Remember years ago when there was some buzz about publication bias in medical journals? Studies finding that drugs were effective were much more likely to get published. If you recall, we were promised that a new day was coming.
Back in 2008, many people assured me change was coming and transparency was taking hold. After all, Congress, just the year before, had passed legislation requiring researchers to release results of all trials on clinicaltrials.gov, a website run by the National Institutes of Health, within a year of completion. The editors of major medical journals had banded together and said they would refuse to publish the results of any study that hadn’t been listed on the trial site from the time the study began.
Well, it hasn’t come to pass. Here are two recent studies on the subject.
Yet last month, Erick Turner and some colleagues released a new analysis, in the journal JAMA Psychiatry, looking this time at drugs used to treat anxiety disorders—and they found almost the same results. Nearly every study (40 of 41) that the FDA determined to be positive ended up getting published. Of the studies the FDA determined weren’t positive, almost half didn’t get published; those that did were largely published in ways that conflicted with the FDA’s findings.
“When the news is good, drug companies are going to see to it that the world knows about it and get the data published,” Turner told me. “If the news is bad, the data is not quite as forthcoming.”
“. . . ways that conflicted with the FDA’s finding”? What does that mean? Strangely enough, the actual journal article puts it in plain language, “We found evidence for study publication bias, outcome reporting bias, and spin.”
Eric Peterson, director of the Duke Clinical Research Institute, says things are improving incrementally and the public now has access to more information about studies that are underway. Yet a study he co-authored, published last month in the New England Journal of Medicine, found that most results of clinical trials are still going unreported.
Peterson and his colleagues combed through some 13,000 clinical trials, most sponsored by drug or medical device companies, to see if they complied with the new legislation requiring them to post results on the NIH website. The study found that that only 38 percent of studies completed between 2008 and August, 2012 had reported results by September, 2013. Even fewer, 13 percent, had posted their results within the one-year time limit established by Congress.
“There is still a problem here,” Peterson says. “Evidence can be hidden or misconstrued and the doctor and patient can be misled. But now we know more about it.”
So, studies with positive findings are much more likely to be published, and negative results get misrepresented.
How does this affect practice?
Before he began working at the FDA in 1998, Turner treated patients as a private psychiatrist and “naively believed all the literature I was reading. My assumption was the drugs work and when they don’t, there’s something unusual about the patient.” Once he started working at the drug agency, he got to see a lot of negative studies that the public never saw and realized his assumptions had been wrong.
It would seem to me that this is an important problem to solve.
- If you’re someone who’s skeptical about the push for new drugs to treat addiction and other medical problems, you want to get 100% of the results out there so we can more clearly see what the right practice decisions might be.
- If you’re someone who thinks “evidence-based” medications should be more widely used (and your annoyed by my use of quotation marks), more transparency will help reduce skepticism.