Every day, there is another medical study in the news. There’s another newspaper or TV story telling us that X can cure depression or make you thinner or cause autism or whatever. And since it’s a medical study, we usually think that it’s true. Why wouldn’t it be?
But what most people don’t realize, let alone really think about, is that there might be other studies that show that X does none of those things — and that some of those studies might never have been published.
Just this week, the journal Pediatricsreleased an article that perfectly demonstrates this problem. There have been a number of studies that have shown that a certain type of medication, selective serotonin reuptake inhibitors (SSRIs), can help stop the repetitive behaviors of autism, like hand-flapping or head-banging. If you were to do a search of the medical literature, as doctors and parents and patients often do, you’d think that using SSRIs is a good idea. But when researchers dug deeper, they found that there were just as many unpublished studies that showed that SSRIs didn’t help. If they had all been published (they were all good enough to be published), that same search of the medical literature would have shown that using SSRIs isn’t a good idea.
This is bad. We rely on studies to guide our decisions. What is going on?
The journals that publish articles certainly play a role. After all, it’s cooler to publish a study that has a grabby headline, that promises an answer or a cure. That’s much more likely to get readers than a study that says that something doesn’t do anything at all. But it turns out that the researchers themselves play a bigger role.
Some researchers don’t even write up their studies or try to publish them. ….
- Medical Research We Never Hear About: The Problem of Unpublished Studies (thehealthcareblog.com)
From the 28 January 2012 article
Academic publishing is a very good game indeed if you can manage to get into it. As the publisher the work is created at the expense of others, for free to you. There are no advances, no royalties, to pay. The editing, the checking, the decisions about whether to publish, these are all also done for free to you. And the market, that’s every college libarary in the world and they’re very price insensitive indeed….
There’s not much new about this analysis and investors in Reed Elsevier, the owners of Elsevier, either do or should know all of this.
However, there’s something happening that might change this, for Reed Elsevier shareholders, quite delightful position. That is, a revolt of the academics who provide both the papers and the readership.
A start was made by British mathematician Tim Gowers, in a blog post here. That wasn’t the very start, but it looks like one of those pebbles that starts the avalanche rather than the one that just tumbles down the hillside. And there’s a great deal to be said for a scientific post which references Spike Milligan‘s superb book, Adolf Hitler, My Part in his Downfall.
“I am not only going to refuse to have anything to do with Elsevier journals from now on, but I am saying so publicly. I am by no means the first person to do this, but the more of us there are, the more socially acceptable it becomes, and that is my main reason for writing this post,”
There is now a petition running for academics to sign up to this, here….
- Could LexisNexis and Thomson Reuter legal publishing model go up in smoke? (kevin.lexblog.com)
- Elsevier Publishing Boycott Gathers Steam Among Academics (chronicle.com)
- Death to Elsevier! (freethoughtblogs.com)
- Death to Elsevier! (scienceblogs.com)
- Boycott Elsevier (whyevolutionistrue.wordpress.com)
- The cost of knowledge (terrytao.wordpress.com)
- On Elsevier (michaelnielsen.org)
- Scientists Organize Elsevier Boycott (science.slashdot.org)
- Boycott Elsevier (blogs.discovermagazine.com)
- Elsevier Snapped by Price Elasticity (arnoldit.com)
- The boycott Elsevier movement (marginalrevolution.com)
- Lists of Elsevier journals to boycott (rrresearch.fieldofscience.com)
Many NIH-funded clinical trials go unpublished over two years after completion (with ClinicalTrials.gov link for many trial study results)
[Flahiff’s note: It is possible that many of these unpublished clinical trial results would have made a positive difference in many people’s lives. These unpublished results have the potential of aiding many researchers. They can prevent unnecessary duplicate trials, point to areas needing more research, and potentially provide groundwork for collaboration.
On another note, it is good to see that published research papers are now more accessible to all. As of 2008, research papers based on NIH grants must be submitted to PubMed Central (PMC) when those papers are accepted for publication in a peer-reviewed journal. PMC will then make the papers freely available to the public within 12 months of publication.
I look forward to the day when all research papers are freely available to the public. There are a myriad of issues, as who pays for the publishing, the peer review process, and where the research papers should be “housed”. However, I believe the more scientific research results are disseminated in easily accessible format, the more we can advance in technology applications and filling in knowledge gaps.]
In a study that investigates the challenges of disseminating clinical research findings in peer-reviewed biomedical journals, Yale School of Medicine researchers have found that fewer than half of a sample of trials primarily or partially funded by the National Institutes of Health (NIH) were published within 30 months of completing the clinical trial.
These findings appear in the January issue of the British Medical Journal, which focuses on the topic of unpublished evidence.
“When research findings are not disseminated, the scientific process is disrupted and leads to redundant efforts and misconceptions about clinical evidence,” said Dr. Joseph Ross, first author of the study and a Yale assistant professor of medicine. “Such inaction undermines both the trial in question and the evidence available in peer-reviewed medical literature. This has far-reaching implications for policy decisions, and even institutional review board assessments of risks and benefits associated with future research studies.”…
Ross said that there may be many reasons for lack of publication, such as not getting accepted by a journal or not prioritizing the dissemination of research findings. Still, he said, there are alternative methods for providing timely public access to study results, including the results database at ClinicalTrials.gov** that was created in response to Federal law.
[From the About Page at Clinical Trials.gov
US Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a “responsible party” (i.e., the study sponsor or designated principal investigator) register and report results of certain “applicable clinical trials” that were initiated or ongoing as of September 27, 2007…]
ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions.
ClinicalTrials.gov currently contains 118,682 trials sponsored by the National Institutes of Health, other federal agencies, and private industry.
**Here is how one can check for study results
(remember, researchers are not mandated to submit study results to ClinicalTrials.gov, they are voluntary)
ClinicalTrials.gov records with published results listed via the PubMed medical literature search service.
- Use the Advanced Search with the search phrase clinicaltrials.gov[si]
Use the Builder limit results by topics (as a disease, medical device), year(s), name of researcher/invesitator)
- Need help searching? PubMed has tutorials , including a YouTube at the Advanced Search Page
Ask for assistance from a reference librarian at your local public, academic, hospital, or medical library.
Many academic, hospital, and medical libraries offer at least basic search help to all. Call ahead and ask
about their services. You may be pleasantly surprised.
- Many NIH-funded clinical trials go unpublished over 2 years after completion (eurekalert.org)
- The White House Calls for Information on Public Access to Publications and Data (The Scholarly Kitchen)
- How to obtain free/low cost medical and scientific articles(jflahiff.wordpress.com)
- Patients want to understand the medical literature (with links to resources for patients) (jflahiff.wordpress.com)
- Missing trial data threatens the integrity of medicine (eurekalert.org)
- Poor patient recruitment cited in call for trial disclosures (fiercebiotechit.com)
- A Present for NIH: President Signs Law Creating New Translational Center (news.sciencemag.org)
- NIH and Non-profits Sign Research and Development Agreement (kauffman.org)
- NIH establishes National Center for Advancing Translational Sciences (jflahiff.wordpress.com)
From the 8 August 2011 Science Intelligence and InfoPros blog posting
In this podcast from Copyright Clearance Center, Rafael Sidi, Elsevier talks about a new app ecosystem.
Sidi explains that “as a scientific publishing company, we are moving to a solution space and we don’t want to be just an information provider, but we want to also provide solutions to our customers, to our market… We want to go to the community, collaborate with the community and build the solutions together with the community.”
In order to have their “data easily remixable, reusable,” they are “going to the crowd. We are letting them play with our data and build on top of our data stuff that they need to build, because at the end, scientists and researchers, they know their problem better than us.”
With the main goal to accelerate science, Elsevier reaches out to the community in hopes to collaborate to find new solutions. “We want to create an incubation environment for the scientific and research community. [In some case], we providing some seed funding to startup companies… Our goal for the future, definitely, we want to create an Elsevier incubation environment.”
The podcast and transcript are available at:
- New Study on Integrated Oil Reservoirs Pushes Science Forward (prweb.com)
- Elsevier Announces Winners of the Executable Paper Grand Challenge (prnewswire.com)
- Elsevier Introduces Genome Viewer (prnewswire.com)
- Elsevier Upgrades Illumin8, Enhancing Access To Critical Information At The Front End Of Innovation (dailymarkets.com)
- New: Elsevier Enriches Online Articles with Google Maps ” INFOdocket (infodocket.com)
From a Reuters Health Information news item
Nearly half of surgeons who earned more than $1 million from companies that make orthopedic devices did not disclose it when they published medical journal articles, U.S. researchers said on Monday.
“The findings raise troubling questions about undisclosed payments or royalties and other fees from medical device companies that could lead to biased scientific conclusions,” said David Rothman of the Institute on Medicine as a Profession, a think tank based at Columbia University in New York.
Members of Congress including Senator Charles Grassley, an Iowa Republican, have been pushing to limit the influence drugmakers have over the practice of medicine in the United States after investigations revealed that Harvard University psychiatrist Dr. Joseph Biederman and others failed to fully disclose payments from drug companies.
Rothman’s team used a public database to check the accuracy of surgeons’ financial disclosure statements.
They focused on five companies: Biomet; DePuy Orthopedics, a unit of Johnson & Johnson; Smith & Nephew; Stryker and Zimmer.
These companies made a total of 1,654 payments that amounted to $248 million in 2007 for consulting, honoraria or other payments for services, the team reported.