Two American pharmaceutical companies, AbbVie and Intermune, have taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing.
In my opinion, both companies have been involved in activities that seem to prove the need for more transparency and not less.
AbbVie is a new company founded to carry on the work of most of the former medicines division of Abbott Laboratories. This was not a third party takeover, but a split of one company into two separate entities. AbbVie is basically the old medicines division of Abbott and therefore inherited the Corporate Integrity Agreement signed between Abbott and the US Government last October.
In October 2012, Abbott was required to pay $1.5 billion in criminal fines and civil settlements for promoting a medicine, Depakote, to treat dementia and schizophrenia. The medicine was not authorised for these indications.
According to the US Dept of Justice:
“Abbott has pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved. In an agreed statement of facts filed in the criminal action, Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use. In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use”.
According to the Agreed Statementof Facts, Abbott delayed for years in disclosing the full results of clinical trials showing that Depakote was no more effective than a placebo, and aggressively promoted Depakote through its sales force, special “educational” material, speakers fees, and selective use of study results.
For schizophrenia, Abbott submitted to the FDA in January 2002 the results of a trial described as “negative” by the company itself. (This was a trial of Depakote combined with another medicine.) Patients showed some improvement up to 21 days, but not up to 28 days – the primary “endpoint” of the study. However, Abbott used the 21 day results, the “secondary endpoints to promote Depakote to health care providers as a treatment for schizophrenia” at least up to 2006. The promotion was expensive and intensive and is described in the Agreed Statement.
Abbott carried out a second study on Depakote and had concluded by January 2005 that the results were negative. However, they continued for a very long time to use the first study in their promotion and did not disclose, even to their own reps, the results of the second study. In August 2006 they published a synopsis of the second study, which spoke of the Depakote combination as being “well tolerated”. It did not mention that patients treated with Depakote were more than twice as likely to suffer from “somnolence” than those treated with the alternative.
If the company had made a full and timely disclosure of their clinical trial results in this case they could not have continued to misbrand this medicine for as long as they did.
I will say something, also interesting, about the other company, InterMune, in a later post. ENDAuthor : Jim Murray