medicine and the pharmaceutical industry

1
Developmental Medicine & Child Neurology 2006, 48: 627–627 627 Medicine and the pharmaceutical industry One privilege of working in the health service today is the enormous range of effective therapies available to us. Adv- ances in surgical techniques, tools, and materials have been more than matched by the vast number of pharmaceutical products addressing an ever wider range of conditions. Even for conditions where treatments have been available for many years, newer agents may be more potent, have less adverse or unwanted effects, and be easier to take than their predecessors. This is a huge contribution by the pharmaceutical industry. The other side of the coin, and of course there always is one, is the concern, voiced by several commentators, that the prior- ities of drug companies may not coincide with the health needs of the population. 1,2 Despite ever-increasing resources, the number of innovative products introduced each year is falling. 1 Equally importantly, most of the money spent annually on medical research is devoted to the eventual development of new pharmaceutical products or testing the effects of those currently the subject of sales drives. All other forms of research, including studies using drugs no longer under patent, risk being starved of funds, not to mention top calibre researchers. In the field of disability we are well aware of ‘Cinderella’ specialities that are under-researched because there is no easily available funding. The other major concern is the marketing process. We understand that to bring a drug successfully to market costs many millions of dollars, partly due to the regulatory hurdles set up to protect patients. This expenditure needs to be recouped, which means that the resulting products have to be sold. Apparently, the expenditure on marketing may be about twice that spent on research and development. 1 As most drugs have to be prescribed, doctors are an important focus of this huge budget. Lurid stories appear regularly in the lay press about generous hospitality offered to doctors by pharmaceut- ical companies on dubious grounds. At first it all seems a little over-hyped, as most of us consider ourselves fairly indepen- dent minded, reasonably incorruptible, and would not partici- pate in such events – would we? However, there are more subtle ways of potential com- promise. In the UK, I attend clinical and educational meetings which only occur through industry support. This year the reg- ulations governing this form of sponsorship have been tight- ened. 3 Last year I accepted an invitation from a distinguished colleague to lecture on how to tailor treatment to the patient at a sponsored academic meeting outside the UK. The next series of contacts was from a separate company who started to dis- cuss organizational details, but later tried to arrange a meeting with a representative of the sponsoring company to discuss the event, and then offered slides to help with the lecture. By this stage the lecture had been restricted to the adverse effects of drug therapy. Interestingly, the slides highlighted unwanted effects of rival products but did not mention any adverse effects from the drug made by the sponsoring company. Finally, a contract arrived which specified that all material provided for the meeting was confidential, became the prop- erty of the sponsoring company, and could be adapted and promulgated as they wished. It also specified ‘working with the company or its representatives providing input on the devel- opment and preparation of meeting materials’. After I expl- ained that it was unusual to sign a contract to lecture at an academic meeting, this was omitted. The meeting was in a plush hotel and the delegates were an invited audience. The rest of the faculty were highly respected colleagues, well known in the field. The generous honorarium has made my university research fund much healthier. But was it an academic meeting or a promotional event? Two years ago the National Institute of Clinical Excellence in the UK drew up guidelines for epilepsy management. During this process it asked for the names of experts who could advise it and who were independent of the pharmaceutical industry. It was surprising how many of those considered had some sort of link with one or more companies, for example, by membership of an advisory panel. And, if attendance at subsidized confere- nces and meetings was included no one was completely indep- endent. The data on which these guidelines are based is also variable. There is concern that some trials demonstrating effi- cacy may be massaged by selective publishing or by statistical manipulation. 2,4,5 Consensus papers have been offered to us on the use of a particular therapy that arise from a meeting of distinguished colleagues sponsored by one of the companies concerned. In a recent case we found that those attending the meeting had received a generous honorarium which had not been declared, despite the major conflict of interest. Journal editors can also be influenced through pressure on advertising budgets. In that respect DMCN’s independence is a strength. Most companies and doctors act honourably. However, it is worrying that respected members of the medical profession, including ‘opinion formers’, can appear to be endorsing a product and receiving payment to do so. Pharmaceutical com- panies have their job to do and we have ours, but it is in both our interests that when supping together, each party uses a suitably long spoon. Peter Baxter DOI: 10.1017/S0012162206001320 References 1. Law J. (2006) Big Pharma: How the World’s Biggest Drug Companies Control Illness. London: Constable. 2. Delaney B. (2006) Is society losing control of the medical research agenda? BMJ 332: 1063–1064. 3. http//www.abpi.org.uk/links/assoc/PMCPA/code06use.pdf 4. Ridker PM, Torres J. (2006) Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000–2005. JAMA 295: 2270–2274. 5. Hampton T. (2005) Biomedical journals probe peer review. JAMA 294: 2287–2288. Editorial

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Page 1: Medicine and the pharmaceutical industry

Developmental Medicine & Child Neurology 2006, 48: 627–627 627

Medicine and thepharmaceuticalindustry

One privilege of working in the health service today is theenormous range of effective therapies available to us. Adv-ances in surgical techniques, tools, and materials have beenmore than matched by the vast number of pharmaceuticalproducts addressing an ever wider range of conditions. Evenfor conditions where treatments have been available for manyyears, newer agents may be more potent, have less adverse orunwanted effects, and be easier to take than their predecessors.This is a huge contribution by the pharmaceutical industry.

The other side of the coin, and of course there always is one,is the concern, voiced by several commentators, that the prior-ities of drug companies may not coincide with the health needsof the population.1,2 Despite ever-increasing resources, thenumber of innovative products introduced each year is falling.1

Equally importantly, most of the money spent annually onmedical research is devoted to the eventual development ofnew pharmaceutical products or testing the effects of thosecurrently the subject of sales drives. All other forms of research,including studies using drugs no longer under patent, riskbeing starved of funds, not to mention top calibre researchers.In the field of disability we are well aware of ‘Cinderella’specialities that are under-researched because there is no easilyavailable funding.

The other major concern is the marketing process. Weunderstand that to bring a drug successfully to market costsmany millions of dollars, partly due to the regulatory hurdlesset up to protect patients. This expenditure needs to berecouped, which means that the resulting products have to besold. Apparently, the expenditure on marketing may be abouttwice that spent on research and development.1 As most drugshave to be prescribed, doctors are an important focus of thishuge budget. Lurid stories appear regularly in the lay pressabout generous hospitality offered to doctors by pharmaceut-ical companies on dubious grounds. At first it all seems a littleover-hyped, as most of us consider ourselves fairly indepen-dent minded, reasonably incorruptible, and would not partici-pate in such events – would we?

However, there are more subtle ways of potential com-promise. In the UK, I attend clinical and educational meetingswhich only occur through industry support. This year the reg-ulations governing this form of sponsorship have been tight-ened.3 Last year I accepted an invitation from a distinguishedcolleague to lecture on how to tailor treatment to the patient ata sponsored academic meeting outside the UK. The next seriesof contacts was from a separate company who started to dis-cuss organizational details, but later tried to arrange a meetingwith a representative of the sponsoring company to discussthe event, and then offered slides to help with the lecture. Bythis stage the lecture had been restricted to the adverse effectsof drug therapy. Interestingly, the slides highlighted unwantedeffects of rival products but did not mention any adverseeffects from the drug made by the sponsoring company.

Finally, a contract arrived which specified that all materialprovided for the meeting was confidential, became the prop-erty of the sponsoring company, and could be adapted andpromulgated as they wished. It also specified ‘working with thecompany or its representatives providing input on the devel-opment and preparation of meeting materials’. After I expl-ained that it was unusual to sign a contract to lecture at anacademic meeting, this was omitted. The meeting was in aplush hotel and the delegates were an invited audience. Therest of the faculty were highly respected colleagues, well knownin the field. The generous honorarium has made my universityresearch fund much healthier. But was it an academic meetingor a promotional event?

Two years ago the National Institute of Clinical Excellence inthe UK drew up guidelines for epilepsy management. Duringthis process it asked for the names of experts who could adviseit and who were independent of the pharmaceutical industry. Itwas surprising how many of those considered had some sort oflink with one or more companies, for example, by membershipof an advisory panel. And, if attendance at subsidized confere-nces and meetings was included no one was completely indep-endent. The data on which these guidelines are based is alsovariable. There is concern that some trials demonstrating effi-cacy may be massaged by selective publishing or by statisticalmanipulation.2,4,5 Consensus papers have been offered to us onthe use of a particular therapy that arise from a meeting ofdistinguished colleagues sponsored by one of the companiesconcerned. In a recent case we found that those attending themeeting had received a generous honorarium which had notbeen declared, despite the major conflict of interest. Journaleditors can also be influenced through pressure on advertisingbudgets. In that respect DMCN’s independence is a strength.

Most companies and doctors act honourably. However, it isworrying that respected members of the medical profession,including ‘opinion formers’, can appear to be endorsing aproduct and receiving payment to do so. Pharmaceutical com-panies have their job to do and we have ours, but it is in bothour interests that when supping together, each party uses asuitably long spoon.

Peter Baxter

DOI: 10.1017/S0012162206001320

References1. Law J. (2006) Big Pharma: How the World’s Biggest Drug

Companies Control Illness. London: Constable. 2. Delaney B. (2006) Is society losing control of the medical research

agenda? BMJ 332: 1063–1064.3. http//www.abpi.org.uk/links/assoc/PMCPA/code06use.pdf4. Ridker PM, Torres J. (2006) Reported outcomes in major

cardiovascular clinical trials funded by for-profit and not-for-profitorganizations: 2000–2005. JAMA 295: 2270–2274.

5. Hampton T. (2005) Biomedical journals probe peer review.JAMA 294: 2287–2288.

Editorial