viernes, 12 de octubre de 2012

Rationality's Rottweiler sinks his teeth in big pharma

ORIGINAL: New Scientist
12 October 2012

"I think this is a cause for national scandal" (Image: Kris Krüg)
The scourge of bad science is at it again. This time Ben Goldacre has got the powerful pharmaceutical industry in his sights. And he's very angry

Of all the "bad science" topics you could have chosen, why decide to target the pharma industry in your new book, Bad Pharma?
I've been talking about bad behaviour by drug companies for many years now. The full story of how medical practice is distorted hasn't been told clearly enough. It's a huge interlocking ecosystem of failures that all work together to create a very dangerous system, and I think when the public learn about what's being done, they'll be angry.

What exactly is the problem?
Drugs are tested in poorly designed studies, which are then selectively reported, with unflattering data hidden. This biased evidence is then communicated to doctors in a chaotic and distorted system by marketing departments and Chinese whispers. I have an almost grudging respect for the clever ways in which data can be distorted, but as a result of this distortion patients suffer and die unnecessarily.

It's worth being clear that those in the industry aren't the only people at fault. Many senior academics, doctors, regulators and patients' associations have failed to protect patients' interests. I think this could be like the scandals of the expense claims of British members of parliament, or phone-hacking by journalists: things that feel normal within these communities may suddenly land some people in jail.

You call the situation a "murderous disaster". Isn't that a bit melodramatic?
Not at all. In medicine, evidence isn't an abstract academic thing, it's used to make real decisions. People die unnecessarily because of distortions in the evidence base. That's a disaster, that's murderous, and I can't think of any other way to express it.

If you've not read the book, you might think I'm some deranged conspiracy theorist... but if anyone's not going to be a deranged conspiracy theorist, it's probably me.

Are you hoping that the book will get people up in arms about this issue?
I think this is a cause for national scandal, but it's a sophisticated national scandal. It's not "oh my god, these people are deliberately killing babies". I don't imagine that any one of the people I describe in the book - who have made decisions that resulted in avoidable suffering or death - could willingly drown a kitten or suffocate an old lady. But when doctors give a treatment that they have been misled into believing is the most effective, they are inflicting avoidable suffering and harm on their patients.

But the pharma industry has produced many effective medicines, so it cannot be all bad, can it?
There is no medicine without medicines, and drugs companies have produced huge numbers of fantastic treatments. I'm totally fine that we have drugs companies innovating new products.

The problem is, if they are allowed to distort the evidence on how good a drug is, then they distort clinical decision-making in a way that harms people. These are systemic problems, affecting all of medicine.

What's the worst aspect of bad practice?
By far the most important issue is missing data. We know that about half of all trials that are conducted in medicine never get published, and that trials with positive results are about twice as likely to be published as trials with negative results. That's one of the reasons why, overall, industry-sponsored trials are about four times as likely to give a positive result, compared with independently funded trials. This results in a distorted picture. If a drug company can conduct many trials, but only publish the ones with positive results, then doctors are plainly misled about the benefits of that treatment.

What can be done to fix this problem?
We need clear regulations, muscularly enforced. Firstly, we need to make sure that every clinical trial has its results published within a year. Secondly, we need all the clinical trial results from past decades, which we now know are still being withheld, on drugs that are currently in use.

Are you hopeful that this will happen?
Every single intervention that people claim has fixed the problem of missing clinical trial data has, in reality, failed. Every single one. My hope for this book is that it will make it impossible for people to pretend that we have fixed this.

The pharma industry still claims, today, that it publishes all the evidence for all trials on all drugs, when the evidence shows that this is simply untrue. I would invite them to sign up to one simple commitment: "If we are ever found to be withholding any trial results on any drug, then we will pay back every penny we ever took from selling it." If they are so sure they publish everything, they should be happy to sign such a pledge.

How do you think Bad Pharma will be received?
I'm really interested to see how this book lands. It addresses some huge problems, a vast web of failures that all play off each other. If enough people learn about this stuff, that helps to move things on almost in itself. I'm sure it will be rubbished to high heaven and that there'll be elaborate smear campaigns to follow, but then I've had elaborate smear campaigns before from many industries and all kinds of disgruntled people. It goes with the territory.

Do you get hate mail?
I'm an investigative journalist. I've been on the receiving end of libel actions, crude attempts at blackmail, threats, and bizarre smears from journalists, quacks, anti-vaccination conspiracy theorists and major companies. Smears usually reflect pretty badly on the people making them - I'm never impressed when I see it done to other writers.

Did you ever imagine that a love of data and statistics would lead to you having such a high public profile?
I'm not famous, but I do recommend my own level of highly contextual microfame. Standing with the comedian Dara Ó Briain on London's Charing Cross Road at midnight would put you off proper fame for life. But anyone who recognises me in the street and says hello usually shares my interests, and has something interesting to share. It's pretty much ideal.

What's next for you?
There's lots of interesting stuff going on around evidence-based social policy, and I recently co-authored a UK Cabinet Office paper on randomised trials in government, with some very smart civil servants. It's a fascinating battle. For example, everybody thinks evidence-based medicine is a force of nature, but even 30 years ago many senior doctors regarded it as bizarre. "I'm the world expert, how dare you question me, I know what works from personal clinical experience." You see a lot of the same behaviour and beliefs in government and business, but that could change.

Then again, maybe after writing about the $600-billion drugs industry I'll be framed for some lurid and improbable crime, in which case: new horizons.

Profile

Ben Goldacre is a psychiatrist and epidemiologist specialising in "unpicking dodgy scientific claims". He wrote The Guardian newspaper's Bad Science column and a bestseller of the same name. His new book is Bad Pharma: How drug companies mislead doctors and harm patients (Fourth Estate)

From issue 2885 of New Scientist magazine, page 28-29.
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