- Email: [email protected]
Good manners for the pharmaceutical industry
THE LANCET
THE LANCET Volume 349, Number 9066 EDITORIAL
Good manners for the pharmaceutical industry The hard-sell public-relations machine of the pharmaceutical industry seems to have become an inescapable feature of modern medicine. Allexpenses-paid trips to conferences, champagne receptions, and the like for doctors and journalists are common. This activity is expected of any global industry. Where the behaviour becomes less tolerable is when it seeks to interfere with the running of an ostensibly independent trial. A recent example of this type of activity is the pressure exerted by BristolMyers Squibb, on ethical grounds, to end an independent trial of one of its drugs. The trial in question is the third International Collaboration on Ovarian Neoplasm study, ICON3, in which patients with epithelial ovarian cancer are randomised to receive paclitaxel plus carboplatin or an appropriate platinum control. Accrual so far is 1254 patients, in all of whom resection had been attempted; most have stage III or IV disease. The trial is being coordinated mainly through Italy’s Mario Negri Institute and the UK Medical Research Council. Last week, the trial’s independent data monitoring committee reviewed the evidence, both the data from the ICON3 patients so far and the relevant external data. Although the committee has not made a formal announcement, its conclusions were presented at an open meeting in London, UK, on June 2. It decided that there was no need to close the trial on the basis of the outcomes and toxicity data. Moreover, having reviewed the external data, the committee concluded that there is major uncertainty over the use of paclitaxel as a first-line therapy in epithelial ovarian cancer. The concern about previous evidence was based on the relatively small size of these trials, and the risk of false positive and negative results. Indeed, the data-monitoring committee is convinced that the questions addressed in ICON3 have assumed even greater importance, owing to the clear need for reliable data in this area. Thus the independent monitoring committee strongly recommended that the trial should continue, aiming for an accrual of 2000 patients, and it is likely that the trial’s steering committee will endorse this view. Such an endorsement of a trial’s continuation is strikingly at odds with the company’s claims that evidence of efficacy is overwhelming, and with its Vol 349 • June 7, 1997
calls for a halt on ethical grounds. A Bristol-Myers Squibb representative argued that the Inter-Group study, the preliminary results of which were presented at the American Society of Clinical Oncology meeting last month, confirmed the benefits of paclitaxel-plus-cisplatin therapy for advanced disease, which were shown by the US Gynecologic Oncology Group last year (N Engl J Med 1996; 334: 1–6). And a statement from Tony Hooper, the company’s UK managing director, read “In our opinion the closing of ICON3 is necessary because, in this study, 2 out of 3 patients are denied the proven Taxol-based regimen . . . the first-line treatment with Taxol-based regimens should now be the standard of care for all advanced ovarian cancer patients”. Interpretation of data from clinical trials can be a difficult and contentious business. Where the expression of an opinion about trial data steps over the mark and is, to our minds, unethical, is when one considers the confusing message that is sent out to the patient, and the resultant pressure put on independent researchers. (The health page of one UK daily newspaper has already spread the “Taxol works” message.) Patient activists have assumed more and more power over the past few years, largely as a result of the efforts of the AIDS movement (see p 1705). The inclusion of the patient’s perspective has become an important asset to all aspects of drug development. But just as patients’ consent must be informed, so should their advocacy. Indirect drug-company influence on advocacy is widespread, notably in providing funds for groups and societies, a transaction in which the patient derives some benefit. However, drug companies must set aside the temptation, via the press, to hijack patients’ lobbying powers, for that way the patient can only lose. Perhaps some employees within the drug industry need a few lessons in etiquette. The first two rules of good manners should be that clinical researchers do not deserve to be harangued for practising good clinical research, and that patients have a right to unbiased, complete research findings.
The Lancet 1635
THE LANCET Volume 349, Number 9066 EDITORIAL
Good manners for the pharmaceutical industry The hard-sell public-relations machine of the pharmaceutical industry seems to have become an inescapable feature of modern medicine. Allexpenses-paid trips to conferences, champagne receptions, and the like for doctors and journalists are common. This activity is expected of any global industry. Where the behaviour becomes less tolerable is when it seeks to interfere with the running of an ostensibly independent trial. A recent example of this type of activity is the pressure exerted by BristolMyers Squibb, on ethical grounds, to end an independent trial of one of its drugs. The trial in question is the third International Collaboration on Ovarian Neoplasm study, ICON3, in which patients with epithelial ovarian cancer are randomised to receive paclitaxel plus carboplatin or an appropriate platinum control. Accrual so far is 1254 patients, in all of whom resection had been attempted; most have stage III or IV disease. The trial is being coordinated mainly through Italy’s Mario Negri Institute and the UK Medical Research Council. Last week, the trial’s independent data monitoring committee reviewed the evidence, both the data from the ICON3 patients so far and the relevant external data. Although the committee has not made a formal announcement, its conclusions were presented at an open meeting in London, UK, on June 2. It decided that there was no need to close the trial on the basis of the outcomes and toxicity data. Moreover, having reviewed the external data, the committee concluded that there is major uncertainty over the use of paclitaxel as a first-line therapy in epithelial ovarian cancer. The concern about previous evidence was based on the relatively small size of these trials, and the risk of false positive and negative results. Indeed, the data-monitoring committee is convinced that the questions addressed in ICON3 have assumed even greater importance, owing to the clear need for reliable data in this area. Thus the independent monitoring committee strongly recommended that the trial should continue, aiming for an accrual of 2000 patients, and it is likely that the trial’s steering committee will endorse this view. Such an endorsement of a trial’s continuation is strikingly at odds with the company’s claims that evidence of efficacy is overwhelming, and with its Vol 349 • June 7, 1997
calls for a halt on ethical grounds. A Bristol-Myers Squibb representative argued that the Inter-Group study, the preliminary results of which were presented at the American Society of Clinical Oncology meeting last month, confirmed the benefits of paclitaxel-plus-cisplatin therapy for advanced disease, which were shown by the US Gynecologic Oncology Group last year (N Engl J Med 1996; 334: 1–6). And a statement from Tony Hooper, the company’s UK managing director, read “In our opinion the closing of ICON3 is necessary because, in this study, 2 out of 3 patients are denied the proven Taxol-based regimen . . . the first-line treatment with Taxol-based regimens should now be the standard of care for all advanced ovarian cancer patients”. Interpretation of data from clinical trials can be a difficult and contentious business. Where the expression of an opinion about trial data steps over the mark and is, to our minds, unethical, is when one considers the confusing message that is sent out to the patient, and the resultant pressure put on independent researchers. (The health page of one UK daily newspaper has already spread the “Taxol works” message.) Patient activists have assumed more and more power over the past few years, largely as a result of the efforts of the AIDS movement (see p 1705). The inclusion of the patient’s perspective has become an important asset to all aspects of drug development. But just as patients’ consent must be informed, so should their advocacy. Indirect drug-company influence on advocacy is widespread, notably in providing funds for groups and societies, a transaction in which the patient derives some benefit. However, drug companies must set aside the temptation, via the press, to hijack patients’ lobbying powers, for that way the patient can only lose. Perhaps some employees within the drug industry need a few lessons in etiquette. The first two rules of good manners should be that clinical researchers do not deserve to be harangued for practising good clinical research, and that patients have a right to unbiased, complete research findings.
The Lancet 1635