Is there a cure for corporate crime in the drug industry?

#MSBlog Pharma behaving badly; when will they learn? We need them to clean up their act!

Yet another Pharma bashing Editorial:

Courtney Davis. Is there a cure for corporate crime in the drug industry? BMJ 2013;346:f755

Some excerpts

…… Nearly 30 years ago, Braithwaite’s Corporate Crime in the Pharmaceutical Industry showed that unethical and corrupt behaviour was endemic in the sector. Sadly, there is growing evidence that little has changed. Recent research suggests that violation of the law continues to be widespread. Most new medicines offer little or no therapeutic advantage over existing products, so promotion plays a huge role in achieving market share. In a crowded and competitive marketplace the temptation for companies to resort to misleading claims is great. According to Gøtzsche (doi:10.1136/bmj.e8462),1 as of July 2012, nine of the 10 largest drug companies were bound by corporate integrity agreements under civil and criminal settlements or judgments in the United States. The corporate activity that has led to recent government investigations has involved unethical and unlawful practices that are well beyond mere administrative offences…..

….. Whistleblowers’ and other “insider” accounts in the US typically include allegations that companies systematically planned complex marketing campaigns to increase drug sales, which involved illegal and fraudulent activities. These included active promotion of off label, or otherwise inappropriate, use of drugs, despite company knowledge that such use could seriously harm patients…..

…. How successful, then, have governments responsible for protecting citizens been in curbing illegal activity ….. ?…..

…. Although stronger sanctions are needed to deter drug companies from wrongdoing, this may be insufficient to protect the public because legal resolution of complex criminal and civil investigations takes years, during which time unethical and illegal behaviour may continue unabated. …..

…. Why have drug regulatory agencies played such a small role in prosecuting large companies given the evidence of extensive illegal activity uncovered in recent cases in the US that were brought by other prosecuting or investigating bodies? The reality is that, with current resources, medicines regulators can police only a fraction of the industry’s ever expanding promotional activities…..

…. There are some signs that change is afoot in the US, with additional funding granted for FDA fraud detection and prosecution alongside other signals from Congress that the agency should increase its enforcement activity. A similar shift in the UK is less likely given successive governments’ determination to “reduce burdens on business.” …

…. Individual instances of corporate malfeasance are indicative of wider systemic problems. Whether companies continue to “get away with it” depends, in part, on whether regulators can develop credible systems of detection, enforcement, and punishment….

“As I have stated before the MS community needs Big Pharma, drug development doesn’t happen outside of Pharma. We are counting on them to address the massive unmet need in MS. It is therefore in our interests for them to clean-up their act. It is clear that self-regulation is not working. Déjà vu? It is no wonder that some people think they have taken over from the Banking sector as being the bad boys, and girls, on the block!” 
Other posts on this topic that may be of interest:
07 Oct 2012
Bad Pharma. “In response to some recent comments on the blog some of you may be encouraged to read Ben Goldacre’s new book, or watch his new TED Talk. We are acutely aware of the issues he raises and these need to 
06 Nov 2012
Good Pharma? For those you following the Good Pharma – Bad Pharma debate may find last week’s BMJ Editorial by Fiona Godlee interesting: Fiona Godlee. Clinical trial data for all drugs in current use. BMJ 2012;345:e7304 
09 Oct 2012
Maybe too busy writing a book about Bad Pharma :-). ReplyDelete. amy Saturday, October 13, 2012 12:40:00 am. Ah… true an fair enough 🙂 I accidentally thought his TEDMed talk was delivered in 2010. Bad Pharma isn’t 
06 Feb 2013
Natalizumab will have one owner; good or bad news?  What’s even more mind-blowing is the evidence of how little lifesaving AIDS drugs actually cost to produce, yet Pharma screws ill people in order to facilitate its greed.
28 Jan 2013
Should Pharma come clean? #MSBlog: Should pharma companies release clinical data to the public?  Multiple Sclerosis Research: CCSVI – Bad Science. 23 Mar 2012  Multiple Sclerosis Research: Good Pharma?
15 Feb 2012
Bad news for Neuroscience R&D. Bad news for neuroscience research as big pharma scale down their research and development activities in this area. Novartis shut brain research facility, Nature 2011; 480:161-162.
18 Jul 2012
In response to an anonymous comment earlier this morning regarding Big Pharma’s massive bribery network. Prog G initially posted  We have replaced the video link with something more helpful in this context; bad science!
19 Mar 2012
 given the extraordinary burdens neurological diseases cause, they must become more of a priority.” “This is very bad news for the field of MS; no R&D means a shrinking pipeline. We rely on Big Pharma to deliver innovative 

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