“Eventually, all things merge into one, and a river runs through it. The river was cut by the world’s great flood and runs over rocks from the basement of time. On some of the rocks are timeless raindrops. Under the rocks are the words, and some of the words are theirs. I am haunted by waters.”
Norman Maclean, A River Runs Through It and Other Stories
I’m not sure why, but this feels like a story that needs a history to go along with it. In August 2012, I was wandering the Internet looking for I-don’t-recall-what, and I landed on the GSK site where I found something I hadn’t seen before – all the raw data from Paxil Study 329. Like many, I had been mildly obsessed with that study ever since running across Jon Juriedini‘s 2003 letter, and I knew that data hadn’t been there before [a movement…]. I wrote David Healy thinking that if anyone might know why it was there, he would. And he did, telling me that Peter Doshi, an epidemiologist, had gotten GSK to publish it a week or so before. Apparently, that was part of the settlement that Elliot Spitzer got in 2004, but they’d only published summaries until pressed by Doshi. I didn’t know who Peter Doshi was, but quickly found that he and colleague Tom Jefferson were running down the Tamiflu story. Governments were spending billions stockpiling Tamiflu in case of a flu epidemic, but the Cochrane group found that there were many missing trials and Roche wouldn’t release them. Here are some references from their work [Drug Data Shouldn’t Be Secret, The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience]. That was my introduction to the movement that ultimately became the AllTrials petition and campaign. Back then, I stuck with having a shot at the Paxil Study 329 data [starting with the lesson of Study 329: the basics…].
Later, in September 2012, when I ran across the now famous Ted Talk by
Ben Goldacre [
something of value…], there it was again – Tamiflu. And if you’re interested in what I’m interested in, who wouldn’t start following Ben Goldacre and buy
Bad Science and
Bad Pharma [now on the shelf next to Healy’s
Pharmageddon]? And that gets me to the House of Commons. Following Goldacre is like hitting a moving target, but I ran across some comment he made about testifying to Parliament, and ended up watching it. He and BMJ Editor
Fiona Godlee [
Secrecy Does Not Serve Us Well] met with the House of Commons Committee of Public accounts in June and delivered a performance for posterity [
goldacre and godlee…]. Godlee’s final comment was the essence of simplicity, but dead on the mark [
a sticky wicket…]:
"Unless we can find a solution to the commercial incompetence problem, we have to recognize that the pharmaceutical industry has an irreducible conflict of interest in relation to the way it represents its drugs, in science and in marketing. And unless we can resolve this in a way that is more in the public interest and in patients’ interest, I would argue that drug companies should not be allowed to evaluate their own products."
Some day, there will be a book, or a graduate thesis, or maybe a panel at a meeting where this story gets told, and the people highlighted in red above will be the central characters – semi-independent streams that all run together to make a river. And one of the big waypoints on that river will be the House of Commons Thirty-fifth Report of Session 2013–14 entitled
Access to clinical trial information and the stockpiling of Tamiflu that has just been released. There are plenty of other streams entering this river, but this is just a blog, not a thesis or an awards ceremony. But it’s the stuff of awards ceremonies, and I hope one comes along some day. I’m not going to try to summarize this report and its recommendations to Parliament. It’s short and the recommendations are in bold. Suffice it to say that they say everything about clinical trial data and data transparency that’s right – and that’s the river that runs through it…
We do not have to look far to find other areas of medicine where data does not warrant treatment:
http://www.kevinmd.com/blog/2014/01/arthroscopic-surgery-partial-meniscal-tear-unnecessary.html
This blog has also covered the Zoloft question as it winds its way through the courts.
Over medication and even invasive surgery are no barriers for some to make a profit in medicine. While they are quick to defend this profit, the economic cost to the patient and society is crippling. The losses on a personal level are never measured as one person is left with a medical history that precludes certain jobs, or worse, is burdened with a life long handicap due to a doctor’s or company’s profit drive.
Steve Lucas
Ripping off governments all over the world was a step too far. I’d like to see some of these pharmaceutical companies crushed like a cigarette, and want some of those researchers and CEOs to go to prison.
what are the future prospects for academic psychiatry?
pharma has no interest in funding CNS research
NIMH budget 2014 remains essentially what it was in 2005 ($1.4 billion plus) and $100 million of this is dedicated to brain mapping
how will changing funding levels affect them