Nov 22 2012
Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry
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27 Responses to “Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry”
I have read the book. It is horrifying. A major part of what is described about the practice of RCTs (setting them up, writing down the results, publishing) is a description of what I would call simply fraud (to be sure, fraud that is probably going on in a much more intense way in SCAM*).
The only plea that can be used is that in science one is ‘exploring’ and that trying to find out what is going on (what does the drug actually do, for which patients does it work best?) is something entirely different providing a formal proof of effectivity. But this exploring leads to very many dead ends. This is well known in the pharmaceutical industry. I forgot the figures but for every 1000 compounds tried out, only one will be somewhat promising. I think this is basically what Ioannidis has observed: if you do exploration in a field where there thounds or even much more possibilities, then you’ll end up with very many duds.
In physics people are more careful. In particle physics and astronmy, where enormous amounts of data are handled, p=0.000001 is the norm in exploratory research.
However, when one presents a proof of effectivity to a regulatory body, then all this exploratory behavior is taboo.
I guess that the scientists who run experiments for pharmaceutical companies know very well what is proper and what not. But when the company spends twice as much a PR as on research, one can imagine what the scientists will do when the PR department tells them what to do to prevent $100,000,000 or a multiple to be written off ‘because after all the new drug isn’t really that good’. When the sales and PR departments are the actual bosses, you can expect that science takes a back seat.
* In SCAM one doesn’t have to leave’s one chair to see how the proponents lie and cheat at every turn. If one just reads carefully what the SACMmers write in their own defense one can see the lies and obfuscations. Just a week ago I was confronted with such a blatant lie: the Belgian homeopaths want to be ‘recognized’. They prepared a report to the government, in which they stated that this recognition was already the case in the Netherlands. Actually they more or less copied the membership requirements of homeopathic associations (such as ‘must have 3 years of medical training’) and implied these were government requirements. Then universities get only a few days to comment on this, and if they don’t, it becomes part of an ‘official government report’. A similar farce has been performed in Switzerland.
Thanks for promoting this sadly important book. Without a doubt the best read of 2012.
I keep repeating this in sceptical circles, and will do so again; this is a topic many sceptics and quackwatchers really need to read up on. Sure, each case is a hell of a lot more work than SCAMs, but the damage it does is proportional to said work.
In the EBM/EBP-community this is nothing new, but even for people who are reasonably well informed on the topic, Bad Pharma has been an eye-opener of sorts. Just to use myself as an example: sure, I´d read most of the papers Goldacre cites, and have heard my share of anecdotes from friends and acquaintances who have been bullied out of research, prescribed crap drugs or withheld data, but it never really added up until I read Bad Pharma. I blame it on my own lazyness (and the fact that researching research fraud and misconduct in “real” medicine is a lot more time consuming than with SCAMs. To me it is, anyway, though this might be because of the many great resources online).
Again; thanks for bringing up Bad Pharma, and for the service you keep providing with your posts.
http://www.guardian.co.uk/science/audio/2012/oct/22/science-weekly-podcast-ben-goldacre-bad-pharma
This is a podcast I subscribe to from The Guardian. It’s an extended interview with Dr Goldacre on Bad Pharma.
I agree with the others. This is a terrifying, flabbergasting book. My reading of it was punctuated with so many gasps and muttered profanities that my partner is now reading it out of sheer curiosity!
Congratulations to Ben Goldacre on striking gold yet again. A truly talented man.
The very first time I heard of SBM was on “Bad Science book” that I bought when I was on Scotland. That inspired me to study about clinical trials, basic science and philosophy. Most of people don’t realize how they are fooled every day because of their lack of this kind of knowledge…
I don’t really understand why the book is available on Uk but not in USA. That don’t make any sense, since both use english and kindle format.
It will be published in the US in January 2013 by Faber and Faber.
Being a cancer patient, I dread the publication of this book. I so wish these ideas could be discussed other than through the popular press–since that same press has failed totally in presenting the science and the need for urgent action on climate change. That press has failed to give us accurate financial information, accurate political information, accurate military information . . .and so on.
The number of patients in my local support group who are using herbs and vitamins and crushed-up-whatevers has tripled. New, for profit hospitals charge MEDICAID patients $3 co-pays for chemotherapy, but they build acupuncture rooms, give away ginger candies and hire art therapists in the cancer clinic.
However useful it will be as a critique, the sCAM believers will use this book as a pitchfork of fear to drive throngs of ill-informed consumers to their quasi-relgious belief system and away from real medicine–some of which has saved many lives and improved the quality of life for millions.
I managed to get advanced copy of this book on Amazon via an Irish bookstore. It’s fantastic, and if anything, Ben Goldacre pulls his punches when exposing how Pharma hides data and manipulates perception of the efficacy and safety of drugs.,
Case in point: early in the book Goldacre describes how Pharmacia/Upjohn successfully marketed reboxetine has safe and effective, when it had suppressed data that showed there was neither. This much of the story Goldacre got right. However, what he doesn’t say is that this drug company enlisted gadfly psychiatrist David Healy to promote reboxetine as safer and more effective than SSRIs. Healy conducted the dubious Normal Volunteers study with a handful of his his clinic staff serving as research participants. He claimed that a number of them became suicidal when switch from reboxetine to an SSRI. The article was published without any conflict of interest disclosure. The odds ratio for the link between SSRIs in suicidality in this study is absurdly high.
http://davidhealy.org/wp-content/uploads/2012/05/2000-Healy-Healthy-Volunteer-Suicide.pdf
Goldacre is far too cozy with uncritical of David Healy and got defensive when I posted on Twitter my account of David Healy and reboxetine. You can read it here.
https://dl.dropbox.com/u/23608059/martyrdom%20of%20healy.pdf
Although not perfect, Bad Pharma is still a damn good book.
Even when a trial’s protocols are published in advance, researchers can still choose to abandon the outcome measures which they had laid out there, and come up with more flattering alternatives. In the UK a group of researchers are fighting against Freedom of Information requests for the outcomes of a trial of behavioural interventions which was funded by public money: http://www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po
It seems to me that many of Goldacre’s concerns are even more problematic for psychosocial interventions where things like blinding and the accurate measuring of meaningful outcomes are often much more difficult, even for researchers unaffected by any bias or self-interest.
mho,
“However useful it will be as a critique, the sCAM believers will use this book as a pitchfork of fear to drive throngs of ill-informed consumers to their quasi-relgious belief system and away from real medicine–some of which has saved many lives and improved the quality of life for millions.”
I do hope you are not suggesting that the truth be suppressed because if its supposed adverse consequences.
Besides, it’s unknown what the consequences might be. It might actually result in a complete revamp of the pharmaceutical industry’s marketing arm. And a more ethical pharmaceutical inductry could result in a further marginalising of sCAM.
It is hardly ever bad move to tell the truth.
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mho, BillyJoe:
I really can´t see supressing information as being the right way forward here. Mainly because the entire SCAM/Conventional-thing is a useless division (well, not in law). What we need to know is what works, and shoddy trials and literature should be exposed and picked to pieces no matter where it might come from.
As to the effects on the SCAM-community, I very much doubt anything will change most of their minds. THey´re already throwing around their conspiranoia, and all information like this does is show that the EBM and sceptic communities actually take fraud in the medical industry seriously. In addition it can be a handy way of introducing critical thinking to true believers.
I had a fellow student who was an acupuncturer and aromatherapist, and who “hated” big pharma and homeopathy (why on earth she chose our profession I´ll never know). I avoided the acupuncture for some time, feeding her with non-conspiranoia criticism of the pharmaceutical industry and gave her information on trials of homeopathy. It only took a term before she was coming to me asking why on earth I hadn´t shown her that acupuncture was bunk, and that her attacks on BP had been misguided. But of course, she was one of very few exceptions in my experience.
I’m glad to see that SBM isn’t ONLY bashing alternative medicine.
My bottom-line approach is, it’s the substance that matters, and if it’s not something that is meant to be in our bodies without harm, then, it matters little what clinical trials say, which is what pharmas have gotten more and more away from. It’s “the dose of the poison” was said long before modern meds ventured into all kinds of foreign unnatural substances that were never meant for human consumption. This was said recently on another site…Carletta Casey (Atlantic, Iowa) says:
October 13, 2012 at 11:12 am
This is totally unacceptable. I have worked in the health care field for over
50 years, and back in the 1950′s a drug was tested for 15+ years before put on the market. As years passed the years shortened and now it is out of the
factory today and tomorrow people are the “testors” not rats or guinea pigs.
This is ludicrous and must stop. We need to make a statement to congress, who
by the way get paid to “look the other way”!!!!
Sorry, to be redundant, but, I just wanted to say also, it’s nice to see SBM actually bringing this out in topic! I wasn’t coming back for a while to give you all and myself a rest
but, just thought I’d mention this here 
@jmcohen87,
“I’m glad to see that SBM isn’t ONLY bashing alternative medicine.”
You could have seen that a long time ago. In fact, my post from 3 days ago doesn’t mention anything about alternative medicine, and there are many, many other examples. We “bash” anything that is not good science, wherever we find it. It’s just that we find so much more of it in CAM!
Another point: there is less need to criticize mainstream medicine because it is already self-critical: the studies I cited in my article were all from mainstream medical journals. There is more of a need for criticism of CAM because it doesn’t criticize itself.
This book is about valid criticisms of big pharma. Addressing these will improve medical care.
“now it is out of the factory today and tomorrow people are the “testors” not rats or guinea pigs.” etc. illustrates ignorant criticism.
How is that ‘ignorant criticism’ weing? Just going by the results of meds put out.. the bad effects, lawsuits, deaths, along with other side effects… the short time they’re created, packaged and sold on to the public without effective testing, how is that not valad criticism? Sorry, didn’t want to get into this
so if I don’t respond, please don’t think I’m ignoring..see you all hopefully another time 
…and, of course, we should pay very close attention to what Carlette Casey says because, you know, it’s anecdotal personal experience and that’s the most reliable evidence ever don’t you know.
“if it’s not something that is meant to be in our bodies without harm, then, it matters little what clinical trials say”
Question: are antibiotics meant to be in our bodies without harm? If Rusty’s child were dying of bacterial pneumonia, would she reject antibiotics? If she accepted them, would it matter which one had been shown superior by clinical trials?
I’ve had more than one person lately justify to me the use of acupuncture or CAM generally by pointing to Goldacre’s book. It’s been very helpful to turn around and show that this blog is supportive of criticizing bad science whether in the CAM world or in medical research. It always takes the other person by surprise.
As has been pointed out, it is simply false to say that CAM works, because these problems exist in the pharmaceutical industry. Or vice-versa. One does not imply the other, even though otherwise very intelligent people that are dedicated to science and truth will seemingly make that leap with very little consideration as to what they are claiming.
I think it is incredibly important not to compromise ourselves by ever insinuating for a moment that the practice of medical research and the ways of the pharmaceutical industry are without fault. If we do, we commit a similar error to the one I described above, i.e. because CAM is quackery, then medical science is always a clear, unbiased and effective system for the treatment of patients. There are gaps in our knowledge not just because we haven’t made certain scientific discoveries yet. They exist, because of the less than ideal cultural and economic settings in which real practical medical science takes place.
That doesn’t mean that we give up on science-based medicine any more than it means that we turn to CAM for “cures” when medical science offers none. But I think people like to fit everything within a nice, neat narrative of “how the world works” when the world is simply messy and sometimes there are no good answers, at least not in the present moment.
I’m not weing, but the assertion that “back in the 1950′s a drug was tested for 15+ years before put on the market” is nonsensical. The polio vaccine took about three years from initial testing to rollout. Mycostatin, about four years from isolation to production.
Sorry, Narad, Carlette Casey said it is true on that cute little blog RH referenced, so that’s the end of the matter. You just haven’t got into the headspace of the congenial CAM consumer yet.
I bet you don’t even know what a rose smells like.
I assure you that I’ve used too much rose in a sherbet in just the past couple of months.
Oh, and Enovid looks to have taken about two and a half years.
agreed–truth should not be supressed.
Though it might not seem relevant, I’ve recently read this lecture by Admiral Gehman at the US Naval Academy and been seeing applications all over the place. Read it. You will not regret it. His central thesis is that organizations may perceive threats, and then people will (not always consciously) act to mitigate those threats, and a wise person understands this and tries to avoid pushing organizations into doing that. He’s specifically talking about how organizational problems can lead to tragedies (specifically, the USS Cole bombing and the loss of the Space Shuttle Columbia), but the lesson has much broader application, I think.
http://www.usna.edu/ethics/publications/documents/GehmanPg1-28_Final.pdf
Think of it this way. If you are working for a pharmaceutical corporation, and you know there is this big effort to make this amazing, blockbuster drug, and your data is suggesting that maybe it’s not all it’s cracked up to be, what will you do? Your data may represent a threat to your department. Will you do what, years later, will seem to be the right thing, and tell people? Or do you do what might seem like the right thing now, and keep digging until the data stops looking like a problem? That’s more or less what he describes NASA doing with the information that foam shedding had very nearly destroyed Atlantis on ascent, two flights before Columbia’s final flight, when it missed a critical electronics box on an SRB by just a foot. That should’ve been a “ground the fleet” finding, but somehow good engineers who consider the astronauts family gradually massaged it until it became an acceptable anomaly rather than the very narrow escape from disaster that it actually was. If it happened there, it can happen in any organization. Normalizing anomalies so they go away and stop being a threat to your organization. I’m sure it happens in clinical trials too.
[...] Excellent review of Goldacre’s Bad Pharma, and much Ben Goldacre in the MR comments section here, and many excellent points raised by others [...]
[...] few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are [...]