Ethics in Biotech: Doing What is Right and Doing What is Best Careerwise?
Just got done reading the book Bad Blood about the Theranos scandal. Plus, I have consulted on two patent infringement cases involving opioids. Today, I listened to a federal prosecutor and prominent attorney representing a large metro county prosecuting a case against the pharma industry and their marketing practices. In both these situations, I believe that scientists were under tremendous ethical and career pressures to do either the right thing or to just shut up and do the status quo. They feared that they would lose their jobs if they did stand up and tell the truth scientifically.
In the case of the Theranos, there are several ethical issues. The biggest as it relates to career choices is finding the right fit in your potential boss before you commit to that position. Further, there is an another part of this question that should be address is knowing when to go around your boss to solve a problem or do what is in the best interest the company and shareholders (not necessarily your boss). Let's start with the story of Ian Gibbons, the senior scientist at Theranos. He was a distinguish biochemist and former of professor of biochemistry at University of Hawaii before joining Theranos. His two bosses were Elizabeth Holmes, a Stanford dropout, and Sunny Balwani, a former financier and operating officer in the IT industry. Sunny was Ian's direct supervisor. Hardly, a great scientific acumen in the C suite and Sunny was Elizabeth's boyfriend. Gibbons toiled on developing this blood analyzer according to Elizabeth's ideas but as we know this (her) idea was garbage and could never could be accomplished because the science was wrong. I suspect that Gibbons came to this conclusion but feared telling Elizabeth this. Ultimately, under pressure to produce this hypothetical and impossible vision of Elizabeth's dream of a disruptive blood analyzer, he committed suicide. I interviewed the whistleblower in this case via email; the problem here was the leadership and the idea. So, I know similar types of disputes like this happen in the biotech industry (maybe not as dramatic as this). Let's start with the simple questions:
1) Given the differences in scientific expertise and training between Ian and his boss Sunny and Elizabeth, why should Ian have any respect for his bosses?
2) Did Ian have the right to go directly to Elizabeth and tell her directly this blood analyzer will not work according to what you claim because the science is incorrect?
3) If you feel Ian did not have a right to approach Elizabeth, the CEO, tell me why?
4) Do you agree that Ian should never have taken this position given the difference in the scientific acumen of its CEO and that of Ian's? How could this problem been avoided? Personally, Sunny and Elizabeth never should have been hired in these positions; they were unqualified. What would you do if you were Ian?
Let start there for now. Hopefully, you see that the decisions you make in these situations can have a profound impact on your career. I will follow up with the opioids and the MSL stores later.
Personally, I don't think your questions of are relevance - irrespective anyone's scientific expertise or business expertise, there is an ethical responsiblity to speak up and raise issues when patient safety is at risk, irrespective of cause.
That being said, more the issue of what restricts those from speaking up in situations like this, among others, and it comes down the basic realities of poor organizational behavior (surrogate term for toxic politics), high pressure environments that cloud an individual to respond appropriate or even understand fully there is an issue to respond to. And there are many studies here, corporate psychology, group psychology - irrepective of your questions the fact is there can be enormous pressures in the corporate world that do inhibit an individuals ability to do the right thing.
And those presseus can be many, not just fear of job loss, in very very toxic environments people can experience very bad depression, they can become silent. and they....can be come inhibited. Inhibited to even quit, speak up or seek medical attention.
So in this situation, one can't negate the stress behind what people are experiencing, which can blind judgement, decision making and performance. And for career, this is an important feature to know about. Many times, if not most, people don't want to be bothered by whistle-blowning and to deal with those stresses. If they can muster any energy, they quit. That's a reality.
So, its not about the questions you ask, no matter what there was ethical responsiblity raise. And ..part of it is knowing when to raise hands and when to... walk way. Sometimes, one can't - and well...this is just a sad case.
And you have other cases where it's just bad practice and others, we'll just don't know better - so...that's as best as one can get. Never underestimate the personal stresses one can go through in any job - blame ..is an easy out. Many don't look at root-causes, as in this case...I'd say tremendous pressure, high stress (obviously), sad outcome. There are times when in a career one needs to put oneself first - especially if one is in a position to detect stressful, personally impacting situations.
I dont think that the scientific acumen of the CEO should matter. Often I think that having a business oriented CEO is better than a scientific one. That the scientific responsibility within the company is good is important but it doesnt have to be the CEO.
Of your numbered questions above I have actually done number 2 ie as lead scientist I went to the CEO and inventor and said that the invention might not work and that we needed to do additional tests. It turned out that it did work with some modifications but that is irrelevant for the question