The British Medical Journal (BMJ) published a poll in late-October 2012 asking, “Who is mainly at fault for denying access to negative clinical trial results?” Respondents were able to choose from a list of potential culprits – legislators, universities, ethics committees, the pharmaceutical companies and regulators.
There was only one reason why this poll was being run: the recent publication of Ben Goldacre’s Bad Pharma: How Drug Companies Mislead Doctors, a door-stopping 450-page assault on the misconduct of the pharmaceutical industry.
Goldacre is best known as the author of Bad Science, which started as a column in the UK’s Guardian newspaper. There, he used his epidemiological training to reveal all manner of quackery with a rare ability to explain complicated ideas to non-experts.
In Bad Pharma he repeats this trick, but the headline news is infinitely more disturbing: contemporary medicine is acutely sick and in desperate need of therapy. Usually, it’s naturopaths who run this argument, portraying what they see as contemporary medicine’s de-humanising reductionism.
Goldacre’s perspective is very different: medicine’s evidence base has been undermined by an unscrupulous alliance of the pharmaceutical industry and regulators, which leads to the routine suppression of negative studies revealing many drugs to be either ineffective or less effective than those they seek to replace.
This suppression has been wilful and many academics (the industry’s “key opinion leaders”) have acted as willing partners in the enterprise, putting their names to ghostwritten articles reporting positive trials, while failing to publish negative trials.
Since there’s so much missing data, we can’t really say whether the therapies we use work or not. Thus, according to Goldacre, medicine’s evidence base is irredeemably corrupted and needs reconstruction. Reform, he believes, must be root-and-branch, with pressure exerted by doctors and patients.
Any argument is only as good as the evidence that supports it. And in Bad Pharma, there’s an almost overwhelming amount of convincing evidence. But we would be wrong to think of Goldacre as a lone voice. We’ve been here before. In only January this year, a BMJ editorial described missing trial data as a “threat to the integrity of evidence based medicine”.
In 2009, Irving Kirsch published The Emperor’s New Drugs: Exploding the Antidepressant Myth. Kirsch demonstrated that in trials, SSRIs (a common class of antidepressants known as selective serotonin re-uptake inhibitors) performed no better than placebos, a fact that would have been known had some clinical trial data not been suppressed by pharmaceutical companies. Regulators happily licensed these new drugs in full possession of this knowledge.
Goldacre’s work, then, is a lightning conductor for much that has come before. But more than that, Big Pharma is a campaigning work, designed to catalyse a movement and leverage access to the corridors of power. Goldacre has also taken to social media to reinforce the message of his book, keeping the momentum building.
So far this strategy has worked spectacularly well. The Emperor’s New Drugs was every bit as damning as Big Pharma, but it might as well have been published in Antarctica to an audience of penguins for the impact it had on the general public. Big Pharma, on the other hand, has been unanimously endorsed and promoted by the British broadsheet newspapers.
And Goldacre’s Twitter feed has been running hot. In two tweets on 23 October, he referred to the woeful inadequacy of the European Medicines Agency (the EU drugs regulator) and its desultory attempts to create an adequate and functional trials register. This prompted member of parliament and doctor Sarah Wollaston to ask questions about missing and suppressed data in the British House of Commons. And the UK Health Minister Norman Lamb has agreed to meet academics to discuss this “really important” issue.
It’s clear that Goldacre cares about medicine, patients and science. If he is able to maintain the rage, his efforts might help usher in a new era of truly evidenced-based biomedicine. But there’s also cause for scepticism.
Goldacre himself looks to stronger regulation and legislation to fix the problem. Others are not so sanguine. Veteran economist Harry Shutt emailed Goldacre, saying:
this profit-maximising industry is totally unsuited to being run on profit-maximising lines by conventional shareholders.
Shutt suggests public ownership of pharmaceutical companies may be the solution. While Goldacre maintains that he doesn’t want “a central-command state economy”, this may be the only way to contain greed and corruption within the pharmaceutical industry.
Tim Scanlon
Debunker
I'm quite a fan of Ben Goldacre's work. Whether he is tackling pseudo-science or bad science, he is all about science in medicine. I find it disturbing that not-medicine usurps his work to support their rubbish, because he is just as critical of not-medicine as he is of big pharma.
I highly recommend people watch his TED talks http://www.ted.com/speakers/ben_goldacre.html
jerry sprom
logged in via email @gmail.com
Tim,
CAM is clearly not without fault. There are plenty within the skeptic movement to remind the community of that (including Ben Goldacre). But the fact is, as Ben points out in his book, you would save more lives, prevent more suffering and save much more public and private money by encouraging medicine and the industries that support it to clean up its own backyard. IMO Ben makes a mockery of these skeptic associations, including the likes of Friends of Science in Medicine, who consistently criticise CAM and remain silent on matters of medicine.
Tim Scanlon
Debunker
Jerry, I think you will find that Ben is a member of the skeptic movement. He is a regular contributor to their projects and information campaigns. I think you will also find that skeptics are just as critical of big pharma, you just hear less about it due to the court actions.
Tim Scanlon
Debunker
Sorry, I've just seen Ben's comments on skepticism, he doesn't self identify as a skeptic. It mainly seems to be because he doesn't care about other charlatans, just the medical ones. He does still involve himself with their work though.
jerry sprom
logged in via email @gmail.com
Tim
I just noticed that the Australian skeptics are holding their national convention shortly. They have a panel discussing An Evidence-Based approach to medical treatment. I wonder how much time they will spend discussing Ben's book and getting stuck into Big Pharma.
Sue Ieraci
Public hospital clinician
A reply to jerry sprom's question about sceptics and pharmaceutical companies:
Australian Skeptics has a chapter called Science-Based pharmacy, which is very much about keeping the manufacturers honest.
You can read some of it here:
http://sciencebasedpharmacy.wordpress.com/
jerry sprom
logged in via email @gmail.com
Sue,
I am not sure a link to a blog from a Canadian Pharmacist constitutes a 'chapter' of the Australian Skeptics. Regardless, I think the amount of comments/debate on this topic and the conspicuous absence of the regulars who are quick to jump on the CAM threads, speaks volumes.
Ken Harvey
Adjunct Associate Professor of Public Health at La Trobe University
Jerry, many of us are equally critical of Big Pharma and are working to improve it. You might like to look at:
http://www.gopetition.com/petitions/petition-to-accc-on-medicines-australia-code-authorisat.html
For an update, see http://www.medreach.com.au/?p=591
Sue Ieraci
Public hospital clinician
To jerry sprom, who says "the conspicuous absence of the regulars who are quick to jump on the CAM threads..." I count at least three here, out of only a small number of comments.
"Conspicuous absence"?
I think you might find, if you really talked to people who value science-based medicine, that they would not be automatic fans of multinational corporations.
jerry sprom
logged in via email @gmail.com
Thanks for the link Ken.
Felix MacNeill
Environmental Manager
I think the final bit about the problems of a profit-maximising industry running things is the essence. Ever since the 1980s we've been under the hypnotic influence of the cult of neo-liberalism. Just because the private sector and the market place can do SOME things better than government or not-for-profit got inflated into the idea that the should be left to do everything without any 'dead hands'. You'd have thought the GFC would have woken us up but the trouble is that we've all become just a tad addicted to the products of unconstrained consumerism and it's a rare addict who will sack his dealer.
It's also based on the comically fantastic concept of a free market. Free beer is considerably more plausible.
George Michaelson
Person
The IPR drug companies hold should be conditional on the methods they used to secure the rights. If they surpress information materially useful to public health, then their rights should be constrained.
Sean Lamb
Science Denier
I have suggested before that a statutory split between drug development, manufacturing and marketing on one hand and safety and clinical trials on the other might go a long way to solving problems. In other words a company could either do drug development or do clinical trials, but could not do both.
After all, we split the energy market into generation and retail.
Sue Ieraci
Public hospital clinician
Sean Lamb - how would one go about doing drug development without doing clinical trials?
Sean Lamb
Science Denier
The normal way, Dr Ieraci,
Find a target, use a combination of rational design and/or high through-put screening of a library to find possible compounds for that target, investigate interactions in a cell culture model, then move into an animal model. Once they feel they have a promising candidate, they put it out to tender to the clinical trial companies, who work with the regulators to design appropriate clinical trials.
The clinical trial company hand the complete data to the regulators to determine approval and to the drug development company who can decide if they want to go ahead with production.
Brett Montgomery
General Practitioner
The idea of a "split" reminds me of the reform agenda (bit.ly/Wnr4Vc) suggested by Healthy Skepticism (a fine organisation). The agenda is detailed but I will quote the section on splitting the functions of the pharmaceutical industry:
"Pharmaceutical companies currently have four main functions: manufacturing, research, promotion, and education. Performance of those functions is currently distorted by incentive systems that reward only activities that increase sales of more expensive drugs regardless…
Read moreSue Ieraci
Public hospital clinician
Replying to Mr Lamb's "the normal way"below:
That "normal way"would only operate for entirely new compounds, which are occurring in diminishing numbers these days. The majority of new pharmaceuticals entering the market are refinements of previous compounds, whose advantages are generally seen in incremental improvements in outcome and/or decreases in complications - not the sort of stuff that can be tested in the lab.
I am no fan of multinational companies - whether they be mining companies…
Read moreStephen Pritchard
Researcher, cognitive science
Thanks for the article. Its something I need to know more about, but haven't done the research at this stage.
Just on the general idea that public ownership is the obvious solution, here are some rejoinders that spring to mind:
1. A drug company is going to be working hard to develop cures that work, because a functional cure will offer the easiest and least complex way to make a profit. Cures that don't work are harder to profit from, I would think. Profit motive doesn't just drive unscrupulous behaviour, it can obviously drive good things too.
2. Publicly run institutions have their own motives, which wouldn't necessarily lead to good drugs any quicker than the private sector. Governments wanting to look good? Is that any less of a motive to spruik favourable data and hide unfavourable data than the profit motive? Have govts never exaggerated the positive impact of a govt program to improve their reputation, while downplaying or hiding the negatives?
Duncan Kemp
Manager / Engineer
Stephen, I think that you have that the wrong way around.
The pharmaceutical companies have a tremendous profit motive for fixing the symptom, but not curing the disease. It is much better for them for someone to have to buy a drug every week, rather than take one expensive drug and be cured for life. (for example, diabetes)
Whereas the public service, with its conservative decision making, will probably not be encouraged to release a drug which has harmful side effects on people. The other point to remember is that the public service is subject to Freedom of Information laws, and reporting to parliament.
There needs to be a middle way where companies are encouraged to release drugs to fix the system and also to find cures for the diseases. We have a sort of system for that now.
john mills
john mills is a Friend of The Conversation.
artist
You guys are the best, mainstream media are so corrupt and wont even talk big pharma, let alone expose them, thanks so much for being there, and honest, The fact is that (big pharma) can test a poison on you that adversely effects you and a hundred others, but, if they get "one good result" out of 100 bad results, they can throw the 99 bad results out, and get a pass on that "one good result", and do!!, they then hand that "bad medicine" onto "their mates", the psyches!!, to poison you and me with…
Read moreJohn Wright
Director
Whilst in the UK recently (where Ben Goldacre's book is quite rightly receiving much attention) I listened to my good friend and cholesterol skeptic Malcolm Kendrick open a 2 day nutrition and metabolism research meeting on broadly the same subject, i.e. the 'flexible' nature of what constitutes evidence in evidence based science.
Two points struck me during the presentation, the first a slide looking at the financial relationships between the Key Opinion Formers on The National Cholesterol Education…
Read moreSue Ieraci
Public hospital clinician
John Wright I agree with the need for healthy scepticism, but, if one rejects the opinion of experts, should the opinion of the inexpert be preferred?
I can't follow the logic of rejecting the opinion of people who are educated and experienced in a particular profession. IF they have to make decisions with that knowledge and experience, and be held accountable for them, then their understanding of both the evidence and the practice are highly likely to be more valid than the opinions of the untrained and inexperienced. Don't you agree?
John Wright
Director
Sue, opinion whether from the experienced or the naive, is simply that, opinion. It is not a replacement for evidence. The problem with medicine in particular is that opinion drives the selection criteria for what constitutes evidence, despite claims of systematic reviews!
Read moreOne of the amusing eye opening revelations from Taubes Good Calories-Bad Calories, was the number of references in 2editions of Joslins Endocrinology from German and Austrian sources immediately before and after the second world…
Sue Ieraci
Public hospital clinician
"You will I am sure have been around long enough to remember the consultant whom if you challenged would inevitably mean a poor reference."
John, I may have been around long enough, but that has not been my experience. In particular, as a consultant and teacher myself, I have always found that being challenged by trainees keeps me on my toes. I don't know about your friend, but my training was far from military and I have no inclination to enter the military. Could it be the company you keep…
Read moreMatt Moore
Thinger
There is currently zero appetite to nationalize another industry in the US and the UK so advocating such a course of action isn't going to get much traction.
It should be noted that national govts already have a lot of power over pharma companies - as both regulators and buyers (directly or indirectly) of medicines. This power is not wielded as effectively as it could be. I would like to see govts use their existing powers effectively. If the system remains broken then a more dramatic approach may be required.
"Nationalize pharma" does not seem like a politically feasible opening gambit.
Elizabeth Hart
Independent Vaccine Investigator
So, Saint Ben Goldacre gives us “a door-stopping 450-page assault on the misconduct of the pharmaceutical industry”...
Read moreYet Goldacre’s own ‘Bad Science’ forum remains an effective gatekeeper for the vaccine industry.
I have tried to raise serious discussion on his ‘Bad Science’ forum about individual vaccines, e.g. questionable universal HPV vaccination; the second arbitrary dose of the live MMR ‘booster’; problems with the effectiveness of the whooping cough vaccine; and concerns about ‘lethal…