‘Bad pharma’, by Ben Goldacre
With a subtitle that says ‘How drug companies mislead doctors and harm patients’ you’re hardly expecting a comedy. Shockingly: on page 5 Ben Goldacre already dissolves all hopes that it might not be as bad as the title suggests, by saying: ‘… it is so deep-rooted that even if we fixed it today – right now, for good, forever, without any flaws or loopholes in our legislations – that still wouldn’t help, because we would still be practising medicine, cheerfully making decisions about which treatment is best, on the basis of decades of medical evidence which is – as you’ve now seen – fundamentally distorted.’
The first 100 pages focus on missing data; the first chapter highlights many different ways in which data that should reach the (professional) public does not reach the (professional) public.
Goldacre elaborates on the fact that industry-sponsored studies are more likely to produce results that flatter the sponsor’s drug, than studies that are not financed by the industry. Although each drug trial should be registered and subsequently be published, the latter step is often omitted (a whole chapter is dedicated to problems arising from ‘Bad regulators’). Guess when this happens most often.
This is not only due to evil intentions, also subconscious publication bias is probably part of the problem, just because of choice of priorities, and the fact/perception that some journals are only interested in positive outcomes.
Whether purposeful or not, publication bias is a big problem, because it means that doctors who want to prescribe the best drug for their patients’ needs, cannot do this because they do not have access to all necessary information. And, what’s more, they wouldn’t be able to find it even if they knew that they are missing information.
Unfortunately, we can’t be all satisfied about the clinical data that does get published. Due to the commercialisation of clinical trials, more and more rather useless information is published. People participating in a drug trial are supposed to reflect a population that can be expected to benefit from the drug. Instead, clinical trials are nowadays often outsourced to poor (read: cheap) countries, where regulations may be less strict. Individuals who participate in trials (for instance because it will get them free medical check-ups), might not at all be in a similar health condition as the people for whom the drugs are ultimately intended. So, the conclusions of these trials might not be so valuable. (I’m ignoring the ethical aspects of this type of outsourcing here…).
The same is true when new drugs are tested against a placebo, rather than against the current best option. The outcome of the latter comparison is what matters to patients, while proving just that it is ‘better than nothing’ is what matters to the pharmaceutical company’s financial department.
Many more ways in which trials can be designed badly are discussed (so the book serves as a refresher’s course on methodology if you like).
The one on marketing is also an interesting chapter. Not surprisingly, advertising expenses are not linearly correlated to a drug’s effectiveness. Impressive budgets are dedicated to further dissemination of a carefully designed message, to manipulate perception of a certain drug and to direct prescription behaviour. Doctors might not acknowledge it, but since much relevant information is lacking, prescription behaviour is not as rational as it may feel to them. But marketing tricks go beyond convincing doctors that your drug is much better than its cheaper copy. It also involves convincing people that they are patients, so that they will go and ask their doctors for a given drug.
Ben Goldacre not only points at those to blame, he also describes how the situation could be improved. As mentioned above, it’s not going to be all well overnight. However there is clearly no other choice, so he tries to push every discipline involved towards action by giving practical suggestions on how to change the current situation.
Although probably quite impressive already, I’ve given you a far-from-complete glimpse of the topics discussed in Bad Pharma. Ben Goldacre gets repetitive at times when he gets highly passionate about the stuff he wants us to know, but I’m inclined to forgive him. It’s been a very interesting read. I didn’t consider myself naïve about drug companies: I knew they were no charities. But I clearly hadn’t thought about all ways things go wrong. It’s incredible how the wish to earn more money can overrule all other objectives, for instance, patient’s benefits…
I can’t help but think that some selection bias was involved during the writing of this book. Not a whole lot of positive examples are discussed. But, having said that, that doesn’t make the message any less alarming; all negative cases are explained and referenced in detail, so I am convinced they are true. However many positive situations can’t compensate what’s wrong in the system.
This is a very comprehensive and important read for anyone prescribing drugs, anyone taking drugs or anyone otherwise involved in the health care system. Ì have never worked in clinical science, but I have learnt a lot and feel that this is important stuff to be aware of. Bad Pharma is thought provoking, even depressing, but word needs to get out for change to happen.
This article was written for BitesizeBio.com, an online magazine for cell and molecular biologists.