March 15

COI in Drug Studies Sneaking Back

A McGill study analyzing 29 "studies of studies" (meta-analyses) found that important declarations of financial conflicts-of-interest in individual drug trials disappeared when those studies were combined in meta-analyses.

Dr. Brett Thombs and his McGill graduate students analyzed 509 drug trial reports included in 29 "studies of studies" and found that only 2 of the 29 meta-analyses mentioned who funded the original drug trials. The team identified 7 meta-analyses where every single drug trial included was paid for by the manufacturer of the drug being studied:

"Not one of the meta-analyses mentioned whether researchers who conducted the trials were employed by industry or personally received money from industry."

Meta-analyses are conducted by experienced experts in the field. Thus, the McGill study finding underscores how easily researchers who analyze drug studies are either duped or complicit in disregarding the bias that permeates their analyses.

Dr. John Ioannidis , a foremost expert on clinical trial methodology has identified various factors that, one way or another, confound the integrity of medical research reports. He found that "as much as 90% of the published medical information that doctors rely on is flawed." 

We believe that the single most potent factor undermining the veracity of medical research and meta-analyses is imbedded financial conflicts of interest.  

See also, John H Noble , Jr., PhD  "Meta-analysis: Methods, strengths, weaknesses, and political uses," REVIEW ARTICLE in Journal of Laboratory and Clinical Medicine, 2006 and "Detecting bias in biomedical research: looking at study design and published findings is not enough," Monash Bioethics Review, Vol 26, Nos1-2, 2007.



Conflicts-of-Interest in Drug Studies Sneaking Back Into Medical Journals, Say Investigators

ScienceDaily (Mar. 11, 2011) — 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’s Lady Davis Institute for Medical Research and McGill University in Montreal.

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

Led by Dr. Brett Thombs and McGill 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’s 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 "studies of studies," 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.

"Only 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," said Thombs, a psychologist and assistant professor in the Department of Psychiatry at McGill University. "Not one of the meta-analyses mentioned whether researchers who conducted the trials were employed by industry or personally received money from industry."

"Most people want their physicians to make treatment decisions based on high-quality, unbiased evidence," said Roseman. "Researchers 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."

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.

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

"What is surprising is that many researchers who do meta-analyses don’t seem to be aware of these important issues," added Roseman. "We 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."

Thombs, Roseman and their colleagues have called for changes in policy on how evidence on drug treatments is reported in meta-analyses. "Unless we require authors of meta-analyses to provide this information for consumers, it will be lost," emphasized Thombs. "Patients 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."

"Few 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," added Thombs. "Yet 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."

The Canadian Institutes of Health Research and the Fonds de la Recherche en Santé Québec 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 McGill 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.

Story Source: The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Jewish General Hospital, via EurekAlert!, a service of AAAS.

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