http://bmj.com/cgi/content/full/324/7337/612/a
| Home | Help | Search/Archive | Feedback | Table of Contents |
|
EDITOR
I
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
Apotex, 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9
| 1. | Spurgeon D. Report clears researcher who broke drug company
agreement. BMJ 2001; 323: 1085 |
|
| Home | Help | Search/Archive | Feedback | Table of Contents |
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
