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Both these authoritative books paint a similar picture of systemic corruption in the pharmaceutical industry, which has effectively bought out the health system. This means journals, medical education, doctors and psychiatrists, patient groups, governments and regulators.  This has happened gradually over the last hundred years and the whole system is now so integrated that it will require a revolution for real change to come about. Peter Gotzsche is co-founder of the Cochrane Collaboration, which sets the gold standard for systematic reviews of medical literature.  Ben Goldacre is a doctor and science journalist who specialises in identifying bad science, which in the present book he levels at pharmaceutical trials. Both books cover similar ground, but Goldacre’s contains more specific suggestions for what readers can actually do about the various issues raised.

Gotzsche’s  book  contains forewords by Richard Smith of the BMJ and Drummond Rennie from the JAMA and neither minces his words. The industry is worth some $700 billion a year; so enormous amounts of money are at stake and fundamentally influence the way in which the system operates. Enormous fines have been levied on industry leaders, the largest being $3 billion on GSK, but, compared with the revenues involved, these fines are likened by Goldacre to parking tickets, and normal service is resumed with bland assurances that industry practices have now changed for the better. Both books are strictly evidence-based and the Gotzsche study contains numerous references at the end of every chapter. In his introduction, he reminds readers that drugs are the third leading cause of death in the US and Europe after heart disease and cancer. He compares the tobacco and drug industries  (he could have added the food industry) in their “morally repugnant disregard for human lives”, much of which stems from the financial incentives in the system.

Gotzsche began his own career in the pharmaceutical industry, and so he knows it from the inside. He justifies his title involving organised crime, showing how companies repeatedly flout the law and pay the fines. Because patients trust their doctors, this trust is routinely extended to pharmaceutical companies who do not deserve it. A friend who used to work in the industry was told by a senior figure that they were not interested in cures but rather in drugs that are taken for the long term, which are much more profitable.

Many of the same issues are identified in both books: missing data, where negative studies are withheld, industry-favourable results from industry-sponsored research, poor trial design, corrupt regulation, doctors paid for seed trials and lectures, ghost written papers, journals paid vast sums for paper reprints, and governments worried to regulate the industry properly in case this damages exports -  the UK government is a case in point, overruling the findings of an authoritative House of Commons report. Regulators within the FDA who identify safety issues with drugs being tested can be removed from their positions as troublemakers (the FDA is largely funded by the industry).  In one example, an experienced FDA medical officer who had reviewed a drug that was subsequently removed was sacked at the request of the offending company. The pattern is one of the intimidation of scientists who warned about the drug and protection of the drug by senior people. Agencies are also notoriously unwilling to acknowledge the harms of drugs they have approved. Goldacre quotes an industry document with instructions to cultivate personal relationships with leading experts in each relevant field and hire them as consultants or advisers. Gotzsche provides a detailed and revealing analysis of the situation in Denmark.

Both books focus on marketing activities, which account for a quarter of industry expenditure and include penetration into every area of the medical system with the object of influencing doctors’ decisions in favour of their own product. Doctors themselves do not think they are subject to influence, although they feel their colleagues may well be.  They have also got used to industry-sponsored conferences, research grants and lecture fees. Some doctors regard themselves as impartial if they are paid by a number of separate companies, and Gotzsche gives an example of a paper where the conflicts of interest were so long for the three authors that they could not be fitted into the journal article and were listed on the website. John Bell, the Regius Professor of Medicine at Oxford received a staggering €322,450 in 2011 for his role on the Board of Directors at Roche. In 2012, the editor of the BMJ wrote reminding him that the company had not made their unpublished Tamiflu studies available to the Cochrane researchers, but Bell simply referred the letter back to the company.  The fact that four of the biggest hip and knee implant companies paid more than $800 million in 6,500 “consulting agreements” with doctors between 2002 and 2006 gives one an idea of the scale.

The situation in psychiatry is even worse with disease mongering on an industrial scale. Amazingly, psychiatrists still feel that psychiatric conditions are underdiagnosed when 25% of the US population in 2012 have a mental illness, double the figure is 20 years ago. DSM-V will contain a record number of syndromes, for instance by medicalising grief and defining bereavement as a depressive disorder if it has lasted more than two weeks. In DSM-III,  the period was one year and in DSM-IV two months.  As Gotzsche quips,  why not two days in DSM-VI?!  Moreover, 100% of DSM-IV panel members on  ‘mood disorders’ had financial ties to the industry. He conducted a little experiment using DSM-IV criteria tests on eight of his friends  for depression, ADHD and mania and not one survived all three tests -  two had depression and four had ADHD, while 7/8 qualified or mania. A leading psychiatry textbook was ghost-written by GSK. Academics who sign ghost-written articles add them to their publications list and are more likely to be promoted. Chemical imbalance is often cited as a reason for prescribing psychotropic drugs, but it turns out that these drugs actually cause chemical imbalance, which makes it very difficult to come off them. Many other spine-chilling examples are given.

Reform has to entail transparency and accountability.  Despite the enormous fines, no industry executive has been sent to prison even when tens of thousands of people have died as a result of industry behaviour. Some progress has been made recently with the new AllTrials initiative, but general system failure calls for a revolution across the board. After busting nine industry myths, Gotzsche proposes a raft of measures involving some radical proposals, including that for-profit is the wrong model “since control of medical practice by market economics does not serve the needs of the patient and is not compatible with an ethically based profession.” Drug regulatory agencies should be publicly funded and divisions within those agencies dealing with the harms of drugs should be separated from the divisions that approve them. Goldacre puts forward similar proposals and reports the reactions to his book on publication,  which included some doctors writing to him saying that the public should not be alarmed in this way. On the contrary, the public should be very alarmed, as you will be if you read either or both books on these matters of life and death.  It will take a well-organised public campaign for the requisite action to be catalysed, given the power of inertia and entrenched vested interests.

Acknowledgement

Reprinted from Network Review - Journal of the Scientific and Medical Network. Issue 114 pg 42. April 2014.

Further Information

Available from Amazon

www.amazon.co.uk/Deadly-Medicines-Organised-Crime-Healthcare/dp/1846198844

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www.amazon.co.uk/Bad-Pharma-How-Medicine-Broken/dp/000749808X

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