New code of honour

The ABPI's revised Code of Conduct means pharma firms that offer hospitality to encourage a drug's uptake can be heavily penalised. David Quainton reveals how PROs can avoid the association's wrath

The pharmaceutical industry is in a quandary. After scandals around drugs such as Vioxx and Seroxat, and as pharma-baiting film The Constant Gardener this week celebrates its Oscars success, drugs firms desperately need to regain public trust.

But promotion of pharmaceuticals is unlike other areas of the PR industry. And some practices that are taken for granted by PROs in other sectors are increasingly seen as potentially damaging to pharma firms. For example, when dealing with matters of health, it is deemed unethical if the judgement of opinion leaders is seen to be clouded by extravagant hospitality.

The ongoing British attempt to move away from shady practices around the marketing of drugs has led to a gradual tightening of the Association of the British Pharmaceutical Industry's Code of Practice. The document, which first landed on PROs' desks in 1993, has undergone its most comprehensive review to date.

The ABPI gets tough
The newest version of the code, which came into effect on 1 January, bids to ensure that pharmas' promotional material and data are 'appropriate, factual, fair and capable of substantiation, and that all other activities are appropriate and reasonable'. In other words, PROs more than ever must scrutinise their own actions.

One consequence of the new code is that relations between pharmas and patient groups will be more closely monitored, while the Champagne soirée to get the ear of a medical professional or journalist is officially dead.

To make matters more difficult for PROs, the ABPI is increasingly keen to ensure its rules are obeyed. Abbott Laboratories was suspended from the ABPI last month for 'flagrant abuse' of the code.
All-expenses-paid trips to greyhound races, Wimbledon's Centre Court and a lap-dancing club were considered, unsurprisingly, to be less than ethical.

Abbott received a six-month suspension of its membership, one of the strongest penalties ever handed out by the ABPI. Coming shortly after the updated rules came into effect, the sanction was a sure sign that the industry's governing body is ready to take its members to task. The most recent companies to be suspended before Abbott were Duphar and Fisons, both 12 years ago.

A further sign of the code's renewed rigour is the ABPI's decision to bring in an agency to promote it. From April, Santé Communications will target the association's members, as well as medics, patient groups and other PR agencies, in a campaign designed to boost awareness of the updated code's implications. According to Santé founder Liz Shanahan, some PROs use the code as an excuse for poor promotional performance. But clear dissemination of the code's messages should prevent this in the future.

And as healthcare PROs will be aware, part of their obligation to abide by the rules includes training - the requirement is for all people affected by the code, including PROs, to receive training on its guidelines.

Opinion is divided on the preparedness of the PR sector to cope with the new code. One senior healthcare PRO suggests the revised rules could hinder PR practice, but Shanahan argues: 'It is not so restrictive that practitioners cannot perform everyday activities.' So which aspects of the guidelines most impact the work of PR people in the pharma arena?

As a way of ensuring the code is adhered to, sanctions have been toughened and companies will now find themselves subject to various penalties much more quickly. These include public reprimands, corrective statements, the APBI enforcing an advertisement of breach of its code, and pre-vetting of advertising and PR activity. The time for appeal has also been shortened.

But the code can only be enforced if healthcare professionals, patients and journalists understand when it is being flouted. The Medicine and Healthcare products Regulatory Agency has rolled out a yellow card scheme, designed to allow patients to report any unpleasant side effects of a drug.

After a pilot in January 2005, the scheme was made national in October last year. It is the sort of openness that the pharma industry seems keen to foster, and the scheme is widely supported.

The ABPI's tactic is different to its government agency counterpart. Having brought in Santé, the trade body hopes to improve practice by targeting healthcare professionals first and patient groups second.

But what about the journalists with experience of less scrutinised sectors, who have perhaps become used to staying in five-star hotels at the expense of a company? What happens when they move to a healthcare magazine and are taken on a first-class trip to Moscow? Will they report a practice that to them seems normal?

'It's an area we will have to consider looking at,' admits ABPI head of public affairs Heather Simmons.

The broader message from the pharmaceutical industry is that the code itself is not enough to change perceptions - that the image of a tarnished industry can only be recovered by transparency and ethical practice. Perhaps in recognition of this, many major pharmas have taken matters into their own hands by putting their drugs' trial data, good or bad, onto the internet.

The role of the PRO is not only to support the client's interpretation of the code but to reinforce the importance of the code to those clients that may not understand its implications.

This may be less of a problem at global pharma firms, which tend to have a sophisticated approach to best practice, but could be more of an issue for smaller companies, or those entering the UK market for
the first time.

Robust counsel
'Agencies and individuals should not be complacent about the recent updates to the code,' says Just Health PR co-founder Emma Crozier. 'We have an obligation to our clients to provide strong counsel that reflects the most up-to-date guidance.'

Some PROs will inevitably push at the boundaries of the code, and some may be found in breach. It is the effectiveness of the reporting of these incidents and the subsequent action taken that will determine the code's success in regulating the industry more effectively.

'The code's true parameters will be decided by the actions of those the ABPI believes to have gone too far,' says Ozone director Andrew Knill.

It is important to note that while Abbott's suspension was implemented last month, the case concerned a breach of the code before its January update. Perhaps Abbott's representatives thought they could get away with taking doctors to a strip club - there had, after all, not been any punitive action from the association for many years.

The new rules are only the first step on the road to rehabilitation for the pharma sector. Now its practitioners must respond if they are to make the case for greater probity and win back public confidence. 'The industry is making great strides to recover lost ground,' says Lilly UK communications manager Dominic Wake. 'But however tough the code is, it is by our own behaviour that we will be judged.'

Pharma under fire
* Anti-depressant Seroxat caused widespread concern when studies suggested it raised the risk of suicide in some patients. Despite GlaxoSmithKline's defence of its product, a 'wrongful death' suit was filed against it in June 2001 by the surviving family of Donald Schell, who killed his wife, daughter and granddaughter while on the drug (they settled out of court).

* In 2002 the Journal of the American Medical Association published a report from five Harvard Medical School physicians suggesting adverse reactions to drugs could be 'a leading cause of death in the US'. They advised using older therapies, known to be safe, over new varieties. 

* In the same year, newspapers suggested scientists were accepting large sums of money to endorse medicines through ghost-written articles. Cardiology and psychiatry were singled out as areas in which busy doctors were putting their name to articles they may not have read properly.

* In September 2004, Merck & Co was knocked for six by the wholesale withdrawal of arthritis drug Vioxx. The blockbuster was found to double the risk of heart attack and stroke, and constituted the biggest-ever pharma withdrawal. Vowing to fight all lawsuits, Merck's record so far is won three, lost one.

* In 2004, New York attorney general Eliot Spitzer began civil proceedings against GSK for suppression of studies on Seroxat, known as Paxil in the US. The company responded by publishing all five of the documents in question.

* In June 2005 the Medicine and Healthcare products Regulatory Agency admitted that it misled the public over support to allow statins, a group of heart drugs, over the counter. It had claimed that two thirds of those consulted had supported giving OTC status to statins. The government agency later revealed that only a third had backed the change, and apologised for the mistake.

* Hollywood is the latest player to take a swing at the industry.
The Constant Gardener (pictured), an adaptation of John le Carré's novel about pharma malpractice in Kenya, has done little to encourage the notion of a clean and open industry.

Relations with patient groups
'Pharmaceutical companies can interact with patient or user organisations, such as disability, carer or relative organisations - as well as consumer groups - to support their work. This includes assistance in the provision of appropriate information to the public, patients and carers.' ABPI Code of Conduct

The revision of the ABPI's code, although broadly more restrictive, does not just a provide a set of obstacles to PROs. In fact, the updated guidelines for the first time give their blessing to the co-operation of pharmas and patient groups. This means PROs can target these groups and foster relationships with them in order to promote their company or client. But, of course, there are caveats.

'If you're giving money to patient groups you have to be open about it and that should be on paper and a website,' says Lilly UK comms manager Dominic Wake. 'And planning should be clear and accountable.'

The key to fostering relationships with patient groups, Wake says, is to get written agreements between the parties about the nature of the relationship and what they hope to achieve from it.

Just Health PR co-founder Emma Crozier has had success working with patient groups in the areas of asthma, attention deficit hyperactivity disorder (ADHD) and cholesterol management. She says the collaborations succeeded because all sides stood to benefit and ground rules were set out early on.

'While the updated code provides some guidance, PROs need to take responsibility for ensuring that each individual industry/advocacy partnership operates to reflect values inherent in the code,' she says.

Mutual benefits
In layman's terms this means that relationships must be formed on honest grounds. While there may be a temptation to sweeten a potential partner, the code looks for transparency and balance. If the only benefit for the patient group is funding rather than education, for example, then it is unlikely to be viewed favourably by the ABPI.

Crozier says a 'working charter' drawn up early in the relationship with contribution from both sides satisfies the ABPI. 'You need a clear goal in mind,' she says. 'For example, reducing the stigma around adult ADHD.'

But interaction with patient groups does not have to eschew the needs of the client. 'You are allowed to promote a drug to a patient group as long as there is balance,' says ABPI director of public affairs Heather Simmons.

'It's the same with all parts of the code. If you show the bigger picture rather than focus on your own interests then it is seen to be fair,' she explains.

Training requirements/warnings
'Companies must ensure that all relevant personnel are appropriately trained in the requirements of the code and must have robust operating procedures... Information and claims about side effects must reflect available evidence or be capable of substantiation by clinical experience.' ABPI Code of Conduct Companies signed up to the ABPI have always had to ensure staff competency. However, the revised code expands the training requirement to all people who are engaged in contracts with pharmaceuticals - including PROs. The ABPI has its own training scheme which, inevitably, it suggests would be helpful for PROs to attend.

Although in-house training is deemed just as effective, this does not mean training can be taken lightly.

'At Lilly we're planning to train all agencies in-house,' says Lilly UK comms manager Dominic Wake. 'Lilly's internal guidelines, as at many pharmas, are even stricter than the ABPI's.'

The feeling among Big Pharma, which has seen investor confidence dwindle in the past five years, is that the code is a minimum requirement, and in-house rules are often more prescriptive.

According to Nexus Communications associate director of healthcare Caroline Lynch, greater training could have a wider impact: 'The level of knowledge and training required to be good at the job could result in more specialist agencies, rather than general PR agencies that happen to do some pharmaceutical business,' she argues.

In terms of stating side effects, the code is open to interpretation. Although there is no requirement for side effects of medicines to appear on all PR material, many PROs feel it is good practice to highlight them. But practitioners should beware of good-practice overkill.

'PR material needs to be balanced,' says ABPI director of public affairs Heather Simmons. 'That can mean side effects, but it does not have to. There is no general requirement.'

Negative indications
According to Simmons, the level of negative information required on PR material depends on the story being told. When talking about an older drug, such as aspirin or penicillin, it is not necessary to hamper promotional text with side effects that are well known.

According to some PROs it is smaller firms that will have to pay most attention to the code. Rules such as restrictions on the words 'safe', 'safety' and 'proven safety' are easy to forget when compiling a press release.

And PROs will also have to rein in superlatives when trying to describe a client's latest product. The message from the code is to make information educational and trustworthy.

Hospitality events
'The provision of hospitality is limited to refreshments/ subsistence, accommodation, genuine registration fees and the payment of reasonable travel costs which a company may provide to sponsor a delegate to a meeting.' ABPI Code of Conduct

When Abbott Laboratories staff paid a visit to a lap-dancing club they probably knew they were stretching the rules of the code. As well as this incident, which led to its suspension from the ABPI, two further complaints were heard and one was upheld - concerning two Abbott managers arriving late, and more than a little tipsy, at a party for hospital staff paid for by the company.

This is just the sort of activity that the pharmaceutical industry has been desperate to distance itself from. As a result, the most marked and prescriptive section of the revised code is the area on meetings and hospitality. Whereas the code was tight before, it is now positively draconian. It leaves no doubt that meetings between pharma reps and doctors or journalists are only allowed in the interest of education.

This means economy-class travel, that venues must be appropriate to the purpose of the meeting and that only two-star accommodation is suitable for overnight stays. Moreover, 'spouses and other accompanying persons' must pay for themselves and are not allowed to be present at meetings.

Many healthcare professionals suggest such lavish meetings were a thing of the past anyway, but some -off the record - claim generous hospitality still exists within the sector. 'It's unreasonable to assume it doesn't happen, though some will contend it doesn't,' says one senior healthcare professional.

'I hear about it quite a lot,' says another. 'Sometimes it can even influence awards, and there have been conferences in far-flung destinations that can hardly be called educational.'

Under the code there is no excuse for such trips. 'Whereas journalists may have previously been an exception to the rule, they are now recognised as an audience,' says Lilly UK comms manager Dominic Wake. 'They won't be taken to hotels that just happen to have golf courses attached.'

Caroline Lynch, Nexus Communications associate director of healthcare, says it is difficult to get round these restrictions safely, although it is possible to 'schmooze' and still tick all the ABPI boxes. 'For example, educational seminars can have quizzes,' she explains. 'Doctors do not want to be bored, and games will help. There are ways to engage without breaking the rules.'

ABPI director of public affairs Heather Simmons says the old code allowed for some bending of the rules. If a doctor specifically asked for first-class rail or air tickets back then, the firm in question would not have attracted the attention of the ABPI. Now there are no excuses.

Travel restrictions
'There has to be a valid reason for all expenses,' Simmons says. 'If there is travel outside of the UK then it has to be justified. If the meeting can take place over here, it should do so.'

That said, there are likely to be a number of medical professionals who expect first-class travel to an event, even if they might not want to go at all. This means the onus is well and truly on PROs to make sure their delegates are aware of the restrictive nature of the code.

Simmons reveals that  the new rules move the UK in line with Scandinavia, Germany and the US, where tight regulation has been in place for a number of years. In the UK there has been a general move towards greater self-regulation, partly inspired by the conclusions of the Government's Health Select Committee report last year (on The Influence of the Pharmaceutical Industry). The ABPI, for instance, is a trade body, not a government organisation.

'I don't think there were thousands of unjustified trips,' says Simmons. 'But there's no room for doubt now. The revised code shows Britain's pharmaceutical industry is taking self-regulation seriously.'

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