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BMJ 2002;324:612 ( 9 March )

Letters

News article on report about drug researcher was biased

EDITORI wish to draw attention to an error in an article by Spurgeon.¹ The drug company Apotex was sponsoring research into a new drug, deferiprone, and terminated a contract with one of the researchers because of several matters, but not as a result of her publishing her claims about the investigational drug.

The researcher declared her intention to publish her claims only after the company had terminated her contract. Had Spurgeon contacted other parties involved in this controversy he would have realised that the information on which he reported was inaccurate. Instead, he seems to have relied on a report commissioned by the Canadian Association of University Teachers, a union of teachers that was supporting the researcher.

Even if the union's motives had been to establish the truth I question how the committee, selected by the union, could have investigated a complex matter by obtaining direct input from only one of the four major parties concerned. Though it may have had access to some documents, particularly those provided by the researcher in question, it did not have many of those belonging to the other parties.

Because of the lack of a balanced input the report seems merely to represent the researcher's pleadings. Apotex agreed to provide input if the panel would investigate specific matters pertaining to the case, and on which it was based, but such assurances were not provided. This led Apotex to conclude that the assessment might not be truly independenta fact borne out by the report.

Although the report acknowledges that three of the four parties did not participate in the inquiry, Spurgeon's article failed to make this bias clear. The pro-researcher position of the report is evident throughout. For example, it failed to note that the researcher did not acknowledge in her publication that hers was a dissenting view among scientists who were studying the drug and that subsequently she and her supporters attempted to prevent publication of other scientists' views of the drug.

The researcher's claims regarding deferiprone were evaluated by the European Agency for the Evaluation of Medicinal Products in a special hearing, in addition to the standard assessment of safety and efficacy that is part of the regulatory process for the marketing authorisation of a new drug. After this evaluation the agency recommended the approval of deferiprone, a decision that was then authorised by the European Commission. This approval was particularly important because deferiprone was the first orally active iron chelator approved in Europe. Patients who were unable to tolerate the only other treatment (an injectable drug) now have an alternative.

Elie Betito, director, public and government affairs. 
Apotex, 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9

© BMJ 2002
 

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NEWS
Report clears researcher who broke drug company agreement.

David Spurgeon
BMJ 2001 323: 1085. [Full text]  

 

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