Now that we covered some basics in terms of ethical decision-making, let’s turn to some of the problems or challenges in ethics. Although this next challenge is not unique to pharma, I have seen its repercussions while working as a consultant on ethics for pharmaceutical and biotechnology companies.
I call the issue the “limbo” paradox. A paradox occurs when government, accreditation entities, or a company wishing to move beyond a culture of compliance to a culture of conscience (Koski, 2003) raises the bar (or costs) for regulatory compliance or ethics too high. Usually these efforts are well-intended or respond to specific regulatory findings or ethical lapses. However, raise the bar too high, too fast and just like in limbo dancing, people will take the easy way out and duck beneath the bar. The result can cause disconnects between ethical practices and shortcuts to meet short-term financial or productivity targets.
Making its way around the blogosphere in ethics circles is an interesting proposal to develop what’s being called a “good housekeeping” seal for ethics in the pharmaceutical and biotechnology industries (click here, here, and here). Specific details of the program components are scant in my Internet search, but here is a brief summary of what I could gather about this:
“Excellence in Ethics Accreditation” program:
- The program would function as a “seal of approval” that a company aspires to and has policies, procedures, education, and other programs to ensure ethical oversight of R&D and sales and marketing practices.
- An advisory council of approximately 30 people to develop accreditation standards has been meeting since 2009 and includes a variety of stakeholders, including the following:
- Members of Harvard’s ethics center
- Two former FDA Commissioners (Mark McClellan and Andrew von Eschnebach)
- An unknown number of pharmaceutical industry executives, patient advocates and physicians.
- Importantly, the program has not accepted funding from individual pharmaceutical or biotechnology companies and is rather funded through a variety of non-profit or grant-making institutions, including the Susan G. Komen Foundation, Harvard’s Safra Center, the Raskob Foundation and Bioethics International.
- The program is looking for a company to step up and volunteer to pilot the initiative.
I have been making this type of argument for many years (Perlman, 2004a and 2004b; 2005) and am happy to see it gaining additional traction. Especially since there is now a robust accreditation process for human research protection programs through the Association for the Accreditation of Human Research Protection Programs (AAHRPP), if a company were to organize their clinical research enterprise into such a program that promotes ethics in clinical research, many companies could seek this type of accreditation. Alternatively, if a company uses an independent institutional review board (IRB), it could enhance public trust by only using those IRBs that have received AAHRPP accreditation. This would cost the industry $0 and be a good first step to improving public trust. As for communicating this message, companies would need to be sure such a plan doesn’t backfire. Spending tons of money to promote how ethical a company is for making such a move for free would amount to a kind of business ethics blunder similar to “greenwashing.” Soft promotion and communication is the key here.
Now for the challenges associated with implementing an ethics accreditation program like the one outlined. Which company would be the first to join? Why would they? Does the idea sound too much like a rushed limbo contest? What if the effort had the support of PhRMA or BIO? Would companies adopt policies and procedures like they did when PhRMA released its voluntary guidelines on R&D and sales and marketing practices? What about the proposal could be easily implemented as a first step in a long-term incremental plan to avoid the limbo paradox? Please join the discussion by commenting on these or related questions in the comments section on PM360’s Facebook Page.
Koski, G. (2003). Changing the paradigm: New directions in federal oversight of human research. Journal of Pediatric Gastroenterology and Nutrition 37, Supplement, (pp. S2-SS6).
Perlman, D.J. (2004a). Implementing a Research Ethics Infrastructure: Implications for Institutions, Sponsors, and Industry. SoCRA Source 42: 31-35.
Perlman, D.J. (2004b). Ethics in Clinical Research: A History of Human Subject Protections and Practical Implementation of Ethical Standards. SoCRA Source 40: 37-42. Available online here.
Perlman, D.J. (2005). Putting the “Ethics” Back into Research Ethics: A Process for Ethical Reflection for Human Research Protection. Journal of Research Administration 36(1): 13-23