Pharmaceutical companies bend or withhold scientific data and lie about their drugs, in ways which endanger, harm or kill sick people, to make a profit. That is the shocking reality laid bare in Ben Goldacre’s new book, ‘Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients’. This is a prime example of the way the profit motive rewarded by Capitalism stands in front of human progress.
The book’s indictment of the pharmaceutical industry stems from the fact that drugs are tested by companies which manufacture and sell them for profit. As a result, the scientific reality of the effectiveness of new drugs and the potential harm they may do is hidden by companies in the interests of making large sums of money (about $600 billion a year).
The aim of clinical drug trials should be to objectively ascertain the effectiveness and safety of new drugs. However, drug trial results which reflect badly on products which may be profitable to Big Pharma are routinely hidden. Drug companies as a matter of course only submit trial data for publication in the scientific literature which shows their products in a positive light.
As only data published in the scientific literature is accessible to Doctors, patients and those who run health services, negative information about new drugs is hidden from those who need it to inform their decisions about whether or not to use new drugs.
Goldacre describes this in a recent TED talk as “a cancer at the core of evidence based medicine”. It is known in the medical profession as publication bias and a 2011 systematic review of the phenomenon (a huge meta-analysis of all of the clinical trial literature) revealed that the results of half of all clinical trials that are carried out by drug companies are never reported and that positive findings about new drugs are twice as likely to be published than negative findings. Another damning piece of evidence which Goldacre cites in his book is a 2010 systematic study (Ann Intern Med. 2010 Aug 3;153(3):158-66.Outcome reporting among drug trials registered in ClinicalTrials.gov. Bourgeois FT, Murthy S, Mandl KD.) which found that 85% of pharmaceutical company funded trials showed their drugs had positive effects, compared to only 50% in government funded trials.
This says Goldacre ”is research fraud”; misrepresentation of the truth about a drug not by fabricating trial data but by selectively publishing that which shows it in a positive light. It is in the interests of drug companies to do this; if they didn’t their product might not sell, meaning they would lose an immense R&D investment (it often costs around $4 billion dollars to bring a drug to market) and they would not make money.
As a result the clinical trial data available to Doctors is often incomplete or misleading because the data is generated and controlled by drug companies who only publish favourable results. Consequently Doctors must decide which medicines to prescribe their patients based on potentially meaningless data; decisions which if made badly can mean severe side effects or even patient death.
As Goldacre puts it in the introduction to Bad Pharma “in medicine doctors and patients use abstract data to make decisions in the very real world of flesh and blood. If those decisions are misguided, they can result in death and suffering and pain”. Goldacre’s anger is evident here, arguably stemming from the fact that as a medical doctor he prescribed the antidepressant Reboxetine based on misleading and incomplete trial data he had read (because it was the only data published), which hid the fact that Reboxetine gave worse side effects than other antidepressants. Currently the practice of hiding undesirable data is perfectly legal and Reboxetine remains on the market, making money for its manufacturer despite being an inferior drug.
In the recent past pharmaceutical companies have hidden information about severe drug side effects from Doctors and patients; side effects in severity up to and including patient death. For example the diabetes drug Rosiglitazone made by Glaxosmithkline was found to increase the risk of heart attacks. Rosiglitazone came on the market in 1999, was found to increase heart problems in 2003 by the WHO, a result confirmed by GSK and the FDA in 2006 but not published by them until 2008. In 2007 a meta-analysis was published which showed that Rosiglitazone increases the risk of heart problems by 43%, meaning that for several years Doctors would have prescribed it without knowing the risks to which they were exposing their patients.
There have been many cases where trial data which indicates side effects has been hidden and patients have suffered; GSK tried to obscure the fact that the antidepressant Paroxetine increases the risk of suicide and the fact that the now banned painkiller Vioxx increased the risk of heart attacks was not initially widely advertised by its manufacturer whilst it was on the market and being prescribed to patients.
In 2009 Tamiflu was stockpiled in the UK and by governments around the world during the hysteria of the Swine Flu epidemic, at a cost of £500 million to the UK taxpayer. However, it is not clear that Tamiflu would have ever been effective against swine flu, had the epidemic spread to the UK because Roche who make Tamiflu have withheld clinical trial data about the drug. If Tamiflu was clearly effective why would they withhold the data proving it?
The likely reality is that Tamiflu is not always an effective treatment against influenza infection and that had swine flu become epidemic in Britain, the public would have suffered for the lack of an effective treatment. Even governments then, are at risk of being misled by the hiding of evidence by drug companies, at great cost to their people in taxes and potential suffering.
Drugs are not developed by pharmaceutical companies if they cannot generate profit. Therefore, as drug companies have monopolised the development, production and distribution of medicines, people around the world suffer unnecessarily. Research for treatments for diseases which affect those in the developing world, where consumers and governments are poorer, have not received the same research resources as first world diseases. Resources are more often poured into research into treatments for first world health problems like obesity and neurological disease to cater to the lucrative first world drug market.
Historically research into treatments for distinctly third world pestilences like African Sleeping Sickness and Malaria has not been as rigorously pursued because less profit is to be made from such drugs. We shouldn’t devalue research into treatment for diseases that people in the developed world suffer from but the scale of the potential benefit in terms of ending human suffering of finding treatments for diseases prevalent in the developing world, diseases often far more tractable than Western health threats like late-in-life Cancers and neurological disease, demands that research resources are more evenly distributed. Profit, rather than minimizing human suffering, is the principal motivation of those who direct the research and business strategies of drug companies and this results in unnecessary misery on a global scale.
In his book Goldacre adopts a reformist stance, writing that “The current regulations – for companies, doctors and researchers – create perverse incentives; and we’ll have better luck fixing those broken systems than we will ever have trying to rid the world of avarice”. Nevertheless, by allowing market forces to control how our medicines are discovered, tested and distributed we inevitably invite the desire for profit to block human progress. This book highlights once again the pernicious effects of Capitalism on humanity.
Capitalism rewards personal greed and the quest for profit. In the field of drug development the drive for profit by pharmaceutical company executives has corrupted what should be a selfless struggle to assuage human suffering; the discovery and design of medicines that make sick people well. Proper reform of drug trial regulations, forcing all data about new drugs to be freely available to everyone, even if it reflects badly on the products of drug companies is critical but though this might stop misleading data causing harm it would not rid us of the corrupting profit motive which drives drug development today and which limits its effectiveness in ending human misery.
The best solution to the corruption of the Pharmaceutical Industry is to end profit driven drug design and distribution. Given how important the development and production of medicines are to society, how beneficial they are and how damaging they can be if they go wrong, the only way to make the drug industry is truly serve humanity as a whole is to take it from the forces of Capital. We must nationalise the pharmaceutical industry. Take profit out of the equation and let society pay for the democratically controlled development, manufacture and distribution of drugs, in the interests of alleviating human suffering by curing disease. This is what medicine should be all about.