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|03-25-2006, 01:34 PM||#1|
Drug industry (mal)practices....?
The clinical trial of a new drug that resulted in serious adverse reactions, putting six young men into intensive care at London's Northwick Park hospital, has provoked widespread criticism of the pharmaceutical industry. Though the seriousness of these reactions - two patients remain in a critical condition - merits a thorough investigation, at least this episode reveals a drug company attempting to develop useful new drugs. Unfortunately, this is more than can be said for the activities of others in the pharmaceutical industry.
The type of drug under investigation in the Northwick Park trial - developed from monoclonal antibodies - appears to be a significant innovation. This technology has already yielded important new drugs for use in conditions such as cancer and rheumatoid arthritis and there are promising signs that the potential of these drugs can be exploited in other areas. This is significant because, as the pharmaceutical industry has emerged over the past two decades as one of the largest volume and most profitable spheres of capitalist enterprise, the pace of innovation appears to have slowed. Commercial success has been based on a handful of 'blockbuster' drugs - notably antidepressants (so-called SSRIs like Prozac) and cholesterol-lowering drugs (statins), which are increasingly marketed, with dubious therapeutic benefit, to the 'worried well'.
Instead of pursuing the arduous quest for new drugs, some drug companies seem to be spending much of their time trying to maximise the yield on existing medications. Strategies for achieving this have included the production by different companies of 'me-too' imitations of successful drugs (drugs sufficiently different to allow a distinct brand, but conferring no benefits in terms of efficacy or safety); extending the patents on existing brands by a range of tactics (including litigation); and cultivation of close relations with regulatory bodies and government and professional agencies concerned with promoting treatment guidelines.
Today, it sometimes appears as if the most important sphere of pharmaceutical investment is not in research and development, but in marketing. One critic of the industry has argued that much of its investment in R& can be shown to be devoted to marketing (1). Enormous resources are expended in promoting pharmaceutical products to health professionals and, increasingly, to the public - through direct advertising in the USA, and through stealth in the UK, where some drug companies promote conditions, such as 'erectile dysfunction' or even fungal nail infections, rather than drugs. Here, we find a fascinating contrast between the media response to the Northwick Park trial and the lack of publicity received by the report last month that one of Britain's leading pharmaceutical firms - Abbott Laboratories - had been suspended from the Association of the British Pharmaceutical Industry (2).
The Abbott suspension was the result of a number of breaches of the industry's code of practice concerning hospitality offered to the medical profession in the course of promoting company products. The company was found guilty of the following offences:
On two occasions, company reps had taken a total of more than 60 hospital doctors to meetings at a greyhound racing stadium in Manchester, while racing was in progress. Though the company could produce no records of what medical topics were covered at these meetings, the authorities concluded that it was 'highly likely' that the meetings were of 'mainly a social or sporting nature'.
After a hard day's work at a promotional workshop, a senior manager borrowed £1,000 from a local rep to cover the cost of taking a health professional to a lap-dancing club, an event at which 'high standards had not been maintained'. The rep never got his money back and both left the firm.
A senior manager took senior hospital consultants to Wimbledon, providing 'centre court tickets and full hospitality'. The authorities found that there was no educational or scientific input at this event.
An evening meeting for 15 people at Christmas, found to have no educational content, resulted in a restaurant bill of £800.
The company admitted, rather awkwardly, that 'a narrow silo in the organisation had exposed themselves and Abbott to an environment and circumstances that failed to uphold the standards of the company or the industry'. Yet the industry's trade organisation refused to accept Abbott's pleas that this behaviour was exceptional and it was suspended from the ABPI for six months. All staff involved have either left or been sacked and this episode has resulted in a wave of austerity sweeping through relations between the industry and the medical profession.
Given what might be described as a mutually corrupting relationship that prevails between drug companies and doctors, it seems unlikely that the Abbott suspension will have any lasting effect. Though Abbott's promotional activities might have been more colourful than the familiar round of lunches and dinners and golf weekends, subsidised conferences and journals (featuring ghost-written articles, selectively published results and cultivated 'opinion leaders'), all these are likely to continue, providing dubious educational value but excellent marketing opportunities. It is unfortunate that the glare of publicity is now focused on the most creative aspect of the pharmaceutical industry, while its other side remains in the shade.
Dr Michael Fitzpatrick is author of The Tyranny of Health: Doctors and the Regulation of Lifestyle, Routledge, 2000 (buy this book from Amazon UK or Amazon USA), and MMR and Autism: What Parents Need to Know (buy this book from Amazon (UK) or Amazon (USA)).
(1) Marcia Angell, 'The Truth About the Drug Companies', Random House 2004
(2) Company suspended from ABPI membership over breaches of code, ABPI, 10 February 2006; see Code of Practice Review, February 2006