You may have seen one of the latest corporate ‘scandals’ in the news. This time GSK (Glaxo Smith Kline) have been fined approximately £38m. The competition and markets authority (CMA) stated that GSK was guilty of ‘illegal behaviour designed to stifle competition at the expense of the NHS and taxpayers’.

The Financial Times describes the CMA fine as relating to ‘£50m of payments made by GSK to rival companies in deals to delay the arrival of copycat versions of its Seroxat anti-depressant, also known as paroxetine’.

Just in case you’re not aware, in very broad terms the way that these drug companies often work is as follows. They spend money developing a drug (research, clinical trials etc) and then if the drug is deemed ‘safe’ by each country’s various regulatory bodies (e.g. the FDA) it can be licensed for use in that country, and the manufacturer will generally patent their drug, in this case ‘Seroxat’ (the GSK specific patented name of this particular drug).

Now let’s just pause for a second and examine what Seroxat is. Seroxat (Paxil in the U.S.) is an SSRI. Essentially an SSRI drug acts to block serotonin (a neurotransmitter) being reabsorbed back into the nerve cell (presynaptic) after it has transmitted a signal. The idea being that this will then increase the level of serotonin in the synapses. Serotonin tends to be found in the ‘circuitry’ that can influence mood. So the very general idea is, more serotonin, better mood. If you know all about this, apologies for the repetition. If you didn’t, hopefully you get the idea.

The reason for going into a little bit of background is that taking this drug will directly influence thinking and mood. So that’s a powerful agent to be ingesting. It also places a huge responsibility on the manufacturer to make sure it’s safe. Or at least it should. It’s important to note also that the different formulations of these SSRIs can all have different side effects and so even for that reason alone, they need to be tested very carefully indeed.

Let’s then skip back to GSK and specifically Seroxat. Once a patent runs out on a drug, typically other manufacturers can and will step in and manufacture what is called a generic, rather than a branded version of the drug (the generic drug is essentially doing the same thing as the branded drug ( bioequivalence)). This has the effect of driving the price down. GSK has been fined for a so called ‘pay-for-delay’ deal, where they have paid rival companies to delay the arrival in the marketplace of cheaper generic rivals to Seroxat.

Hence the CMA’s statement about stifling competition and expense to the NHS and taxpayers.

In the interest of fairness, I should point out that GSK is considering an appeal and states that it entered into those agreements in order to settle costly, complex and uncertain patent disputes. The CMA has pointed out that after the generic Seroxat (called Paroxetine) entered the market properly at the end of 2013 that the average price for the drug fell more than 70% in two years. You can make your own mind up on that one.

I would say however that if drug patent laws really are that complex and uncertain, and if the pharmaceutical companies do want things to be straightforward and transparent, then perhaps diverting the millions spent on these ‘agreements’ to a team of legal experts to unravel the tangled legal web, and also perhaps having greater clarity from regulatory/governmental bodies, if required, may well negate the need to have these ‘agreements’ (which they got fined for anyway) in the first place.

Now bear with me on this, because I want to explore things in a little more detail.

I mentioned earlier that SSRIs (like all drugs) have to be tested very carefully indeed. You may or may not have heard of Study 329. Study 329 was a randomised controlled trial that explored the efficacy (and harm/side effect) of Paroxetine (Seroxat/Paxil) in the treatment of major depression in adolescents. The 2001 study concluded that ‘Paroxetine is generally well tolerated and effective for major depression in adolescents’. Please read that last sentence again.

That’s good isn’t it?

Not really, because that wasn’t exactly true. A recent study ‘Restoring study 329: efficacy and harms of Paroxetine and imipramine in treatment of major depression in adolescence’ (Sept 2015 BMJ) has come up with some very different findings, having managed to gain access to the original data.

N.B. Paxil (Seroxat/Paroxetine) became the number one antidepressant in the U.S. with sales of over 300 million dollars by the end of 2001. GSK has already been fined $12 billion for false and fraudulent claims in the U.S. in 2012. However the ‘Restoring study 329’ was the first time that the original data from the 2001 ‘Study 329’ had been properly accessed and held up to scrutiny.

Here are the results of the new 2015 restoring study.

‘The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.7 (least squares mean) (95% confidence interval 9.1 to 12.3), 9.0 (7.4 to 10.5), and 9.1 (7.5 to 10.7) points, respectively, for the paroxetine, imipramine and placebo groups (P=0.20). There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group’.

Stepping through that paragraph a little; the HAM-D scores are the Hamilton Rating Scores for Depression. This is basically a questionnaire which results in a score that can act as a guide to someone’s psychological wellbeing. I have my doubts that that was the correct instrument for this study in the first place, but that’s another story.

It would appear then that these drugs were no better than the placebo, but also that there was in actual fact a significant increase in suicidal thoughts.

So we have a drug that is at best, no better than placebo in efficacy, and a damn sight worse in terms of the harm that it does.

Notice this section from the report as well –

‘Use of an idiosyncratic coding system: The term “emotional lability,” as used in SKB’s (Smith KlineBeecham) adverse drug events coding system, masks differences in suicidal behaviour between paroxetine and placebo’.’

What the report is highlighting here is that the original coding system was downplaying the severity of many of the side effects. They were, through use of an inappropriate coding system, being diluted.

Suicidal behaviour is not emotional lability!

One of the conclusions of the new 2015 study is:

‘The extent of the clinically significant increases in adverse events in the paroxetine and imipramine arms, including serious, severe, and suicide related adverse events, became apparent only when the data were made available for reanalysis. Researchers and clinicians should recognise the potential biases in published research, including the potential barriers to accurate reporting of harms that we have identified. Regulatory authorities should mandate accessibility of data and protocols.’

I believe that regulatory authorities definitely should mandate accessibility…but it’s a pity that they have to.

Now you may be wondering why we have taken this canter through the land of SSRIs and pharmaceutical organisations. Well, because it hopefully stops and makes us think. Stops and makes us think about the blatant, flagrant, deliberate disregard of the consequence of actions, that has and is still taking place within some corporations. I’m sure that GSK is full of ideologically sound, bright, eager, well meaning people. And they are perhaps doing nothing different than many other companies do in relation to patents. Also the original (and extraordinarily misleading) original 329 study was published several years ago when the company was called SmithKlineBeecham.

I’m using the GSK £38m fine and the Study 329 as examples of what can go on and what does go on when ethics, morals and decency are thrown out of the window in favour of a quick buck.

I’m also hoping to highlight how inured we can get to the headlines. ‘Oh it’s just those naughty drug companies again’. ‘Oh that’s just business’. No it is not. It has nothing to do with business. If the CMA are correct, then this is greed. Pure and simple. But where does that level of greed come from? The employees? I doubt it. The managers? Probably not. The leaders? Mostly not…but some leaders somewhere must be involved.

There are many issues to consider, but here are two:

i) We will never be able to know how many young people committed violent acts, including committing suicide due to taking this drug because the true danger of the side effects was unknown/obfuscated. However, one, is too many.

ii) We must not allow ourselves to become accustomed to the ‘corporate greed’ headlines. We must remember that behind every one of these headlines, there will almost certainly be a high human cost. This is one of the reasons that I have gone into a little bit of detail here. It is important to recognise the damage that can be done, and to actually consider that there is often a conscious, and misguided effort to look no further than this week’s sales figures, or the upcoming board meeting.

How many times will we have to hear about individuals who simply turn a blind eye/look the other way? How often do people say that they will do things differently tomorrow/next week/next month/next year? And yet they rarely, if ever, do.

Why does this lack of taking responsibility and doing the right thing become so easy? No doubt there are many reasons, however, I believe that one of the reasons for this can be found in social psychology. You may have heard of the bystander effect. The gist of this idea is that the bigger the crowd, the less likely we are to help someone in distress. This is sometimes described as the probability of getting help being inversely related to the number of bystanders. There are many examples of individuals in distress being ignored by lots and lots of people. One factor in that effect can be something called diffusion of responsibility. Putting it crudely, we expect/hope that the issue will be/is someone else’s responsibility, and that we can quite simply hide in the crowd. This could be considered to be akin to groupthink.

However, that is not a luxury a real leader has. And one of the issues is that the more people who acquiesce to organisational/team transgressions, the easier it can be to just let it go…just this once, and then just this once again… This then can become the culture.

In my opinion, one of the leader’s jobs is to help set the culture, to generate the tone. This will generally mean that at least initially, the leader will be in the minority if they are attempting to generate a cultural shift. This doesn’t mean that the leader should not seek help, and allies, but it does mean that there are likely to be more people who are comfortable with the status quo, than who are not.

So what does that all mean for us, right now? Well we can all begin to make a difference, however slight. It all counts, it all adds up. It may be that right now there is one thing that you know that you need to do which you know to be right, and better in the long run. It may also be that not everyone can see this or wants to see this. You may also be procrastinating and/or wavering.

If that is the case, grab yourself a quiet few moments somewhere that it is likely that you won’t be disturbed, and in relation to this thing that you know you need to do, take time to write down the answer to these two questions:

i) If you don’t do this thing/take this action, what will it cost you and others?

ii) If you do take this action/do this thing, what will you and others gain?
That simple little exercise may well help you move forward in a way that you will ultimately be most happy with.

Remember, it’s easy to distance ourselves from the effect of our cause. It’s easy to fit in with the crowd. It’s easy to promise ourselves we’ll do something differently next time. It’s easy to think short term.

It’s also often really quite easy to do the right thing. It’s also often the case that it’s just easier not to.

The choice is ours.