Re: Restoring the integrity of the clinical trial evidence base
Letter to the Editor, BMJ
In their editorial on “Restoring the integrity of the clinical trial evidence base,” editors of the BMJ and PLOS Medicine describe the crisis of hidden or misreported information as “one of the leading scientific problems of our time…”1 It is also producing an epidemic of harmful side effects, and most new drugs over the past 30 years are little or no better than existing ones.2-4 Patent replacement drugs are the main product of corporate research.
Widespread patient harm is a central product of hidden or misreported trial reports. As rational actors who design trials around end points that they can feature in the marketing plans for a given drug, companies primarily make trials or selective results invisible or unpublished that will not help sell drugs more widely.
The costs of minor variations with hidden risks of harm consume about 80 percent of increased pharmaceutical costs and are a good reason for nations to support the AllTrials and RIAT initiatives.5 Driving these avoidable costs and harms, Mintzes et al. found that 97 percent of the time, pharmaceutical reps fail to provide minimally adequate safety information about drugs to physicians.6 Worse, serious harms were rarely mentioned for drugs identified as harmful, and companies kept promoting them.
Even among published results, numerous studies show that companies bias clinical trials, then bias further published articles about trial results, and bias a third time the marketing material used by drug reps in order to understate risks of harm and overstate benefits. The FDA and EMA do little to correct this misinformation and allocate only a small fraction of their budgets to carrying out their mission to protect the public from harmful drugs. Thus the mission and legal power of prescribing physicians to improve the health of patients is seriously distorted or corrupted, as evidenced by the finding that most physicians rate harm-inducing commercial information as “good or excellent.”6
When will this risk-proliferating syndrome stop, as it has in a few health care systems where drug reps and free samples are prohibited and replaced by commercial-free information?7 Patients and physicians want superior new drugs whose risks of harm are fully known, not minor variations with few advantages to offset their hidden risks of harm.
References
1. Loder E, Godlee F, Barbour V, Winkler M. Restoring the integrity of the clinical trial evidence base. BMJ 2013 (13 June);346:f3601.
2. Light D, Lexchin J. Pharmaceutical R&D - what do we get for all that money? BMJ 2012;344:e4348
3. Moore T. Prescription for Disaster. New York: Simon & Schuster; 1998.
4. Light DW. Bearing the risks of prescription drugs. In: Light DW, ed. The Risks of Prescription Drugs. New York Columbia University Press; 2010:1-39.
5. Morgan SG, Bassett KL, Wright JM, et al. "Breakthrough" drugs and growth in expenditure on prescription drugs in Canada. BMJ 2005;331:815-6.
6. Mintzes B, Lexchin J, Sutherland J, et al. Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States. Journal of General Internal Medicine 2013 (Apr 5):s11606-013-2411-7.
7. Levine S, Campen D, Millares M, Barrueta A. Kaiser Permanente's prescription drug benefit. Health Affairs 2000 (Mar);19:185-90.
Competing interests:
No competing interests
18 June 2013
Donald W Light
professor
Edmond J. Safra Center for Ethics, Harvard University
Rapid Response:
Re: Restoring the integrity of the clinical trial evidence base
Letter to the Editor, BMJ
In their editorial on “Restoring the integrity of the clinical trial evidence base,” editors of the BMJ and PLOS Medicine describe the crisis of hidden or misreported information as “one of the leading scientific problems of our time…”1 It is also producing an epidemic of harmful side effects, and most new drugs over the past 30 years are little or no better than existing ones.2-4 Patent replacement drugs are the main product of corporate research.
Widespread patient harm is a central product of hidden or misreported trial reports. As rational actors who design trials around end points that they can feature in the marketing plans for a given drug, companies primarily make trials or selective results invisible or unpublished that will not help sell drugs more widely.
The costs of minor variations with hidden risks of harm consume about 80 percent of increased pharmaceutical costs and are a good reason for nations to support the AllTrials and RIAT initiatives.5 Driving these avoidable costs and harms, Mintzes et al. found that 97 percent of the time, pharmaceutical reps fail to provide minimally adequate safety information about drugs to physicians.6 Worse, serious harms were rarely mentioned for drugs identified as harmful, and companies kept promoting them.
Even among published results, numerous studies show that companies bias clinical trials, then bias further published articles about trial results, and bias a third time the marketing material used by drug reps in order to understate risks of harm and overstate benefits. The FDA and EMA do little to correct this misinformation and allocate only a small fraction of their budgets to carrying out their mission to protect the public from harmful drugs. Thus the mission and legal power of prescribing physicians to improve the health of patients is seriously distorted or corrupted, as evidenced by the finding that most physicians rate harm-inducing commercial information as “good or excellent.”6
When will this risk-proliferating syndrome stop, as it has in a few health care systems where drug reps and free samples are prohibited and replaced by commercial-free information?7 Patients and physicians want superior new drugs whose risks of harm are fully known, not minor variations with few advantages to offset their hidden risks of harm.
References
1. Loder E, Godlee F, Barbour V, Winkler M. Restoring the integrity of the clinical trial evidence base. BMJ 2013 (13 June);346:f3601.
2. Light D, Lexchin J. Pharmaceutical R&D - what do we get for all that money? BMJ 2012;344:e4348
3. Moore T. Prescription for Disaster. New York: Simon & Schuster; 1998.
4. Light DW. Bearing the risks of prescription drugs. In: Light DW, ed. The Risks of Prescription Drugs. New York Columbia University Press; 2010:1-39.
5. Morgan SG, Bassett KL, Wright JM, et al. "Breakthrough" drugs and growth in expenditure on prescription drugs in Canada. BMJ 2005;331:815-6.
6. Mintzes B, Lexchin J, Sutherland J, et al. Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States. Journal of General Internal Medicine 2013 (Apr 5):s11606-013-2411-7.
7. Levine S, Campen D, Millares M, Barrueta A. Kaiser Permanente's prescription drug benefit. Health Affairs 2000 (Mar);19:185-90.
Competing interests: No competing interests