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Ethics, Sustainability and Corporate Responsibility
5 years ago I worked as a Compliance Officer for one ethical pharmaceutical company’s representative office in St. Petersburg. It was a real challenge for me as I hadn’t such experience before; and for my company as well – I was the first Compliance Officer in Russia.
On that position my responsibilities included but not limited to the following:
- Internal consultations on business conduct and ethical matters including support for customer facing colleagues in development and adaptation of clinical, promotional and sales activities to the standards of Company’s business conduct and applicable Standard Operating Procedures (SOPs);
- Providing overall support, monitoring and control over implementation of global compliance initiatives, online trainings on Code of Ethical Business Conduct, FCPA, etc.
- Providing appropriate guidance and education to employees; development and implementation of appropriate training programs for field force and office colleagues to ensure compliance with ethical standards, Corporate procedures and local SOPs on Compliance;
- Maintenance, improvement and adoption of the SOPs on Compliance, including Local Procedure on interactions with healthcare professionals and government officials, in line with the applicable legislation, global initiatives, Corporate procedures and industry standards (in Russia it is AIPM Code established by Association of International Pharmaceutical Manufacturers);
- Participation in periodic local audits, pre-audits, corporate internal audits; tracking and reporting of all gaps identified, due diligence projects;
- Discovering and resolving of the compliance issues;
- Support for local compliance investigations (review and evaluation of documents and records, personnel interviews, report drafting);
- Communicate Company’s business conduct externally to build understanding among customers, competitors, and public; develop a proper compliance communication strategy.
So as you can see I was the person wholly responsible for all ethical matters within the Company including everything related to the wide range of ethical dilemmas.
There were a lot of ethical dilemmas that I have faced during my more than one year experience as a Compliance Officer. Obviously most of those situations are still highly confidential so unfortunately I cannot describe them in every detail. But one of these dilemmas was very interesting and didactic – that is why I assume it deserves special consideration.
One of the main aims of our representative office was clinical trials conduction; mostly they were a part of global researches initiated by Headquarter. Conducting Clinical research is an ethical challenge itself. At all costs the rights, safety and well being of trial participants and the integrity of trial data have to be ensured. Conducting researches in a global setting is a further challenge. There are cultural differences between different geographical areas and regions; some are obvious, like different languages, religions, customs, governments, manner of clothing etc. There are however many subtle differences which can impact clinical research conditions.
I was integrated as an external monitor in one of our research teams conducted clinical study A123456 which was in a phase II, open-label single arm study to investigate the efficacy and safety of one of our molecules (B123456) in patients with advanced C123456 disease which has high level of mortality in the population.B123456 should be administered for a total of 10 cycles, the maximum dose being 250 mg bis in die.
I discovered that a 26 year female subject, participating in this study, was suspected of having double dosed her study medication, B123456.
The double dosage was marked in the patient’s diary. But, regardless of that important fact, she claimed to have abided by the protocol. Several questions required answers:
- Why did the double-dosing appear in the patient’s diary?
- Was it a mistake made by the patient?
- Or was it intended?
- Did Dr. Ivanov (principal investigator) fail to see the maximum dose of 250 mg bis in die?
- Or did he ‘empirically’ prescribe 1000 mg, thereby hoping to achieve a higher response?
What at first glance appeared to be an easy-to-solve case, proved to be otherwise. On further scrutiny, conflicting explanations emerged:
- the patient took the decision independently, however refrained eventually from taking the double dose;
- the option had indeed been discussed with the Dr. Ivanov, but was never effected. Therefore it appeared in the diary;
- the patient would terminate the study and double dose via a compassionate use program, hence again the appearance in the diary.
Various stakeholders have been involved in this process. First of all, it was the patient. Then – patient’s carers (parents and other relatives). Principal Investigator – Dr. Ivanov which was friend of mine and there was a potential negative consequences for his professional reputation. All our research team and a lot of external stakeholders. Whole map of stakeholders is below.
Actually it was unprecedented ethical dilemma for me. Generally I understood that ‘framing a choice as a dilemma between two “rights” can itself sometimes be a form of rationalization, obscuring the “wrong” that may lurk there’ (Gentile 2010, p. 176).
But there were no alternatives in this case. It was very dangerous and even impossible to keep silent about it. That is why I have decided to start with full investigation of this issue. And I was very limited in time because at least for one of the stakeholders it was a matter of life and death.
The story is even more so complicated because an additional cycle was initiated since the patient claimed to have lost her study meds; discordant data existed between the Case Report Form and the patient’s diary; drug counts at the pharmacy were done much too late; the patient presented with elevated liver enzymes and it was unclear whether this was related to the dosing error, etc… (Dr. Ivanov would show me a computed tomography later, revealing liver metastasis the size of half the abdomen. Clearly the enzyme elevations were not drug induced.)
There was a potential conflict of interests for me. The group atmosphere within the research team was very friendly. We had a long history of close relationships especially with Dr. Ivanov. And further investigation may negatively impact them. On the other hand I was responsible for Good Medical conduction of the study which means control and absolutely clear reporting of the issues highlighted.
Initial point for me as for individual is that ‘ethics is a branch of philosophy and is therefore concerned with formal academic reasoning about right and wrong, but values are the commonsense, often taken-for-granted, beliefs about right and wrong that guide us in our daily lives’ (Fisher 2012, p. 150). In terms of values which were in conflict I would like to mention the opposition into myself of two values – value of organizational duty and value of patient’s life.
Overall the study team including me could not finally decide whether a (deliberate) progressive disease was made by the principal investigator. This caused difficulty during the subsequent assessment of the potential Qualifying Quality Issue that was reported.
I have arranged a face to face meeting with the Dr. Ivanov to enable further discussion.
It appeared the patient’s relatives comprised of physicians. Eminent physicians that is, all of whom had an opinion, and that opinion was not supportive of our study. The patient was urged to seek rescue therapy. Or she could double dose in order to hope for a better response.
As this was an end-of-life setting – and the Principal Investigator recently told the patient she was about to die shortly – she confronted him with these options. Dr. Ivanov found himself in a difficult situation. He confirmed both options presented by the patient; however they would imply study termination, as they violated the protocol.
Hence the Principal Investigator initially was confronted with an ethical dilemma: continuing the study, or succumbing to the family pressure, which was now transferred onto his shoulders. In the end, we succeeded in convincing the patient and her partner to stay in the study.
Eventually, several weeks later, Dr. Ivanov had decided to withdraw the patient from the study due to her rapid deterioration. She died less than two weeks later.
Based on the information that I was able to determine from direct physician to physician discussions, the issue was clarified to the extent possible. In consequence, there was no clear evidence of a progressive disease, and therefore the Qualifying Quality Issue was not confirmed.
A confidential Monitor to Principal Investigator discussion on site was paramount to clarify as far as possible the situation. Unfortunately, after all, the actual dosing remains inconclusive. A final drug count did suggest a double dosing of 16 days. However, did the patient actually do this? Perhaps it was marked in her diary ‘to please’ her family. The only way we would have certainty about it would be if a blood sample were drawn.
Thinking about this case could make us contemplate. Does this happen more frequently? How would we as patients react in such a situation? Would we adhere to the treatment in any way possible hoping to be cured? Or would we abandon it and accept our destiny?
As a result of the described ethical dilemma I have initiated an update of the existing Standard Operating Procedure on Clinical Trials. The main point I have added to the SOP is related to the Good Clinical Practice Standards further implementation including clear reporting by Principal Investigator on all stages of clinical study. This kind of values should not be formulated in isolation, but built as part of the organisation’s overall strategy (Institute for Leadership and Management 2013, p. 11.) This SOP should prevent situations when for some reason or other Principal Investigator faces ethical dilemmas and makes decisions on his own authority. And that should help him to share responsibility and the burden of decision via stage by stage reporting and straight talk with other research team members.
- C. M. Fisher, Alan Lovell, Néstor Valero-Silva. Business Ethics and Values. Pearson Education, 2012
- Mary C. Gentile. Giving Voice to Values. Yale University Press, 2010
- Institute for Leadership and Management (2013). Added values: The Importance of Ethical Leadership. Available at: https://www.i-l-m.com/~/media/ILM%20Website/Downloads/Insight/Reports_from_ILM_website/Added%20Values%20Report_Final%20pdf.ashx [July 2014]