This is the Fifteenth in the Persecution Series, after The Persecution of Heretics, The Persecution of Vulnerable Adults, Harassment from the BBC to GMC, Harassment from Rolf Harris to James Coyne to Doctor Who, Persecution: Black Riders in the Shire, Persecution: Rumbles from Mordor, of which there were eight in the SUI Cide Series SUI Cide in Betsi, SUI Cide Trick or Treat, The SUI Cide Note, SUI Cide or Homicide, SUI Cide in the OK Corral, SUI Cide & Peace in our Time, The SUI Cide Apparatus, Professional SUI Cide. This marks a new Pharma sub-series.
Faced with questions about the $3 Billion fine imposed on GSK in 2012 – is it just the cost of doing business? Andrew Witty snapped back:
“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.
The $3 Billion fine stemmed in the first instance from Study 329 for which New York State sued GSK for fraud. This is the study that colleagues and I are rewriting at the moment – at what risk?
Pharma has taken a regulator to Court twice. The second was in 2013 when AbbVie took the European Medicines’ Agency (EMA) to the European Court to protect Humira in 2013.
The first case happened in 1969, when Upjohn took FDA to Court over Panalba.
The 1962 amendments to the Food and Drugs Act required companies to show their drug was effective using controlled trials. For all drugs licensed prior to 1962, FDA insisted on a retrospective Drug Evaluation Study Initiative (DESI) to look at these. DESI convened panels of medical academics to adjudicate on each of the older drugs.
At the time there were many combination products – combinations of two antibiotics or an antidepressant and a tranquilizer. FDA and most academic physicians did not approve of combination products, whether antibiotics, analgesics or psychotropics. DESI recommended removing most of them from the market.
In 1969, DESI lined up Upjohn’s Panalba for the chip. Panalba was a combination of tetracycline and novobiocin. By FDA’s calculations Panalba was likely responsible for 12-15 deaths per year that would not have happened if doctors had used tetracycline alone. At the time Panalba was making $18 million per year for Upjohn – 12% of their income; $1 million per death. There was evidence that Upjohn knew of the risks the drug posed and in house evidence that Panalba was no more effective than tetracycline alone.
The company chose option 5.
Liaising with the Secretary of State for Health in the new Nixon Administration that had just taken power, Upjohn pursued a legal action all the way to the Supreme Court.
When the details of the case were presented some years later to business management students in the University of Pennsylvania, Scott Armstrong found that none of his class supported Upjohn and all bar two of the 71 found Upjohn’s behavior irresponsible.
But when he got students to role play the Upjohn Board and faced them with the decision to pull the drug or not, he found to his astonishment that 79% of respondents opted to take the same course of action as Upjohn and none withdrew the drug. This result has been widely replicated in different national groups with socialist Swedes behaving the same as capitalist Americans, and the idealistic young in just the same way as their cynical elders.
Debriefing the subjects and attempting to adjust the board and the circumstance to see if behavior could be modified, Armstrong and others were left with the conclusion that it is generally accepted that the primary duty of Board members is to stockholders rather than to society at large. Board behavior can be modified by appointing stakeholders but even then few Boards opt to remove Panalba from the market.
Armstrong modified the role play experiments by introducing an Upjohn safety officer who told the Board that the company did have hidden evidence supporting the complaints – to no effect.
In real life not even the death of the CEO’s wife from suicide, from the Company’s drug Prozac, has led to a decision to pull the drug or add warnings.
Putting people in a group where the unstated assumption is they will behave like a proper Board produces a situation which has commentators reaching for comparisons with the Milgram experiment where decent ordinary people in experimental settings can be induced to give life-threatening shocks to innocent strangers simply because they are asked to do so by the conductor of the experiment.
What’s true of a pharmaceutical company Board is probably no less true of a Hospital or other Board especially when these boards see themselves as being in the business of defending brand value.
The only thing that appears to modify the likely behavior of a Board is a threat of boycott – that is if maintaining the drug on the market led to the kind of disenchantment that caused the company share price to fall, the Board would respond.
While in real life this is close to what happened when GSK threatened not to supply anti-retrovirals to South Africa, Fear not, Andrew shall never vanquished be until Great Birnam Wood to high Dunsinane Hill shall come against him.
Doctors don’t do Boycotts. Why should they? They don’t suffer the consequences of pills going wrong.
We have to accept Andrew Witty’s suggestion that he and other employees of GSK are just like us, even if few of us can imagine being party to behaviors that warrant a $3 Billion fine. But Armstrong’s study suggests we are more like him than Andrew is like what we might like to think of ourselves.
The problem is if everyone is so good, whence the growing Fascism in healthcare? We can retreat to the wilder shores of conspiracy theory and claim the problems are down to the Germans, the Jews, or a Socialist cabal. Or we (including Andrew) can attribute the problems to a few people somewhere in a pharmaceutical company who break laws.
If we accept that the Board of GSK and other companies are populated with people just like you and me, who are perhaps even less likely to break the law than you or I, the $3 Billion fine for GSK notwithstanding, then the more sensible option is that the problem must stem from the system – which is just the opposite to what Andrew is saying.
We can change systems from the top-down or the bottom up. RxISK is about bottom-up change.
If GSK loses with a Boycott, so do we. We lose access to useful treatments. This led RxISK to propose an alternative to a Boycott – an AbbVie. Rather than not speak to GSK or other companies, to AbbVie means to speak as much as possible to a company telling them and the world more about their drug – feeding back the range of effects the drug has, some good, many bad. This is a way to make drugs better – a good medicine is a chemical plus good information.
(Ditto for a hospital).
There is little doubt that people in GSK and other pharmaceutical companies have the experience of being ever more adherent to protocols for Good Laboratory Practice, Good Research Practice, Good Marketing Practice etc
They likely feel little connection with the increasing numbers of people who die a premature death because of pharmaceuticals – and why should they given that no-one in GSK ever prescribes a drug?
But still someone is responsible for all these deaths…
To be continued.