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Gathering dust

If being ready for the unexpected is vital, why do companies spend time developing crisis management plans only to ignore them?

An old 'in and out' tray covered in dust on a deskCrises are something no company wants to deal with, the Toyota car recall fiasco being the latest example. They can and do occur in the pharmaceutical sector; in last month's issue, PM recalled how journalists, including myself, had reported on the 'Elephant Man' drugs trial scandal, and how those involved dealt with the huge media interest. 

Four years on, Parexel, the US clinical trial company is still going, declined to comment on the incident, while TeGenero, the German manufacturer of TGN 1412, has long since ceased trading. Northwick Park hospital, the site at which the independent trial unit was based in north London, has admitted it continues to deal with its legacy.

So what have been the long-term implications of the trial, and how would current crisis communications experts have dealt with it?

To recap: Parexel began a Phase I clinical trial in March 2006, where eight volunteers, including two on placebo, were injected at intervals with the trial drug designed to treat leukaemia and chronic inflammatory conditions. By midnight, the six who had received the active drug had been transferred to Northwick Park's intensive care unit, suffering organ failure and swelling. Hours later, newspaper and TV reporters and cameramen were swarming. Investigations, official reports and health updates on the 'guinea pigs' ensured a flow of stories for months. 

It is important not to criticise key players with the benefit of hindsight. Rod Clayton, head of Issues and Crisis at Weber Shandwick, says: "There's always a risk of being presumptuous in second-guessing the decisions that people took in a crisis because one doesn't know the full facts. There could have been very good reasons for some decisions even though on the face of it those reasons are hard to imagine."

Also, this was an extraordinary set of events – the expert report published later called it 'unprecedented'. Even the best communications crisis specialists would have found it a challenge. Claire Eldridge, managing director of healthcare PR firm Aurora says: "Unless you handle crises for a living, this is a once in a lifetime story; the circumstances of this particular crisis are very rare and extraordinary – making it a great news story."

John Clare, who runs LionsDen Communications, and does just that, says: "In 18 years advising pharmaceutical companies through issues and crises around the world, I'd never seen anything like it."

However they and many other crisis communications executives felt that communicating quickly, saying sorry openly and expressing sympathy, was vital, which – significantly – can be done without admitting liability.  

Mr Clare says the aim is to prevent your client becoming the reference point for disaster. "On this occasion the effects were so fast, dramatic and immediately identifiable to the drug that the usual questions re cause and effect and other potential reasons didn't apply. The drug was caught holding the smoking gun, and wild speculation ruled the day."

So what could have been done? "Communicate early, widely and often. I would have advised the various parties to be clear about who had responsibility for what. At the same time rumour and speculation should be managed by using independent third-party experts to quell the wilder stories," he says.

He believes that, as far as Parexel was concerned, a senior spokesman, including the chief executive should have come forward to speak, not just once, but as often as necessary. "Parexel was in a difficult situation re client confidentiality, but there comes a time when you have to defend your own, as far as it is defensible. The CEO should have been on the front foot, expressing sympathy with the victims, not being door stepped on TV news.

"What's needed in these situations is a human face. Lawyers usually advise companies against saying 'sorry' but as communicators we usually say that's a good start. Expressing a human emotion doesn't necessarily mean admitting liability."

Rod Clayton agrees. "Lawyers sometimes object to the notion of taking responsibility, but taking responsibility for fixing a problem goes a long way towards gaining goodwill and understanding, and it is not the same as accepting responsibility for causing the problem. Parexel appears to have made the wrong choice in not communicating and therefore appeared harsh and uncaring."

Eldridge asserts that if Parexel had a tight confidentiality agreement with TeGenero and was not allowed to comment on the trial, 'why not say so?'

Although Northwick Park is still remembered for the case, communcations experts praised its media work. "Northwick Park appears to have been put in the frontline by default and I think that they came out of this quite well because their spokesman actually did his job and talked. The Trust managed to handle a high level of inquiries and address them directly, though as the trial site it inevitably took a hit. TeGenero was probably destined to suffer financially whether it spoke or not," says Clayton. 

 

Tips for managing a crisis

1. Do not say no comment – the less said by those involved, the longer the story will run. Tell the truth, tell as much as you can and tell it quickly
2. The chief executive should apologise and act sympathetically towards patients and their families – which can be done without admitting liability
3. Be transparent – take corrective action and tell people about it. Show people you are remedying the problem and offer a clear outline of everything being done to support any injured/affected people
4. Prepare for the worst case scenario with a crisis plan in place and regularly update it with statistics and hard facts
5. Make sure internal communications are in place to limit damage done by staff blogs and Facebook updates/Twitter and have consistent messages.

 

Having a crisis plan in place was seen as vital, complemented by media training and simulation exercises, and this plan needs to be kept up to date so that statistics and other data are current. Justine McGuinness, an independent issues management expert who runs PCL, says: "Having a dynamic crisis management plan is important. So many companies seem to have a dusty old file that everyone ignores, if they have a plan at all. Yet being ready for the unexpected could be the difference between surviving or seeing your reputation, share price and customers evaporate."

One upshot of the case was that the public became more aware of clinical trials and that people were paid expenses to go on them. Surprisingly, there was a subsequent increase in applications to take part, according to the Medical Research Council. Matt de Gruchy, client services director for Ogilvy Healthworld UK, says he believes Parexel missed a big opportunity to explain the whole clinical trial process.

This is significant as more and more centres are starting to conduct drug trials, throwing up an important need for education and training for doctors and nursed involved, who need to understand informed consent, patient communication, contingency and emergency preparedness, monitoring and protocols. 

He adds: "Patients who take part in clinical research are in some respect "heroes" and a vital part in getting valuable drugs to market. Some positive case studies could have been used, or some statistics, to show how the clinical trial process works. Had the facts of clinical trials been presented in a clear and concise fashion, I think much of the furore could have been avoided."

Certainly companies need to demonstrate that risk to volunteers, although it exists, has been minimised. At the same time, it is important for people to be reminded that safety trials are exactly that. Clayton says: "This isn't a perfected product and that's why it isn't generally available. I suspect that many pharma companies have thought carefully about all the issues raised."

One issue that was not covered but could have been 'severely problematic' was the ethical issue of limited liability towards paid volunteers.

A big difference between handling a crisis in 2006 and 2010 is the developments in digital communications and social media which require new strategies and tactics. Firstly, the speed at which information is needed, thanks to the demands of the internet and online news, has increased dramatically. Some journalists have two-hour turnarounds for writing stories for their newspapers' website.

At the same time sites such as Facebook and Twitter have come into their own, which has an impact on how companies communicate internally in a crisis. If staff are blogging or tweeting about their working day, in a crisis this needs to be managed, as reporters will be using those sites as sources of stories.

Justine McGuinness said strong and speedy internal communications are just as important as talking to journalists. She adds: "With greater use of digital applications such as Twitter and blogs, I think two linked aspects of crisis planning are becoming more pressing; the way information about a crisis is disseminated to employees and deciding how to manage your messages digitally. The sheer scale of online information means you have a clear strategy as to how to, or where, the limits of online engagement for your company lie. It is all part of effectively managing a crisis in a modern media setting."

But even in this brave new digital world, there are some basic principles that never change. As John Clare concludes: "As crisis and communication consultants, we're jugglers, not conjurors. We can't make the problem disappear, or turn back the clock." And that's something all companies need to take on board.

The Author
Jacqui Thorton is a freelance journalist and media trainer who runs Jacqui Thorton Communications

To comment on this article, email pm@pmlive.com

 

1st April 2010

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