#ben-goldacre
For several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any research at all. #data
Companies are perfectly entitled to conduct seven studies, but only publish the two positive ones, and this behaviour is commonplace. What’s more, it happens in every field of science and medicine. #data #medicine
Pharmaceutical companies spend tens of billions of pounds every year trying to change the treatment decisions of doctors: in fact, they spend as much on marketing and advertising as they do on the research & development of new drugs. Since we all want doctors to prescribe medicine based on evidence, and evidence is universal, there is only one possible reason for such huge spends: to distort evidence-based practice. All of this money comes directly from patients and governments, so we ourselves are paying for this privilege. Doctors spend forty years practicing medicine, with very little formal education after their initial training. Medicine changes completely in four decades, and as they try to keep up, they are bombarded with information: from adverts that misrepresent the benefits and risks of new medicines; from sales reps who spy on patients’ confidential prescribing records; from colleagues who are quietly paid by drug companies; from ‘teaching’ that is sponsored by industry, from independent ‘academic’ articles that are quietly written by drug company employees; and worse. #drugs #marketing #education
While the deficit of a marketing drive can be ignored by an ethical doctor, the problems caused by distorted evidence affect everybody, without exception. The most expensive doctors in the world can only make decisions about your care on the basis of the evidence publicly available to them, and nobody has a special inside track. If this evidence is distorted, then we are all exposed to avoidable suffering, pain and death. #ethics #suffering #responsibility
Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine [...] this is a bizarre situation to arise in medicine, a discipline where everything is supposed to be based on evidence, and where medico-legal anxiety. In one of the most regulated corners of human conduct we’ve taken our eyes off the ball, and allowed the evidence driving practice to be polluted and distorted. It seems unimaginable.
This means changing the behaviour of academic journals, and here we are faced with a problem. Although they are usually academics themselves, journal editors have their own interests and agendas, and have more in common with everyday journalists and newspaper editors than some of them might wish to admit. [...] Whether journals like this are a sensible model for communicating research at all is a hotly debated subject in academia, but this is the current situation. Journals are the gatekeepers, they make decisions on what’s relevant and interesting for their audience, and they compete for readers. This can lead them to behave in ways that don’t reflect the best interests of science. #communication #science
It’s naive, perhaps, to expect consistency from a drug company, but [...] it’s clear that industry utterances are driven by the maximum they can get away with in each territory, rather than any consistent review of the evidence. #naivety #justice
[the] ethical question: trial participants are supposed to come from the population of people who could realistically benefit from the answers provided by that trial. If participants are the uninsured, and the drugs are only available to the insured, then that is clearly not the case. #ethics
One thing is clear from all the stories in this book: drug companies respond rationally to incentives, and when those incentives are unhelpful, so are drug companies. #incentives
In the UK, [...] our health care is provided by the state, not just free at point of access, but also through one single administrative entity, the NHS. As a result of this happy accident, we have large numbers of health care records that can be used to monitor the benefits and risks of treatments. #healthcare #NHS
When it comes to the secrecy of regulators, is it clear that there is an important cultural issue that needs to be resolved. #culture
A regulator and a doctor are trying to make two completely different decisions about a drug, even though they are using (or in doctors’ case would like to use) the same information. The regulator is deciding whether it’s in the best interests of society that a particular drug should ever be available for use in its country, even if only in some very obscure circumstance, such as when all other drugs have failed. Doctors, meanwhile, are making a decision about whether they should use this drug right now, for the patient in front of them. [...] This crucial distinction is not widely understood by patients, who often imagine that an approved drug is a safe and effective one. [...] But that’s not true: regulators frequently approve drugs that are only vaguely effective, with serious side effects, on the off-chance that they might be useful to someone, somewhere. They are used by doctors and patients as second-best options, but we need all the facts to make safe and informed decisions. #relativity #medicine #risk #decision-making
Too much information, communicated chaotically, is every bit as unhelpful as too little information. #communication #chaos
Drugs are approved on weak evidence, showing no benefit over existing treatments, and sometimes no benefit at all. This gives us a market flooded with drugs that aren’t very good. We then fail to collect better evidence on them when they’re available, even when we have legislative power to force companies to do better trials, and even when they’ve promised to do so.
People often talk about the difficulties in recruiting patients for research: but one study described how 186 patients with depression enquired about participating in two different trials of antidepressants, and more than seven out of every eight had to be turned away as they weren’t eligible. #research
[the problem of trial patients being unrepresentative] can make a trial completely irrelevant to real-world populations, yet it is absolutely routine in research, which is conducted on tight budgets, to tight schedules, for fast results, by people who don’t mind if their results are irrelevant to real-world clinical questions. This is a quiet, dismal scandal. There’s no dramatic newspaper headline, and no single killer drug: just a slow and unnecessary pollution of almost the entire evidence base in medicine.
It’s impossible to overstate how many gaps have been left in our clinical knowledge through unjustified, blind faith in surrogate outcomes. #pursuit-of-knowledge #knowledge
There are much more concrete concerns from [...] trials, because they can also produce poor-quality data, since the design is geared towards marketing, rather than answering a meaningful clinical question. #marketing #meaningfulness
I think we need a cultural shift in the way we all, as patients, view our reciprocal relationship with research in medicine. We only know what works because of trials, and we all profit from the participation of patients before us in these trials; but many of us seem to have forgotten this. By remembering, we could create a social contract whereby everyone expects their health service to be constantly conducting trials, simple A/B tests, comparing treatments against each other to see which is the best, or even the cheapest, if they’re both equally effective. #social-contract
In almost every developed country in the world, medicine is provided free at point of access, by the community, funded through taxation. From the perspective of the community, this whole process could be viewed as a simple bargain: we provide medicines free at point of access: in exchange, you need to let us know what works best for you and others. The NHS could be in a constant cycle of testing and learning, improving its performance, and improving outcomes for everyone in the country, and everyone in the world, by creating better knowledge on what works. #tax #growth #pursuit-of-knowledge
Trials should be embedded in all clinical practice, as the norm, as an everyday act.
The exciting future, for evidence-based medicine, is an information architecture that can get the right evidence to the right doctor at the right time. #information-architecture
The scale of [the pharma industry’s spend on marketing] is fascinating in itself, when you put it in the context of what we all expect from evidence-based medicine, which is that people will simply use the best treatment for the patient. Because when you pull away from the industry’s carefully fostered belief that this marketing activity is completely normal, and stop thinking of drugs as being a consumer product like clothes or cosmetics, you suddenly realise that medicines marketing only exists for one reason. In medicine, brand identities are irrelevant, and there’s a factual, objective answer to whether one drug is the most likely to improve a patient’s pain, suffering and longevity. Marketing, therefore, one might argue exists for no reason other than to pervert evidence-based decision-making in medicine. #objectivity
The head of NICE, Professor Sir Michael Rawlins, points out that the cost of manufacturing these drugs is often a tenth of the price for which they are sold, that we pay high prices in part for marketing (some of which goes directly to patient groups), and that when we spend money on one thing, we can’t spend it on something else. This last gritty reality, which would present itself in any medical system without infinite money, is often not welcomed by patients or the public. #money
Econometric models - as far as any mortal can follow them through - suggest that marketing has more influence on drug-usage patterns than the publication of new evidence. #marketing
Our systems for disseminating knowledge are ad hoc and antiquated, built on centuries-old platforms where science is presented in essay form, and printed on paper, with no clear mechanism for getting the right information to the right doctor at the right time. In a world where the information architecture of medicine is so massively flawed, simply getting under someone’s nose counts for a lot. #knowledge
The Department of Health spends a few million pounds a year providing independent medicines information to doctors. The industry spends tens of billions on providing biased information. This presents a bizarre situation: doctors’ continuing education is paid for, almost exclusively, by the industry whose products they buy with public money, and by the industry that has been shown to routinely mislead them. #deception
Pfizer’s [fine] in 2009 was the largest criminal fine ever imposed in the US, until it was beaten by GSK. But when you consider these figures alongside the revenue for the same companies, it becomes clear that they are nothing more than parking tickets.