Dec 022014

The decision by The BMJ to further try to enforce its separation from industry is somewhat at odds with the essentially wholly private sector leadership of pharmaceutical R&D.  The lay perception of the #BMJ might be of a respected medical journal, but in fact it’s a USD120m+ revenue international publishing enterprise with 50+ journals. While potential conflicts of interest are important to consider, assess and account for, to assume that industry connectedness is entirely or even somewhat negative is shortsighted and destructive given the increased complexity of R&D. And The BMJ is part of that same health care industry, happily profiting off its back. To put in place yet more barriers to prevent leading investigators articulating the clinical meaningfulness of their trials is surely counter productive. As they address diseases ever more specifically and in ever smaller more segmented patient cohorts, it seems folly to try to stymie the debate that should ensue from these trials’ findings. The BMJ seems to have overlooked the fact of the multi million dollar business that it has become, that open access is increasingly democratising science, that peer review should be about what you’ve done not who you are, and that Impact Factors aren’t perhaps what they once were.

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.

May 292012

The default challenge tends to be one of two ice-breakers;‘Why China?’, or ‘Why Singapore?’.

Then follows an interesting brainstorm that probably should have happened somewhere back up the road and ends with even less clarity than it started. The key point tends to be a wish to expand to AsiaPac but a stumbling block often manifests in the shape of a lack of definition of this region. Go here for a brief aside on that point. The point is there’s a gut enthusiasm to move into the China market but Singapore is thrown into the mix as an option as the archetypal easy place to do business in Asia which just so happens to also be a thriving biotech hub. But the question is shouldn’t a China entry be founded on more than a gut feel… there’s often a sense that even so long after opening-up a kind of gold fever persists as a feature of foreign direct investment in China. Then again, wouldn’t a successful entrepreneur in a niche professional services field in the pharma sector pay heed to his instincts given the continued double-figure growth rates in China. Especially as so often the motivation is on the back of serendipitous account opportunity with its attendant security of – at least in the short term – likely cashflows.

But still there’s the question, why China – what about India, Brazil, Russia, Turkey, the Middle East, or the still vibrant Southeast Asian markets – all closer to home geographically, economically solid bets and all to greater or lesser degrees far less culturally removed. What is with the often sudden-onset allure of China?

In reality it often tends to be a response to fast-moving events on a key account; client corporate strategic refocusing on China cascades down from the blue to directly impact on the product-market, with implications even for the well-oiled machine that is the global publication planning account. The potential opinion leadership qualities of key Chinese investigators are abruptly realized, the brand director is packed off to Shanghai and before you know it your global capabilities, international KOL-management abilities, global infrastructure and knowledge of Chinese peer-review journals is all coming under scrutiny. This sudden global contraction can expose the agency, and with so many clients’ emerging market strategies still in a state of flux this can create a tension between proven abilities and questions over the ability to step up in the short-term.

So just how much at risk are specialist agencies without a presence in Asia or specifically in China? Here we risk getting into a definitional game of what is a specialist agency, a game in which the big groups’ geographic reach and networks at least on paper you might think hand them a straightforward win. Certainly for a specialist agency servicing ethical pharma with its focus on evidence-based communications, defining and redefining its mission, staying relevant and, just as importantly communicating that relevance, is an ongoing challenge. The current environment is one of unrelenting turbulence caused by the jostling for position and consolidation of competitors, and the ebb and flow of different operating models in the bow waves of big pharma’s never-ending regional restructures. Considering, say, pre-launch key stakeholder below-the-line communications it’s certainly the case that there is considerable clinical trials activity in China but this does not necessarily translate into a need for on-the-ground strategic publications support in China at least immediately. But… by not being there it does provide an open door for the big players. Not that it means they can do your job but clients in China are inclined to value the security of a brand over the unknown. A first step then is clearly to work with your client and make it clear you are prepared to commit but help ease their concerns by demonstrating the short-term lack of impact such a shift is likely to have. A medium-term strategic plan both for the onsite management of the account and for the wider agency business implications is called for.

Following your client and going to China for a share of market per se are clearly very differentiated strategies but it would be a waste not to examine the broader opportunities of expansion given the situation. While the market currently is more traditional above-the-line advertising-dominant, there are – given the Chinese take-up of mobile web and willingness to enthusiastically engage – fast-growing opportunities in digital media and dialogic communications. But even agencies with a relatively well established foothold in Asia can become unnerved by making a definitive shift of focus to China. Inevitably though, just as Europe is not going to be a satisfactory long-term base for servicing your Shanghai clients, neither will clients accept that a regional six-hour flight from Singapore constitutes reasonable locality, however special your specialty.

Next up, how to start up.