Jul 082012

The recent findings against GSK may relate to a previous era of marketing (slightly questionable) but is it right to single the industry out for criticism. However dark this particular episode, was GSK solely culpable and should the industry carry the can for how its products are deployed? It already works within the most rigorous of regulatory constraints and pharma is after all just one point on the healthcare continuum. But media coverage has made little attempt to contextualize its position in the wider healthcare environment. Pharma makes the bullets but the media presents it as pulling the trigger too. For industry insiders the story is hardly news, aside perhaps from the scale of the penalty, and even this had been anticipated. However in trying to consider the episode from the perspective of external stakeholders there are aspects that should concern those who work in, believe in and otherwise see the overwhelmingly positive benefits of the sector.

For a start, how has the role of the doctor been portrayed? It seems to have been pretty much disregarded in this case. Patient-doctor relationships are supposed to be the epitome of trust; doctors have a vocation, the practice of medicine is inherently altruistic. Albeit this altruism pays quite well, very well in the US. Doctors have a pretty complex job and I agree that GSK’s actions here in deliberately misinforming prescribers was destructive and reprehensible. But, GSK didn’t write the Wellbutrin scripts and its hard to see that lessons have been properly learned if other aspects of the path to treatment are ignored.

Since when did doctors become obligated to sales reps? I have no problem with the notion of a sunny weekend’s golf in exchange for having your ear bent for an hour over the latest data. Of course if this data then turns out to be selective, with potentially destructive effects on practice then that’s different and is anyway surely a great way for pharma to go about destroying the very relationships that maintain its viability. But in principle, laying on a round of golf for a doctor as a thankyou for taking time out to listen to the data in his own time doesn’t seem unreasonable. Regardless, the separation of education and promotion has dealt with this aspect. But the fact remains that media sees any interaction of the industry with healthcare as blatant villainousness and as nothing short of buying-off prescribers. What has the AMA had to say about any of this in the last week? It’s been pretty quiet. Does the media really believe that a dodgy detail can subvert the whole prescribing process? If indeed it does, why is it not calling the integrity of the physician into question? And more specifically, what about the top-tier influencers – the key opinion leaders or ‘external experts’, who are viewed by jobbing prescribers as pivotal points of reference. They do have a useful role to play, in essence helping to distil masses of data into digestible and practical treatment algorithms. However, these same opinion leaders who are quite legitimately paid in an advisory capacity during the pre-marketing phase are the same doctors rolled out to give the golf-day lecture. They have been close to the data for a period of time… there is no way that pharma pulled the wool over these guys eyes. They know the data inside out. There’s an unhealthy continuum then with conflict at one end, outright corruption at the other.

And what of the FDA? The personal sales culture was clearly cynical but regulation evidently failed. There has been little criticism of the body yet how long did it take regulators to acknowledge the whistleblowers? And what of other professional groups – the American Psychiatric Association for example – it’s not clear from the media coverage whether the targets of the mis-selling were mainly primary care physicians or specialists, but presumably psychiatrists should have been more wary of the sales bluster behind an antidepressant.

Pharma can be a frustrating industry to be involved with – along with big oil and big banking it provides a soft target. However, more so than the other bigs, ethical pharma, for all its decriers, continues to advance human wellbeing. While pharma’s response has been to take it on the chin,  an understandable commercial desire not to further rock the boat, but this acquiescence and unquestioning culpability hardly does much to provide a foundation for the sector to more assertively position itself in the future; on the contrary it threatens to leave the space uncontested for the usual idealists to promote their pharma-is-evil-all-drugs-should-be-free agenda.

The generalist media while tending not to get too involved in the guts of the case have at least been fairly consistent in acknowledging the industry has moved on. A media-friendly CEO and the essentially historical nature of the case has helped. But again, even this ever-so-slightly positive spin doesn’t do much to dispel the negative image of a profit-hungry industry; a notion promoted by the usual vocal activists who overlook the humanitarian support already extended.

Beyond the doctor’s role another factor not called into question is more reflective of generalised nanny-statism in the West. Go and see a doctor in Beijing and there’s a good chance you will leave the consulting room with enough medication to start a small dispensary. Inappropriate prescribing is hardly the preserve of any particular healthcare system nor can it be ascribed exclusively to pharma’s ropey detailing. Even Hong Kong’s well-regulated healthcare system enjoys a parallel independent pharmacy trade where most anything is available OTC. The point here is about taking a degree of personal responsibility as an Rx end-consumer. The industry and its affiliated marketing and education networks have been engaged from long before the period encompassed by this GSK debacle in making balanced information accessible to consumers and enabling more participative consulting room experiences. Pharma has proactively tried to extend this engagement though social media but ironically, regulators have stymied use of emerging channels by exhibiting the same inertia in drafting web 2.0 usage guidelines as they did in failing to clamp down quickly on GSK’s malfeasance. Intuitively these channels should be the least contentious of any, given their 24-7 global scrutiny.

At heart then is a pretty clear cut issue of big pharma making stuff up. While tighter regulation, full availability of trial results, and public scrutiny in the social media space will mitigate the chances of this happening again there remains plenty of room for other actors in the healthcare space to play their part. Pharma needs to redouble its own efforts to do the obviously right thing and get itself into a position worthy of the ethical tag, a standpoint from where it can then legitimately look to adopt a much more forthright stance in the face of its critics.