Open Medicine EU

Like AbbVie, described in my last post, a second American company, InterMune, has taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing.

On 4th March a federal appeals court upheld the conviction of the former chief executive of InterMune, W. Scott Harkonen, relating to the dissemination of false and misleading statements about the results of a clinical trial of the medicine Actimmune. (Mr Harkonen may launch further appeals.)

According to an earlier statement from the FBI:
“Evidence at trial further showed that Harkonen caused InterMune to issue a false and misleading press release publicly announcing the results of a clinical trial of Actimmune for the treatment of IPF on Aug. 28, 2002. Although the clinical trial had failed, InterMune’s press release falsely stated that the results of the clinical trial established that Actimmune helped IPF patients live longer. The headline of the press release read, “InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF,” with the subheading “Reduces Mortality by 70% in Patients with Mild to Moderate Disease.”

In 2006, the company itself had reached a Deferred Prosecution Agreement with the Department of Justice and agreed to paid fines and penalties of $36 million. One clause in the agreement states that it “does not provide any protection to any former employee of InterMune”. Mr Harkonen had left the company in 2003.

Actimmune was promoted as treatment for idiopathic pulmonary fibrosis (IPF), a rare but fatal disease. Treatment cost around $50,000 per annum, generating revenue of over $100 million, mostly for treatment of IPF. (Doctors may prescribe but companies may not promote medicines for uses for which they have not received an authorisation. )

In so far as the offending press release had a basis it seems to have come from the selective use of the data from a clinical trial labelled GIPF-001 – a practice sometimes known as data mining or data dredging. From the beginning, there were some sceptical voices about the company’s claims and in January 2004 an article in the New England Journal of Medicine concluded that Actimmune “did not affect progression-free survival, pulmonary function, or the quality of life”.

Another case for timely and full disclosure.

On the indictment of Mr Harkonen, Intermune issued a press release, of which this is an extract:
“Since 2004, InterMune has been a transformed company with a new management team, a rigorous compliance program and a promising pipeline focused on serious pulmonary and hepatic diseases.”

Still, it’s a pity that the earlier experiences of InterMune and AbbVie/Abbott have not convinced them of the merits of more transparency on the part of the European Medicines Agency… END

Author :