Ben Goldacre, Saturday 21 November 2009, The Guardian
Once your medicines regulator decides it should change the side effects warnings on the patient information of a drug taken by millions of people, how long do you think it would take for that change to be implemented?
In February 2008 the Medicines and Healthcare products Regulatory Agency published Drug Safety Update, Volume 1, Issue 7. This is a boring government document which you have not read. After a review of clinical trial data, spontaneous reports of suspected adverse drug reactions, and published literature, they concluded: “product information for statins is being updated to reflect a number of different side-effects as class effects of all statins.”
Everyone likes to be informed, and many people make an informed decision to stop taking statins, because of well-documented side effects such as muscle problems. What were the MHRA going to put on the new labels? “Patients should be made aware that treatment with any statin may sometimes be associated with depression, sleep disturbances, memory loss, and sexual dysfunction.” They also planned a new warning to explain that – very rarely – statin therapy might be associated with interstitial lung disease.
Now before we go any further, we should be clear on one thing. There are lots of people out there who want to tell you that statins do more harm than good, and many of these people have vitamin pills and magic diet books to sell. Back in the real world, the evidence shows that statins are effective: they reduce your risk of having a heart attack, and your risk of death over a given time period, but they reduce these risks as a proportion of your pre-existing risk, so if you are at high risk of having a heart attack to start with, a statin is more worthwhile than if you’re only moderate risk. Although of course you still have to decide if you’re the kind of person who feels enthusiastic about taking a preventive drug every day for years on end.
And we should also remember that some of these new side effects, like many of the zillions of side effects listed on patient leaflets – often in an unhelpful and unranked barrage of information – are only weakly associated with the drug. These are warning notices, and some of them are based on circumstantial evidence, speculation, and preliminary data.
But this side effects information is made available for all drugs, because it’s strong enough to be worth sharing, because it might be useful to somebody somewhere, because it might make doctors more inclined to take a specific side effect more seriously from patients, because they might act as a focus for more detailed quantitative work, and so on.
This is not the new thalidomide, and it is not a story about how statins are a hidden killer: this is, rather, a story about how risk information is disseminated to patients and doctors, and how it can be disappeared.
Because the decision to add these new side effects to the label was made in February 2008, and they still haven’t appeared. When will they make it onto the label? Soon. Hopefully. It has taken until November 2009, and the implementation has just been announced, a full 21 months later.
Why did it take so long? The mighty Drugs and Therapeutics Bulletin was sent free to all doctors in the UK until a few years ago, when the government decided to cancel a collective subscription that kept everyone up to date. DTB have discovered, from the MHRA – the regulator of the pharmaceutical industry, which is funded by the pharmaceutical industry – that implementing these changes in the statins’ drug leaflets was delayed for one reason: “one of the innovator MA [marketing authorisation] Holders was not in agreement with this wording.”
So a drug company has been able to delay the inclusion of safety warnings on a drug prescribed to 4 million people, for 21 months, because they didn’t agree with the wording. There is no conceivable world in which this is a good thing.