Research at mercy of drug firms, study says
Sydney Morning Herald
By Ruth Pollard Health Reporter
June 6, 2005
A study released today suggests that the publication of incomplete or biased pharmaceutical trials is common.
Interference is most blatant when the research shows potentially negative outcomes of a drug or treatment, the report, published in the Medical Journal of Australia, finds.
Fifty-five specialists reported that the publication of key research findings had been delayed, another 41 said the potentially negative findings were not published at all and 22 said the published report had been edited to make the drug appear better than the study’s results justified.
Incomplete or biased reporting of the results of clinical studies had been highlighted by the recent controversies involving antidepressants in children and cardiovascular problems associated with the COX-2 inhibitor class of anti-inflammatory drugs, according to the study.
The authors found evidence of a changing relationship between the drug industry and researchers, as much of the commercially sponsored research was now conducted by contract research organisations rather than academic centres.
Slightly more than 820 medical specialists responded to the survey, of whom 40 per cent reported involvement in pharmaceutical industry-sponsored research in the last 12 months.
Noting that collaborative research between medical specialists and drug companies had been responsible for significant advances, the authors also warned that ethical compromises and questionable practices were frequent.
“Our findings underscore the necessity for ethical committees to oversee not only the conduct of research but also the analysis and reporting of results to ensure the public has access to accurate data on the benefits and harms of … treatment.”
A co-author of the report, David Henry, a professor of clinical pharmacology at the University of Newcastle, said a recently established national trial registry would go some way to ensuring the results of clinical research would be monitored.
The participation of a senior clinical representative from one pharmaceutical company, Merck & Co, in the study, indicated some parts of the industry were willing to examine the issues, Professor Henry said.
There might also be a role for public agencies such as the Pharmaceutical Benefits Scheme to run large comparative trials that examined whether a new drug was better than existing treatments, he said.
“The PBS spends $5.8 billion per year on drugs,” he said. “Just spending 1 per cent of that on trials would answer a lot of questions.”
In an accompanying editorial in the journal, the director of the Nordic Cochrane Centre in Denmark, Peter Gotzsche, said the research agenda served the interests of the drug industry rather than the patient.
“Surveys have shown the manipulation of clinical trials … is common,” Dr Gotzsche said.
He noted the recent controversy over the anti-arthritis drug Vioxx, which was withdrawn from the market by its manufacturer, Merck, on September 30 last year because of evidence it increased the risk of cardiovascular disease.
An analysis of the drug – a COX-2 inhibitor – by Merck concluded that there was no increased risk of heart attack or stroke, whereas another analysis carried out independently of the company concluded there was an increased risk.
“It is likely that the widespread use of COX-2 inhibitors has caused thousands of premature deaths,” Dr Gotzsche said in the MJA.