GLOBAL: Make Big Pharma provide their raw data: critic

Revealing conflicts of interest involving university researchers who consult for pharmaceutical companies will do little to make the research more transparent, says a British-based academic. David Healy has called for clinical trial data to be taken out of the hands of the drugs companies and made more accessible.

Healy says a recent spate of allegations against several high-profile researchers plays into the hands of the pharmaceutical industry. The highly published Cardiff University professor of psychiatry would like to see a different approach taken to cleaning up pharmaceutical research.

"Access to data is the key issue," says Healy, who says much raw information from pharmaceutical industry trials is never made available and thus allows for wild claims about a certain drug to be made by those speaking on behalf of the industry, including those speaking or writing as paid university-based consultants.

"If a person like me could see the data, they (the consultants) would be a lot more careful with what they say."

Healy's comments come on the heels of a recent high-profile resignation stemming from a conflict-of-interest allegation. Just before Christmas, Emory University in Atlanta announced that Charles Nemeroff would be stepping down as head of the department of psychiatry and behavioural sciences, a post he held for 17 years.

An internal investigation showed that between January 2000 and January 2006, Nemeroff received more than US$800,000 from GlaxoSmithKline PLC for presentations he did not report to Emory.

Charles Grassley, a US senator, has been spearheading an investigation of 30 National Institutes of Health grant recipients. Nemeroff is only the latest psychiatric researcher and influential speaker to be outed for keeping its university in the dark over paid consultancy fees.

Earlier in the year, the Iowa Republican made public other unreported earners. His investigation of Joseph Biederman and Timothy E Wilens from Harvard University concluded that they each received at least $1.6 million, from 2000-2007, in pharmaceutical industry consultancy money.

He also brought to light the case of Melissa DelBello, a researcher at the University of Cincinnati, who received $238,000 in 2003 and 2004 from Astra Zeneca, the company that makes Seroquel, which received a positive review in a study she headed up, despite half of the subjects dropping out because of bad side effects.

Other alleged conflicts of interest he brought forward include Alan Schatzberg, chair of the psychiatry department at Stanford University and Karen Wagner from the University of Texas.

While Healy finds the large amounts of money being spread around university psychiatry departments to be a widespread practice by the drugs industry, the one-time consultant himself and now critic of the industry sees that issue as a red herring.

Healy, whose criticism of Big Pharma has led him to denounce such nefarious practices as the ghost-writing of journal articles and burying of negative clinical-trial results, says trying to vet researchers over who pays them is akin to asking them about who their friends are and what religion they practise.

Healy himself had been caught up earlier in a dispute over his criticism of the pharmaceutical industry. In August 2000, Dr David Goldbloom, the Physician-in-Chief at the Centre for Addiction and Mental Health (CAMH) and a professor of psychiatry at the University of Toronto, wrote to Healy offering him the position of Clinical Director, Mood and Anxiety Disorder Program, CAMH. In November, Healy was then invited to a meeting at the university where he spoke about the inadequacy of clinical trials which he said demonstrated treatment effects and not whether or not a drug worked. He said the fact that unsuccessful clinical trials were suppressed and successful clinical trials were over-reported was not science.

Shortly after his talk, Healy received an email from Goldbloom retracting the job offer. Healy believed this occurred because of his critical views of the pharmaceutical industry and especially Eli Lilly, a company that had made significant contributions to the university. In September 2001, Healy filed a lawsuit against the the CAMH and the university for $9.4 million in damages and lost income. At a press conference, he said his greatest concern was academic freedom and that with some of the damages awarded he would set up a fund to promote academic freedom. The lawsuit was settled out of court and although the details were not disclosed, the settlement did result in Healy being offered a visiting professorship at the University of Toronto.

He says the influence of a drugs company becomes less significant once you bring forth the raw data behind the article, which would then allow sceptical researchers to review it. He adds that punishing a few bad apples allows for the pharmaceutical companies to continue their current practices of holding back their data.

Healy says pharmaceutical companies have been given too easy a ride by those who accept articles on new drug research without asking for access to all the research material. "The journals and science societies roll over quite easily."

He says the way to change things is to have publications such as the New England Journal of Medicine and the Journal of the American Medical Association become more scrutinising: asking for the authors to make their raw data more available.

Karen Buckley, a spokesperson for the New England Journal, does not see this happening in the near future. "That would be a large step outside our role," Buckley said, adding that making available the raw data for the studies that journals publish would be too difficult, considering their resources, as they would have to be 20 times the size.

Buckley defended her publication's current practices, which she felt offered transparency. She said editors will spend months with a manuscript, asking authors questions, including asking them to disclose the role of the company in the study and to specify who had control over the data and publication of the research.

* For a detailed account of David Healy's work and his criticisms of the pharmaceutical industry,