Notice it doesn’t say that the meds were ineffective in their off labelnuses, just that the uses were not government approved.
Need to think about that one.
Glaxo settled without admitting to any wrongdoing to both criminal and civil charges as well as "compensatory" amount to government for their "investigations".
The beneficiaries, outside of DoJ and SAOs, will be 3 (or possibly more) whistleblowers (and their lawyers) who provided the basis for the charges and settlement by filing the lawsuit in 2003 in Boston, under the whistleblower statutes on a qui tam provision on the government behalf under the Federal False Claims Act.
They are former senior management employees of Glaxo, Thomas Gerahty and Mathew Burke; lawyers say that plaintiffs are usually entitled to between 15% and 30% of government's civil suit "recovery" amount.
Let's not forget that doctor have prescribed off-label use of many drugs that were deemed either more effective or cheaper substitute with the same efficacy as the FDA-approved drug for certain diseases.
The most recent highly publicized "controversy" was the use of cancer drug Avastin instead of much more expensive and difficult to obtain Lucentis, for the treatment of wet AMD (age-related macular degeneration) which is the leading cause of blindness, usually in the elderly. Some ophthalmologists even considered Avastin more effective than Lucentis for certain forms of AMD.