91社区

"Studies of studies" can hide financial conflicts-of-interest with drug makers

Hidden financial conflicts-of-interest are sneaking into published drug research through the back door, warns an international team of investigators, led by researchers from the Jewish General Hospital鈥檚 Lady Davis Institute for Medical Research and 91社区 in Montreal.

More and more, policy decisions and what medications doctors prescribe for their patients are being driven by large 鈥渟tudies of studies,鈥� called meta-analyses, which statistically combine results from many individual drug trials.

Led by Dr. Brett Thombs and 91社区 graduate student Michelle Roseman, the team found that important declarations of financial conflicts-of-interest in individual drug trials disappeared when those studies were combined in meta-analyses. Their results will be published in the March 9 issue of the Journal of the American Medical Association (JAMA).

Roseman, the study鈥檚 first author, and the rest of the team reviewed 29 recent meta-analyses on a range of drug treatments published in high-impact medical journals. Those 29 meta-analyses, or 鈥渟tudies of studies,鈥� included results from 509 drug trials. The team documented the funding sources and author-industry financial ties of all 509 trials and whether or not the meta-analyses noted who had funded the trials.

鈥淥nly 2 of the 29 meta-analyses even mentioned the issue of who funded the original drug trials, and even those 2 did it in very obscure places in the published articles,鈥� said Thombs, a psychologist and assistant professor in the Department of Psychiatry at 91社区. 鈥淣ot one of the meta-analyses mentioned whether researchers who conducted the trials were employed by industry or personally received money from industry.鈥�

鈥淢ost people want their physicians to make treatment decisions based on high-quality, unbiased evidence,鈥� said Roseman. 鈥淩esearchers who conduct meta-analyses should be aware of who funds the trials they review and they should assess the risk that findings might be biased due to drug company sponsorship.鈥�

The team identified 7 meta-analyses where every single drug trial included was paid for, at least in part, by the maker of the drug or had investigators linked financially to drug makers. In 6 of the 7 meta-analyses, however, there was no mention of who funded the drug trials.

鈥淐onsumers can be more confident that drugs actually work if there is at least 1 independent evaluation that confirms this,鈥� said Thombs. 鈥淲hen all existing studies are financially linked to drug makers, there is a risk that patients and their physicians may be misled.鈥�

鈥淲hat is surprising is that many researchers who do meta-analyses don鈥檛 seem to be aware of these important issues,鈥� added Roseman. 鈥淲e surveyed the authors of the 29 meta-analyses. Only 7 said that they even recorded who funded the drug trials they evaluated, and only 2 published this information. Furthermore, only 2 recorded author-industry financial ties, and none published this.鈥�

Thombs, Roseman and their colleagues have called for changes in policy on how evidence on drug treatments is reported in meta-analyses. 鈥淯nless we require authors of meta-analyses to provide this information for consumers, it will be lost,鈥� emphasized Thombs. 鈥淧atients and doctors want to have this information, and we believe it is in the best interest of all of us to make sure it is available.鈥�

鈥淔ew people would buy a car whose performance and safety had only been tested by the manufacturer or a house based only on the word of the seller without an independent inspection,鈥� added Thombs. 鈥淵et most drugs that people take have been evaluated, for the most part, by the companies that produce them and profit from their sales. At the very least, doctors and their patients need to know who is evaluating the effectiveness and safety of drugs that are being prescribed.鈥�

The Canadian Institutes of Health Research and the Fonds de la Recherche en Sant茅 Qu茅bec provided funding that supported work on this study. In addition to Thombs and Roseman, other researchers who contributed to this study were Katherine Milette, a 91社区 graduate student; Lisa A. Bero, Ph.D., of the University of California, San Francisco; James C. Coyne, Ph.D. of the University of Pennsylvania, Philadelphia and the University of Groningen, the Netherlands; Joel Lexchin, M.D. of York University, University of Toronto, and University Health Network, Toronto; and Erick H. Turner, M.D., of the Oregon Health and Science University, Portland.