Posted by: Ele Quigan | December 30, 2012

Bad Pharma – Ben Goldacre

Ben Goldacre Bad Pharma

Another holiday another book to read, again non-fiction. Why? I think I’ve realised much like short stories, I’m finding proper fiction – particularly shortlisted fiction is pretty damn depressing. I think that’s what’s put me off reading this Christmas, and why I’m really struggling to pick something up again. It’s grey and miserable again (London I love you but JEEEZZZ some sunshine wouldn’t go astray) and again I’m looking at amazon going what’s next…

but I digress, back to the holiday.

Thailand, wonderful, sunny, beaches, relaxation – What a perfect time to read about the horrendous state of the Pharmaceutical industry.

(P.s good friend who used to work in the industry who may be reading this, this is not an attack, but on reading the facts presented – it made me incredibly sad. I absolutely believe that they have their place, and deserve to make a profit, crikey where would our pensions be if not for the pharmaceutical industry… But please understand that data selection, finishing trials early, misrepresenting trial information, and marketing tactics as the book describes – I’m concerned about taking things at face value and I think it’s worth further review and definitely more regulation)

Anti-depressants. The most saddening chapter in the whole book. From anti-depressants being subscribed to children off label, to how their positive affects have been grossly mis-represented – how the hell are these as successful as they are today. ‘Chemical imbalance’? read up and weep. Seriously this section upset me so much – friends and family and friends of friends have been on these drugs for years. Does it really do anything? I was both gobsmacked and speechless and surprised these things are still on the market.
If you’re on them and they work – I’m not judging you – I’m concerned about the testing methodology and the results presented for Paroxetine. Disclaimer – I’ve prescribed it myself years and years ago – and hated it. While that obviously makes me somewhat biased, I’d recommend doing some research on any drug you’re on and seeing how it was shown to doctors as an effective drug.

Outsourcing. Remember the drug trial that went horrendously wrong? This one – this is not the main reason that drug trials are outsourced (that’s cost) but I still remember this vividly. It stayed in the back of my mind through the book, and kept popping back into my head as to why we don’t see trials gone wrong in the media (a good thing, more positive trials means more drugs to help right?). To quote one of he articles (sorry for the daily mail link, the one on the observer was much shorter) “Why was Nino still injected as the fourth in line when other men were already in convulsions, gripped by agonising head pains?” – This trial went incredibly wrong. I understand that trials need to happen, absolutely! It’s important – however so I don’t inadvertently mis-quote – here’s the piece from Wikipedia that summarises the content of the book better than I could:

The shift to outsourcing raises issues about data integrity, regulatory oversight, language difficulties, the meaning of informed consent among a much poorer population, the standards of clinical care, the extent to which corruption may be regarded as routine in certain countries, and the ethical problem of raising a population’s expectations for drugs that most of that population cannot afford. It also raises the interesting question of whether the results of clinical trials using one population can invariably be applied elsewhere. There are both social and physical differences: Goldacre asks whether patients diagnosed with depression in China are really the same as patients diagnosed with depression in California, and notes that Oriental people metabolize drugs differently from Westerners.
There have also been cases of available treatment being withheld during clinical trials. In 1996 in Kano, Nigeria, the drug company Pfizer compared a new antibiotic during a meningitis outbreak to a competing antibiotic that was known to be effective at a higher dose than that used during the trial. Goldacre writes that 11 children died, divided almost equally between the two groups. He also writes that the participants were not told that the competing antibiotic at the effective dose was available in the next-door building from Médecins Sans Frontières.

There’s so much more to the book that I could list – but these two elements hit home the most. Do read it for yourself, make your own opinions.

Oh actually there’s another interesting part to the book that has stayed with me, and it concerns a drug that in NZ there was quite the kerfuffle over – Herceptin. From a very quick google, here are some articles about it.

‘If I lived in NZ I’d be dead’ http://www.theatlantic.com/magazine/archive/2009/03/my-drug-problem/307279/
‘Hope and dispair in the funding of Herceptin’ http://www.nathaniel.org.nz/component/content/article/15-bioethical-issues/bioethics-and-health-care/173-hope-and-despair-the-funding-of-herceptin
‘Study says Herceptin best over 12 months’ http://www.stuff.co.nz/national/health/7759780/Study-says-Herceptin-is-best-over-12-months
‘Herceptin, at what price a womans life?’ http://media.uow.edu.au/opinions/UOW025806.html

Herceptin struck me as interesting even following it from when it was first introduced, as it absolutely dealt with live/death – and the extension of life. But what value do we put on that? It got me thinking about how drugs are selected even then – cost to life value. How do they do it? these people who choose what drugs are selected? I’m sure it must be just maths, cost to lives saved, but how do they step away from the numbers each day looking at changing a drugs status and seeing those numbers as lives saved or lost? “One death is a tragedy; a million is a statistic” – Joseph Stalin, is what comes to mind when I think of the drug selection process.

So what’s interesting about Herceptin in the sense of this? (pages 252 – 256 of the book, do read it) here’s a link to the research that backs up what is discussed in the book – it makes for sad reading. The entire promotion and media coverage of the drug was primarily a Roche-backed PR orchestration of cherry-picked patients, incorrectly reported side-effects and incorrectly referenced information about cheaper generics disseminated – so what of the actual drug results? “Herceptin doesn’t work at all in 80% of patients and gives you at best a few extra months of life in advanced cases.” more details here
I’m trying to find a better link for that 80% stat as in my opinion it’s something that needs further research and review. From the book (page 253)

“‘More careful analysis of the “50 percent benefit” which had been widely quoted in the medical and non-medical press, and fixed in my mind, actually translated into a 4-5 percent benefit to me, which equally balanced the cardiac risk… This story illustrates how even a medically trained and usually rational woman becomes vulnerable when diagnosed with a potentially life threatening illness”

So what to make of all of this? I hope I don’t get sick, and if I do? I’m going to research the hell out of anything I’m prescribed to make sure I understand the ins and outs of what I’m taking.

Mr Ben Goldacre, as I’m about to tweet you with a link to this review and my overall thoughts, I have a couple of questions that I’d love you to answer if you have any time?

– How has the pharmaceutical community responded to your book? Have they acknowledged any of the changes that you’ve recommended and are any companies looking to implement these as a new approach?

– Shared data was one of the more interesting suggestions in the book (i.e. GP’s collecting data at source from the patients) has there been any movement on this?

– As a general comment it’s incredibly difficult to read how influential some information is (from bad data, to doctors who are paid to influence others about certain drugs). How does this differ in the UK with ‘socialised healthcare’ in comparison to the US where healthcare is a completely different business?

– One of the biggest barriers in my opinion about the dissemination about medical information is the way it is written/presented (i.e. in difficult to understand language). I personally think it’s common across the sciences, and is why a lot of us get information (e.g. the Herceptin example) from the media. Even doing my own research for this post I’m feeling befuddled by confusing language that’s obviously pretty unnatural for me in my day to day life! How do you think the medical/pharmaceutical community should approach this?

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Responses

  1. As an addendum – this was just published in the NYTimes about an Orphan drug – going from $1,650 to over $23,000, and is suggesting it is prescribed for several other conditions. http://www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html?pagewanted=1&_r=0

  2. I think we spoke about this when we picnicked together recently, but thought I’d leave a note anyway. Ben Goldacre’s done a couple of great TED talks videos you might enjoy. The one that relates to Bad Pharma can be found here: http://www.youtube.com/watch?v=RKmxL8VYy0M

    Also, if you get a chance, I think you’d be intrested in his other book, Bad Science. He covers a great point that’s never sat well with me: Journalists who are trained in journalism, being touted as scientific experts. It was something that disturbed me at Uni (I did communications with a couple of journalism papers) and now annoys me more than is totally necessary. I trully believe that journalists should have to properly reference the actual studies they’re talking about – not that I am foolish enough to think that everyone would follow up, but I live in hope that a few people would be interested in further detail.

    He covers some super interesting topics and has some brilliant ideas – was stoked to read your review of Big Pharma, will definitely be adding it to my “need to read” list.

  3. […] incredibly closely aligned to the pharmaceutical industry, which of course if you’ve read Bad Pharma is enough to terrify you. Well terrify is the wrong word, I just feel that we are becoming an […]


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