February 4, 2010

Conflict of Interest

Cellestis has always maintained that the number of peer reviewed studies on QuantiFERON was a valuable marketing tool and that they
have been important to the company’s success. Peer review clinical papers now exceed 400 and are growing. This has been a tremendous assistance in getting guidelines written
(Radford, Bioshares Thredbo 2009)

One of the criteria for submitting studies for peer review is that any conflict of interest be declared. Consider the case of 

Andrew Wakefield, the doctor who champions the alleged link between measles, mumps and rubella vaccine and autism in young children, stands discredited for misleading his medical colleagues and The Lancet, the professional journal that published his findings.

The investigation has found that when he warned parents to avoid MMR, and published research claiming a link with autism, he did not disclose he was being funded through solicitors seeking evidence to use against vaccine manufacturers.

The Lancet said yesterday that The Sunday Times's evidence meant that the finding linking MMR and autism was "entirely flawed" and should never have been published. Last night, John Reid, the health secretary, called for an inquiry by the General Medical Council (GMC) "as a matter of urgency".
Said the editor of Lancet
“If we had known the conflict of interest Dr Wakefield had in this work I think that would have strongly affected the peer reviewers about [its] credibility . . . in my judgement, it would have been rejected” 
The conflict of interest may have been sufficient to bar the study from further review and the failure to disclosure commercial interests has meant that Wakefield's reputation has been severely damaged, probably terminally
last week, the lead author, Dr. Andrew Wakefield, was found to have acted unethically in conducting the research.

The General Medical Council, which oversees doctors in Britain, said that "there was a biased selection of patients in The Lancet paper" and that his "conduct in this regard was dishonest and irresponsible." 
The editor of The Lancet reviewed the General Medical Council report and said
"It's the most appalling catalog and litany of some the most terrible behavior in any research and is therefore very clear that it has to be retracted,"
Professor William Schaffner at the Vanderbilt University School of Medicine also said
"Since Wakefield's study came out, some 20 other studies have come out, and each one of these studies, done by different researchers, in different populations and in different countries, has denied the associations between vaccines and autism," he said.
"Scientifically, this story is over."
What of Wakefield's future? it doesnt look good
The study, which was published in 1998, saw Dr Wakefield leave his NHS job and become a pariah of the medical profession.
"I have been asked to go because my research results are unpopular."
Commercial interests can and do distort the scientific process and studies conducted by independent and reputable establishments are preferred, for obvious reasons.

Google scholar lists 2,560 references to QuantiFERON whilst the search facility at Pubmed lists 355 peer reviewed studies with more under "whole blood interferon gamma release assay".

These studies are an asset to the company and their intrinsic value difficult to quantify - perhaps the present and future value of Cellestis?

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