by Steve Woodruff
Ghostwritten clinical papers. Off-label marketing. Channel-stuffing. Hiding of negative data.
Pharma companies have earned a hefty percentage of the opprobrium heaped on them by a skeptical public. And it’s mainly because of a failure to heed the Golden Rule. We all know the “classical” Golden Rule: Treat others the way you’d wish to be treated. But in so many cases, drug manufacturers seem to adhere to a different version: the Gold-in Rule: Do whatever is necessary to bring in the maximum gold, without getting caught.
Business ethics can seem complicated. Frankly, I think most of it boils to down to a pretty straightforward choice:
Do I do what’s right? Or do I do what is expedient to try to ensure maximum (income/profitability/bonus/stock price/etc.)?
What is right? That’s a debate that can draw in threads from theology, philosophy, psychology, and other disciplines, but let’s not over-complicate it. How would you want to be treated in a similar circumstance?
You’re working on the clinical research side of a pharmaceutical company, and a promising drug candidate starts to show some anomalous results. Some potentially dangerous side effects. Not a whole lot, mind you, and just a bit of tweaking and data-scrubbing could get it below the threshold of statistical significance. The company has been investing millions into this product, and the pipeline is a bit thin. Do you report it? Do you “work the numbers”? Do you ignore and cover over the warning signs? How does all this impact your job?
Wrong questions. How about this – Would I give this drug to my child? Or this: How would my actions look in the newspaper, if unveiled? Conscience and truth line up with the Golden Rule. Selfish pragmatism often sides with the Gold-in Rule instead.
Just last week, I heard the inside story about a smaller pharma company that went kaput a short time ago because of a dubious and dishonest effort to prop up some quarterly sales numbers. Pleasing Wall Street for a few months. Then destroying shareholder value, jobs, and reputations for much longer. Gold-in for a little while. Gold-out thereafter. Dumb.
I would love to see pharma companies adopt the following “Golden Rule” approach as a cornerstone of their mission: The right drug, for the right patient, at the right time, in the right manner. Period. Percolated through an entire organization, this perspective would nip the vast majority of ethics issues in the bud.
What is the root cause of the parade of scandals we see in pharma (and, for that matter, in plenty of other industries)? Most of the time, we need look no further than the Gold-in Rule. We moan and groan about regulatory meddling, whistleblowing, and all the other thorny features of rules and disclosures that address wrongdoing. But who is to blame? All those who lead their companies, their teams, and themselves by the Gold-in Rule.
I’d love to see some pharma CEO take a stand squarely on the Golden Rule and drive it throughout the entire organization, come whatever may. The short-term disruption would pale compared to the long-term benefit.
Steve Woodruff is Founder and President of Impactiviti.
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I have done so many ethics and compliance courses… signed so many affidavits that I understand the way in which we should be doing business… sat through so may seminars on appropriate behaviour.
The things I think that the world needs to see is a truly transparent reporting of the business practices of ethical pharmaceutical companies… much like cycling teams are opening their blood test records to forestall doping accusations.
Even if we did, though, would anybody believe it? When the conspiracy theories about Big Pharma are so far out there, even the disputation of honest business practices becomes “what people believe…”
Look, I don’t know everything, and maybe I’ve taken too big a swig of the Flavor-Aid, but I can’t believe that ethical pharmaceutical companies still try to pull that… stuff… Maybe my opinion is coloured by the fact that a major pharma pays my daily wage, but there’s one thing I think.
I think that Novartis has a management team who will brook no shenanigans. I’ve talked (albeit briefly) with Dr. Vasella. I’ve read the internal blogs written by other members of executive staff. I know how *I* behave, and I can only judge the behaviour of my colleagues by what I see… and what I see is pretty damned good.
Now, I’ll see if I can get somebody internally to start posting a report card (externally created and audited, of course) of our business practices…
FULL TRANSPARENCY : I work for Novartis Pharmaceuticals, but am not a spokesman in any capacity. The opinions expressed here represent only my views. #iwork@novartis
Regarding ethics of pharmaceutical comapnies and new drugs:
I think this debate will not end. Why? AS, it is not only a medical issue…!
Oh Mr Smart…
I remeber while there was a debate regarding R/Warfarin & R/Coumadin. They said alot. We attended a lecture offered by the pharmacetical company concerned with the general point (Generic vs. Brand). Then, a specific mini-lecture concerned with the new Warfarin (R/Coumadin).
During my MSc. examinations, there was a written question concerned with new warfarins and generic warfarins.
Even, in any developing country, no patient could afford for that R/Coumadin. I remember the cost was more than 10 (TEN ) times!.
I answered the quetion well, but with my broken heart…..
http://tabibqulob.blogspot.com/2008/12/generic-vs-brandnew-title-for-old-story.html
Thanks
I presume that the author’s remark, ‘I would love to see pharma companies adopt the following “Golden Rule” approach as a cornerstone of their mission’, could be applied globally, and not just targetted to the pharmaceutical industry. So many professions and industries, including our own, have conflicts that test our integrity. Regrettably, we live in a ‘Cliff Notes’ society where fast track advancement is the preferred pathway. In many instances, there are many checks in the system, which can curb misconduct. In the ghostwriting medical scandal, for example, it would never have become airborne if the physician ‘authors’ pushed back and squelched the effort. Obviously, there is no simple solution available. While you can’t legislate ethics and morality, oversight, accountablity and enforcement can provide incentives to wavering individuals and institutions to do the right thing.
Hi Steve,
Nice post from a nice guy!
And this is why you are President of Impactiviti rather than a CEO of Big Pharma…….
Of course, these ethical issues are not isolated to pharma – as Dr Kirsch (and others) have pointed out, it’s a universal problem. Here’s a counter-balancing post I wrote a while back addressing that issue: http://bit.ly/ktLYw
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