Thursday, 3 July 2014

Deadly Medicines and Organised Crime

I have just finished reading Peter Gøtzsche's 2013 book of the same title. The book is a hard-hitting vituperative attack on pharmaceutical companies, the way they trial their drugs, the way they influence the medical profession and the way they market their products. As Gøtzsche says in the introduction he concentrates on what is wrong with the industry rather than what is right ("... in a study of muggers no-one expects a 'balanced' account mentioning that many muggers are good family men").

The charges levelled by Gøtzsche are so severe that the first thing a reader will want to know is whether they are true. In a short article like this I can't address every issue confronted by Gøtzsche: he makes hundreds of allegations of illegal or unethical behaviour that span every corner of the pharmaceutical industry. But I can tell you of one or two which I think are typical and can offer my opinion on how accurate his criticisms are. So at the outset let me declare that I think he is right - or right enough - that the drug companies are completely out of control, dominated by the profit motive to such an extent that they kill hundred of thousands of patients,  routinely pervert the regulatory process, and unduly influence the medical profession. I think this because the book is painstakingly referenced with sources that bear up the claims that are made.

I often declare that I am an atheist over all conspiracy theories and "The Evil of Big Pharma" has some of the hallmarks of a conspiracy theory. Internet declarations that Aunt Beatrice suffered a stroke after taking Drug X are anecdotes that one cannot check, reek of confirmation bias, and are often made by enthusiasts of Alternative and Complementary Medicine, a "discipline" that is entirely undisciplined and usually not evidence-based. So I approached the thesis of this book rather cautiously. However when I checked a good number of the sources in the book (more of this below) I came to believe that Gøtzsche has done a tremendous job of exposing the heinous practices of an industry that seems to have lost its moral compass.

But first, something about the author.  Peter Gøtzsche became a physician in 1974 and is now Professor of Clinical Research Design and Analysis at the University of Copenhagen. His most telling credential is that he was a cofounder of the Cochrane Collaboration and continues to be a senior member of the Nordik Cochrane Centre. The Cochrane Collaboration is an internationally respected organisation that specialises in meta-analyses of clinical trial data and is the first port of call if you want an honest assessment of what the benefits of a particular drug treatment are. In particular, Cochrane is independent of all industrial drug producers (one of Gøtzsche's criticisms of pharmaceutical companies is that their own testing is self-interested and unreliable - a theme rammed home by Ben Goldacre in Bad Pharma).

So the serious charges levelled by Deadly Medicines and Organised Crime come from a very heavy hitter. Although that in itself is not conclusive that what Gøtzsche says is true one has to wonder why, if he is making it up, he hasn't been sued for libel.

Now let's dip into the book for some examples of the accusations it makes. There are literally hundred of accusations to choose from (and, indeed, their very density makes the book somewhat of a gruelling read).

On 15 January 2009 the US Department of Justice released a statement with the heading "Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa". Briefly, the Eli Lilly company promoted its Zyprexa drug as an effective treatment for dementia (including Alzheimer's disease) flagrantly disregarding that no approval by the US Federal Drugs Agency had been given. According to the statement the company's marketing department "created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law and directed its sales personnel to promote Zyprexa for off-label uses". This appalling and cynical exploitation of a vulnerable sector of society is one of many such criminal behaviours by drug companies.

This example is very clear-cut since the company admitted its crime and paid a large fine (though still comparatively small in comparison to its profits). My second example has not as yet resulted in a prosecution: it is the marketing of the Tamiflu drug. Several countries stockpiled billions of dollars worth of Tamiflu in readiness for a flu epidemic and are now collectively realising they have wasted their money. The makers, the pharmaceutical company Roche, claimed that their trialling of the drug showed that it reduced hospital admissions by over 60%. Yet, despite a concerted campaign by the British Medical Journal and others, Roche would not release the raw data gathered in their trials. It is only now, after several years of stone-walling, that this data is becoming available and when independent experts analysed it a very different picture emerged - that Tamiflu has only marginal effects if any on flu victims. This is a complicated story and some of it is told here and here. Gøtzsche sums it up by calling it "perhaps the biggest fraud ever perpretated" and you can see why he is so blunt.  It is important to note also that Roche was not the only offender in this sorry story - regulators and drug agencies were also negligent in accepting the claims made by Roche without proper scrutiny.

As I just hinted drug companies are not the sole offenders in bringing suspect treatments to market. My last example is about how academics and the medical profession behave unethically (Gøtzsche is especially critical here, possibly feeling a betrayal of the academic standards that himself strongly promotes, and my last example is one of very many similar incidents). The New York Times reported in 2006 of a routine practice by Medtronic who make devices to help with back problem; this company makes cash payments to doctors in exchange for their recommending their devices; for example, one Wisconsin surgeon was paid $400,000 for a mere 8 days of work. While the company is obviously behaving unethically the recipients of these gifts are themselves badly tainted. And this is the tip of a large ice-berg: academic and medical professionals are allowing themselves to be advocates of drug companies for their own profit. It is easy to see how this can begin ("I already think the treatment is effective; how then can it be harmful for me to receive a consultancy fee?"); but it is also easy to see how this can easily lead to whole-sale corruption of an entire group of supposedly unbiased professionals.

To end I think it is worth reflecting on the relationship between academy and commercial interests more generally. It does seem clear that parts of medical academia have become badly corrupted. But Schools of Medicine are particularly at risk from financial manipulation because they interact with an industry which makes huge profits. My colleagues in philosophy or in Ancient Hebrew are probably not at risk. But my colleagues in, say, Computer Science or Food Science perhaps ought to be watchful. There are sensitive moral dilemmas to face here: for example, should a CS department seek or accept sponsorship from MicroSoft or Apple for running a conference? We do it routinely but the example of how drug companies buy endorsement from medical academia makes me think this has the potential to be rather dangerous.

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