Healthy Skepticism Library item: 17372
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Publication type: news
Major LE
Scientists' independence in drug trials questioned: Medical journal editors want more information about the role of pharmaceutical companies in drug trials.
The Guardian 2001 Sep 10
http://www.guardian.co.uk/education/2001/sep/10/research.highereducation
Full text:
Representatives of the UK’s drug industry have said that researchers should have total independence when conducting medical studies. But they will not yet support a proposal by medical journals requiring academics to disclose the role of pharmaceutical companies in studies.
The comments from the Association of the British Pharmaceutical Industry follow yesterday’s statement from thirteen of the world’s leading medical journals attacking drug companies for manipulating medical trials to safeguard investments into new medicines.
According to the journal editors, scientists are often prevented from having access to data which would tell them about a drug’s effectiveness or side effects. They may be given no say in the way a trial is designed, and have only limited participation in interpreting the results.
Some editors now want a signed declaration from the report’s author stating that they accept responsibility for the trial. If the company has sole control of the data, the journals will not publish the study.
Richard Ley from the ABPI said: “We believe that investigators working in scientific trials should enjoy full scientific independence.” However, he would not support moves to disclose the role of sponsors in trials until he had studied the plans in more detail.
The Medicines Control Agency, which regulates medical trials and drug development in the UK, has to be satisfied with the safety, quality and efficacy of any drug before it is licensed. All drug licence applications must be accompanied by clinical trail data.
An MCA spokesman said: “Clinical trials should be conducted in accordance with applicable standards of good clinical research practice to ensure that the rights, integrity and confidentiality of trial subjects are protected, and that trial data and reported results are credible and accurate. The policy on the publication of trail results should be stated in the trial protocols and should be agreed between clinical investigators and research sponsors.”
The statement from journal editors comes amid growing concerns over the dependence of academics on private sponsors for medical research.
In the early 1990s, Dr Nancy Olivieri, a Canadian researcher, gave a favourable report on a drug called Deferipone, which had been developed to treat thalassaemia, a hereditary blood disease. Three years later, Dr Olivieri’s research indicated that instead of helping patients, the drug might harm them, whereupon Apotex Pharmaceuticals, the drug company that partially funded her research, threatened her with legal action if she published her results.
Apotex believed that Dr Olivieri was obliged to keep her findings secret, but after five years of wrangling she put her career on the line and published a report in the New England Journal of Medicine, despite claims from Apotex that she had made research errors and put an inaccurate spin on the data.
More recently, Dr David Healy, a British psycho-pharmacist, had his job offer from the Centre for Addiction and Mental Health (CAMH) at the University of Toronto rescinded, as a result, he says, of linking Prozac to suicide. The centre receives funding from Eli Lilly, the manufacturer of Prozac, though Eli Lilly denies exerting any influence, and the University of Toronto denies that Prozac was connected with the decision.
