No, the title of this post doesn't refer to dead patients ... at least, not directly.
Via Mark Schaver's Depth Reporting comes this post at the Bad Science blog (new to me) on how drug-company-sponsored studies that don't show good results get buried.
Blogger Ben Goldacre says the withdrawal of Vioxx from the marketplace was just a dramatic example, but less dramatic examples permeate drug research, depriving doctors of information they need:
... a paper in the New England Journal of Medicine dug out a list of all trials on SSRIs [a kind of antidepressant -- Lex] which had ever been registered with the Food and Drug Administration, and then went to look for those same trials in the academic literature. There were 37 studies which were assessed by the FDA as positive and, with a single exception, every one of those positive trials was written up, proudly, and published in full. But there were also 33 studies which had negative or iffy results and, of those, 22 were simply not published at all -- they were buried -- while 11 were written up and published in a way that portrayed them as having a positive outcome.
The new study, published this week, has analysed all of the data from the FDA, using the Freedom of Information Act to obtain the results for some of the trials. That medical academics should need to use that kind of legislation to obtain information about trials on pills which are prescribed to millions of people is absurd. More than that, it breaks a key moral contract between patient and researcher.
When a patient agrees to participate in a clinical trial, they give their consent on the understanding that their information will be used to increase the sum of our knowledge about treatments, to ensure that other people, in the future, will be treated more effectively. Burying unwelcome results is an unambiguous betrayal of their trust and generosity.
Goldacre says this "publication bias" has been recognized in medical literature for half a century. (And not just in medical literature, but elsewhere, as in Cynthia Crossen's 1994 book "Tainted Truth: The Manipulation of Fact in America.")
He also offers some solutions to the problem:
... there are two very simple and widely accepted solutions, which have been discussed in the academic literature at length since the 80s, but which are still not fully in place.
The first is obvious. Nobody should get ethical approval to perform a clinical trial unless there is a clear undertaking that the results will be published, in full, in a publicly available forum, and that the researchers will have full academic freedom to do so. Any company trying to silence academics should be named and shamed, and even attempting to do so should be a regulatory offence.
That's the butch solution. But there is also a more elegant one, which is arguably even more important: a compulsory international trials register. Give every trial an ID number, so we can all see that a trial exists, they can't go quietly missing in action, and we know when and where to look if they do.
Doctors -- and, with the growth in marketing of drugs directly to consumers, patients -- need to know not only when something works but also when it doesn't, or when it works no better than existing, cheaper medications. Goldacre points us helpfully in the right direction.