John Blake and Cole Dominguez, executives at Sycamore Pharmaceuticals, are in an extremely difficult position with no easy options. The popular drug Osteoporin produced by Sycamore Pharmaceuticals was aggressively marketed for use in other ailments such as Crohn’s disease and lupus prior to scientific studies regarding their efficacy. Blake and Dominguez were part of the management team that had supported this direction, and suppressed details of negative studies for as long as possible. Sycamore Pharmaceuticals had taken a risk, but not only had the studies come back negative, the problems with the drug from information which had been leaked to the press meant there were possible pending investigations and even criminal charges. There is divergence in the approach that each executive plans to take. Dominguez is more concerned about getting in trouble with management and losing his job than he is of the FDA. This fear is his priority, and he does not show concern about the wider implications of what they have done and what he is planning to protect. If Blake were to come to me for advice, then I would recommend that he follow two strategies, that being to tell the truth to the FDA with regard to the suppression of the studies, but only to do so in a way that ensures he is protected from negative outcomes.
The pharmaceutical industry is not known for its ethical practices, but it is pervasive in the health and medical industries, even playing a critical role in medical school education (Holloway 2014). Gotzsche captured the reality of this business in the title of his article “Corporate crime in the pharmaceutical industry is common, serious and repetitive” (Gotzsche 2012). Realistically, Blake was already aware of many of the fraudulent and even criminal practices in this industry, however it is the willingness to disclose these wrongdoings by whistleblowers which is needed in order to fight its corruption. Further, this industry has incredible influence, and Blake would be unlikely to work again even in a related field if he was known to be a whistleblower of pervasive industry practices. While it is clear that Blake is thinking about the ethics of having marketed a useless drug to people who are suffering from illnesses, and wishes to right the wrong, he will gain strength in his resolution if he has less to fear. Perhaps he may not say much to the FDA agent but that his information will be forthcoming. In the meantime, in order to ensure his protection he must find a new position in a different company as quickly as possible. Blake should also take care to avoid expressing his opinion around his colleagues, to reduce evidence in the workplace regarding his plan to give evidence against Sycamore. Finally, Blake should ensure that he avails himself of any protections that can be applied with regard to legislation and processes to protect whistleblowers.
It will take courage for Blake to honestly reveal the timing and content of the scientific studies, however there are practical steps which Blake can take to reduce the concerns he might have about retaliation by his company and potential impacts on his career path and progression. The best way to build courage is strategies that mitigate potential negative outcomes for him personally. Unfortunately that puts him in a continued uncomfortable situation at work until he can find his opportunity for an exit strategy. Another source of courage is a continued focus on the people who are being harmed by the use of Osteoporin, given that they do not need it and it might be displacing a treatment more likely to have better results. Off-label marketing of prescription drugs by pharmaceutical companies is a great problem in the US, and enforcement has often been very difficult (Kesselheim et. al. 2011). It is for this reason that Blake should cautiously move forward with a plan to tell the FDA the truth, because it is a truly heroic act that can protect millions of people from the unscrupulous practices of the company.
Possible reasons why Dominguez and Blake went along with the deception in the first place include the fact that they were following orders from management, xxx. It is difficult for anyone who has not been in that situation to determine whether they would have participated in suppressing the negative studies. There are psychological and social factors which can have a great impact on the decisions which are made, in this case fear in particular. While it seems too easy to state that one would take the ethical high road, unless one has a good deal of emotional intelligence, courage and the ability to let a situations such as this fall down a slippery slope one might be at the mercy of fear, just as Dominguez is. Dominguez feels he needs his job, and is more afraid of the repercussions from senior management. When under the spell of a strong emotional reaction such as fear there may be a great difficulty in implementing the right choices, even if that is what the individual prefers. Fear doesn’t prevent making the right choices; it affects the capacity to do so.
The public and potential consumers of pharmaceutical drugs have more to fear than the executives who will be interviewed by FDA agents about the marketing practices relating to Osteoporin, as not only does it not deal with their health concern, it could cause harm and it represents an economic loss to consumers who use it in ways that are not proven to be effective. Blake cannot fight these unethical practices alone, however many whistleblowers are not adequately protected for their work to ensure the health and safety of the general public.
- Gotzsche, P. C. (2012). Corporate crime in the pharmaceutical industry is common, serious and repetitive. BMJ, 345. HeinOnline:e8462.
- Holloway, K. (2014). Uneasy subjects: Medical students’ conflicts over the pharmaceutical industry. Social Science & Medicine, 114, 113-120. DOI:10.1016/j.socscimed.2014.05.052
- Kesselheim, A. S., Mello, M. M., & Studdert, D. M. (2011). Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLoS medicine, 8(4), 553. DOI: 10.1371/journal.pmed.1000431
