Small pharma, small problems?

In any media demonisation of the KOL-industry relationship, the emphasis is upon 'Big Pharma'. Somehow smaller companies, 'Little Pharma' if you will, slip through under the radar. As a counterpoint to David Gillen's testament, Malcolm Allison, Head of Strategic Marketing at Actelion opened the door on a more Lilliputian pharmaceutical world.

Allison outlined the history of the company from modest beginnings with an orphan Roche drug for pulmonary artery hypertension (PAH), a rare condition most commonly diagnosed at post mortem. Over 10 years they have grown to 2000 people. 'We are the third largest pharmaceutical company in Basel' Allison laughed, acknowledging that Roche and Novartis were numbers 1 and 2.

The rarity and severity of PAH pose unusual problems. There are few patients, they are commonly misdiagnosed and the condition is rapidly fatal. This poses unique problems for a company with a drug for this condition. How can one reach the patients? As expected KOLs play a vital role but in a way quite different from most conditions. Rather than pick and choose from a long list of suitable KOLs, Actelion engaged with all the KOLs worldwide. All 4 of them.

Not surprisingly, the relationship between these KOLs and the company is very close. 'These people are our friends' says Allison. The KOLs conduct clinical trials, and have helped build reference and referral centres. Whilst the relationship might seem cosy to the outsider, Allison is forthright in its defence. 'How could we possibly have done anything differently? There are people alive today who wouldn't be if we had not gone that way'.

Nonetheless, as the company expands, Allison recognises that the company needs to respond to the call for regularisation of relations and applauds the steps that Pfizer and Lilly have taken in compliance. Allison sounds a warning bell that, in a small field such as PAH, enforcing a more distant KOL-industry relationship may actually be detrimental to patient care.

The key is documentation and audit. Despite its modest size, Allison acknowledges that the rules are the same as for the pharmaceutical giants. Actelion is developing an in-house tracking system that will allow all aspects of the relations to be monitored transparently. Transparency - that word again.