October 20, 2016
There should never be a situation where a pharmaceutical company that has spent hundreds of millions of dollars – and sometimes billions – developing a new drug is allowed to conduct its own self-controlled clinical trials, because the financial incentives to skew the outcomes of those trials in the company’s favor are far too great.
And yet it happens all the time, according to a recent report by NPR.org.
The publicly funded broadcast company says that doctors often turn to specially crafted studies when they are attempting to understand what is often confusing and contradictory findings in scientific literature. That’s because such studies are considered to be the “gold standard” for research.
However, a leading advocate for such studies is warning that they are increasingly being subverted by commercial interests, meaning their accuracy, too, is now in question as drug makers and the scientists they utilize improperly influence outcomes.
NPR.org notes that for years these studies, which are called meta-analyses and systematic reviews, appeared to fill information gaps with more complete findings. Doctors who once relied on each other for expert advice increasingly turned to crafted studies.
But over the years the number of such reviews ballooned and began offering contradictory findings. So in the 1990s doctors and medical advisory boards began to utilize studies that combined several different research projects that analyzed all of the available data to come to a general conclusion. That helped fast-track searches for answers.
Commercial interests taint 8 in 10 studies
Such studies are “extremely important,” Dr. John Ioannidis, a professor of medicine health research and policy at Stanford University, told NPR.org, adding that he himself has conducted several meta-analyses over his career. “They’re trying to make some sense out of a very convoluted scientific medical literature.
However, he said, now “there are just too many meta-analyses.”
Indeed, in a recent study on the issue, titled “The Mass Production of Redundant, Misleading and Conflicted Systematic Reviews and Meta-Analyses,” Ioannidis chose example studies involving antidepressants.
He said that there were 185 published in academic literature over a period of just seven years, which translates into roughly 25 such meta-analyses per year, for the same drugs and the same indication for those drugs – major depression.
Worse, those studies are being conducted by scientists who have financial interests in the outcome, Ioannidis found. About eight-in-10 of them “have been funded or have some other conflicts of interests with manufacturers of these drugs,” he said.
Further, if one were to examine their conclusions, nearly all – with one exception – claim there are no issues or caveats with taking antidepressants.
If any downsides are mentioned at all, he said, you have to read deep into the studies to find, say, warnings about increased risk of suicide.
The problem is actually worse
That, of course, is very misleading to doctors who are turning to such analyses in order to get a quick take on what works and what does not, as well as the risks-versus-reward. Ioannidis told NPR.org that Big Pharma has begun using such analyses for commercial reasons rather than as an unbiased examination of the evidence. That, of course, represents a danger to the public.
Ioannidis said that drug makers can produce results or give the interpretation that most fits their interests and needs with self-funded analyses.
“So you can have the most power and prestigious design in current medical evidence, and it can be easily manipulated as an advertisement, as a marketing tool,” he said, noting that defeats the primary reason for such studies in the first place – making an over-abundance of findings more comprehensive and understandable.
Clinical professor emeritus Peter Kramer of Brown University, author of “Listening to Prozac,” delved deeply into the conduct of meta-analysis studies when writing his latest book, “Ordinarily Well.” What he discovered was even worse than Ioannidis claims.
In addition to finding commercial interests, Kramer also said he found many cases of academic bias among researchers, further skewing results.