Apologies for the hysterical headline but it’s just the kind of irresponsible, ill-informed screamer that regularly heads stories about some new study that “proves” that vitamins are ineffective generators of expensive urine and may well be dangerous.
If you want to know why such studies are all too often based on poor science and frequently unreliable, read no further. Go straight to the website HealthInsightUK.org where nutritionist Patrick Holford has posted a careful and detailed analysis of the latest “vits are rubbish” paper, widely publicised in the newspapers before Christmas.
Once you’ve read it you may still be sceptical about the benefits of vitamins but you will have to admit that you can’t use this piece of research to make the case. You might even feel an apology was due. (This is not to say that good research can’t reveal problems with vitamin use or suggest ways they can be used more effectively, but the broad brush attacks invariably turn out to be more polemic than proper science.
Painting a grim picture
Meanwhile I’m going revisit the report on the flu drug Tamiflu by the Commons Public Accounts Committee , which I wrote about here last week . The oral evidence from Dr Fiona Godlee, editor of the BMJ and Ben Goldacre, author of “Bad Pharma” paints a grim picture of the realities of drug regulation – as opposed to the official line that it is all careful, thorough and evidence based.
This in turn is highly relevant to the vitamin debate. Not because poor evidence for drugs means there is good evidence for all vitamin uses, but because if drug data is dodgy or downright deceptive, it makes sense to take that into account on a when personally weighing up the risks and benefits of drugs vs. vitamins.
Most coverage of the report ignored the revelations about inadequate regulation because only geeks and obsessive have the time to read such things. So courtesy of an obsessive, here are some quick-read highlights.
In theory evidence based medicine relies on testing drugs against a placebo in clinical trials to discover if they are safe and effective. In fact evidence gathered in this way is not worth much since it’s reliably estimated that at least half of drug company trials run on drugs we use today not been published, making a mockery of the principle. What’s even worse is that keeping unfavourable results hidden is not actually breaking the law.
You should be worried
As Goldacre commented: “The public should be worried that there is no competent legislation to ensure that doctors and researchers have access to all the methods and results of all the trials. (The result is) that we cannot practice evidence-based medicine in the way we purport to.” The implication is that evidence has become an arm of companies’ marketing division with limited scientific value.
As Godlee remarked: “The pharmaceutical industry has an irreducible conflict (between) science and marketing in the way it represents its drugs. Unless we can resolve it in the public interest I would argue that drug companies should not be allowed to evaluate their own products.”
Defenders of the system claim that failing to publish data isn’t such a problem since companies have a legal obligation to provide the drug watchdogs – the MHRA in the UK, the EMA in Europe – with all the data anyway.
Dr Godlee made it clear that this was another comforting fantasy. She explained that as a result of investigations by the Cochrane Collaboration (the research body that triggered the transparency campaign in Europe by demanding to see all the trials carried out by Roche on Tamiflu) it turned out that Roche had funded 123 completed trials of the drug.
The madness of the situation
However the EMA had seen a mere 15 incomplete accounts of these trials. No figure was given for the MHRA but it is unlikely to be any greater, while NICE (the body that is responsible for deciding if a drug is cost effective) had received tiny fraction of the total – just 4 incomplete accounts.
Why, the chairman wanted to know, since the drug watchdogs were entitled to all information, hadn’t they asked for it? “Good question.” Godlee replied and went on to speculate on the reason. “They think they have it all. They are under-resources and stretched and tend to take the manufacturers word for it. The madness of the situation is that we are getting a very partial, incomplete and misleading picture of the effectiveness of many drugs.”
She described how NICE, the body that should have been the most concerned at how little information it appeared to be getting on which to make cost-effective decisions about the UK’s 13 billion pound drug bill, appeared even more complacent.
Four out of 123 ain’t bad
When she contacted NICE to ask them to withdraw approval of Tamiflu until they had seen all the data, she said, the body of academic experts who reviewed the data for NICE replied that they were “convinced they had seen all they needed to see” and described the NICE review as “adequate”. Remarkable optimism when you’ve seen four out of 123.
It’s a system that is clearly dysfunctional, isn’t in patients’ interest and cries out for reform. Last week I was optimistic that there would have to be some significant changes. This week I’m not so sure following a brief article in the BMJ by Peter Doshi, the Cochrane Collaboration researcher who triggered the missing Tamiflu data investigation.
Concerned that reforms that allowed drug companies to set their own conditions for making data available, Doshi warns the result could be a “maze” that would actually frustrate efforts at greater transparency. The only solution, he wrote, is to put the watchdogs, specifically the EMA which hold “vast swathes of data”, in charge of creating a far more open regime.
He can’t have heard Dr Godlee’s evidence.