Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients by Ben Goldacre Page A

while the content is haphazard and badly organised, with lots missing, and too little information to enable you to work out if a trial was prone to bias by design. Once again – partly, here, through casual thoughtlessness and incompetence – it is impossible to get access to the basic information that we need. Drug companies and regulators deny this: they say that if you search their websites, everything is there. So let’s walk, briefly, through the process in all its infuriating glory. The case I will use was published three years ago in JAMA as a useful illustration of how broken the FDA site has become: 68 replicating it today, in 2012, nothing has changed.
    So: let’s say we want to find the results from all the trials the FDA has, on a drug called pregabalin, in which the drug is used to treat pain for diabetics whose nerves have been affected by their disease (a condition called ‘diabetic peripheral neuropathy’). You want the FDA review on this specific use, which is the PDF document containing all the trials in one big bundle. But if you search for ‘pregabalin review’, say, on the FDA website, you get over a hundred documents: none of them is clearly named, and not one of them is the FDA review document on pregabalin. If you type in the FDA application number – the unique identifier for the FDA document you’re looking for – the FDA website comes up with nothing at all.
    If you’re lucky, or wise, you’ll get dropped at the Drugs@FDA page: typing ‘pregabalin’ there brings up three ‘FDA applications’. Why three? Because there are three different documents, each on a different condition that pregabalin can be used to treat. The FDA site doesn’t tell you which condition each of these three documents is for, so you have to use trial and error to try to find out. That’s not as easy as it sounds. I have the correct document for pregabalin and diabetic peripheral neuropathy right here in front of me: it’s almost four hundred pages long, but it doesn’t tell you that it’s about diabetic peripheral neuropathy until you get to page 19. There’s no executive summary at the beginning – in fact, there’s no title page, no contents page, no hint of what the document is even about, and it skips randomly from one sub-document to another, all scanned and bundled up in the same gigantic file.
    If you’re a nerd, you might think: these files are electronic; they’re PDFs, a type of file specifically designed to make sharing electronic documents convenient. Any nerd will know that if you want to find something in an electronic document, it’s easy: you just use the ‘find’ command: type in, say, ‘peripheral neuropathy’, and your computer will find the phrase straight off. But no: unlike almost any other serious government document in the world, the PDFs from the FDA are a series of photographs of pages of text, rather than the text itself. This means you cannot search for a phrase. Instead, you have to go through it, searching for that phrase, laboriously, by eye.
    I could go on. I will. There’s some kind of ‘table of contents’ on the seventeenth page, but it gets the page numbers wrong. I’ve finished now. There is simply no reason for this obfuscation and chaos. These problems aren’t caused by technical issues specific to trials, and they would hardly cost any money at all to fix. This is plainly, simply, unhelpful, and the best we can hope is that it’s driven by thoughtlessness.
    That’s a tragedy, because if you can unearth this document, and decode it, you will find that it is full of terrifying gems: perfect examples of situations in which a drug company has used dodgy statistical methods to design and analyse a study, in such a way that it is predestined – from the outset – to exaggerate the benefits of the drug.
    For example, in the five trials on pregabalin and pain, lots of people dropped out during the study period. This is common in medical trials, as you will