Swiss biotechnology company Serono has been reprimanded by the Association of the British Pharmaceutical Industry for offering what amounted to financial inducements to doctors to prescribe its multiple sclerosis drug Rebif in an observational study.
Last week, the ABPI upheld a complaint filed by rival company Schering Healthcare which claimed that the study, referred to by Serono as a clinical audit, was in fact clinical research and so subject to clauses in the industry’s recently-updated Code of Practice that prohibit offering financial rewards to doctors as ‘disguised promotion’.
The ABPI said it was clear that the project was not a clinical audit, because there was no attempt made to examine clinical practice and compare it with treatment guidelines.
Serono has held its hands up to the ruling, and a spokeswoman said there was no intention to break the Code of Practice, although the firm accepts that it was breached.
Part of the problem, said Serono, is that the legal and regulatory requirements for clinical trials vary from one country to another, and this can make it hard to establish an overall line of conduct.
The reprimand referred specifically to a project called: Clinical Practice Audit: Outcome of high dose interferon therapy following dose escalation from lower dose therapy.
In the study, neurologists were encouraged to switch patients who were still showing signs of MS progression on ‘low-dose’ therapy with either Rebif (interferon beta-1a) or two competing products – Schering’s Betaferon (interferon beta-1b) or Biogen Idec’s Avonex (interferon beta-1a) – in return for a £700 fee.
Schering had complained about the protocol’s referral to Betaferon as a ‘low-dose’ product, and also that the fee paid to doctors per patients for administrative costs – 1,000 euros or sterling equivalent – was inappropriately high and amounted to paying the doctors to prescribe Rebif.
As a result of the case, Serono's UK arm has launched an internal probe and implemented new compliance protocols to ensure it does not happen again, said the spokeswoman.
Meanwhile, company staff are receiving training and senior managers will have their job descriptions altered to make it clear that compliance with the Code of Practice is mandatory.
Swedish trial also probed
Meanwhile, Serono has also fallen foul of the Swedish Association of the Pharmaceutical Industry, the LIF, for allegedly paying an unreasonably large fee to a doctor involved in a clinical trial of its Raptiva (efalizumab) treatment for psoriasis.
The doctor was reportedly paid 2.4 million Swedish kronor ($327,000) for treatment of 60 patients, prescribing around half the country’s total number of Raptiva prescriptions in the first quarter of 2006.
In a statement issued on June 7, the LIF said the case, highlighted in Swedish newspaper Sydsvenska Dagbladet, was in breach of its guidelines for clinical studies not only because of the level of remuneration, but also because it had not been referred to the regional ethics committee and there was no written agreement between the company and the local health authority.
Serono is now under investigation by Swedish prosecutors over the case, according to the LIF, whose director general Richard Bergstrom said in a statement that “the case highlighted in ... Sydsvenska Dagbladet is totally unacceptable. LIF clearly and unequivocally distances itself from the actions by the company.”
Serono’s spokeswoman said the company was unable to comment on the case, other than to say that the company was cooperating with the investigation.