Relationships with the drug industry: More regulation, greater transparencyBMJ 2009; 338 doi: http://dx.doi.org/10.1136/bmj.b211 (Published 04 February 2009) Cite this as: BMJ 2009;338:b211
- Harlan M Krumholz, Harold H Hines Junior professor of medicine and epidemiology and public health12,
- Joseph S Ross, assistant professor34
- 1 Section of Cardiovascular Medicine and Robert Wood Johnson Clinical Scholars Program, Department of Medicine, Section of Health Policy and Administration, School of Public Health, Yale University School of Medicine, PO Box 208088, New Haven, CT 06520-8088, USA
- 2Yale-New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, CT, USA
- 3Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, USA
- 4James J Peters VA Medical Center, Bronx, New York, USA
- Correspondence to: H M Krumholz
The relationship between drug and device companies, the medical profession, and the public is at a critical juncture. Individuals who have placed their interests in profit and influence over patients and public health have overshadowed much of the good work and reputations of those who have engaged in constructive interaction.1 As a result, public perception of the drug industry, doctors and scientists is at an historic low.2 3 The public is well served when industry, clinicians, and academicians work together for the common good, generating new knowledge and ensuring appropriate and rapid dissemination of effective products to save lives and improve quality of life. To restore the public’s trust we must set a path forward that encourages ethical collaboration and discourages activities by industry, researchers, or practising doctors that are largely self serving or place financial benefit above patients and the public good. Setting explicit standards of conduct for interactions between industry and both patients and physicians can assist all parties. We propose six.
Standards to restore trust
Firstly, let’s dispense with promotional activities such as direct to consumer advertising and distribution of drug samples in settings where prescribing decisions are made. Promotions, samples, and advertisements are intended to create demand and rarely provide educational value.4 They can have the unfortunate consequence of influencing patients to request treatment that is not indicated or for which less expensive, equally effective alternatives exist.
Secondly, we should forgo gifts. Doctors do not need trinkets, meals, or other gifts, and industry can probably do without the expectations of giving them. Small gifts may seem innocuous, but cognitive psychologists have shown that they have outsized influence.5 The value of the interaction between industry representatives and physicians should relate to information exchanged, not the gift received.
Thirdly, clinicians, researchers, academic institutions, clinics, and hospitals must disclose all payments and gifts from industry, regardless of size or whether they were paid directly, through a third party, or to a charity or other organisation. Transparency cannot ensure ethical conduct, but disclosure will open up interactions with industry to the public and should inhibit payments that are embarrassing or questionable.
Fourthly, industry sponsorship of continuing medical education must stop because it diminishes credibility regardless of its quality. Physicians should fund their own education, perhaps subsidised by government or private-public partnerships to reflect its value as a public good.
Fifthly, industry sponsored clinical studies should be visible, accountable, and comply with mandatory standards set by institutional review boards, data safety and monitoring boards, and steering committees to protect patient volunteers. In addition, external investigators should receive the study’s raw data and rights to publication. Seeding trials and ghostwriting should be prohibited. Trials should be publicly registered and their results should be posted within two years of completion regardless of peer review publication. Registration should include naming members of the data safety and monitoring board and steering committee (which is ideally composed of non-employees), investigators, and pre-specified data analysis plans including primary and secondary outcomes.
Finally, let’s accept divergent views, defend free speech, and acknowledge that there is great value in the respectful exchange of ideas. We need to overcome an unfortunate history of intimidation exhibited by some companies against physicians who have expressed opinions that did not favour their product.6 We also need to eliminate efforts by opinion leaders at some academic centres to leverage funding from companies in exchange for favouring industry products or neutralising critics.
All six of these actions are practical and can be taken immediately if industry, researchers, and clinicians commit to a new era of interaction to restore the public’s trust. They reflect a widely shared view in industry,7 the Association of American Medical Colleges, and the Medicare Payment Advisory Committee. They are also in line with recent legislation and ongoing discussion in the US Congress. Leading companies and physicians have already taken many of these steps to promote the best care for patients—it’s time for the rest to follow.
Cite this as: BMJ 2009;338:b211
Competing interests: None declared.
Provenance and peer review: Commissioned; not externally peer reviewed.