I’ve got a good story for you. One that goes back to the early days of this blog, a time when I wrote about cycling.
It turns out that the biggest medical news thus far in 2016 has a connection, albeit slight, to the recent doping news out of Belgium.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
You’ve heard the news from Cyclocross Worlds: an under-23 year-old woman was caught with a motor in her bike. Although the mainstream media was surprised, one Italian journalist called it “old stuff.”
How does cheating in sports relate to medical science? The connection is trust and confidence – the ability to believe.
Medical science is in the midst of a confidence crisis. One problem is replication. More and more, one group’s discoveries cannot be replicated by another group. For a cycling connection, think about the records set in the famous climbs of the Tour de France during the EPO era: they cannot be replicated, because they were not real.
Another problem with medical science is that negative studies get published less often than positive studies. A drug company does four studies on its new drug. Two studies show positive effects and two are neutral. Which studies do you think make it into journals? This is called publication bias–and it has the effect of making a treatment look more positive than it is. It would be like racing a bike only on days when you were good.
Then there is something called data-dredging. A major study collects data from numerous centers across the globe. The raw datasheet is massive.
Look at the picture of the cone to the right. In the same way th
at cutting a cone in different ways leads to different shapes, a group of scientists can analyze their data sets in ways that produce positive results. There are supposed to be rules to prevent this, but the rigor with which statistics are judged varies. Consider the case when peer-reviewers are friends of the author, or, say, when the journal editors know a study will lead to prestige or big sales of reprints.
The point is that in medical science and in sports, there are great treasures but only for great results.
That’s why a new proposal from a group of medical editors is big news. The proposal would require that authors of studies share their raw data as a condition of publication in the journal. Medical researchers will have six months after a study is published to share the data.
This utterly disrupts the status quo. Currently, raw data has remained the property of either the scientists or the sponsor of the trial. It’s hard work designing a trial, collecting the data, and doing the analyses. Scientists, therefore, would often write many papers from the datasheets, sometimes over the course of years. These datasheets provided the gratification delayed for the grunt work of research. Publications are the currency of progress in academics.
If this proposal is enacted, outside researchers, who had no connection to the study, can look at the data and do their own analyses. They can verify the findings, try to disprove the findings, or ask different questions. Think about that. Is it right that almost anyone with a laptop can benefit from the hard work of the original researchers?
Another issue here is the importance of honoring the patients who volunteered to be experimented on. These people are owed a great debt: to maximize the knowledge generated from the experiment. Would any patient consent to a study if their data was not used to advance science?
My essay on this was one of the toughest I’ve written. It took hours upon hours. I tried to see the proposal from both sides. An outsider sees obvious advantages, but researchers have serious concerns.
The title is linked below:
To Believe in Science Is to Believe in Data Sharing
Photo: Bigstock
