martin Van Der Weyden, Editor MJA, ABC Radio 'PM' Program

Discussion - International Committee Slams Drug Companies

COLVIN: Finally tonight a big serve for the big drug companies today from some of the people whose approval they need most. Thirteen members of the International Committee of Medical Journal Editors - representing journals and Internet databases around the world - have signed an editorial on the way commercial interests are skewing the results of drug trials.

The signatories, including the editor of the Medial Journal of Australia as well as those of the Lancet and the Journal of the American Medial Association criticise the move away from independent academics towards private research groups.

They say these private contractors now get six out of every ten research grants from pharmaceutical companies. Corporate sponsors, the editorial says, can dictate terms that are not always in the interests of the study participants or the advancement of science.

The journals involved are extremely influential and publication in them can in itself have a big effect on any drugs future. Their criticism will be a bombshell for the drug companies. I spoke to the editor of the Medical Journal of Australia, Martin Van Der Weyden.

VAN DER WEYDEN: If research is conducted by a company that has subcontracted to a pharmaceutical firm, there are a number of characteristics of the research reports that follow. The first is that they are of a lesser quality compared with that arising from academic centres. Secondly there well may be censoring of information that occurs.

COLVIN: Censorship by the drug company.

VAN DER WEYDEN: Censorship by vested interests. Thirdly it's been shown that the likelihood of information not being published is much more likely to occur in the commercial setting as opposed to the academic centre - or information that's incomplete.

COLVIN: Meaning that when it doesn't come out the way they want they effectively suppress it?

VAN DER WEYDEN: Well somebody effectively as a result decides that certain information shouldn't happen. And there are two typical examples of this. One was in Canada where a researcher was asked to look at a certain agent that chelates out iron in patients who have iron overload, particularly patients who have required multiple transfusions. And the information wasn't allowed to be published.

The second notorious case was a study done by a researcher in San Francisco that looked at thyroid replacement in individuals who've got deficiency of the thyroid gland. And the question was whether or not the drug that was supported by the pharmaceutical firm was better than other preparations.

When it turned out that the study showed it was no different, there was a lot of hullabaloo about getting this into the public domain.

COLVIN: If the information source is polluted, isn't it reasonable to expect that at some stage the patients … that patients will be harmed by this?

VAN DER WEYDEN: The Cochran Centre - which is a organisation in United Kingdom - has vigorously argued that all randomised control trials and all information arising from randomised control trials should be published. And the reason they say that is, unless we do this, we'll have an unnecessary bias in information.

To my way of thinking, it is probably unethical not to publish information because, in lieu of this information, we are wasting patient participation in trials for which answers may already be known, and we're wasting research resources.

COLVIN: So it's not just a question of the studies that are actually suppressed, it's also a question of, in studies which are published, the raw data not being allowed to be analysed by anybody else?

VAN DER WEYDEN: The reason why we've issued this statement is that we want to establish transparency, and we want to establish transparency vis-a-vis the integrity and the intellectual freedom and full access to information.

COLVIN: What are your new rules going to filter out? I mean how many papers do you think will fall by the wayside now?

VAN DER WEYDEN: Hard to know, hard to know. My journal - the Medical Journal of Australia - doesn't received many randomised control trials. There's a considerable amount of evidence to show that to bring a drug onto the market costs roughly about $500 million.

And most drug companies now want to have big trials. Big trials because they've got to satisfy the FDA etcetera, etcetera, etcetera. So they're gonna be multinational, they're going to be run by firms that control the process, and the role of doctors really is just to contribute - in inverted commas - patients to the trial. And this makes a mockery of the way trials were run in

the past.

Trials that were run in the past, were done from academic centres. So the design was in the control of the academic centre. Patient recruitment was in control. Analysis of information was in control. Interpretation of the clinical meeting was in control of what we perceived to be independent investigators.

COLVIN: Do you think by bringing in the new rules that you can actually move the situation back to what it should be?

VAN DER WEYDEN: It's hard to know what the impact of this is going to be, but it's a statement, it's a powerful statement as far as I'm concerned that the editors believe that there's something wrong, and it needs to be addressed.

COLVIN: Martin Van Der Weyden, editor of the Medical Journal of Australia.

Ends

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