Latest news and views from around the Bennett Institute
“If you’re a huge company trying to develop a new drug or treatment, the temptation to hide ‘bad’ results might be a strong one. Until now, you would be able to hide those results with few consequences.”
In this Wired article, Abigail Beall, discusses the Alltrials campaign and the FDAAA TrialsTracker
The latest price concession information for January has been released by the PSNC (in fact, two sets of data in quick succession). The PSNC have also stated that they are “still in discussion with the DHSC regarding further January 2018 price concessions”. Therefore we have made some calculations based on what we know at the moment - as soon as there are changes we will update this blog. For January 2018, on the surface price concessions look better than in previous months, with an estimated impact of about £12.6 million. This brings the total for the financial year to date to approximately £297 million. This is based on an estimated actual cost, using November data for December and January, so there will be slight changes when the actual data is available.
With the launch of our FDAAA TrialsTracker, applicable trials that have failed to report their results on ClinicalTrials.gov are starting to appear. If you go here on our Tracker (the “All Trials” view, and toggle the “due” filter) you can see all the trials that have not yet reported.
Non-reporting of clinical trial results in an ongoing, global public health issue. We are going to start highlighting some of these unreported trials in blog posts to shine a light on what information is being withheld from the public as a result of non-reporting.
When you produce online tools from data, you often get useful feedback that helps you improve the outputs. (Send us feedback any time!). Additionally, when you use data, you learn about interesting glitches in it, some of which can be entirely undocumented. Here we share one example of helpful feedback, and how we used it to improve our tool.
First some background. Trial reporting is a huge problem in medicine: the results of clinical trials are routinely withheld from doctors, researchers, and patients. We think all trials should be reported. The WHO agrees. A US law called the FDA Amendments Act requires some trials to report their results on ClinicalTrials.gov: this law has many loopholes, but it’s an important start. Since the results reporting requirements of FDAAA came into full force, our FDAAA TrialsTracker has been identifying the individual trials that have breached it. You can read our paper on how the tool works: we also blogged about our methods for identifying overdue trials. Staff in universities who manage trial reporting are already telling us that they find our tool useful.
Now that we’ve launched our FDAAA TrialsTracker, we plan on occasionally taking a closer look at some of the trials that go unreported. Our first blog was about a trial examining 2 drug combinations for managing pain during labor (NCT01846221).
So why do we think this specific trial is due to report? While we go through how we established our criteria and set up our database in detail in our preprint paper on Biorxiv, we wanted to walk you through exactly what fields matter on ClinicalTrials.gov and how we used them to build our tracker. We think we were able to do this well, but are open to feedback and will amend our paper and methods as necessary.
“Institutions that fail to report the results of their drug and medical trials will be named on a new website.”
In this BBC article, Chris Foxx, highlights the FDAAA TrialsTracker. Quoting Bennett Institute Director, Ben Goldacre, “I’m not interested in naming and shaming people in order to criticise them. This project is being done to nudge institutions to prioritise trial reporting.”
This week, we launched our FDAAA TrialsTracker which gives you a live look at whether individual sponsors and trialists are meeting their responsibility to report the results of clinical trials on ClinicalTrials.gov. A lot of work went into the tracker and making sure we got it right. You can read all about our methods, in detail, here but the short version goes like this…
Certain trials registered on ClinicalTrials.gov, the US trial registry run by the National Institutes of Health (NIH), are required to report their results. This requirement began with the passing of the FDA Amendment Act of 2007 (FDAAA) but different interpretations of the broad requirements laid down under FDAAA led to some confusion over who was required to report and when. In September of 2016, a “Final Rule” was published by the NIH that clarified and expanded how the reporting requirement under FDAAA would operate moving forward. The Final Rule came into effect on January 18, 2017.
The latest price concession information for January has been released by the PSNC (in fact, two sets of data in quick succession). The PSNC have also stated that they are “still in discussion with the DHSC regarding further January 2018 price concessions”. Therefore we have made some calculations based on what we know at the moment - as soon as there are changes we will update this blog. UPDATE: We’ve now updated the data, both with the final concessions list for January 2018, and the actual cost data for December 2017.
We’ve been thinking in the Bennett Institute about doing stories, using our prescribing data, to go with landmark clinical trials and systematic reviews. Here’s an example.
A new systematic review published this week in JAMA shows that Omega-3 “fish oil” pills don’t really help improve cardiovascular health. As a systematic review, it’s a very useful overview of previous existing research. Perhaps reassuringly, as that evidence accumulated over time, clinicians were already changing their prescribing behaviour. Here’s the long-term NHS prescribing data from our database: NHS doctors gradually began to reduce prescribing of omega-3 a long time ago. Peak omega-3 was 2011!
Everyone at the Bennett Institute wishes you a very Happy New Year!
Unfortunately, the NHS is still having the same problems in sourcing generics. The PSNC announced the latest list of price concessions for December 2017, slightly smaller than November’s, with 86 lines. However, we still estimated a monthly impact for the NHS in December of £27 million, bringing the total excess cost for the nine months to December to £285 million:
Everyone at the Bennett Institute wishes you a very Happy New Year!
Unfortunately, the NHS is still having the same problems in sourcing generics. The PSNC have just announced the latest list of price concessions for December 2017. The list was slightly smaller than November’s, with 86 lines,but we are still estimating an monthly impact for the NHS in December of £27 million. This brings the total excess cost for the nine months to December to £285 million:
Many people I’ve spoken to aren’t aware that gluten-free foods can be prescribed, but it happens quite extensively in an effort to help patients with coeliac disease adhere to a gluten-free diet.
Below is a chart showing the rate of gluten-free product prescribing since 1998, where there is a gradual increase until 2011, when guidance changed to recommend only prescribing of staple foods such as bread and flour. Recently there has been a sharper decline.
In our second full year of existence we produced even more exciting outputs and continued to grow. You can see the team on our website: Emma-Jane has been our project manager since the Spring; we have two new part-time coders working for us; and researchers Alex, Nick, Daniel and Karolina all started this year. We’ve delivered a range of great new features on OpenPrescribing, got great progress on numerous pre-launch projects, and have a nice portfolio of papers submitted.
We’ve taken a quick look at the data to see why, despite the number of price concession lines have increased to 91 in November, the estimated total excess cost has reduced. (Reminder - we’ve used September prescribing data to estimate the effects, as that’s the latest data available).
The full table is below, but here are some highlights:
As always, you can find our Drug Tariff viewer at www.openprescribing.net/tariff. We’d love to know what you think about the work we’re doing, or anything to do with the OpenPrescribing tool. Please let us know on Twitter, our Facebook page, or via email at feedback@openprescribing.net.
The PSNC has published the list today of Price Concessions for November 2017. The list is the biggest yet, at 91 lines.
We’ve taken a first stab at calculating the estimated effect for CCGs, using September 2017 prescribing data. The Google Sheet can be found here. (edit) - the Google Sheet now also contains national calculations per presentation and all CCG presentation data.
A couple of calculation changes:
The total for England (actual cost) for November is £38.5m. We’ll do some further calculations when we get the chance. It’s less of an impact than we were expecting - possibly as some of the “big excess” items have been removed. We’ll take another look tomorrow!(edit) - we’ve taken a quick look - and here are some of the reasons why the total cost of price concessions is lower.
We have been writing a lot recently about the effect of price concessions on the NHS primary care drugs bill, and on the problems community pharmacy are facing.
We’ve been asked for some CCG-level data, and so here it is; both for the confirmed data for April-September 2017, and for an estimate for October, which is based on October price concession data with September’s prescribing data.
(edit) We’ve also been asked how the costs were calculated. We calculate the difference in the unit cost, i.e. (price concession cost per pack - DT cost per pack)/pack size and then multiply by the prescription quantity for each affected presentation. Please note that these calculations are based on Net Ingredient Cost (NIC) not Actual Cost, and so the impact to CCGs will be slightly lower (about 7%).
Today we’ve released our new Drug Tariff viewer. It was a dataset that we previously didn’t hold, but thought that it would be useful to turn into a graphical viewer for people to use to see how the reimbursement price on drugs changes over time, and also to use as the basis of the effect that price concessions are having on the NHS.
However, obtaining and normalising the data proved to be a bit of a challenge.
The Drug Tariff, published on behalf of the Department of Health and updated monthly, is a strange and mysterious document, written largely in legalese, and understood by pharmacists and almost no-one else. Ask a GP where they find out the cost of the drug, and they’ll say either their computer system or the BNF. For pharmacists, it’s usually the Drug Tariff (or the Tariff). And that’s usually where the most accurate price will be found.
