The truth about drug companies (again)BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f632 (Published 30 January 2013) Cite this as: BMJ 2013;346:f632
- Carl Elliott, professor, Center for Bioethics, University of Minnesota
At this stage in the game, the crimes and sins of the pharmaceutical industry are not really in serious dispute any more. Thanks to the hard work of government prosecutors, muckraking reporters, and whistleblowing employees, we know that big pharma rigs clinical trials, hides unfavourable results, ghostwrites journal articles, manipulates professional bodies and regulators, bribes physicians, bullies its enemies, and engages in spectacularly inventive public relations schemes to increase sales of drugs that it knows to be dangerous or worthless. All of this harms patients, by crooking the regulatory process and distorting the medical literature so that doctors unwittingly end up making bad clinical decisions.
All this has been documented. You may disagree about how widespread the problem is. You may quibble over statistics. Or, like the pharmaceutical industry itself, you may say that the problems are all in the past and have now been corrected. But to deny the problems entirely would mean ignoring a large body of evidence, much of which has been collected and deployed to effect by Ben Goldacre in his new book, Bad Pharma. Goldacre’s rhetorical strategy in this 450 page broadside is comparable with the military doctrine of overwhelming force: to document as many varied examples of industry wrongdoing as possible to render futile any response other than surrender.
Academic physicians are not innocent of sin themselves, of course. Just why so many of them have been complicit in industry wrongdoing is not hard to figure. Physicians are no more immune to greed and vanity than anyone else, and many have the additional fear that their careers will founder if they don’t play the industry game. In the United States, many physicians are expected to generate revenue for the academic department that employs them, including some portion of their salaries. Industry sponsored research is a good way to do this. Whether such arrangements are anything more than a revenue generating scheme is a matter of debate. In the era of multisite corporate trials, managed by contract research organisations, many site investigators contribute practically no intellectual work to the project. The trials are designed, analysed, and written up by industry employees. But where there is money to be made, and publications to be generated, academics will be eager to collaborate.
Of the industry’s many and varied sins, the greatest—at least for Goldacre—is infidelity to the truth: hiding research data, manipulating results, and rigging studies. How this harms unwitting patients is well known, but less obvious is the way it betrays the research subjects who have taken part in medical research. Those participants take personal risks to their own health in the belief that the knowledge generated will be used to improve the health of others. And some of those participants will die. Yet there is a good chance that the results of a trial will be buried or spun, or that the trial was rigged for promotional purposes from the start. This unfortunate fact is never mentioned in the informed consent documents that must be provided to research subjects. In fact, consent forms often say just the opposite: that the research will be used to create knowledge and help others. Given how many studies routinely go unpublished, this is a blatant falsehood. “Despite all this regulatory theater, which hinders good research on routine practice,” Goldacre writes, “we allow these forms to tell outright lies about the control of data, and we fail to police one of the most important ethical problems in the whole of medicine.”
In the church of academic medicine, where every member must profess faith in the sanctity and holiness of medical research, this embarrassing secret was rarely spoken aloud until recently, even among the bioethicists who claim to advocate for patients. Why? Because, as Goldacre puts it, “If word gets out that trials are often more promotional than genuinely scientific, recruitment will become even more difficult.” And hindering trial recruitment would mean excommunication.
You might think that the research ethics committees charged with protecting human subjects would object to trials rigged for promotional purposes. Why should an ethics committee (or institutional review board) approve a trial designed to favour the sponsor’s drug? One likely answer is that most members do not have the training in biostatistics and study design to recognise rigged trials. Perhaps the most valuable chapter in Bad Pharma is one titled “Bad trials,” which explains the subtle and clever ways in which sponsors fix trials in order to get the results they want.
When it comes to hidden data, writes Goldacre, “The answer is not to hide this problem but to fix it.” On 18 January, a group of 53 former research participants under the auspices of the “All Trials Registered, All Trials Reported” public petition wrote a letter to the European Medicines Agency. Pointing out that about only half of clinical trials over the past 30 years have been published, the group demanded a public registry of all trials and the publication of their results.
Even if initiatives like this do not succeed, they ought to be applauded and encouraged. As impressive as Bad Pharma is, it is only the most recent of several books on industry wrongdoing, each of which has managed to outrage a certain constituency but none of which has led to major reform. This is where Goldacre may well be different. What sets this author apart from most other writers is his charisma, his energy, and his unfiltered comic bluntness. He seems capable not only of writing excellent books, but of leading a movement for change. This is a rarer and more valuable talent.
Cite this as: BMJ 2013;346:f632
US: Faber & Faber; 2013; 448 pages
UK: Fourth Estate; 2012; 448 pages
Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
Provenance and peer review: Commissioned; not externally peer reviewed.