Most medical trials are industry-funded, creating major potential for conflicts of interest. A study of 200 such trials has found the companies doing the funding are usually involved in every stage of the research, and this involvement is seldom fully disclosed when the results are published. Although the results have been widely alleged, confirmation raises big questions about how to make vital trials more independent.
Professor Lisa Bero of the University of Sydney investigated the extent of industry influence on trials by surveying authors of 200 papers in the seven highest impact peer-review medical journals. Eighty responded and their answers have been analyzed in the British Medical Journal. The study was limited to phase III and IV trials that were fully funded by industry, but had at least one author from a university, clinic or hospital. Five-sixths were drug trials, with the remainder testing either vaccines and medical devices.
The funders were involved at the design stage in 92 percent of cases, although academics had the final say in a third of cases. Much more disturbingly, those who stood to benefit also took part in the data analysis in 73 percent of cases, something Bero described to IFLScience as “quite critical”. Often the analysis occurred without input from the papers' academic authors. Bero told IFLScience in some cases the academics never even got to see the raw data and “[d]idn't know if all the data had been included in the analysis.”
In only 4 percent of cases were the funders entirely hands-off, leaving the entire process to the academic researchers.
Bero told IFLScience a 40-percent response rate is quite normal for surveys like this, and she saw no obvious differences between the papers whose authors replied, and those where they did not. Nevertheless, Bero said it is plausible authors may be less inclined to talk about the cases where industry involvement was most intrusive.
Bero added to IFLScience that these papers were “[t]he cream of the crop”, having been published in top journals, and it is reasonable to suspect things are worse in lower impact and more specialist publications.
Modern medical research is caught in a bind. After disasters like Thalidomide, society has demanded enormously costly safety trials, but governments are seldom willing to pay for the most expensive parts. Only rarely can charities afford to step up, so the money almost always comes from the pharmaceutical companies that make fortunes if the results are favorable.
The paper proposes academics “Demand control over design, data storage, and full data ownership, analysis, and reporting, thereby improving independence and greater reliability of trial results.” It also provides suggestions for greater transparency of the influence industry does have. Whether this is enough, remains to be seen.