The Duchenne’s treatment Eteplirsen has been in the news this week, as a troubling example of the FDA lowering its bar for approval of new medicines. The FDA expert advisory panel decided not to approve this treatment, because the evidence for any benefit is weak; but there was extensive lobbying from well-organised patients and, eventually, the FDA overturned the opinion of its own panel.
This is not the first time we’ve seen peculiar activity around Eteplirsen. Read the rest of this entry »
There are recurring howls in my work. One of them is this: in general, if you don’t know which intervention works best, then you should randomise everyone, everywhere. This is for good reason: uncertainty costs lives, through sub-optimal treatment. Wherever randomised trials are the right approach, you should embed them in routine clinical care.
This is an argument I’ve made, with colleagues, in endless different places. New diabetes drugs are approved with woeful data, small numbers of patients in trials that only measure blood tests, rather than real-world outcomes such as heart attack, renal failure, or death: so let’s roll out new diabetes treatments in the NHS through randomised trials. We rely on observational studies to establish whether Tamiflu reduces complications of pneumonia: that’s silly, we can do trials, and we should. Statin treatment regimes in widespread use have never been compared head-to-head, using real-world outcomes such as heart attack, stroke, and death: so let’s embed randomised trials as cheaply as possible in routine clinical care (we’ve done two pilots, to document the barriers).
This week a dozen colleagues and I published yet another application of this basic, simple principle, as an editorial in the BMJ. The Cancer Drugs Fund is being marketed as a way to generate new knowledge: but in reality, the data that will be collected is weak, Read the rest of this entry »
Here’s a useful paper we’ve just published in the BMJ, documenting problems in transparency around approval processes for randomised trials. There’s a basic rule in clinical research: you’re only supposed to do a trial comparing two treatments when you really don’t know which one is best, otherwise you’d be knowingly randomising half your participants to an inferior treatment. Despite this, it’s already known that trials are sometimes conducted where one group get a substandard treatment.
We wanted to find out how ethics committees come to approve such trials. Read the rest of this entry »
Hi there, I’m doing a few events in Australia and NZ this week: in Sydney, Melbourne, Auckland (only 25 tickets left), and Brisbane. Here‘s a good fun interview I did with The Conversation that gets very nerdy, on the poor state of science, COMPare, statins, reproducibility and transparency. I’ll post a big backlog of interviews, and papers, over the next week or two. So, come, come, I’ll see you in Oz! Read the rest of this entry »
The Cabinet Office has come up with a crazy plan to ban academics like me from talking to politicians and civil servants. In this piece I explain why that is an almost surreally stupid idea. I also describe how I hustle, in Whitehall, to try and get government policy changed on open data, scientific transparency, and evidence based policy. Readers with a weaker constitution should be forewarned that this piece contains lurid descriptions of very positive experiences I have had with Oliver Letwin, and other popular right-wing hate figures. There is no apology for that, in the name of pragmatism and democracy: we should train academics to talk to ministers, and encourage them to do it.
(Sorry, I keep forgetting to post things on badscience.net, this will change shortly, I have a big backlog of posts and will splurge over the next month or two!).
Here’s a strange thing, a seedy curio rather than a massive scandal, but I’d be interested to know what you make of it. This week lots of academics all received the same unsolicited marketing email from a large well known research company called Cyagen, who make transgenic mice, stem cells, and so on. The email was headed “Rewards for your publications”. In it, Cyagen make a rather strange offer: “We are giving away $100 or more in rewards for citing us in your publication!”.
The business model is very specific: if you cite them in an academic paper then you get $100, multiplied by the Impact Factor of the journal (a widely used measure of the journal’s influence). So if you cite them in the New England Journal of Medicine, which has an impact factor of 56, then you will receive $5600 from Cyagen. If you cite them in the British Medical Journal, you get $1700. And so on. Read the rest of this entry »
Me and a dozen other academics all just wrote basically the same thing about Open Science in the Journal Of Clinical Epidemiology. After the technical bits, me and Tracey get our tank out. That’s for a reason: publishing academic papers about structural problems in science is a necessary condition for change, but it’s not sufficient. We don’t need any more cohort studies on the global public health problem of publication bias; we need action, of which the AllTrials.net campaign is just one example (and as part of that, we do still need many more audits giving performance figures on individual companies, researchers and institutions, as I explain here). We have a paper coming shortly on the methods and strategies of the AllTrials campaign that I hope will shed a little more light on this, because policy change for public health is a professional activity, not a hobby. Where academics are sneery about implementation, problems go unsolved, and patients are harmed.
Ironically all these papers on Open Science are behind an academic paywall. The full final text of our paper is posted below. If you’re an academic and you’ve ever wondered whether you’re allowed to do this, but felt overwhelmed by complex terms and conditions, you can check every academic journal’s blanket policy very easily here.
And lastly, if you’re in a hurry: the last two paragraphs are the money shot. Enjoy.
Fixing flaws in science must be professionalised. Read the rest of this entry »
There are some big problems in medicine, and the public are right to be concerned about our shortcomings. Last week we found out that the Chief Medical Officer has written to the Academy of Medical Sciences, asking for an authoritative review into problems in the evidence we use to choose treatments, focusing especially on concerns around statins and tamiflu.
Will the Academy’s review be a whitewash? We hope not. But we are concerned that they may suffer from a lack of vision, and ambition, in trying to fix the problems in medicine.
So here is our call to arms, in a BMJ editorial. Like everything, I hope it is accessible to a general audience as well as doctors and researchers, because we need everyone’s help to fix these problems. We demonstrably cannot move forward on our own, because we have not.
And now, in whispering tones: this list of fixes is taken from a longer list in the last chapter of my super secret new book on statins, out in six months, which I am “not yet talking about” in public (you heard it here first). In that book I set out the evidence on statins, what we know, what we don’t know, and how we can get better data. Then, I set out a Better Medicine Manifesto: clear, deliverable fixes, that will make medicine better, to a soft metal soundtrack.
This link will get you free access to the BMJ piece:
Here are a couple of fairly detailed interviews I’ve done over the last two weeks, both on the problem of clinical trial results being withheld.
The first is with On The Media, an excellent NPR show, the clip is here. Read the rest of this entry »
As you’ll hopefully know by now from reading Bad Science, Bad Pharma, and my endless columns on the subject, medicine has a problem: the results of clinical trials are routinely and legally withheld from doctors, researchers, and patients. We started the AllTrials.net campaign two years ago to build a global campaign on this issue, and we’ll be publishing a big roundup of what we’ve done soon, along with (crucially, I think) our tactics and methods, in a spirit of pooling knowledge on how to achieve policy change for problems in science. Please do get your professional body to sign up.
This week there was an amazing landmark announcement from the World Health Organisation: they have come out and said that everyone must share the results of their clinical trials, within 12 months of completion, including old trials (since those are the trials conducted on currently used treatments). This is great news, but it’s not enough. The WHO announcement was in PLoS Medicine, with a commentary from WHO staff explaining their reasoning (it’s very good) and a commentary from me, explaining why we need to audit missing data, and act on that audit data.
This, I think, is the only way forward. We have seen that the FDA are unwilling to implement the laws they have available to them, and that other countries such as the UK are unwilling even to consider such legislation. In the absence of serious engagement on this issue from the policy community, now doctors, payers (such as the NHS), and enlightened funders need to take action themselves. If we fail to do so, we may be judged harshly by our patients. Read the rest of this entry »