Drug Studies Often Play Down Adverse EventsOct 27, 2009 | Parker Waichman LLP Although drug and medical clinical trials are necessary to rooting out potential problems and dangers with medicines and procedures, study authors are known to often minimize negative data on such trials. The LATimes wrote that, according to an emerging report, this is the case more often than not.
“The reporting of harm is as important as the reporting of efficacy in publications of clinical trials … However, harm is frequently insufficiently reported,” quoted the LA times citing the French researchers writing in a study being published in today’s edition of the Archives of Internal Medicine. Often, research highlights the positives while skating over risks, adverse events, and problems with efficacy and safety, to name a few.
According to the LATimes, the research team looked at 133 studies published during 2006 in five of the most highly regarded medical journals: The New England Journal of Medicine, Lancet, Journal of the American Medical Association, British Medical Journal, and Annals of Internal Medicine. Of the studies reviewed, 83 percent assessed new drugs; 55 percent were funded in whole or in part by for-profit companies, said the LATimes. Interestingly, the research revealed that about 11 percent—15 studies—never made mention of any adverse events and six others mentioned adverse events but did not supply numerical data, reported the LATimes.
For those studies that did provide so-called “hard numbers,” there was distortion in presentation such as 36 studies not differentiating between “minor and severe side effects,” 17 reporting “only the most common side effects,” and 16 only listing the “most severe” side effects, said the LATimes. Also, five only discussed those negative effects “linked to the drug or treatment being studied in a statistically significant way,” said the LATimes, which explained that “such side effects are rare” and trials are not set up for that detection.
Another way that information is massaged, the team found, was by only discussing the number of study participants who experienced an adverse reaction as opposed to the total number of reactions, explained LATimes; 31 of the 90 studies that included numerical data on side effects applied this distortion. Also, the team found that of the articles, only 17 described adverse events necessitating participants dropping out of the studies; 63 provided no such details, according to the researchers, said LATimes.
The Consolidated Standards of Reporting Trials—CONSORT—was updated in 2001 to emphasize the need to report “all important adverse events or side effects.” Despite this, said the French team, “the reporting of harm remains inadequate,” quoted LATimes.
In an accompanying editorial written by Dr. John Ioannidis of the University of Ioannina School of Medicine in Greece—Dr. Ioannidis was among the first to research how safety data are presented in journals—this under-reporting is attributable, in part, to drug companies focused on “silencing the evidence” that products could cause harm, said LATimes. Dr. Ioannidis discussed, in particular, two drugs on which we have long been reporting: Vioxx and Neurontin. Vioxx was pulled from the market over its links to doubling heart attack and stroke risks and Neurontin, said LATimes, has been associated with a significant—80 percent—increase in suicidal ideation and actions. Said, Dr. Ioannidis, “In these cases, marketing needs prevail over scientific accuracy and clinical prudence.”